YEAR IN CARDIOLOGY SERIES
The Year in Interventional Cardiology
Simon R. Dixon, MB, ChB*,*,
Cindy L. Grines, MD* and
William W. O'Neill, MD
* William Beaumont Hospital, Royal Oak, Michigan
University of Miami, Miami, Florida
Manuscript received February 7, 2009;
accepted February 18, 2009.
* Reprint requests and correspondence: Dr. Simon R. Dixon, Department of Cardiovascular Medicine, William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, Michigan 48073 (Email: sdixon{at}beaumont.edu).
Key Words: interventional • cardiology 2008 • review
We are honored to provide readers of the Journal with this review of major scientific work published in the field of interventional cardiology in 2008. In addition, we have included late-breaking trials presented at the American College of Cardiology (ACC), Transcatheter Cardiovascular Therapeutics, and American Heart Association (AHA) conferences. We hope that this report will provide a broad overview of the field for general cardiologists, as well as a framework for more detailed study for those with a specific interest in interventional cardiology.
 |
Percutaneous Coronary Intervention (PCI) Guideline Update
|
|---|
An update of the ACC/AHA/Society for Cardiac Angiography and Interventions 2005 Guideline Update for PCI was published early in 2008 (1). This focused update provides revisions to existing guideline recommendations based on new clinical trial data and opinion in this rapidly evolving field. The document highlights certain key areas, including unstable angina/non–ST-segment elevation myocardial infarction (NSTEMI), facilitated PCI, rescue PCI, PCI after fibrinolysis, ancillary therapy for ST-segment elevation myocardial infarction (STEMI), antiplatelet therapy, bare-metal stents (BMS) and drug-eluting stents (DES), and finally, secondary prevention. Full review of the updated guideline recommendations is beyond the scope of this article. Careful reading of this document is essential for all those involved in the practice of interventional cardiology.
|
Acute Myocardial Infarction (AMI)
|
|---|
STEMI update.
The ACC/AHA STEMI guidelines were revised and published as a focused update in 2008 (2). Essential changes in the guidelines include: 1) emphasis on pre-hospital electrocardiography and transport of STEMI patients directly to a PCI facility (bypassing hospitals that are not PCI capable); 2) facilitated PCI with full-dose thrombolytic agents may be harmful (Class IIIb); 3) clopidogrel should be added to aspirin in STEMI patients regardless of reperfusion status (Class Ia) and long-term maintenance (e.g., 1 year) is reasonable (Class IIa, Level of Evidence: C); 4) intravenous beta-blockers should not be given to STEMI patients with signs of congestive heart failure (CHF) or low cardiac output (Class IIIa); 5) nonsteroidal anti-inflammatory drugs (except for aspirin) should not be given (Class IIIc); and 6) routine coronary angiography may be considered after thrombolytic therapy in patients not receiving reperfusion therapy (Class IIb) with PCI of a hemodynamically significant stenosis in a patent vessel (Class IIb). However, late PCI of a totally occluded infarct artery is not recommended in asymptomatic patients who are hemodynamically and electrically stable and do not have ischemia. Stone (3,4) provided an excellent 2-part review article on primary angioplasty.
Regional care systems.
Several groups reported findings after development of regional systems for STEMI care. Le May et al. (5) reported that acceptable door-to-balloon times are more often achieved when paramedics triage and transport STEMI patients directly to a PCI center compared with patient referral from the emergency department. Aguirre et al. (6), Flesch et al. (7), and Holmes et al. (8) showed that timely mechanical reperfusion can be achieved for patients initially presenting to a non-PCI center, with well-organized transfer protocols and coordinated systems of care.
Time to treatment.
Excessive delay to primary PCI continues to be an issue, especially when the patient presents to a non-PCI facility. The National Cardiovascular Data Registry (NCDR) (9) reported that 15,049 patients at 491 hospitals underwent primary PCI after being transferred from a non-PCI facility between 2005 and 2006 (the median door-to-balloon time was 152 min (door-to-door: 109 min and PCI hospital door-to-balloon: 38 min). Although the delay was shortened compared with earlier years (180 min), there remains room for improvement. The Get With the Guidelines database (10) reported 62,814 AMI patients, of whom 5,649 arrived during off hours (nights, weekends, and holidays). Although off-hour patients had longer door-to-balloon times (110 min vs. 85 min, p < 0.001), no measurable differences were found in mortality.
Quality of care.
Two important ACC/AHA reports on performance measures for patients with STEMI and NSTEMI were published in 2008 (11,12). These documents are an update of the ACC/AHA report on performance measures in 2006. Key changes include: deletion of beta-blocker on arrival, revision of 9 measures, and addition of 4 new measures, including evaluation of left ventricular (LV) systolic function, time to transfer and time to PCI for STEMI patients presenting initially to a facility without PCI, and inpatient referral for cardiac rehabilitation. The second article focuses on measurement of time to reperfusion, and provides clarification on specific inclusions and exclusions for this measure, as well as the time point when reperfusion is achieved. Readers are encouraged to examine these documents for more detail.
In other articles, Glaser et al. (13) examined factors contributing to the worse prognosis of STEMI patients presenting during off hours, and found that this seemed to be related to both diurnal differences in patient and lesion characteristics (e.g., more shock and multivessel disease), as well as increased risk of procedural complications (13). Lev et al. (14) compared the predictive value of 4 different risk scores and found that the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications), Thrombolysis In Myocardial Infarction, and PAMI (Primary Angioplasty in Myocardial Infarction) risk scores all had a high predictive accuracy for 30-day and 1-year mortality; however, the Global Registry of Acute Coronary Events risk score had a low predictive value for outcomes.
PCI after thrombolysis.
The CARESS in AMI (Combined Abciximab Retaplase Stent Study in Acute Myocardial Infarction) trial (7) treated 600 STEMI patients <75 years of age with half-dose retaplase, abciximab, aspirin, and heparin, then randomized to immediate transfer for PCI versus transfer only for rescue PCI (persistent ST-segment elevation) (15). The combined end point of death, myocardial infarction (MI), or refractory ischemia was improved in the immediate PCI group (4.4% vs. 10.7%, p = 0.004); however, bleeding was increased. In a large French registry, early PCI after full-dose thrombolysis was associated with similar 1-year survival to primary PCI alone (16).
Facilitated PCI.
Although facilitated PCI with full-dose thrombolytic agents was found to be harmful, Denktas et al. (17) found that facilitation with reduced-dose thrombolytic agents was safe and effective in a nonrandomized observational experience. A large randomized trial comparing half-dose retaplase plus abciximab had improved ST-segment resolution but no improvement in clinical outcomes to primary PCI (18). Several randomized trials investigated the use of glycoprotein (GP) IIb/IIIa agents for facilitated PCI. Consistently, there was no improvement over primary PCI in randomized comparisons with pre-hospital eptifibatide (19), tirofiban (20), or abciximab (18). These data confirm previous reports that primary PCI without facilitation is the strategy of choice.
GP IIb/IIIa inhibitors.
A previous meta-analysis suggested improved mortality using abciximab during primary PCI. The FATA (Facilitated Angioplasty with Tirofiban or Abciximab) trial randomized 738 patients to abciximab versus tirofiban and found better ST-segment resolution in the abciximab group (21). Although abciximab has been shown to reduce stent thrombosis and acute ischemia, a randomized trial of 800 primary PCI patients found no improvement in infarct size with abciximab compared with placebo (22). In another randomized trial, intracoronary abciximab bolus (followed by 12-h intravenous infusion) was superior to intravenous bolus and infusion at improving perfusion and reducing infarct size after primary PCI (23).
Although STEMI studies showing the benefits of GP IIb/IIIa agents have used abciximab, eptifibatide is used more frequently because of cost concerns. In a retrospective analysis of 3,541 STEMI patients undergoing primary PCI use of eptifibatide (n = 2,812) compared with abciximab (n = 729) resulted in similar rates of in-hospital death, MI, or stroke (24). In a retrospective analysis of patients receiving bolus only (n = 1,565) compared with bolus plus infusion (n = 1,064) of GP IIb/IIIa showed similar ischemic outcomes, but reduced bleeding and cost compared with the bolus-only strategy (25).
Bivalirudin.
Bivalirudin was found to be superior to heparin (either enoxaparin or unfractionated heparin [UFH]) plus GP IIb/IIIa agents in the HORIZONS AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial. Despite an increased risk of acute stent thrombosis with bivalirudin, bleeding and clinical outcomes were improved at 1 month (26) and remained significant at 1 year.
DES.
Several registries of DES for AMI found clinical event rates that were similar to (27) or superior to those for BMS (28–31). An editorial suggested a need for better large randomized trials and longer follow-up to address late stent thrombosis and poor patient compliance with medication (32).
Kelbæk et al. (33) randomized 625 STEMI patients to DES versus BMS. At 8 months, angiographic restenosis and target lesion revascularization (TLR) were improved with DES; however, there was a trend for higher mortality. Van der Hoeven et al. (34) found that sirolimus-eluting stents (SES) reduced angiographic restenosis and TLR but were associated with a higher incidence of late stent malapposition. Valgimigli et al. (35) randomized 745 STEMI patients to SES versus BMS and found reduced major adverse cardiac events (MACE) at 8 months. The HORIZONS AMI trial randomized 3,006 patients to paclitaxel-eluting stents (PES) versus BMS; PES was superior at reduction in angiographic restenosis and TLR at 1 year (4.5% vs. 7.5%, p = 0.002) with similar rates of stent thrombosis, MI, and death (36). Lee (37) randomized 328 STEMI patients to zotarolimus-eluting stent (ZES), SES, or PES. Angiographic restenosis was significantly lower with SES compared with other DES; however, clinical outcomes were similar. These data add to the evidence that DES reduce target vessel revascularization (TVR) after primary PCI, and in the short term, seem to be safe.
Late reperfusion.
There is still controversy about the role of PCI in patients presenting late after the onset of AMI (>12 h). Abbate et al. (38) performed a meta-analysis of 3,560 patients undergoing PCI versus medical therapy alone. Late PCI (median 12 days) was associated with a significant improvement in survival (mortality 6.3% vs. 8.4%, odds ratio [OR]: 0.49, p = 0.03) and favorable effect on ventricular function and remodeling. In contrast, the OAT (Occluded Artery Trial) investigators (39) found no benefit of late reperfusion for persistent infarct artery occlusion in stable patients 3 to 28 days after MI.
Distal embolization.
Distal embolization is common during infarct angioplasty. Using a Doppler guidewire, Okamura et al. (40) showed that embolization occurs most frequently after stenting, followed by first balloon inflation. Until now, however, most studies have shown little or no benefit of routine thrombectomy in AMI. In the largest trial to date, Svilaas et al. (41) randomized 1,071 AMI patients to adjunctive thrombus aspiration with the 6-F Export catheter (Medtronic, Minneapolis, Minnesota) versus conventional PCI. Thrombus aspiration was associated with a significant improvement in myocardial blush and ST-segment resolution. At 1 year, the thrombus-aspiration group also had a lower incidence of death or re-infarction (42). In another smaller randomized trial, VAMPIRE (VAcuuM asPIration thrombus REmoval), thrombus aspiration was also associated with an improved rate of myocardial blush grade 3, and lower MACE rate at 8 months (43). Vlaar et al. (44) also compared the effectiveness of 2 aspiration catheters (Diver [Invatec, Roncadelle, Italy] versus Export [Medtronic]) and found no difference in size distribution of retrieved thrombotic particles with either device.
A small randomized trial evaluating use of embolic protection showed improved ST-segment resolution in patients treated with a proximal occlusion device (45). In contrast, Kelbæk et al. (46). found no benefit of distal embolic protection with the FilterWire device (Boston Scientific, Santa Clara, California). Dangas et al. (47) also reported that distal protection does not seem to be beneficial in rescue PCI. Finally, Kramer et al. (48) performed histological analysis of aspirated material in 1,315 AMI patients, and found that older thrombus (>1 day) was an independent predictor of long-term mortality.
Adjunctive therapies.
Several studies in 2008 investigated novel pharmacologic or mechanical adjuncts to limit myocardial injury in AMI. In a small pilot trial, 58 patients were randomized to receive intravenous cyclosporine or saline immediately before PCI. Infarct size, measured by release of creatine kinase, troponin I, and magnetic resonance imaging in a subgroup, was significantly smaller in patients who received cyclosporine (49). In another trial, intracoronary KAI-9803 in anterior MI patients with total occlusion of the left anterior descending artery (LAD) led to favorable improvements in ST-segment resolution, creatine kinase release kinetics, myocardial perfusion grade, and infarct size (50). Ishii et al. (51) provided a review article summarizing the role of various other pharmacologic adjuncts to reperfusion therapy, including adenosine, atrial natriuretic peptide, nicorandil, and statins. Left ventricular unloading seems to be another promising strategy for reducing infarct size. Sjauw et al. (52) studied the effect of unloading with the Impella 2.5 (Abiomed, Danvers, Massachusetts) percutaneous LV assist device in nonshock anterior AMI. Patients treated with the Impella 2.5 device had a greater improvement in LV ejection fraction at 4 months compared with a control group.
Cardiogenic shock.
Seyfarth et al. (53) reported results of a small randomized trial evaluating the Impella 2.5 device in cardiogenic shock. Compared with intra-aortic balloon pump, patients treated with the Impella 2.5 device had a higher cardiac index and less lactic acidosis. An interesting report from Apolito et al. (54) suggests that public reporting of outcome data may deter physicians from providing revascularization to shock patients. In this analysis, New York patients were less likely to receive angiography or PCI, and also waited significantly longer to receive a coronary artery bypass graft (CABG) than non-New York patients with shock. Reynolds et al. (55) provided a comprehensive review article of etiology, pathophysiology, and contemporary treatment of cardiogenic shock complicating AMI.
Cell therapy.
