YEAR IN CARDIOLOGY SERIES
The Year in Interventional Cardiology
Simon R. Dixon, MBChB*,*,
Cindy L. Grines, MD* and
William W. O'Neill, MD
* William Beaumont Hospital, Royal Oak, Michigan
University of Miami, Miami, Florida
Manuscript received December 28, 2009;
accepted February 2, 2010.
* 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 • stent • vascular • peripheral
We are honored to provide readers of the Journal with this review of major scientific work in the field of Interventional Cardiology in 2009. In addition, we have included late-breaking trials presented at the American College of Cardiology, Transcatheter Cardiovascular Therapeutics, European Society of Cardiology, and American Heart Association conferences. We hope that this article 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.
 |
Focused Update
|
|---|
A focused update of American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions guidelines for ST-segment elevation myocardial infarction (STEMI) and percutaneous coronary intervention (PCI) was published in 2009 (1). Important changes in this update are summarized in Table 1. Readers are encouraged to examine this document in detail.
|
Acute Myocardial Infarction
|
|---|
Primary PCI.
In a meta-analysis of 23 randomized and 32 observational studies, Huynh et al. (2) reported significant improvement in mortality, stroke, and reinfarction comparing primary PCI with thrombolysis.
PCI after thrombolysis.
Although the role of facilitated PCI remains controversial, many studies suggest it is superior to thrombolysis alone. The TRANSFER-AMI (Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction) study enrolled 1,059 high-risk STEMI patients treated with lytics at non-PCI centers and randomized them to immediate transfer for PCI within 6 h versus delayed catheterization (3). Immediate transfer for PCI was associated with reduced major adverse cardiac event (MACE) (11.0% vs. 17.2%; p = 0.004) with no increase in major bleeding. A Norwegian study (4) randomized 266 patients treated with tenecteplase in remote hospitals (>90-min transfer times) to immediate transfer for PCI versus conservative care. The group randomized to transfer for PCI had reduced ischemia at 30 days and an improved composite of death, myocardial infarction (MI), or stroke at 12 months. Similarly, the 1-year follow-up of the REACT (Rescue Angioplasty versus Conservative Management or Repeat Thrombolysis) trial found that rescue PCI after failed thrombolysis (5) improved event-free survival compared with conservative care (81.5% vs. 67.5%; p = 0.004).
Facilitated PCI.
Conversely, pharmacologic facilitation is of no benefit compared with primary PCI. The FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial reported that thrombolytic- or abciximab-mediated facilitation, or both, before PCI was associated with higher bleeding but no short-term clinical advantage compared with primary PCI. However, at 1 year, a trend for lower mortality was suggested in facilitated patients with anterior MI (6.5% vs. 9.9%; p = 0.093) (6) or in high-risk patients who sought treatment at a remote hospital within the first few hours from symptom onset (7).
Drug-eluting stents (DES).
A meta-analysis of 13 trials randomizing 7352 patients to DES versus bare-metal stents (BMS) for acute myocardial infarction (AMI) found reduced target vessel revascularization (TVR) (relative risk: 0.44; 95% confidence interval: 0.35 to 0.55), but no increased risk of death, MI, or stent thrombosis (ST) (8). Long-term follow-up of randomized trials suggest continued safety and efficacy of DES compared with BMS (9–13). A recently reported randomized trial (n = 466) confirmed that the sirolimus-eluting stent (SES) was superior to the BMS at improving restenosis and TVR (14). An endothelial progenitor cell capture stent had similar restenosis rates but slightly higher ST compared with BMS in a small trial (15).
Thrombectomy.
In 2 small randomized trials, aspiration thrombectomy during primary PCI was associated with higher rate of ST-segment resolution and myocardial blush grade of 2 or more (16,17). In a substudy of 1 trial, patients with anterior STEMI treated with thrombectomy had less microvascular obstruction and smaller infarct on cardiac MRI (16). In the other study, the thrombus aspiration group had a higher ejection fraction (EF) and less remodeling at 6 months (17).
In contrast to these findings, a randomized trial using proximal embolic protection (Proxis, St. Jude Medical, St. Paul, Minnesota) found no difference in ST-segment resolution at 60 min in patients treated with the protection device (18). However, there did seem to be a higher rate of immediate complete ST-segment resolution in the Proxis group.