Two meta-analyses examined the concept of stem cell therapy after AMI. Zohlnhöfer et al. (56) reported 10 trials that randomized 445 patients to control versus granulocyte colony stimulating factor to augment the number of circulating stem cells after AMI. There was no significant difference in infarct size and ejection fraction between the treatment groups. Conversely, selective infusion of stem cells into the infarct artery resulted in improved ejection fraction and reduced infarct size in a meta-analysis of 13 trials and 811 patients (57).
|
Acute Coronary Syndromes (ACS)
|
|---|
Steg et al. (58) studied outcomes in patients with NSTEMI and CHF in the Global Registry of Acute Coronary Events. Patients with CHF were less likely to undergo revascularization than those without CHF. After adjustment for differences in baseline risk, revascularized patients had lower 6-month mortality, suggesting that broader use of PCI in these high-risk patients may be beneficial. Ndrepepa et al. (59) reported 1-year outcomes of the ISAR-REACT 2 (Intracoronary Stenting and Antithrombotic Regimen–Rapid Early Action for Coronary Treatment 2) randomized trial. In high-risk patients with NSTEMI undergoing PCI after pre-treatment with 600 mg clopidogrel, adverse events occurred less frequently with abciximab. Mehta (60) presented results of a randomized trial of an early (within 24 h of symptom onset) versus delayed (>36 h) invasive strategy in high-risk ACS patients. The early strategy did not reduce the incidence of the composite end point of death, MI, or stroke at 6 months; however, there was a reduction in the incidence of refractory ischemia in the early invasive arm.
|
Elective PCI
|
|---|
Left main disease.
Current American and European guidelines recommend CABG for unprotected left main (ULM) disease, with PCI reserved only for patients who are high risk, inoperable, or refuse surgery. Taggart et al. (61) summarized the surgical consensus, namely that CABG is proven therapy, and that PCI has limited value and may even be inferior to medical therapy for patients not suitable for surgery. Teirstein (62) provided a more balanced overview, and pointed out that numerous unanswered questions remain before routine PCI of ULM disease can be recommended.
In 2008, a number of registries and randomized trials began to provide clarity on the role of ULM PCI. Biondi-Zoccai et al. (63) performed a meta-analysis of 16 studies of DES implantation for ULM disease. Among 1,278 patients treated with a DES, in-hospital and 6-month mortality were 2.3% and 5.5%, respectively. The MACE and TVR rates were significantly lower in ostial and shaft lesions versus distal bifurcation disease. The rate of MACE was lower for DES compared with BMS, driven mainly by a lower rate of restenosis and TVR. The DELFT (Drug Eluting stent for LeFT main) registry (64) reported outcomes for 358 consecutive patients with ULM disease. Procedural success was 89.6%, and in-hospital mortality was 3%. Overall 3-year mortality was 9.2%.
The optimal technical approach to distal left main stenting is unclear. Palmerini et al. (65) provided data from a large, multicenter Italian registry in which 773 patients underwent PCI for distal left main disease (1 stent in 456 patients, 2 stents in 317). The adjusted 2-year survival was significantly better for the single- versus 2-stent strategy. When 2 stents were used, there was no difference between crush versus T-stent versus culotte techniques. Thus, like other bifurcation disease, distal left main disease should be treated with single stent implantation if technically possible.
Mehilli (66) presented results of a randomized trial of SES versus PES in 607 low-risk patients with ULM disease (ISAR-LEFT MAIN [Intracoronary Stenting and Angiograpic Results: Drug Eluting Stents for Unprotected Coronary Left Main Lesions]). The primary end point, 1-year MACE, was similar between SES- and PES-treated patients (15.8% vs. 13.6%). Angiographic restenosis was also similar (19.4% vs. 16.0%).
Several nonrandomized comparisons of PCI versus CABG for ULM disease were published in 2008. Seung et al. (67) reported outcomes in 2,240 patients treated with PCI or CABG from January 2000 to June 2006. In this matched comparison, there was no difference in long-term mortality or the composite of death, MI, or stroke, but a higher rate of TVR was observed in patients treated with PCI. Other studies also reported similar survival between PCI- and CABG-treated patients (68–70). White et al. (71) provided further insight by stratifying outcomes according to baseline risk. Survival was similar for low-risk patients. However, survival was lower among high-risk patients treated with PCI. In aggregate these registries suggest equipoise for low-risk patients with ULM disease and provide an excellent foundation for several recently completed randomized trials.
The first of these randomized trials is the Polish LE MANS (Study of Unprotected Left Main Stenting Versus Bypass Surgery) trial (72). Buszman et al. (72) randomized 105 low-risk patients (age 60 years, LV ejection fraction 53%) and found greater improvement in late LV ejection fraction (3.3 ± 6.7% vs. 0.5 ± 0.8%, p = 0.047) for PCI-treated patients compared with CABG.
Serruys (73) presented results of the left main subset of the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and cardiac surgery) study (348 patients randomized to CABG, 357 randomized to Taxus stent implantation [Boston Scientific, Minneapolis, Minnesota]). Patients were low risk (Euroscore 3.9, age 65 years, 75% male). At 1 year, mortality was similar in both arms (4.4% CABG vs. 4.2% PCI, p = NS), but there was a higher incidence of stroke in the CABG group (2.7% vs. 0.3%, p = 0.009). Repeat revascularization at 1 year was higher in the PCI arm (12.0% vs. 6.7%, p = 0.02). The combination of these registries and the SYNTAX trial now allow clinicians to make more scientific decisions about revascularization for ULM disease. The higher the patient risk, the more likely that CABG improves survival. Conversely, low-risk patients, especially those without bifurcation disease, seem to be well suited for PCI with DES implantation.
Multivessel disease.
The year 2008 started with an anti-PCI groundswell. The New York State database was analyzed by Hannan et al. (74). This large, prominently publicized article reported on all New York State patients with multivessel disease who had PCI or CABG from January 2003 to December 2004 and were followed up until December 2005. A total of 9,965 patients underwent PCI, and 7,437 patients underwent surgery. Patients with ULM and AMI were excluded. Unadjusted survival was similar. After adjustment for differences in baseline variables, CABG treated patients with 3- and 2-vessel disease with proximal LAD involvement had lower mortality. Park et al. (75) studied 3,042 patients with multivessel disease treated from January 2003 to December 2004. Unadjusted 3-year mortality was higher for CABG (7.0% vs. 4.4%, p = 0.01). Adjusted mortality was similar. These 2 large registries show that such large differences are present in baseline severity of illness and surgical and PCI outcomes that fundamental scientific differences cannot be found without properly sized randomized trials.
Two moderate-sized randomized trials presented midterm follow-up. Booth et al. (76) followed up 988 patients for 6 years who were treated with PCI (n = 488) or CABG (n = 500). Mortality was greater for PCI patients at 2 years, and this persisted at 6-year follow-up (10.9% vs. 6.8%, p = 0.02). The ARTS (Arterial Revascularization Therapies Study) investigators (77) followed up 607 multivessel DES-treated patients for 3 years. Outcomes were compared with surgical patients and non-DES stent patients in the ARTS I study. In addition, outcomes for the 159 diabetic patients in ARTS II were compared with the ARTS I cohort. These data show that for ARTS-eligible patients, overall 3-year survival and 3-year risk of stroke is similar for DES, non-DES, and CABG therapy. Differences in outcomes were greater in the diabetic subgroups. There was a trend toward lower mortality for CABG and DES compared with non-DES therapy. In addition, risk of cerebrovascular accident diverges for the 3 treatments. Daemen et al. (78) provide a meta-analysis of the ARTS I, ERACI II (Argentine Randomized Trial of Coronary Angioplasty with Stenting Versus Coronary Bypass Surgery in Patients with Multiple Vessel Disease), MASS II (Medicine, Angioplasty, or Surgery Study II), and SOS (Stenting Of Saphenous vein grafts) trials. Five-year follow-up in the 3,051 patients randomized to stent or surgery therapy are presented. Risk of death, stroke, and MI was 16.7% vs. 16.9% (p = NS). Risk for TVR was higher for the stent therapy (29% vs. 7.9%, p = 0.001). For diabetic patients, mortality trended higher in the PCI group (12.4% vs. 7.9%, p = 0.09).
Results of the 3-vessel disease subset of the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) study were also presented; 1,095 patients were randomized to CABG (n = 549) or multivessel PCI with the Taxus DES (n = 546) (79). At 1 year there was no difference in the incidence of death, MI, or stroke; however, the rate of revascularization was significantly higher in the PCI group (14.7% vs. 5.4%, p < 0.001). The difference in MACE was greatest in patients with high baseline risk (SYNTAX score  33).
Finally, Pijls (80) presented results of the FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) trial, which randomized 1,005 patients with stenoses 50% to angiography-guided PCI or fractional flow reserve (FFR)-guided PCI. Patients in the FFR-guided group were less likely to receive a stent (1.9 ± 1.3 vs. 2.7 ± 1.2 stents/patient). At 1 year, patients in both groups had similar angina relief; however, the composite end point of death, MI, or TVR was significantly lower in the FFR group (13.2% vs. 18.4%, p = 0.02).
Isolated proximal LAD disease.
Goy et al. (81) presented 10-year follow-up of 123 patients treated with PCI (n = 52) or CABG (n = 59). MI-free survival was excellent at 90% for both groups. PCI patients had a 26% rate of TVR, whereas no CABG-related patients required TVR at 10-year follow-up. Kapoor et al. (82) performed a meta-analysis of 9 randomized trials of PCI or CABG for proximal LAD disease (633 PCI-treated patients, 577 CABG-treated patients). The 5-year survival was similar (92.8% vs. 90.6%); TVR was higher for PCI (33% vs. 7.3%). Angina relief was greater with CABG.
PCI versus medical therapy.
Holmes (83) provided an excellent review of the subject and concluded that PCI provides superior angina relief versus medical therapy, but does not prevent MI or death. Weintraub et al. (84) confirmed these findings in a quality-of-life analysis from the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial. Angina relief and quality of life was better initially for PCI therapy, but this benefit disappeared at 3 years. Both authors conclude that for patients with stable coronary artery disease and mild or no symptoms, initial medical therapy is an acceptable alternative to initial PCI therapy. Schomig et al. (85) performed a meta-analysis of 17 randomized trials comparing PCI and medical therapy. Unlike the COURAGE trial, Schomig included stable post-MI patients. In this analysis, mortality was lower for PCI therapy, especially in patients with recent MI who had angina or exercise-induced ischemia.
No surgery on site.
There has been debate about the safety and results of PCI at facilities without on-site cardiac surgery. In one of the largest series to date, Frutkin et al. (86) reported outcomes of 1,090 elective PCIs performed at a hospital without cardiac surgery. A low incidence of complications was observed, and only 2 patients required transfer for emergency CABG. It is important to note that this center has highly experienced interventionalists and well-defined protocols for transfer.
Outcomes research.
In 2008, there were many reports addressing clinical outcomes after PCI. Singh et al. (87) studied sex differences in mortality after PCI among 18,885 patients treated at the Mayo Clinic. A significant improvement in survival was seen for both men and women over the past 25 years. After adjustment for baseline risk, no difference in short- or long-term mortality was observed between men and women. In another report, Singh et al. (88) provided validation for the new Mayo Clinic Risk Score model in a large patient cohort from the NCDR. This risk score, which uses 7 simple clinical and noninvasive variables, provides clinicians an excellent tool for risk assessment and decision making before diagnostic angiography.
Rao et al. (89) studied trends in use of the radial approach for PCI. Among 593,094 patients, radial PCI was performed in only 1.32% of total procedures, although an increase was observed in 2007. Lower rates of bleeding and vascular complications were seen with the radial approach.
Applegate et al. (90) examined trends in vascular complications after diagnostic catheterization and PCI in 35,016 procedures from 1998 to 2007. A significantly lower incidence of vascular complications was observed during this time, which the investigators attributed to improvements in procedural factors such as use of fluoroscopy-guided femoral access and smaller sheath sizes. Similarly, Doyle et al. (91) reported a marked decline in the incidence of major femoral bleeding after PCI over the past decade. The relationship between peri-procedural bleeding and 1-year outcome was emphasized in a report from Ndrepepa et al. (92). Bleeding within 30 days independently predicted 1-year mortality (hazard ratio: 2.96, p < 0.001).
Two studies evaluated the impact of pre-procedural cardiac troponin levels on outcome after PCI (93,94). Both studies showed that baseline elevation of the cardiac troponin level is an important predictor of ischemic complications and prognosis. In another report, Wang et al. (95) found that the majority of hospitals in the U.S. do not systematically assess cardiac markers after elective PCI. As expected, hospitals that routinely performed biomarker testing had higher rates of periprocedural MI; however, these hospitals had a trend toward lower mortality and greater adherence to recommended medications.
From et al. (96) examined outcomes in 138 nonagenarians undergoing PCI and observed high technical success and good clinical outcomes in carefully selected patients. In other reports, Mercado (97) found that urinary dipstick proteinuria was independently associated with mortality in patients undergoing PCI. Kip et al. (98) highlighted the wide heterogeneity in definition of the term MACE, and recommend that investigators design separate composite end points for evaluation of safety and effectiveness outcomes.
Bifurcation disease.
Percutaneous treatment of bifurcation disease remains challenging. Ormiston et al. (99). provided insight into crush bifurcation stenting and post-dilation strategies using microcomputed tomography in bench deployments. Importantly, less side-branch ostial stenosis was observed with 2-step kissing post-dilation, the minicrush technique compared with conventional crush, and use of stents with larger cell size (>3.5 mm).
Three clinical trials evaluating treatment of bifurcation lesions were presented at the Transcatheter Cardiovascular Therapeutics conference. The BBC-ONE (British Bifurcation Coronary study: Old, New and Evolving strategies) study (100) randomized 500 patients with bifurcation lesions to complex stenting (crush or culotte) or simple stenting (main vessel with provisional T-stent) using the Taxus stent. At 9 months, the primary end point, a composite of death, MI, and target vessel failure, was significantly lower in the simple stent arm (8.0% vs. 15.2%, p = 0.009). Stent thrombosis was higher with complex stenting (2.0% vs. 0.4%). In another study, Routledge et al. (101) also showed excellent clinical outcomes associated with a simple stent strategy. Among 424 consecutive patients, the provisional side-branch stent strategy was used in 92% of patients with a high initial success rate, and a low rate of MACE at 2 years (13.6%). This important shift in thinking to use a 1-stent technique as the default for most patients was further emphasized in a review by Latib and Colombo (102).