Adjunctive agents.
Several studies in 2009 investigated novel pharmacologic or mechanical therapies to limit myocardial injury in AMI. In patients with anterior wall STEMI of <6 h, Stone et al. (19) demonstrated that a 90-minute infusion of supersaturated oxygen into the left anterior descending coronary artery (LAD) after reperfusion significantly decreased infarct size compared with controls (18.5% vs. 25% of the left ventricle [LV]; p = 0.02). Sezer et al. (20) found that intracoronary streptokinase administered immediately after reperfusion reduced infarct size and LV volumes at 6 months. In a small randomized trial, high-dose erythropoietin administered during primary PCI (with repeat doses at 24 and 48 h) had no effect on convalescent LV EF assessed by magnetic resonance imaging (MRI) at 6 months (21). Fokkema et al. (22) randomized 448 patients to 2 doses of intracoronary adenosine (120 µg) or placebo after thrombectomy. The primary end point, residual ST-segment elevation at 30 to 60 min after PCI, was not significantly different between groups. In another trial (n = 234), intravenous FX06 (a naturally occurring peptide derived from human fibrin) reduced necrotic core 58% on MRI at day 5, but there was no difference in scar size at 4 months (23).
Transfusion.
There has been increased attention to the impact of blood transfusion after PCI. Three studies in 2009 identified a strong relationship between blood transfusion after primary PCI and increased risk of short- and long-term mortality (24–26). Whether blood transfusion plays a causative role in these adverse outcomes or is simply a marker of increased risk remains unclear. Nonetheless, these data should serve as a call to re-examine the indications and optimal threshold for transfusion in anemic patients after PCI.
Outcomes.
Two studies evaluated the relationship between volume and primary PCI outcomes. Srinivas et al. (27) studied 7,321 AMI patients in the New York State PCI Registry. Risk-adjusted in-hospital mortality was highest for low-volume operators (<10/year) in low-volume hospitals (<50/year) compared with high-volume physicians in high-volume centers. In another analysis, Kumbhani et al. (28) found high-volume primary PCI centers (>70/year) had shorter door-to-balloon times, but similar in-hospital mortality to medium-volume (36 to 70/year) and low-volume (<36/year) centers.
Cardiogenic shock.
Lim et al. (29) evaluated the outcomes of PCI for cardiogenic shock in 45 elderly patients ( 75 years of age). Rates of stenting (86.7%) and IIb/IIIa use (68.9%) were much higher than in prior shock studies. In-hospital and 1-year survival was similar to that of younger patients (<75 years of age). These data suggest that percutaneous revascularization is reasonable in carefully selected elderly patients with shock complicating AMI. Mehta et al. (30) examined Thrombolysis In Myocardial Infarction (TIMI) flow after PCI in shock patients and found that patients with TIMI flow grade <3 had a substantially higher mortality (63% vs. 27%) than patients with TIMI flow grade 3.
Cell therapy.
Very small embryonic-like stem cells have been found in peripheral blood samples of AMI patients, but not in normal volunteers (31), suggesting that these may play a role in cardiac and endothelial repair. Intracoronary infusion of bone marrow-derived stem cells was shown to improve regional myocardial function (32) and global ejection fraction (33) in prospective, randomized trials. A nonrandomized observational study also suggested improved LV function, exercise capacity, and mortality in AMI patients treated with intracoronary stem cells (34).
|
Acute Coronary Syndromes (ACS)
|
|---|
Timing of intervention.
Although the efficacy of invasive management of ACS is well established, optimal timing of intervention and adjunctive pharmacotherapy is not settled. The year 2009 brought numerous trials in this area. Mehta et al. (35) randomized 3,031 patients with ACS to early routine invasive (<24 h from admission) versus delayed (>36 h from admission) intervention. The trial found no difference in 6-month death/MI/stroke (9.6% vs. 11.3%; p = 0.15) for early versus delayed intervention. For patients in the highest tertile of risk (GRACE [Global Registry of Acute Coronary Events] score >140), outcome was improved with early intervention (13.9% vs. 21%; p = 0.006). A second trial, ABOARD (Angioplasty to Blunt the Rise of Troponin in ACS), evaluated the efficacy of immediate versus delayed intervention in blunting troponin increase (36). Neither peak troponin level nor death/MI/TVR at 1 month was lessened by immediate intervention. Finally, Giugliano et al. (37) evaluated early versus delayed provisional use of eptifibatide in 9,492 patients with ACS who underwent PCI. No difference in death or MI occurred, and early eptifibatide use resulted in more bleeding and a higher need for transfusion (8.6% vs. 6.7%; p = 0.001). Taken together, these trials suggest equivalent efficacy for an immediate or delayed PCI strategy in patients with ACS, with perhaps a need for early intervention in high-risk patients.