The Nordic Bifurcation Stent Technique study (103) compared outcomes with the crush and culotte stent strategies in 424 patients using the Cypher (Cordis Corp., Miami, Florida) SES. There was no difference in clinical outcomes at 6 months. Angiographic follow-up at 8 months showed a very low rate of restenosis in the main vessel with either stent technique, but a higher restenosis rate in the side branch with the crush technique (9.8% vs. 3.8%).
The DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) trial (104) evaluated the Axxess biolimus A9-eluting stent in 302 patients. At 9 months there was a low rate of MACE (7.7%) and ischemic TLR (4.3%) with this novel self-expanding stent.
Vein graft disease.
The AMEthyst (Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System) trial (105) compared use of the Interceptor PLUS Coronary Filter System (Medtronic Vascular, Santa Rosa, California) with approved devices during vein graft intervention. At 30 days the primary end point MACE occurred in 8% of Interceptor and 7.3% of control patients, thus showing noninferiority of this novel embolic protection device.
Two studies evaluated determinants of adverse outcome after vein graft PCI. In a pooled analysis of 3,958 patients, Coolong et al. (106) identified angiographic variables, including saphenous vein graft (SVG) degeneration and estimated plaque volume, as the strongest predictors of 30-day MACE. Similarly, Kirtane et al. (107) found that lesion length was the strongest correlate of outcome in a substudy of the PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) trial. Additionally, both analyses confirmed a clear benefit of embolic protection across a range of angiographic risk, including patients with relatively short lesions.
Chronic occlusion.
Safley et al. (108) studied long-term survival in 2,608 patients undergoing PCI for chronic total occlusion (CTO). Notably, successful PCI for CTO of the LAD was associated with an improved 5-year survival; however, there was no difference in outcome for successful recanalization of the circumflex or right coronary arteries. To evaluate the physiologic effect of CTO revascularization, Cheng et al. (109) performed serial cardiac MRI in 17 patients undergoing CTO PCI. Successful PCI resulted in a significant increase in myocardial blood flow and contractility at 24 h that persisted at 6 months. Courtney et al. (110) published an excellent review article describing the role of cardiac imaging techniques in assisting with patient selection for PCI, as well as innovative technologies that may enhance procedural success.
Direct stenting.
Two studies published in 2008 showed a benefit of direct stenting compared with stenting after pre-dilation. Ormiston et al. (111) found that direct stenting with the Taxus Liberté PES in carefully selected lesions was associated with significantly reduced procedural time, procedural complications, and possibly restenosis. In a small randomized trial, Cuisset et al. (112) measured microcirculatory resistance with an intracoronary pressure/temperature sensor-tipped guidewire and found less microcirculatory dysfunction in patients with stable angina treated with direct stenting compared with conventional stenting.
Radiation safety.
There has been increasing awareness about radiation exposure to the interventionalist. Brasselet et al. (113) compared radiation dosage to the operator between femoral and radial coronary procedures. Radiation exposure to operators was significantly higher using the radial approach compared with the femoral approach despite optimizing radiation protection. This study clearly highlights the need for novel radiation protection systems to reduce operator risk.
|
DES
|
|---|
Stent thrombosis.
In a registry of 8,146 patients treated with DES, stent thrombosis was observed in 3.3% at 4 years (114). Diabetes was predictive of early stent thrombosis, whereas ACS, younger age, and use of PES were associated with late stent thrombosis. In a Spanish registry of 23,500 patients treated with DES, stent thrombosis was observed in 2% at 3 years (115). Predictors of early stent thrombosis included diabetes and renal failure; both early and late stent thrombosis was increased in patients with ACS, LAD stenting, and longer stent length.
Based on predictors of stent thrombosis, Baran et al. (116) developed a risk score (discontinuation of thienopyridine <6 months, diabetes mellitus, lesion length >28 mm, multiple stents, vessel <3 mm diameter, calcification, or left main stent). Stent thrombosis occurred in 0.8% of low-risk patients, 3.6% of medium-risk patients, and 12.6% of high-risk patients.
Although the Endeavor (Medtronic, Santa Rosa, California) DES was thought to have low rates of stent thrombosis, a registry of 3,680 patients treated with second-generation DES (117) found no difference in stent thrombosis rates between Xience (Abbott Vascular, Santa Clara, California) and Endeavor DES. Of concern, Maeng (118) reported 6,122 patients treated with Endeavor or SES in the Western Denmark Heart Registry and found that adjusted rates of death, TVR, and stent thrombosis were higher with Endeavor.
SORT OUT III (The Danish Organization on Randomized Trials with Clinical Outcome), a randomized trial of 2,333 patients, found higher rates of stent thrombosis, MI, and TVR with Endeavor compared with SES (119). Reassuringly, the SORT OUT II trial found no differences in MACE among 2,098 patients randomized to SES versus PES (120).
Mechanisms of DES thrombosis.
Numerous articles were published in 2008 attempting to elucidate mechanisms of stent thrombosis. In a porcine model, overlapping PES resulted in marked intramural thrombi and impaired vasoreactivity (121). An intravascular ultrasound substudy of the Taxus trials found that PES was associated with reduced intimal hyperplasia but expansive remodeling at 9 months (122), possibly contributing to late malapposition.
Acute stent malapposition was observed in 35% of STEMI patients undergoing DES or BMS, and late stent malapposition was observed in DES patients because of positive remodeling (123). An autopsy study (124) suggested that delayed healing and stent thrombosis occurred more frequently when DES was placed in unstable compared with stable plaques. An optical coherence tomography study (125) found that neointimal coverage improved between 3 and 24 months, but the majority of DES still had some uncovered struts. A rabbit study (126) suggested that delayed healing was caused by the polymer (not the drug) on the DES. Another rabbit study (127) found that everolimus-eluting stent had superior endothelialization compared with SES, PES, or ZES. Finally, first-generation DES have been associated with endothelial dysfunction distal to the stent (128–130), and this may be improved with second-generation DES (131). These data suggest that newer-generation stents may improve endothelialization and vasomotor dysfunction.
Late outcome of DES versus BMS.
The New York State Registry (132) compared 11,436 patients treated with BMS (before the release of DES) and 12,526 patients treated with DES. The risk-adjusted 2-year outcomes were favorable in the DES group, including improved nonfatal MI and TVR; mortality rates were similar. Likewise, the Medicare database (133) found reduced rates of repeat PCI, CABG, and STEMI after stenting in the DES era (61.5% received DES, 38.5% BMS) compared with the BMS era. Another Medicare analysis of 76,525 patients who received DES (134) was compared with 2 matched cohort control groups. The DES patients were found to have improved survival as well as reduced TVR and MI compared with both BMS cohorts. The Massachusetts registry (135) compared 11,556 DES patients and 6,237 BMS patients. Two-year risk-adjusted outcomes were superior in the DES group, including mortality (9.8% vs. 12.0%, p = 0.0002), MI (8.3% vs. 10.3%, p = 0.0005), and TVR (11.0% vs. 16.8%, p < 0.0001). The Cleveland Clinic group (136) examined 832 patients who died over a 4.5-year follow-up after stenting. They reported that DES-treated patients had lower all-cause mortality in unadjusted and adjusted Cox proportional models and propensity-matched groups.
Off-label use of DES.
Several groups reported comparisons of DES versus BMS in off-label applications (137–142). In general, off-label use of both DES and BMS are associated with higher event rates compared with on-label use (consistent with higher-risk clinical and lesion characteristics). However, DES seemed to have similar or improved rates of death or MI compared with BMS, and consistently reduced need for TVR. Overall, these data support the use of DES for off-label indications.
DES in diabetic patients.
Diabetes is a powerful predictor of adverse clinical and angiographic events after PCI. Three separate registries compared DES with BMS in diabetic patients and found reduced TVR with similar or improved rates of MI or death (143–145). Subgroup analysis from randomized trials of DES versus BMS found markedly lower rates of TVR, with similar rates of death, MI, and stent thrombosis at 4 years (146). A meta-analysis of registries and randomized trials including more than 11,000 diabetic patients reported revascularization rates of <10% with similar outcomes comparing PES and SES (147). Conversely, a subgroup analysis of the SIRTAX (Sirolimus-Eluting versus Paclitaxel-Eluting Stents for Coronary Revascularization) trial (148) showed reduced TVR with SES compared with PES, and a prospective trial randomizing 400 diabetic patients to SES versus PES (149) found reduced angiographic restenosis at 6 months (3.4% vs. 18.2%, p < 0.001) and TVR at 9 months (2.0% vs. 7.5%, p = 0.017) after SES.
DES in vein grafts.
Saphenous vein graft interventions remain a higher-risk subgroup for PCI. Pucelikova et al. (150) reported 110 patients undergoing SVG stenting (DES in 91%). At 1 year, death occurred in 7.4%, TVR in 19.0%, and MACE in 30.5%. Predictors of MACE included thrombus and length of stented segment. Okabe et al. (151) reported a retrospective series of 138 patients treated with DES in SVG compared with 344 patients treated with BMS to SVG. At 1 year, there was no advantage to DES with regard to death, MI, or TVR. The SOS study (152) randomized 80 patients to undergo stenting of SVG with PES versus BMS. The lesions were relatively focal with mean stent length 16 ± 6 mm. At 12-month angiography, late loss and restenosis (9% vs. 51%, p < 0.0001) favored PES, and at 1.5-year follow up, TLR was reduced (5% vs. 28%, p = 0.003).
DES for in-stent restenosis.
Long-term (>3 years) follow-up of a trial that randomized 150 patients with in-stent restenosis to SES versus percutaneous transluminal coronary angioplasty (153) reported that stent thrombosis was similar in the 2 groups but event-free survival was superior with SES (76% vs. 65%, p = 0.019). The 24-month follow-up of the Taxus V in-stent restenosis trial (154) found reduced TLR with PES compared with brachytherapy (18.1% vs. 27.5%, p = 0.03) with similar rates of death, MI, and stent thrombosis. In another trial, Holmes (155) also found improved outcomes with SES versus brachytherapy at 3-year follow-up.
|
New Stent Technologies
|
|---|
New DES and polymers.
In 2008, there were several publications of new DES technologies. In the SPIRIT III trial, 1,002 patients were randomly assigned to receive either an everolimus-eluting stent or a PES (156). The primary end point, angiographic in-segment late loss at 8 months, was significantly less in the everolimus stent group (0.14 mm vs. 0.28 mm, p  0.004). The rate of MACE at 9 and 12 months was lower in the everolimus group. In a small randomized trial, a novel ZES (ZoMaxx, Abbott Laboratories, Abbott Park, Illinois) resulted in significantly greater late lumen loss compared with a PES (157).
Turco et al. (158) studied outcomes with the thinner-strut Taxus Liberté stent compared with the Taxus Express stent. In small vessels and long lesions, lower rates of restenosis were observed with the Liberté DES.
Several trials evaluated new DES technologies with biodegradable polymers or polymer-free stents. These new-generation stents were designed to improve the safety profile of first-generation DES. Windecker et al. (159) randomized 1,707 patients to a novel biolimus-eluting stent with a biodegradable polymer or SES (with durable polymer). At 9 months, the biolimus-eluting stent was noninferior to the SES for the composite clinical end point. Byrne (160) studied a novel polymer-free dual probucol and rapamycin–eluting stent. Angiographic restenosis and late loss were similar to a permanent polymer SES, but superior to a ZES. In the ISAR-TEST 3 (Intracoronary Stenting and Angiographic Restenosis–Test Efficacy of Rapamycin-eluting Stents with Different Polymer Coating Strategies) trial, Mehilli et al. (161) compared 3 rapamycin-eluting stents (biodegradable polymer vs. permanent polymer vs. polymer-free). The biodegradable SES had a similar rate of angiographic late loss to the permanent polymer stent; however, the polymer-free stent had a significantly higher late loss (0.17 mm vs. 0.23 mm vs. 0.47 mm, respectively). Jabara et al. (162) showed improved vascular healing in an animal model using a new DES with a slow-release biodegradable polylactide polymer and low-dose paclitaxel. In a first-in-man study, Costa et al. (163) evaluated a novel stainless-steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (Vestasync-eluting stent, MIV Therapeutics, Inc., Atlanta, Georgia). At 4 months, in-stent late loss was 0.30 ± 0.25 mm). No adverse events were observed at 6 months.
In contrast to these promising results, a randomized trial evaluating the CoStar DES (Conor MedSystems, Menlo Park, California) (164) found that this novel platform was not noninferior to a Taxus DES. At 8 months, the incidence of MACE (11.0% vs. 6.9%, p < 0.005) and late loss (0.49 mm vs. 0.18 mm, p < 0.0001) were significantly higher with the CoStar stent.
Bioabsorbable stents.
There has been tremendous interest in fully biodegradable coronary DES. Ormiston et al. (165) reported findings from a 30-patient study using a bioabsorbable everolimus-eluting stent that has a backbone of poly-L-lactic acid. At 6 months, angiographic late loss was 0.44 mm, mainly because of a mild reduction of the stent area, with minimal neointimal hyperplasia. Device success was 94%. This study represents a major step forward in clinical investigation of bioabsorbable stent technologies.
|
Pharmacotherapy
|
|---|
Clopidogrel.
Given the short door-to-balloon times, some have questioned the benefit of pre-treatment with clopidogrel before primary PCI. Vlaar et al. (166) performed a meta-analysis of all primary PCI trials with core laboratory angiographic reviews in which pre-treatment status with clopidogrel was known (n = 8,429). In multivariate analysis, pre-treatment with clopidogrel was an independent predictor of early reperfusion (OR: 1.51, 95% confidence interval: 1.31 to 1.74, p < 0.0001) and improved clinical outcome. Conversely, the PRAGUE-8 trial (167) randomized 1,028 patients with stable angina to pre-treatment with 600 mg clopidogrel >6 h before catheterization versus selective administration after initial angiography showed the need for PCI. Pre-treatment with a high loading dose was associated with increased bleeding risk, but no difference in ischemic end points. However, this study was underpowered given the low event rate (0.8%).
Other studies have shown that 600-mg loading doses of clopidogrel achieve stronger platelet inhibition compared with conventional regimens (168). Even patients on chronic clopidogrel therapy have improved platelet inhibition if reloaded with clopidogrel (169). Moreover, the ARMYDA (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) Reload trial (170) showed that ACS patients on chronic clopidogrel therapy benefited from 600-mg reload. The primary end point of 30-day death, MI, or TVR was significantly reduced in the reload group (7% vs. 18%, p = 0.035).
Clopidogrel hyporesponsiveness continued to be an important topic in 2008. Gori et al. (171) showed that dual nonresponsiveness to both aspirin and clopidogrel was infrequent (6%) but identified patients at high risk of DES thrombosis or death. Studies utilizing the Accumetrics (San Diego, California) device (a more rapid and specific measure of P2Y12 responsiveness) found that pre-PCI (172) and post-PCI (173) platelet reactivity was associated with MACE. Increasing the clopidogrel dose in patients who were resistant to the first 600-mg load (vasodilator-stimulated phosphoprotein index >50%) was found to be safe and improved clinical outcomes (174).
Although a number of factors may influence clopidogrel hyporesponsiveness, Trenk et al. (175) found a genetic pre-disposition that influenced the cytochrome P450–dependent conversion of clopidogrel to its active metabolite. External influences may include smoking, which increases active metabolites (176), or medications, such as the proton pump inhibitor omeprazole, which decreased the antiplatelet effect of clopidogrel (177).
Prasugrel.
More potent or more-rapid-acting oral antiplatelet regimens seem to be superior to conventional dual antiplatelet therapy with clopidogrel and aspirin. In the TRITON–TIMI (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel–Thrombolysis In Myocardial Infarction) 38 trial (178), prasugrel plus aspirin was superior to clopidogrel plus aspirin with regard to stent thrombosis (1.13% vs. 2.35%, p < 0.0001) and the primary end point of cardiovascular death, MI, or stroke (9.7% vs. 11.9%, p = 0.0001). Significant advantages of prasugrel were observed regardless of whether patients received DES (n = 5,743) or BMS (n = 6,461). Because prasugrel was associated with more bleeding than clopidogrel, a landmark analysis (179) found that net clinical benefit favored prasugrel both early (day 0 to 3) and later (day 3 to end of trial).
Cilostazol.
Triple antiplatelet therapy (adding cilostazol to clopidogrel + aspirin) has previously been shown to reduce platelet aggregation and restenosis. Park (180) reported a registry of 3,099 patients undergoing successful DES placement who were treated with triple (n = 1,443) or dual (n = 1,656) antiplatelet therapy. After adjustment for selection bias (multiple high-risk features were more common in the cilostazol group), triple antiplatelet therapy was associated with reduced stent thrombosis and MI. Lee et al. (181) randomized 400 diabetic patients treated with DES to receive triple (with cilostazol) versus dual antiplatelet therapy. Triple antiplatelet therapy significantly reduced angiographic restenosis at 6 months (8.0% vs. 15.6%, p = 0.03), 9-month TLR (2.5% vs. 7.0%, p = 0.03), and MACE (3.0% vs. 7.0%, p = 0.066).
Bivalirudin.
Several studies examined the use of bivalirudin during PCI. Bivalirudin was found to be cost effective compared with UFH and GP IIb/IIIa (182). One-year follow-up of the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial found similar rates of ischemia and mortality but a trend for higher rates of MI in the bivalirudin arm (9.3% vs. 7.8%, p = 0.06) compared with UFH and GP IIb/IIIa (183,184).
The ARNO (Antithrombotic Regimens aNd Outcome) trial (185) randomized 900 patients undergoing PCI to bivalirudin versus UFH 100 µ/kg; both groups were pre-treated with clopidogrel and had immediate sheath removal and closure devices. Bivalirudin was associated with a reduction in major bleeding and improved net clinical benefit. The NAPLES (Novel Approaches for Preventing or Limiting Event Study) trial (186) randomized 335 diabetic patients pre-treated with clopidogrel to bivalirudin versus UFH with tirofiban. At 30 days, ischemic events were similar and bleeding was reduced in the bivalirudin arm. Feit et al. (187) reported similar results from subgroup analysis of diabetic patients from the ACUITY trial.
The ISAR-REACT 3 trial (188) randomized 4,570 patients pre-treated with 600 mg clopidogrel to UFH versus bivalirudin. Net clinical benefit was not different between the 2 groups, but bleeding was lower with bivalirudin (3.1% vs. 4.6%, p = 0.008).
Finally, given concerns about the early increase in ischemic events observed in bivalirudin patients not adequately pre-treated with clopidogrel, Cortese (189) reported a study of 178 patients requiring complex PCI who were randomized to conventional versus prolonged (4 h post-PCI) infusion of bivalirudin. Bleeding rates were similar (87% radial access), but reduced post-PCI MI was observed with the prolonged infusion.
Fondaparinux.
Mehta et al. (190) pooled the OASIS (Organization to Assess Strategies in Ischemic Syndromes) 5 and 6 trials comparing fondaparinux with heparin (or enoxaparin) and reported a beneficial effect in patients treated with an invasive (cardiac catheterization) strategy. However, among patients undergoing PCI, there was a significant increased risk of catheter thrombosis with fondaparinux compared with enoxaparin (OR: 3.98, 95% confidence interval: 1.74 to 9.09) and compared with UFH (OR: 8.98, 95% confidence interval: 1.14 to 71.43).
No antithrombin therapy.
The CIAO (Coronary Interventional Antiplatelet-based Only) study (191) randomized 700 stable angina patients with uncomplicated lesions who were pre-treated with aspirin and clopidogrel to heparin versus placebo. Catheters were flushed with heparinized saline (up to 100 times per procedure) and procedure times were short (mean 11 min). Bleeding and clinical events were reduced in the no heparin arm, suggesting that antithrombins may be unnecessary in highly selective, simple elective PCI cases.
Patients on warfarin.
There are few data regarding management of PCI patients requiring long-term anticoagulation with warfarin. Karjalainen et al. (192) reviewed outcomes in 241 PCI patients (80% femoral approach). Mean international normalized ratio at PCI was 2.2 ± 0.5. Access site complications and major bleeding occurred in 5.0% and 1.2% of patients, respectively. These data suggest that uninterrupted anticoagulation is a reasonably safe approach in carefully selected patients. Rossini et al. (193) studied outcomes in patients requiring triple therapy compared with dual antiplatelet therapy alone. As expected, bleeding was more frequent in patients with triple therapy; however, this excess risk was seen mostly in patients with an international normalized ratio >2.6.
|
Contrast Nephropathy
|
|---|
Results of 2 randomized trials evaluating the effect of sodium bicarbonate infusion for prevention of contrast-induced nephropathy (CIN) were published in 2008 (194,195). Both trials enrolled patients with stable renal dysfunction (creatinine clearance <60 ml/min) undergoing coronary angiography or PCI. Compared with saline infusion alone, there was no difference in the incidence of CIN with bicarbonate in either trial. A 1,307-patient meta-analysis by Hogan et al. (196) suggested a possible benefit of bicarbonate; however, this study was limited by marked heterogeneity and probable publication bias, and did not include data from the largest randomized trial by Maioli et al. (195). Kane et al. (197) provided a report emphasizing the importance of minimizing contrast dose in patients with renal dysfunction, and showed a very low rate of CIN in those who receive ultra-low-dose contrast. Harjai et al. (198) compared the value of 4 different definitions for CIN commonly used in studies and found that only 2 (serum creatinine >25% and serum creatinine >0.5 mg/dl) were consistently predictive of clinical outcomes. Based on these data, a novel nephropathy grading system was developed to predict 6-month events. Stone (199) reported findings from of a trial evaluating systemic cooling to prevent CIN. Unfortunately, only 136 of the planned 400 patients were enrolled because the study sponsor became insolvent. Cooling was safe and well tolerated, but no benefit of hypothermia was observed. Finally, McCullough (200) provided an excellent review article on contrast-induced acute kidney injury, covering pathogenesis, risk assessment, prevention, and management of CIN.
|
Peripheral Vascular Disease
|
|---|
AHA Conference on Atherosclerotic Vascular Disease.
Proceedings of the second AHA Conference on Atherosclerotic Vascular Disease were published in 2008 (201–209). The report includes 8 excellent summaries of areas that were addressed at the symposium, including nomenclature for atherosclerotic vascular disease, screening, magnetic resonance and computed tomographic imaging, stroke intervention, carotid artery revascularization, abdominal aortic aneurysm repair, lower-extremity revascularization, and renal artery disease. Readers are referred to the proceedings for detailed information on these subjects.
Carotid disease.
There has been controversy about the safety of carotid stenting. Gurm et al. (210) performed a meta-analysis of 5 trials with 2,122 patients undergoing stenting or endarterectomy for symptomatic carotid disease. There was no difference in the risk of 30-day mortality, stroke, or disabling stroke among patients randomized to either strategy. In another report, Iyer (211) presented 1-year outcomes of the BEACH (Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients) trial, which evaluated high-surgical-risk patients undergoing stenting with the Wallstent plus FilterWire embolic protection device (Boston Scientific, Minneapolis, Minnesota). At 1 year, the primary composite end point occurred in 8.9% of patients; this rate was noninferior to outcomes in similar patients after surgical endarterectomy.
Two trials investigating new embolic protection devices for carotid artery stenting were presented at the Transcatheter Cardiovascular Therapeutics conference (212,213). The EPIC (Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting) trial evaluated the FiberNet (Lumen Biomedical, Plymouth, Minnesota) Embolic Protection System (212), whereas the EMPIRE (A Multicenter Registry Evaluating Neuroprotection During Carotid Stenting with a Novel Flow Reversal System) trial evaluated the GORE (WL Gore and Associates) Flow Reversal System (213). Both studies showed a high procedural success and low rate of stroke and major adverse events at 30 days.
Schofer et al. (214) assessed the timing of embolic events after carotid stenting with serial magnetic resonance imaging; 20% of patients had ipsilateral injury at 3.5 h. Of note, 17% of patients had further evidence of emboli occurring between 3.5 and 18 h after embolic-protected stenting, involving both hemispheres. Causes of late embolization remain unclear but may be related to manipulation of catheters in the aortic arch.
Lin et al. (215) provided a report on feasibility and outcomes after endovascular recanalization for chronic cervical internal carotid artery occlusion. Successful recanalization was achieved in 35 of 54 patients (65%). Two patients had a stroke (4%), and vascular complications occurred in 3 patients, including 1 late pseudoaneurysm, 1 carotid-cavernous fistula, and 1 extravasation. Finally, Levy et al. (216) published a comprehensive review on the treatment of carotid artery disease.
Renal stenting.
Cooper et al. (217) investigated whether adjunctive use of an embolic protection device (AngioGuard, Cordis, Miami, Florida) or GP IIb/IIIa receptor inhibitor (abciximab) during renal artery stenting would improve renal function. At 1 month, a decline in renal function was observed with stenting alone, stenting with embolic protection, and stenting with abciximab alone. However, with combination therapy no change in renal function was noted.
Mahmud et al. (218) reported a novel angiographic method for assessing renal microvascular perfusion—the renal frame count and renal blush grade. Both parameters were impaired in hypertensive patients with unilateral renal artery stenosis, and improved after stenting. Reduction in renal frame count was associated with a blood pressure reduction.
Superficial femoral artery disease.
Two studies published in 2008 investigated use of paclitaxel-coated angioplasty balloons to limit restenosis during endovascular treatment of femoropopliteal disease. Tepe et al. (219) randomized 154 patients to a paclitaxel-coated balloon, uncoated balloon with paclitaxel dissolved in the contrast medium, or uncoated balloon alone. At 6 months, late lumen loss (the primary end point) and the rate of revascularization was significantly lower in the group treated with the paclitaxel-coated balloon. No benefit was seen with paclitaxel in the contrast medium. In another smaller randomized trial, similar benefits were also observed with a paclitaxel-coated balloon (220).
|
Structural Heart Disease
|
|---|
Percutaneous aortic valve replacement.
Percutaneous aortic valve replacement has emerged as a promising new treatment option for aortic stenosis. Grube et al. (221) reported outcomes in 136 patients treated with the CoreValve (CoreValve Inc., Irvine, California) prosthesis. Procedural success with the third-generation valve was 91.2%, and there was a low rate of death, stroke, or MI at 30 days (14.7%). A marked improvement in functional status was observed. A case report (222) of a patient who died 425 days after implant of a CoreValve showed ingrowth of tissue covering the lower part of the valve situated in the LV outflow tract. Schofer et al. (223) published results of a first-in-man study with the novel repositionable prosthesis in high-surgical-risk patients with severe aortic stenosis (Direct Flow Medical, Santa Rosa, California). Valve implantation was achieved in 12 of 15 patients and was associated with a reasonable safety profile. Two reports described new left bundle branch block and atrioventricular block after percutaneous valve implantation (224,225). In the series by Webb (225), 7 of 123 (5.7%) patients required a permanent pacemaker. In another report, Babaliaros et al. (226) reported the use of balloon aortic valvuloplasty to help size the annulus before valve implantation. Zegdi et al. (227) provided important observations regarding post-deployment characteristics of a self-expanding valve stent in 35 patients undergoing surgical valve replacement. In bicuspid valves, the stent was often distorted and underdeployed, which may influence valve results and durability. Chiam et al. (228) and Webb (229) provided nice review articles on transcatheter aortic valve implantation. Finally, Vahanaian et al. (230) published a position statement on transcatheter aortic valve implantation from the European Association of Cardio-Thoracic Surgery and European Society of Cardiology. The document summarizes current techniques and results, as well as recommendations for patient selection, performance of valve implantation, and evaluation of procedural results.
Mitral valve repair.
Sorajja et al. (231) reported a novel method of percutaneous mitral valve repair in which an annulus reduction device is implanted into the myocardium at the posteromedial mitral annulus via the coronary sinus. A significant reduction in mitral annular area was observed, which persisted at 3 months. Compared with other coronary sinus technologies, this technique may be advantageous when the coronary sinus lies superior to the mitral annulus, and also may lessen risk of injury to the circumflex artery.
Pulmonary valve replacement.
Lurz et al. (232) published results with a percutaneous pulmonary valve in 155 patients with pulmonary conduit stenosis or regurgitation. Most patients had tetralogy of Fallot. Valve implantation was achieved with a very high success rate, and freedom from reoperation was 70% at 70 months.
Patent foramen ovale (PFO).
A randomized trial of PFO closure in 432 patients with migraine (STARflex device, NMT Medical Inc., Boston, Massachusetts) (233) found no difference in cessation of migraine headache, and patients in the implantation arm had more serious adverse effects. Taafe et al. (234) performed a randomized trial in 660 patients comparing 3 PFO closure devices. Excellent outcomes were achieved with all devices; however, patients treated with the Helex (WL Gore and Associates, Flagstaff, Arizona) devices were more likely to have a residual shunt at 30 days compared with the other devices. In another study, Hildick-Smith et al. (235) reported that many PFO closure procedures can be performed safely with fluoroscopy alone.
Alcohol septal ablation (ASA).
Three articles in 2008 addressed outcomes after ASA for hypertrophic cardiomyopathy (236–238). All studies showed a reduction in LV outflow tract gradient with ASA and improvement in functional class. Death occurred in 1% to 1.4%, and pacemaker implantation was required in 8.2% to 26%. In the Mayo series, the procedural complication rate was higher than that in matched controls who underwent surgical myomectomy; however, 4-year survival was similar between both groups.
|
Footnotes
|
|---|
Dr. Dixon is a consultant for Abiomed Inc. Dr. Grines is a consultant for Pfizer, Sanofi-Synthelabo, Bristol-Myers Squibb, and the GlaxoSmithKline Global Cardiovascular Board. Dr. O'Neill is a consultant for Medtronic.
|
References
|
|---|
1. King III SB, Smith Jr. SC, Hirshfeld Jr. JW, et al. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (2007 Writing Group to Review New Evidence and Update the 2005 ACC/AHA/SCAI Guideline Update for Percutaneous Coronary Intervention) J Am Coll Cardiol 2008;51:172-209.[Free Full Text]2. Antman EM, Hand M, Armstrong PW, et al. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Group to Review New Evidence and Update the ACC/AHA 2004 Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction) J Am Coll Cardiol 2008;51:210-247.[Free Full Text] 3. Stone GW. Angioplasty strategies in ST-segment elevation myocardial infarction: part I: primary percutaneous coronary intervention Circulation 2008;118:538-551.[Free Full Text] 4. Stone GW. Angioplasty strategies in ST-segment elevation myocardial infarction: part II: intervention after fibrinolytic therapy, integrated treatment recommendations, and future directions Circulation 2008;118:552-566.[Free Full Text] 5. Le May MR, So DY, Dionne R, et al. A citywide protocol for primary PCI in ST-segment elevation myocardial infarction N Engl J Med 2008;358:231-240.[CrossRef][Web of Science][Medline] 6. Aguirre FV, Varghese JJ, Kelley MP, et al. Rural interhospital transfer of ST-elevation myocardial infarction patients for percutaneous coronary revascularization: the Stat Heart Program Circulation 2008;117:1145-1152.[Abstract/Free Full Text] 7. Flesch M, Hagemeister J, Berger H, et al. Implementation of guidelines for the treatment of acute ST-elevation myocardial infarction: the Cologne Infarction Model Registry Circ Cardiovasc Intervent 2008;1:95-102. 8. Holmes Jr. DR, Bell MR, Gersh BJ, et al. Systems of care to improve timeliness of reperfusion therapy for ST-segment elevation during off hours. The Mayo Clinic STEMI Protocol. J Am Coll Cardiol Intv 2008;1:88-96.[Abstract/Free Full Text] 9. Chakrabarti A, Krumholz HM, Wang Y, et al. Time-to-reperfusion in patients undergoing interhospital transfer for primary percutaneous coronary intervention in the U.S.. An analysis of 2005 and 2006 data from the National Cardiovascular Data Registry. J Am Coll Cardiol 2008;51:2442-2443.[Free Full Text] 10. Jneid H, Fonarow GC, Cannon CP, et al. Impact of time to presentation on the care and outcomes of acute myocardial infarction Circulation 2008;117:2502-2509.[Abstract/Free Full Text] 11. Krumholz HM, Anderson JL, Bachelder BL, et al. ACC/AHA 2008 performance measures for adults with ST-elevation and non–ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures for ST-Elevation and Non–ST-Elevation Myocardial Infarction) J Am Coll Cardiol 2008;52:2046-2099.[Free Full Text] 12. Masoudi FA, Bonow RO, Brindis RG, et al. ACC/AHA 2008 statement on performance measurement and reperfusion therapy: a report of the ACC/AHA Task Force on Performance Measures (Work Group to Address the Challenges of Performance Measurement and Reperfusion Therapy) J Am Coll Cardiol 2008;52:2100-2112.[Free Full Text] 13. Glaser R, Naidu SS, Selzer F, et al. Factors associated with poorer prognosis for patients undergoing primary percutaneous coronary intervention during off-hours J Am Coll Cardiol Intv 2008;1:681-688.[Abstract/Free Full Text] 14. Lev EI, Kornowski R, Vaknin-Assa H, et al. Comparison of the predictive value of four different risk scores for outcomes of patients with ST-elevation acute myocardial infarction undergoing percutaneous coronary intervention Am J Cardiol 2008;102:6-11.[CrossRef][Web of Science][Medline] 15. Di Mario C, Dudek D, Piscione F, et al. Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomized, multicentre trial Lancet 2008;371:559-568.[CrossRef][Web of Science][Medline] 16. Danchin N, Coste P, Ferrières J, et al. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction. Data from the French Registry on Acute ST-Elevation Myocardial Infarction (FAST-MI). Circulation 2008;118:268-276.[Abstract/Free Full Text] 17. Denktas AE, Athar H, Henry TD, et al. Reduced-dose fibrinolytic acceleration of ST-segment elevation myocardial infarction treatment coupled with urgent percutaneous coronary intervention compared with primary percutaneous intervention alone J Am Coll Cardiol Intv 2008;1:504-510.[Abstract/Free Full Text] 18. Ellis SE, Tendera M, de Belder MA, et al. Facilitated PCI in patients with ST-elevation myocardial infarction N Engl J Med 2008;358:2205-2217.[CrossRef][Medline] 19. Le May M. A safety and efficacy study of Integrilin facilitated PCI versus primary PCI in ST-segment elevation myocardial infarction (ASIST trial)Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 15,; Washington, DC. 2008. 20. van't Hof AW, ten Berg J, Heestermans T, et al. Prehospital initiation of tirofiban in patients with ST-elevation myocardial infarction undergoing primary angioplasty (On-TIME 2): a multicentre, double-blind, randomized controlled trial Lancet 2008;372:537-546.[CrossRef][Web of Science][Medline] 21. Saia F. Facilitated Angioplasty with Tirofiban or Abciximab (FATA trial)Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 15,; Washington, DC. 2008. 22. Mehilli J. Abciximab in patients with AMI undergoing primary PCI after clopidogrel pretreatment (BRAVE-3 trial)Paper presented at: American College of Cardiology; March 30,; Chicago, IL. 2008. 23. Thiele H, Schindler K, Friedenberger J, et al. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the Randomized Leipzig Immediate Percutaneous Coronary Intervention Abciximab IV Versus IC in ST-Elevation Myocardial Infarction Trial Circulation 2008;118:49-57.[Abstract/Free Full Text] 24. Gurm HS, Smith DE, Collins JS, et al. The relative safety and efficacy of abciximab and eptifibatide in patients undergoing primary percutaneous coronary intervention. Insights from a large regional registry of contemporary percutaneous coronary intervention. J Am Coll Cardiol 2008;51:529-535.[Abstract/Free Full Text] 25. Kini A, Chen VH, Krishnan P, et al. Bolus-only versus bolus + infusion of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention Am Heart J 2008;156:513-519.[CrossRef][Web of Science][Medline] 26. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction N Engl J Med 2008;358:2218-2230.[CrossRef][Medline] 27. Kukreja N, Onuma Y, Garcia-Garcia H, et al. Primary percutaneous coronary intervention for acute myocardial infarction Circ Cardiovasc Intervent 2008;1:103-110. 28. Jensen LO, Maeng M, Thayssen P, et al. Clinical outcome after primary percutaneous coronary intervention with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction Circ Cardiovasc Intervent 2008;1:176-184.[Abstract/Free Full Text] 29. Shishehbor MH, Amini R, Oliveria LPJ, et al. Comparison of drug-eluting stents versus bare-metal stents for treating ST-segment elevation myocardial infarction J Am Coll Cardiol Intv 2008;1:227-232.[Abstract/Free Full Text] 30. Hannan EL, Racz M, Walford G, et al. Drug-eluting versus bare-metal stents in the treatment of patients with ST-segment elevation myocardial infarction J Am Coll Cardiol Intv 2008;1:129-135.[Abstract/Free Full Text] 31. Mauri L, Silbaugh TS, Garg P, et al. Drug-eluting or bare-metal stents for acute myocardial infarction N Engl J Med 2008;359:1330-1342.[CrossRef][Medline] 32. Grines CL, Goldstein JA, Safian RD. Should we routinely use drug-eluting stents for acute myocardial infarction?. Let's wait and see. J Am Coll Cardiol Intv 2008;1:137-139. 33. Kelbæk H, Thuesen L, Helqvist S, et al. Drug-eluting versus bare metal stents in patients with ST-segment elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial (DEDICATION) trial Circulation 2008;118:1155-1162.[Abstract/Free Full Text] 34. Van der Hoeven BL, Liem SS, Jukema W, et al. Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome. Results from the MISSION Intervention Study. J Am Coll Cardiol 2008;51:618-626.[Abstract/Free Full Text] 35. Valgimigli M, Campo G, Percoco G, et al. Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial JAMA 2008;299:1788-1799.[Abstract/Free Full Text] 36. Stone GW. HORIZONS AMI. A prospective, randomized comparison of paclitaxel eluting Taxus stents vs. bare metal stents during primary angioplasty in acute myocardial infarctionPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 15, 2008Washington, DC. 37. Lee CW. The ZEST AMI trial. Comparison of the efficacy and safety of zotarolimus-eluting stent vs. sirolimus-eluting stent vs. paclitaxel-eluting stent for acute myocardial infarction patients. Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 15,; Washington, DC 2008. 38. Abbate A, Biondi-Zoccai GGL, Appleton DL, et al. Survival and cardiac remodeling benefits in patients undergoing late percutaneous coronary intervention of the infarct-related artery. Evidence from a meta-analysis of randomized controlled trials. J Am Coll Cardiol 2008;51:956-964.[Abstract/Free Full Text] 39. Kruk M, Kadziela J, Reynolds HR, et al. Predictors of outcome and the lack of effect of percutaneous coronary intervention across the risk strata in patients with persistent total occlusion after myocardial infarction. Results from the OAT (Occluded Artery Trial) study. J Am Coll Cardiol Intv 2008;1:511-520.[Abstract/Free Full Text] 40. Okamura A, Ito H, Iwakura K, et al. Clinical implications of distal embolization during coronary interventional procedures in patients with acute myocardial infarction J Am Coll Cardiol Intv 2008;1:268-276.[Abstract/Free Full Text] 41. Svilaas T, Vlaar PJ, van der Horst IC, et al. Thrombus aspiration during primary percutaneous coronary intervention N Engl J Med 2008;358:557-567.[CrossRef][Medline] 42. Vlaar PJ, Svilaas T, van der Horst IC, et al. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study Lancet 2008;371:1915-1920.[CrossRef][Web of Science][Medline] 43. Ikari Y, Sakurada M, Kozuma K, et al. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction J Am Coll Cardiol Intv 2008;1:424-431.[Abstract/Free Full Text] 44. Vlaar PJ, Svilaas T, Vogelzang M, et al. Comparison of 2 thrombus aspiration devices with histopathological analysis of retrieved material in patients presenting with ST-segment elevation myocardial infarction J Am Coll Cardiol Intv 2008;1:258-264.[Abstract/Free Full Text] 45. Koch KT. A prospective randomized trial of proximal microcirculatory protection in patients with acute myocardial infarction undergoing primary PCI (The PREPARE trial)Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 15, 2008Washington, DC. 46. Kelbæk H, Terkelsen CJ, Helqvist S, et al. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention. The Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction (DEDICATION) Trial. J Am Coll Cardiol 2008;51:899-905.[Abstract/Free Full Text] 47. Dangas G, Stone GW, Weinberg, MD, et al. Contemporary outcomes of rescue percutaneous coronary intervention for acute myocardial infarction: comparison with primary angioplasty and the role of distal protection devices (EMERALD trial) Am Heart J 2008;155:1090-1096.[CrossRef][Web of Science][Medline] 48. Kramer MCA, van der Wal AC, Koch KT, et al. Presence of older thrombus is an independent predictor of long-term mortality in patients with ST-elevation myocardial infarction treated with thrombus aspiration during primary percutaneous coronary intervention Circulation 2008;118:1810-1816.[Abstract/Free Full Text] 49. Piot C, Croisille P, Staat P, et al. Effect of cyclosporine on reperfusion injury in acute myocardial infarction N Engl J Med 2008;359:473-481.[CrossRef][Medline] 50. Direct Inhibition of  –Protein C Kinase Enzyme to Limit Total Infarct Size in Acute Myocardial Infarction (DELTA MI) Investigators. Intracoronary KAI-9803 as an adjunct to primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction. Circulation 2008;117:886-896.[Abstract/Free Full Text] 51. Ishii H, Amano T, Matsubara T, et al. Pharmacological intervention for prevention of left ventricular remodeling and improving prognosis in myocardial infarction Circulation 2008;118:2710-2718.[Free Full Text] 52. Sjauw KD, Remmelink M, Baan J, et al. Left ventricular unloading in acute ST-segment elevation myocardial infarction patients is safe and feasible and provides acute and sustained left ventricular recovery J Am Coll Cardiol 2008;51:1044-1046.[Free Full Text] 53. Seyfarth M, Sibbing D, Bauer I, et al. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction J Am Coll Cardiol 2008;52:1584-1588.[Abstract/Free Full Text] 54. Apolito RA, Greenberg MA, Menegus MA, et al. Impact of the New York State Cardiac Surgery and Percutaneous Coronary Intervention Reporting System on the management of patients with acute myocardial infarction complicated by cardiogenic shock Am Heart J 2008;155:267-273.[CrossRef][Web of Science][Medline] 55. Reynolds HR, Hochman JS. Cardiogenic shock: current concepts and improving outcomes Circulation 2008;117:686-697.[Free Full Text] 56. Zohlnhöfer D, Dibra A, Koppara T, et al. Stem cell mobilization by granulocyte colony-stimulating factor for myocardial recovery after acute myocardial infarction. A meta-analysis. J Am Coll Cardiol 2008;51:1429-1437.[Abstract/Free Full Text] 57. Martin-Rendon E, Brunskill SJ, Hyde CJ, et al. Autologous bone marrow stem cells to treat acute myocardial infarction: a systematic review Eur Heart J 2008;29:1807-1818.[Abstract/Free Full Text] 58. Steg PG, Kerner A, van de Werf F, et al. Impact of in-hospital revascularization on survival in patients with non ST-elevation acute coronary syndrome and congestive heart failure Circulation 2008;118:1163-1171.[Abstract/Free Full Text] 59. Ndrepepa G, Kastrati A, Mehilli J, et al. One-year clinical outcomes with abciximab vs. placebo in patients with non-ST-segment elevation acute coronary syndromes undergoing percutaneous coronary intervention after pre-treatment with clopidogrel: results of the ISAR-REACT 2 randomized trial Eur Heart J 2008;29:455-461.[Abstract/Free Full Text] 60. Mehta SR. Randomized comparison of early vs. delayed invasive strategies in high-risk patients with non-ST-segment elevation acute coronary syndromes: main results of the TIMing of intervention in Acute Coronary Syndrome (TIMACS) trialPaper presented at: Annual Scientific Session of the American Heart Association; November 10, 2008New Orleans, LA. 61. Taggart DP, Kaul S, Boden WE, et al. Revascularization for unprotected left main stem coronary artery stenosis. Stenting or surgery. J Am Coll Cardiol 2008;51:885-892.[Abstract/Free Full Text] 62. Teirstein PS. Unprotected left main intervention. Patient selection, operator technique, and clinical outcomes. J Am Coll Cardiol Intv 2008;1:5-13.[Abstract/Free Full Text] 63. Biondi-Zoccai GG, Lotrionte M, Moretti C, et al. A collaborative systematic review and meta-analysis on 1278 patients undergoing percutaneous drug-eluting stenting for unprotected left main coronary artery disease Am Heart J 2008;155:274-283.[CrossRef][Medline] 64. Meliga E, Garcia-Garcia HM, Valgimigli M, et al. Longest available clinical outcomes after drug-eluting stent implantation for unprotected left main coronary artery disease. The DELFT (Drug Eluting stent for LeFT main) registry. J Am Coll Cardiol 2008;51:2212-2219.[Abstract/Free Full Text] 65. Palmerini T, Marzocchi A, Tamburino C, et al. Impact of bifurcation technique on 2-year clinical outcomes in 773 patients with distal unprotected left main coronary artery stenosis treated with drug-eluting stents Circ Cardiovasc Intervent 2008;1:185-192.[Abstract/Free Full Text] 66. Mehilli J. ISAR-LEFT MAIN. A randomized clinical trial on drug-eluting stents for unprotected left main lesions. Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 14, 2008Washington, DC. 67. Seung KB, Park DW, Kim YH, et al. Stents versus coronary-artery bypass grafting for left main coronary artery disease N Engl J Med 2008;358:1781-1792.[CrossRef][Medline] 68. Rodes-Cabau J, DeBlois J, Bertrand OF, et al. Nonrandomized comparison of coronary artery bypass surgery and percutaneous coronary intervention for the treatment of unprotected left main coronary artery disease in octogenarians Circulation 2008;118:2374-2381.[Abstract/Free Full Text] 69. Brener S, Galla JM, Bryant R, et al. Comparison of percutaneous versus surgical revascularization of severe unprotected left main coronary stenosis in matched patients Am J Cardiol 2008;101:169-172.[CrossRef][Web of Science][Medline] 70. Dubois C, Dens J, Sinnaeve P, et al. Results of percutaneous coronary intervention of the unprotected left main coronary artery in 143 patients and comparison of 30-day mortality to results of coronary artery bypass grafting Am J Cardiol 2008;101:75-81.[CrossRef][Web of Science][Medline] 71. White AJ, Kedia G, Mirocha JM, et al. Comparison of coronary artery bypass surgery and percutaneous drug-eluting stent implantation for treatment of left main coronary artery stenosis J Am Coll Cardiol Intv 2008;1:236-245.[Abstract/Free Full Text] 72. Buszman PE, Kiesz SR, Bochenek A, et al. Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization J Am Coll Cardiol 2008;51:538-545.[Abstract/Free Full Text] 73. Serruys P. The Synergy between percutaneous coronary intervention with TAXUS and cardiac surgery (SYNTAX)Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 14, 2008Washington, DC. 74. Hannan EL, Wu C, Walford G, et al. Drug-eluting stents vs. coronary-artery bypass grafting in multivessel coronary disease N Engl J Med 2008;358:331-341.[CrossRef][Medline] 75. Park DW, Yun SC, Lee SW, et al. Long-term mortality after percutaneous coronary intervention with drug-eluting stent implantation versus coronary artery bypass surgery for the treatment of multivessel coronary artery disease Circulation 2008;117:2079-2086.[Abstract/Free Full Text] 76. Booth J, Clayton T, Pepper J, et al. Randomized, controlled trial of coronary artery bypass surgery versus percutaneous coronary intervention in patients with multivessel coronary artery disease: six-year follow-up from the Stent or Surgery trial (SoS) Circulation 2008;118:381-388.[Abstract/Free Full Text] 77. Daemen J, Kuck KH, Macaya C, et al. Multivessel coronary revascularization in patients with and without diabetes mellitus. 3-year follow-up of the ARTS-II (Arterial Revascularization Therapies Study-Part II) trial. J Am Coll Cardiol 2008;52:1957-1967.[Abstract/Free Full Text] 78. Daemen J, Boersma E, Flather M, et al. Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: a meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials Circulation 2008;118:1146-1154.[Abstract/Free Full Text] 79. Mohr FW. The Synergy between percutaneous coronary intervention with TAXUS and cardiac surgery (SYNTAX). Primary end point results at one year in subset of patients with three vessel disease. Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 14, 2008Washington, DC. 80. Pijls NHJ. Fractional flow reserve versus angiography for guiding PCI in patients with multivessel diseasePaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 14, 2008Washington, DC. 81. Goy JJ, Kaufmann U, Hurni M, et al. 10-year follow-up of a prospective, randomized trial comparing bare-metal stenting with internal mammary artery grafting for proximal, isolated de novo left anterior coronary artery stenosis. The SIMA (Stenting versus Internal Mammary Artery grafting) trial. J Am Coll Cardiol 2008;52:815-817.[Abstract/Free Full Text] 82. Kapoor JR, Gienger AL, Ardehali R, et al. Isolated disease of the proximal left anterior descending artery: comparing the effectiveness of percutaneous coronary interventions and coronary artery bypass surgery J Am Coll Cardiol Intv 2008;1:483-491.[Abstract/Free Full Text] 83. Holmes DR, Gersh BJ, Whitlow P, et al. Percutaneous coronary intervention for chronic stable angina. A reassessment. J Am Coll Cardiol Intv 2008;1:34-43.[Abstract/Free Full Text] 84. Weintraub WS, Spertus JA, Kolm P, et al. Effect of PCI on quality of life in patients with stable coronary disease N Engl J Med 2008;359:677-687.[CrossRef][Medline] 85. Schomig A, Mehilli J, de Waha A, et al. A meta-analysis of 17 randomized trials of a percutaneous coronary intervention-based strategy in patients with stable coronary artery disease J Am Coll Cardiol 2008;52:894-904.[Abstract/Free Full Text] 86. Frutkin AD, Mehta SK, Patel T, et al. Outcomes of 1,090 consecutive, elective, nonselected percutaneous coronary interventions at a community hospital without onsite cardiac surgery Am J Cardiol 2008;101:53-57.[CrossRef][Web of Science][Medline] 87. Singh M, Rihal CS, Gersh BJ, et al. Mortality differences between men and women after percutaneous coronary interventions. A 25-year, single-center experience. J Am Coll Cardiol 2008;51:2313-2320.[Abstract/Free Full Text] 88. Singh M, Peterson ED, Milford-Beland S, et al. Validation of the Mayo Clinic risk score for in-hospital mortality after percutaneous coronary interventions using the National Cardiovascular Data Registry Circ Cardiovasc Intervent 2008;1:36-44.[Abstract/Free Full Text] 89. Rao S, Ou FS, Wang TY, et al. Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention J Am Coll Cardiol Intv 2008;1:379-386.[Abstract/Free Full Text] 90. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery 1998 to 2007 J Am Coll Cardiol Intv 2008;1:317-326.[Abstract/Free Full Text] 91. Doyle BJ, Ting HH, Bell MR, et al. Major femoral bleeding complications after percutaneous coronary intervention J Am Coll Cardiol Intv 2008;1:202-209.[Abstract/Free Full Text] 92. Ndrepepa G, Berger PB, Mehilli J, et al. Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions J Am Coll Cardiol 2008;51:690-697.[Abstract/Free Full Text] 93. Jeremias A, Kleiman NS, Nassif D, et al. Prevalence and prognostic significance of preprocedural cardiac troponin elevation among patients with stable coronary artery disease undergoing percutaneous coronary intervention: results from the Evaluation of Drug Eluting Stents and Ischemic Events registry Circulation 2008;118:632-638.[Abstract/Free Full Text] 94. Prasad A, Rihal CS, Lennon RJ, et al. Significance or periprocedural myonecrosis on outcomes after percutaneous coronary intervention: an analysis of preintervention and postintervention troponin T levels in 5487 patients Circ Cardiovasc Intervent 2008;1:10-19.[Abstract/Free Full Text] 95. Wang TY, Peterson ED, Dai D, et al. Patterns of cardiac marker surveillance after elective percutaneous coronary intervention and implications for the use of periprocedural myocardial infarction as a quality metric: a report from the National Cardiovascular Data Registry (NCDR) J Am Coll Cardiol 2008;51:2068-2074.[Free Full Text] 96. From AM, Rihal CS, Lennon RJ, et al. Temporal trends and improved outcomes or percutaneous coronary revascularization in nonagenarians J Am Coll Cardiol Intv 2008;1:692-698.[Abstract/Free Full Text] 97. Mercado N, Brugts JJ, Ix JH, et al. Usefulness of proteinuria as a prognostic marker of mortality and cardiovascular events among patients undergoing percutaneous coronary intervention (data from the Evaluation of Oral Xemilofiban in Controlling Thrombotic Events [EXCITE] trial) Am J Cardiol 2008;102:1151-1155.[CrossRef][Web of Science][Medline] 98. Kip KE, Hollabaugh K, Marroquin OC, et al. The problem with composite end points in cardiovascular studies J Am Coll Cardiol 2008;51:701-707.[Abstract/Free Full Text] 99. Ormiston JA, Webster MW, Webber B, et al. The "crush" technique for coronary artery bifurcation stenting: insights from micro-computed tomographic imaging of bench deployments J Am Coll Cardiol Intv 2008;1:351-357.[Abstract/Free Full Text] 100. Hildick-Smith D. BBC-ONE. A randomized comparison of simple versus complex drug-eluting stenting for bifurcation lesions. Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008; Washington, DC. 101. Routledge HC, Morice MC, Lefèvre T, et al. 2-year outcome of patients treated for bifurcation coronary disease with provisional side branch T-stenting using drug-eluting stents J Am Coll Cardiol Intv 2008;1:358-365.[Abstract/Free Full Text] 102. Latib A, Colombo A. Bifurcation disease. What do we know, what should we do?. J Am Coll Cardiol Intv 2008;1:218-226.[Abstract/Free Full Text] 103. Gunnes P. The Nordic Bifurcation Stent Technique studyPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008Washington, DC. 104. Verheye S. The DIVERGE trialPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008Washington, DC. 105. Kereiakes DJ, Turco MA, Breall J, et al. A novel filter-based distal embolic protection device for percutaneous intervention of saphenous vein graft lesions. Results of the AMEthyst randomized controlled trial. J Am Coll Cardiol Intv 2008;1:248-257.[Abstract/Free Full Text] 106. Coolong A, Baim DE, Kuntz RE, et al. Saphenous vein graft stenting and major adverse cardiac events: a predictive model derived from a pooled analysis of 3958 patients Circulation 2008;117:790-797.[Abstract/Free Full Text] 107. Kirtane AJ, Heyman ER, Metzger C, et al. Correlates of adverse events during saphenous vein graft intervention with distal embolic protection. A PRIDE substudy. J Am Coll Cardiol 2008;1:186-191. 108. Safley DM, House JA, Marso SP, et al. Improvement in survival following successful percutaneous coronary intervention of coronary chronic total occlusion: variability by target vessel J Am Coll Cardiol Intv 2008;1:295-302.[Abstract/Free Full Text] 109. Cheng AS, Selvanayagam JB, Jerosch-Herold M, et al. Percutaneous treatment of chronic total occlusions improves regional hyperemic myocardial blood flow and contractility J Am Coll Cardiol Intv 2008;1:44-53.[Abstract/Free Full Text] 110. Courtney BK, Munce NR, Anderson KJ, et al. Innovations in imaging for chronic total occlusions: a glimpse into the future of angiography's blind-spot Eur Heart J 2008;29:583-593.[Abstract/Free Full Text] 111. Ormiston JA, Mahmud E, Turco MA, et al. Direct stenting with the Taxis Liberté drug-eluting stent J Am Coll Cardiol Intv 2008;1:150-160.[Abstract/Free Full Text] 112. Cuisset T, Hamilos M, Melikian N, et al. Direct stenting for stable angina pectoris is associated with reduced periprocedural microcirculatory injury compared with stenting after pre-dilation J Am Coll Cardiol 2008;51:1060-1065.[Abstract/Free Full Text] 113. Brasselet C, Blanpain T, Tassan-Mangina S, et al. Comparison of operator radiation exposure with optimized radiation protection devices during coronary angiograms and ad hoc percutaneous coronary interventions by radial and femoral routes Eur Heart J 2008;29:63-70.[Abstract/Free Full Text] 114. Wenaweser P, Daemen J, Zwahlen M, et al. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study. J Am Coll Cardiol 2008;52:1134-1140.[Abstract/Free Full Text] 115. De la Torre-Hernández JM, Alfonso F, Hernández F, et al. Drug-eluting stent thrombosis. Results from the multicenter Spanish registry ESTROFA (Estudio ESpanol sobre TROmbosis de stents FArmacoactivos). J Am Coll Cardiol 2008;51:986-990.[Abstract/Free Full Text] 116. Baran KW, Lasala JM, Cox DA, et al. A clinical risk score for prediction of stent thrombosis Am J Cardiol 2008;102:541-545.[CrossRef][Web of Science][Medline] 117. De la Torre-Hernández JM. The Spanish ESTROFA-2 registryPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008Washington, DC. 118. Maeng M. Large scale registry examining safety and efficacy of zotarolimus-eluting and sirolimus-eluting stents in patients with coronary artery disease. Western Denmark Heart Registry. Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008Washington, DC. 119. Lassen JF. SORT OUT III. A prospective randomized comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with coronary artery disease. Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008Washington, DC. 120. Galloe AM, Thuesen L, Kelbæk H, et al. Comparison of paclitaxel-eluting and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial JAMA 2008;299:409-416.[Abstract/Free Full Text] 121. Shinke T, Li J, Chen JP, et al. High incidence of intramural thrombus after overlapping paclitaxel-eluting stent implantation: angioscopic and histopathologic analysis in porcine coronary arteries Circ Cardiovasc Intervent 2008;1:28-35.[Abstract/Free Full Text] 122. Aoki J, Mintz GS, Weissman NJ, et al. Chronic arterial responses to overlapping paclitaxel-eluting stents: insights from serial intravascular ultrasound analyses in the TAXUS-V and -VI trials J Am Coll Cardiol Intv 2008;1:161-167.[Abstract/Free Full Text] 123. van der Hoeven BL, Liem SS, Dijkstra J, et al. Stent malapposition after sirolimus-eluting and bare-metal stent implantation in patients with ST-segment elevation myocardial infarction J Am Coll Cardiol Intv 2008;1:192-201.[Abstract/Free Full Text] 124. Nakazawa G, Finn AV, Joner M, et al. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study Circulation 2008;118:1138-1145.[Abstract/Free Full Text] 125. Takano M, Yamamoto M, Inami S, et al. Long-term follow-up evaluation after sirolimus-eluting stent implantation by optical coherence tomography. Do uncovered struts persist?. J Am Coll Cardiol 2008;51:968-969.[Free Full Text] 126. John MC, Wessely R, Kastrati A, et al. Differential healing responses in polymer and non-polymer-based sirolimus-eluting stents J Am Coll Cardiol Intv 2008;1:534-544. 127. Joner M, Nakazawa G, Finn AV, et al. Endothelial cell recovery between comparator polymer-based drug-eluting stents J Am Coll Cardiol 2008;52:333-342.[Abstract/Free Full Text] 128. Kim JW, Suh SY, Choi CU, et al. Six-month comparison of coronary endothelial dysfunction associated with sirolimus-eluting stent versus paclitaxel-eluting stent J Am Coll Cardiol Intv 2008;1:65-71.[Abstract/Free Full Text] 129. Jabs A, Göbel S, Wenzel P, et al. Sirolimus-induced vascular dysfunction J Am Coll Cardiol 2008;51:2130-2138.[Abstract/Free Full Text] 130. Hamilos MI, Ostojic M, Beleslin B, et al. Differential effects of drug-eluting stents on local endothelium-dependent coronary vasomotion J Am Coll Cardiol 2008;51:2123-2129.[Abstract/Free Full Text] 131. Hamilos M, Sarma J, Ostojic M, et al. Interference of drug-eluting stents with endothelium-dependent coronary vasomotion: evidence for device-specific responses Circ Cardiovasc Intervent 2008;1:193-200.[Abstract/Free Full Text] 132. Hannan EL, Racz M, Holmes DR, et al. Comparison of coronary artery stenting outcomes in the eras before and after the introduction of drug-eluting stents Circulation 2008;117:2071-2078.[Abstract/Free Full Text] 133. Malenka DJ, Kaplan AV, Lucas FL. Outcomes following coronary stenting in the era of bare-metal vs. the era of drug-eluting stents JAMA 2008;299:2868-2876.[Abstract/Free Full Text] 134. Groeneveld PW, Matta MA, Greenhut AP, et al. Drug-eluting compared with bare-metal coronary stents among elderly patients J Am Coll Cardiol 2008;51:2017-2024.[Abstract/Free Full Text] 135. Mauri L, Silbaugh TS, Wolf RE, et al. Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts Circulation 2008;118:1817-1827.[Abstract/Free Full Text] 136. Shishehbor MH, Goel SS, Kapadia SR, et al. Long-term impact of drug-eluting stents versus bare-metal stents on all-cause mortality J Am Coll Cardiol 2008;52:1041-1048.[Abstract/Free Full Text] 137. Applegate RJ, Sacrinty MT, Kutcher MA, et al. "Off-label" stent therapy. 2-year comparison of drug-eluting versus bare-metal stents. J Am Coll Cardiol 2008;51:607-614.[Abstract/Free Full Text] 138. Marroquin OC, Selzer F, Mulukutla SR, et al. A comparison of bare-metal and drug-eluting stents for off-label indications N Engl J Med 2008;358:342-352.[CrossRef][Medline] 139. Roy P, Buch AN, Javaid A, et al. Impact of "off-label" utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention Am J Cardiol 2008;101:293-299.[CrossRef][Web of Science][Medline] 140. Brodie BR, Stuckey T, Downey W, et al. Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) Group J Am Coll Cardiol Intv 2008;1:405-414.[Abstract/Free Full Text] 141. Austin D, Oldroyd KG, McConnachie A, et al. Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score matched outcome study Circ Cardiovasc Intervent 2008;1:45-52.[Abstract/Free Full Text] 142. Grines CL. Off label use of drug-eluting stents: putting it in perspective J Am Coll Cardiol 2008;51:615-617.[Free Full Text] 143. Mulukutla SR, Vlachos HA, Marroquin OC, et al. Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry J Am Coll Cardiol Intv 2008;1:139-147.[Abstract/Free Full Text] 144. Ortolani P, Balducelli M, Marzaroli P, et al. Two-year clinical outcomes with drug-eluting stents for diabetic patients with de novo coronary lesions: results from a real-world multicenter registry Circulation 2008;117:923-930.[Abstract/Free Full Text] 145. Garg P, Normand SL, Silbaugh TS, et al. Drug-eluting or bare-metal stenting in patients with diabetes mellitus: results from the Massachusetts data analysis center registry Circulation 2008;118:2277-2285.[Abstract/Free Full Text] 146. Kirtane AJ, Ellis SG, Dawkins KD, et al. Paclitaxel-eluting coronary stents in patients with diabetes mellitus. Pooled analysis from 5 randomized trials. J Am Coll Cardiol 2008;51:708-715.[Abstract/Free Full Text] 147. Mahmud E, Bromberg-Marin G, Palakodeti V, et al. Clinical efficacy of drug-eluting stents in diabetic patients. A meta-analysis. J Am Coll Cardiol 2008;51:2385-2395.[Abstract/Free Full Text] 148. Billinger M, Beutler J, Taghetchian KR, et al. Two-year clinical outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents in diabetic patients Eur Heart J 2008;29:718-725.[Abstract/Free Full Text] 149. Lee SW, Park SW, Kim YH, et al. A randomized comparison of sirolimus- versus paclitaxel-eluting stent implantation in patients with diabetes mellitus J Am Coll Cardiol 2008;52:727-733.[Abstract/Free Full Text] 150. Pucelikova T, Mehran R, Kirtane AJ, et al. Short- and long-term outcomes after stent-assisted percutaneous treatment of saphenous vein grafts in the drug-eluting stent era Am J Cardiol 2008;101:63-68.[CrossRef][Web of Science][Medline] 151. Okabe T, Lindsay J, Buch AN, et al. Drug-eluting stents versus bare metal stents for narrowing in saphenous vein grafts Am J Cardiol 2008;102:530-534.[CrossRef][Web of Science][Medline] 152. Brilakis ES. The SOS (Stenting Of Saphenous vein grafts) randomized, controlled trial of a paclitaxel-eluting stent vs. a similar bare-metal stent in saphenous vein graft lesionsPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 14, 2008Washington, DC. 153. Alfonso F, Perez-Vizcayno M, Hernandez R, et al. Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis J Am Coll Cardiol 2008;52:1621-1627.[Abstract/Free Full Text] 154. Ellis SG, O'Shaughnessy CD, Martin SL, et al. Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial Eur Heart J 2008;29:1625-1634.[Abstract/Free Full Text] 155. Holmes DR, Teirstein PS, Satler L, et al. 3-year follow-up of the SISR (sirolimus-eluting stents versus vascular brachytherapy for in-stent restenosis) trial J Am Coll Cardiol Intv 2008;1:439-448.[Abstract/Free Full Text] 156. Stone GW, Midei M, Newman W, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial JAMA 2008;299:1903-1913.[Abstract/Free Full Text] 157. Chevalier B, Di Mario C, Neumann FJ, et al. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of zotarolimus-versus paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries. The ZoMaxx I trial. J Am Coll Cardiol Intv 2008;1:524-532.[Abstract/Free Full Text] 158. Turco MA, Ormiston JA, Popma JJ, et al. Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut Taxus Liberté stent J Am Coll Cardiol Intv 2008;1:699-709.[Abstract/Free Full Text] 159. Windecker S, Serruys PW, Wandel S, et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularization (LEADERS): a randomized non-inferiority trial Lancet 2008;372:1163-1173.[CrossRef][Web of Science][Medline] 160. Byrne RA. A polymer-free dual drug-eluting stent in patients with coronary artery disease: randomized trial versus polymer-based DES (ISAR-TEST 2 trial)Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008Washington, DC. 161. Mehilli J, Byrne RA, Wieczorek A, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis Eur Heart J 2008;29:1975-1982.[Abstract/Free Full Text] 162. Jabara R, Chronos N, Conway D, et al. Evaluation of a novel slow-release paclitaxel-eluting stent with a bioresorbable polymeric surface coating J Am Coll Cardiol Intv 2008;1:81-87.[Abstract/Free Full Text] 163. Costa JR, Abizaid A, Costa R, et al. Preliminary results of the hydroxyapatite nonpolymer-based sirolimus-eluting stent for the treatment of single de novo coronary lesions. A first-in-human analysis of a third-generation drug-eluting stent system. J Am Coll Cardiol Intv 2008;1:545-551.[Abstract/Free Full Text] 164. Krucoff MW, Kereiakes DJ, Peterson JL, et al. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease. Primary results of the COSTAR (Cobalt Chromium Stent with Antiproliferative for Restenosis) II study. J Am Coll Cardiol 2008;51:1543-1552.[Abstract/Free Full Text] 165. Ormiston JA, Serruys PW, Regar E, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial Lancet 2008;371:899-907.[CrossRef][Web of Science][Medline] 166. Vlaar PJ, Svilaas T, Damman K, et al. Impact of pretreatment with clopidogrel on initial patency and outcome in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a systematic review Circulation 2008;118:1828-1836.[Abstract/Free Full Text] 167. Widimsk P, Motovská,  imek S, et al. Clopidogrel pre-treatment in stable angina: for all patients >6h before elective coronary angiography or only for angiographically selected patients a few minutes before PCI: a randomized multicentre trial PRAGUE-8 Eur Heart J 2008;29:1495-1503.[Abstract/Free Full Text] 168. L'Allier P, Ducrocq G, Pranno N, et al. Clopidogrel 600-mg double loading achieves stronger platelet inhibition than conventional regimens. Results from the PREPAIR randomized study. J Am Coll Cardiol 2008;51:1066-1072.[Abstract/Free Full Text] 169. Collet JP, Silvain J, Landiver A, et al. Dose effect of clopidogrel reloading in patients already on 75-mg maintenance dose: the Reload with Clopidogrel Before Coronary Angioplasty in Subjects Treated Long Term with Dual Antiplatelet Therapy (RELOAD) Study Circulation 2008;118:1225-1233.[Abstract/Free Full Text] 170. Di Sciascio G. Prospective, multicenter, randomized, double blind trial investigating influence on PCI outcome of additional clopidogrel load in patients on chronic therapy—ARYMYDA-Reload. Paper presented at: Annual Scientific Session of the American College of Cardiology; April 1, 2008; Chicago, Illinois. 171. Gori A, Marucci R, Migliorini A, et al. Incidence and clinical impact of dual nonresponsiveness to aspirin and clopidogrel in patients with drug-eluting stents J Am Coll Cardiol 2008;52:734-739.[Abstract/Free Full Text] 172. Patti G, Nusca A, Mangicapra F, et al. Point-of-care measurement of clopidogrel responsiveness predicts clinical outcome in patients undergoing percutaneous coronary intervention. Results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of Myocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) Study. J Am Coll Cardiol 2008;52:1128-1133.[Abstract/Free Full Text] 173. Price MJ, Endemann S, Gollapudi RR, et al. Prognostic significance of post-clopidogrel platelet reactivity assessed by point-of-care assay on thrombotic events after drug-eluting stent implantation Eur Heart J 2008;29:992-1000.[Abstract/Free Full Text] 174. Bonello L, Camoin-Jau L, Arques S, et al. Adjusted clopidogrel loading doses according to vasodilator-stimulated phosphoprotein phosphorylation index decrease rate of major adverse cardiac events in patients with clopidogrel resistance. A multicenter randomized prospective study. J Am Coll Cardiol 2008;51:1404-1411.[Abstract/Free Full Text] 175. Trenk D, Hochholzer W, Fromm MF, et al. Cytochrome P450 2C19 681G>A polymorphism and high on-clopidogrel platelet reactivity associated with adverse 1-year clinical outcome of elective percutaneous coronary intervention with drug-eluting or bare-metal stents J Am Coll Cardiol 2008;51:1925-1934.[Abstract/Free Full Text] 176. Bliden KP, DiChiara J, Lawal L, et al. The association of cigarette smoking with enhanced platelet inhibition by clopidogrel J Am Coll Cardiol 2008;52:531-533.[Abstract/Free Full Text] 177. Gilard M, Arnaud B, Cornily JC, et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin. The randomized, double-blind OCLA (Omeprazole Clopidogrel Aspirin) study. J Am Coll Cardiol 2008;51:256-260.[Abstract/Free Full Text] 178. Wiviott SD, Braunwald E, McCabe CH, et al. Intensive oral antiplatelet therapy for reduction of ischemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomized trial Lancet 2008;371:1353-1363.[CrossRef][Web of Science][Medline] 179. Antman EM, Wiviott SD, Murphy SA, et al. Early and late benefits of prasugrel in patients with acute coronary syndromes undergoing percutaneous coronary intervention. A TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis in Myocardial Infarction) analysis. J Am Coll Cardiol 2008;51:2028-2033.[Abstract/Free Full Text] 180. Park SW. The DECREASE Registry. Drug-eluting stenting followed by cilostazol treatment reduces adverse serious cardiac events. 2008Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 14,; Washington, DC. 181. Lee SW, Park SW, Kim YH, et al. Drug-eluting stenting followed by cilostazol treatment reduces late restenosis in patients with diabetes mellitus. The DECLARE-DIABETES trial (a Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients). J Am Coll Cardiol 2008;51:1181-1187.[Abstract/Free Full Text] 182. Pinto DS, Stone GW, Shi C, et al. Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes J Am Coll Cardiol 2008;52:1758-1768.[Abstract/Free Full Text] 183. White HD, Ohman EM, Lincoff AM, et al. Safety and efficacy of bivalirudin with and without glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes undergoing percutaneous coronary intervention. 1-year results from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. J Am Coll Cardiol 2008;52:807-814.[Abstract/Free Full Text] 184. White HD, Chew DP, Hoekstra JW, et al. Safety and efficacy of switching from either unfractionated heparin or enoxaparin to bivalirudin in patients with non-ST-segment elevation acute coronary syndromes managed with an invasive strategy J Am Coll Cardiol 2008;51:1734-1741.[Abstract/Free Full Text] 185. Antoniucci D. A randomized trial comparing bivalirudin with unfractionated heparin in patients undergoing elective PCI (ARNO trial)Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 15, 2008Washington, DC. 186. Briguori C. Randomized comparison of bivalirudin monotherapy versus unfractionated heparin plus tirofiban in diabetic patients undergoing elective coronary stentingPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 15, 2008Washington, DC. 187. Feit F, Manoukian SV, Ebrahimi R, et al. Safety and efficacy of bivalirudin monotherapy in patients with diabetes mellitus and acute coronary syndromes. A report from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. J Am Coll Cardiol 2008;51:1645-1652.[Abstract/Free Full Text] 188. Kastrati A, Neumann FJ, Mehilli J, et al. Bivalirudin versus unfractionated heparin during percutaneous coronary intervention N Engl J Med 2008;359:688-696.[CrossRef][Web of Science][Medline] 189. Cortese B. Prolonged bivalirudin infusion versus intraprocedural only randomized study: the PROBI VIRI studyPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 15, 2008Washington, DC. 190. Mehta SR, Boden WE, Eikelboom JW, et al. Antithrombotic therapy with fondaparinux in relation to interventional management strategy in patients with ST- and non ST-segment elevation acute coronary syndromes: an individual patient level combined analysis of the fifth and sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) randomized trials Circulation 2008;118:2038-2046.[Abstract/Free Full Text] 191. Stabile E, Nammas W, Salemme L, et al. The CIAO (Coronary Interventions Antiplatelet-based Only) study. A randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention. J Am Coll Cardiol 2008;52:1293-1298.[Abstract/Free Full Text] 192. Karjalainen PP, Vikman S, Niemela M, et al. Safety of percutaneous coronary intervention during uninterrupted oral anticoagulant treatment Eur Heart J 2008;29:1001-1010.[Abstract/Free Full Text] 193. Rossini R, Musumeci G, Lettieri C, et al. Long-term outcomes in patients undergoing coronary stenting on dual oral antiplatelet treatment requiring oral anticoagulant therapy Am J Cardiol 2008;102:1618-1623.[CrossRef][Web of Science][Medline] 194. Brar SS, Shen AY, Jorgensen MB, et al. Sodium bicarbonate vs. sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography. A randomized trial. JAMA 2008;300:1038-1046.[Abstract/Free Full Text] 195. Maioli M, Toso A, Leoncini M, et al. Sodium bicarbonate versus saline for the prevention of contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention J Am Coll Cardiol 2008;52:599-604.[Abstract/Free Full Text] 196. Hogan S, L'Allier P, Chetcuti S, et al. Current role of sodium bicarbonate-based preprocedural hydration for the prevention of contrast-induced acute kidney injury: a meta-analysis Am Heart J 2008;156:414-421.[CrossRef][Web of Science][Medline] 197. Kane GC, Doyle BJ, Lerman A, et al. Ultra-low contrast volumes reduced rates of contrast-induced nephropathy in patients with chronic kidney disease undergoing coronary angiography J Am Coll Cardiol 2008;51:89-90.[Free Full Text] 198. Harjai KJ, Raizada A, Shenoy C, et al. A comparison of contemporary definitions of contrast nephropathy in patients undergoing percutaneous coronary intervention and a proposal or a novel nephropathy grading system Am J Cardiol 2008;101:812-819.[CrossRef][Web of Science][Medline] 199. Stone GW. COOL-RCN. A prospective, randomized examining the safety and efficacy of systemic hypothermia for the prevention of radiocontrast nephropathy. Paper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 14, 2008Washington, DC. 200. McCullough PA. Contrast-induced acute kidney injury J Am Coll Cardiol 2008;51:1419-1428.[Abstract/Free Full Text] 201. Creager MA, White CJ, Hiatt WR, et al. Atherosclerotic peripheral vascular disease symposium II. Executive summary. Circulation 2008;118:2811-2825.[Free Full Text] 202. Hiatt WR, Goldstone J, Smith SC, et al. Atherosclerotic peripheral vascular disease symposium II. Nomenclature for vascular diseases. Circulation 2008;118:2826-2829.[Free Full Text] 203. Criqui MH, Alberts MJ, Fowkes GR, et al. Atherosclerotic peripheral vascular disease symposium II. Screening for atherosclerotic vascular disease: should nationwide programs be instituted?. Circulation 2008;118:2830-2836.[Free Full Text] 204. Josephs SC, Rowley HA, Rubin GD. Atherosclerotic peripheral vascular disease symposium II. Vascular magnetic resonance and computed tomographic imaging. Circulation 2008;118:2837-2844.[Free Full Text] 205. Alberts MJ, Felberg RA, Guterman LR, et al. Atherosclerotic peripheral vascular disease symposium II. Stroke intervention: state of the art. Circulation 2008;118:2845-2851.[Free Full Text] 206. White CJ, Beckman JA, Cambria RP, et al. Atherosclerotic peripheral vascular disease symposium II. Controversies in carotid artery revascularization. Circulation 2008;118:2852-2859.[Free Full Text] 207. Pearce WH, Zarins CK, Bacharach JM. Atherosclerotic peripheral vascular disease symposium II. Controversies in abdominal aortic aneurysm repair. Circulation 2008;118:2860-2863.[Free Full Text] 208. Gray BH, Conte MS, Dake, MD, et al. Atherosclerotic peripheral vascular disease symposium II. Lower-extremity revascularization: state of the art. Circulation 2008;118:2864-2872.[Free Full Text] 209. Rocha-Singh KJ, Eisenhauer AC, Textor SC, et al. Atherosclerotic peripheral vascular disease symposium II. Intervention for renal artery disease. Circulation 2008;118:2873-2878.[Free Full Text] 210. Gurm H, Nallamothu BK, Yadav J. Safety of carotid artery stenting for symptomatic carotid artery disease: a meta-analysis Eur Heart J 2008;29:113-119.[Abstract/Free Full Text] 211. Iyer S, White CJ, Hopkins LN, et al. Carotid artery revascularization in high-surgical risk patients using the Carotid WALLSTENT and FilterWire EX/EZ. 1-year outcomes in the BEACH pivotal group. J Am Coll Cardiol 2008;51:427-434.[Abstract/Free Full Text] 212. Myla S. Evaluating the use of the FiberNet embolic protection system in carotid artery stentingPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008Washington, DC. 213. Hopkins LN. EMPiRE: a multicenter registry evaluating neuroprotection during carotid stenting with a novel flow reversal systemPaper presented at: Transcatheter Cardiovascular Therapeutics 2008; October 16, 2008Washington, DC. 214. Schofer J, Arendt M, Tubler T, et al. Late cerebral embolization after emboli-protected carotid artery stenting assessed by sequential diffusion-weighted magnetic resonance imaging J Am Coll Cardiol Intv 2008;1:571-577.[Abstract/Free Full Text] 215. Lin MS, Lin LC, Li HY, et al. Procedural safety and potential vascular complication of endovascular recanalization for chronic cervical internal carotid artery occlusion Circ Cardiovasc Intervent 2008;1:119-125.[CrossRef] 216. Levy EI, Mocco J, Samuelson RM, et al. Optimal treatment of carotid artery disease J Am Coll Cardiol 2008;51:979-985.[Abstract/Free Full Text] 217. Cooper CJ, Haller ST, Coyler W, et al. Embolic protection and platelet inhibition during renal artery stenting Circulation 2008;117:2752-2760.[Abstract/Free Full Text] 218. Mahmud E, Smith TWR, Palakodeti V, et al. Renal frame count and renal blush grade J Am Coll Cardiol Intv 2008;1:286-292.[Abstract/Free Full Text] 219. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg N Engl J Med 2008;358:689-699.[CrossRef][Medline] 220. Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: Femoral Paclitaxel Randomized Pilot Trial Circulation 2008;118:1358-1365.[Abstract/Free Full Text] 221. Grube E, Buellesfeld L, Mueller R, et al. Progress and current status of percutaneous aortic valve replacement: results of three device generations of the CoreValve revalving system Circ Cardiovasc Intervent 2008;1:167-175.[Abstract/Free Full Text] 222. Linke A, Hollriegel R, Walther T, et al. Ingrowths of a percutaneously implanted aortic valve prosthesis (CoreValve) in a patient with severe aortic stenosis Circ Cardiovasc Intervent 2008;1:155-158.[Free Full Text] 223. Schofer J, Schlüter M, Treede H, et al. Retrograde transarterial implantation of a nonmetallic aortic valve prosthesis in high surgical-risk patients with severe aortic stenosis: a first-in-man feasibility and safety study Circ Cardiovasc Intervent 2008;1:126-133.[CrossRef] 224. Piazza N, Onuma Y, Jesserun E, et al. Early and persistent intraventricular conduction abnormalities and requirements for pacemaking after percutaneous replacement of the aortic valve J Am Coll Cardiol Intv 2008;1:310-316.[Abstract/Free Full Text] 225. Sinhal A, Altwegg L, Pasputi S, et al. Atrioventricular block after transcatheter balloon expandable aortic valve implantation J Am Coll Cardiol Intv 2008;1:305-309.[Abstract/Free Full Text] 226. Babaliaros VC, Liff D, Chen EP, et al. Can balloon aortic valvuloplasty help determine appropriate transcatheter aortic valve size? J Am Coll Cardiol Intv 2008;1:580-586.[Abstract/Free Full Text] 227. Zegdi R, Ciobotaru V, Noghin M, et al. Is it reasonable to treat all calcified stenotic valves with a valved stent?. Results from a human anatomic study in adults. J Am Coll Cardiol 2008;51:579-584.[Abstract/Free Full Text] 228. Chiam PTL, Ruiz C. Percutaneous transcatheter aortic valve implantation: assessing results, judging outcomes, and planning trials: the interventionalist perspective J Am Coll Cardiol Intv 2008;1:341-350.[Abstract/Free Full Text] 229. Webb JG. Percutaneous aortic valve replacement will become a common treatment for aortic valve disease J Am Coll Cardiol Intv 2008;1:122-126.[Abstract/Free Full Text] 230. Vahanaian A, Alfieri O, Al-Attar N, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur Heart J 2008;29:1463-1470.[Abstract/Free Full Text] 231. Sorajja P, Nishimura RA, Thompson J, et al. A novel method of percutaneous mitral valve repair for ischemic mitral regurgitation J Am Coll Cardiol Intv 2008;1:663-672.[Abstract/Free Full Text] 232. Lurz P, Coats L, Khambadkone S, et al. Percutaneous pulmonary valve implantation Circulation 2008;117:1964-1972.[Abstract/Free Full Text] 233. Dowson A, Mullen MJ, Peatfield R, et al. Migraine intervention with STARFlex technology (MIST) Trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache Circulation 2008;117:1397-1404.[Abstract/Free Full Text] 234. Taafe M, Fischer E, Baranowski A, et al. Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder) Am J Cardiol 2008;101:1353-1358.[CrossRef][Web of Science][Medline] 235. Hildick-Smith D, Behan M, Haworth P, et al. Patent foramen ovale closure without echocardiographic control: use of "standby" intracardiac ultrasound J Am Coll Cardiol Intv 2008;1:387-391.[Abstract/Free Full Text] 236. Sorajja P, Valeti U, Nishimura RA, et al. Outcome of alcohol septal ablation for obstructive hypertrophic cardiomyopathy Circulation 2008;118:131-139.[Abstract/Free Full Text] 237. Fernandes VL, Nielsen C, Nagueh SF, et al. Follow-up of alcohol septal ablation for symptomatic hypertrophic obstructive cardiomyopathy: the Baylor and Medical University of South Carolina experience 1996 to 2007 J Am Coll Cardiol Intv 2008;1:561-570.[Abstract/Free Full Text] 238. Kwon DH, Kapadia SR, Tuzcu M, et al. Long-term outcomes in high-risk symptomatic patients with hypertrophic cardiomyopathy undergoing alcohol septal ablation J Am Coll Cardiol Intv 2008;1:432-438.[Abstract/Free Full Text]
Related Article
-
Inside This Issue
J. Am. Coll. Cardiol. 2009 53: A29.
[Full Text]
[PDF]
This article has been cited by other articles:
|
|
|
|
 
R. P. Giugliano and E. Braunwald
The Year in Non-ST-Segment Elevation Acute Coronary Syndrome
J. Am. Coll. Cardiol.,
October 13, 2009;
54(16):
1544 - 1555.
[Full Text]
[PDF]
|
|
|
|
Top
Percutaneous Coronary...
Acute Myocardial Infarction...