Outcomes.
Several substudies of the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial were reported. Nikolsky et al. (38) highlighted the catastrophic prognostic implications of gastrointestinal bleeding (GIB) after PCI. One-year mortality was greater (21.9% vs. 3.9%; p < 0.0001) for the 1.3% of patients who had GIB. In addition, composite ischemia and acute ST was significantly higher (5.8% vs. 2.4%; p = 0.009). Risk factors for GIB included age, smoking status, and baseline anemia. Mehran et al. (39) assessed the prognostic impact of chronic kidney disease. Patients with creatinine clearance of <60 ml/min had a significantly higher 1-year mortality (7.9% vs. 2.8%; p < 0.001) and higher rates of ischemia and GIB. Bivalirudin appeared to lessen the risk of bleeding but did not influence 1-year mortality. Lopes et al. (40) evaluated the impact of age and found that patients older than 75 years had significantly worse outcomes. These patients were more likely to be female, to have lower weight, and to have lower creatinine clearance. Major bleeding was lessened with bivalirudin in these elderly patients (1.7% vs. 3.6%; p < 0.05) compared with heparin plus glycoprotein IIb/IIIa inhibitors. Finally, Prasad et al. (41) examined the prognostic impact of periprocedural or spontaneous MI occurring after PCI. PCI-related MI occurred in 6% of patients, and during follow-up, spontaneous MI occurred in 2.6% of patients. One-year mortality was 16% after spontaneous MI, 6% after periprocedural MI, and 2.6% when no MI occurred (p < 0.0001). Although spontaneous MI did worsen prognosis independently, periprocedural MI did not do so when baseline variable differences were accounted for in linear regression analysis.
|
Elective PCI
|
|---|
Revascularization criteria.
Early in 2009, an important document summarizing appropriateness criteria for coronary revascularization was published (42). In brief, these criteria were developed by scoring 180 prototypical clinical scenarios on a scale of 1 to 9 as inappropriate (1 through 3), uncertain (4 through 6), or appropriate (7 through 9). Key components of the criteria include patient clinical status, level of medical therapy, stress testing findings, and coronary anatomic features. Although these criteria were developed to assist clinicians, health care facilities, payors, and patients, it is important to emphasize that they are not intended to be a substitute for clinical judgment and experience. Nonetheless, the criteria are likely to be studied closely by payors, especially in the current economic climate. Readers are encouraged to review the article in detail.
Medical therapy.
The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) (43) trial provided further debate in the interventional community, but overall adds to the body of evidence that medical therapy is an excellent initial strategy in patients with stable coronary disease. A total of 2,368 patients with type 2 diabetes were randomized to intensive medical therapy or revascularization (PCI or coronary artery bypass graft surgery [CABG]) with medical therapy. At the 5-year follow-up, there was no difference in the rate of death or the composite of death/MI/stroke. Of note, however, 42% of patients in the medical therapy arm crossed over to revascularization. Additionally, patients in the revascularization arm who underwent CABG had fewer adverse events at follow-up compared with medically treated patients, driven largely by a reduced incidence of MI. A meta-analysis by Trikalinos et al. (44) reaffirmed prior observations that PCI does not impact the rate of death or MI in patients with stable disease.
LAD disease.
Thiele et al. (45) presented results of a randomized trial of SES versus minimally invasive coronary artery bypass surgery for isolated proximal LAD disease. At 12 months, TVR was higher for the SES group, but overall, MACE was identical in each group (7.7%).
Multivessel disease.
Results of the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial were published in 2009. One thousand ninety-five patients with 3-vessel or left main disease were randomized to CABG (n = 549) or multivessel PCI with the Taxus DES (n = 546) (46). At 1 year, there was a higher incidence of MACE (death, MI, stroke, repeat revascularization) in the PCI group compared with the CABG group (17.8% vs. 12.4%; p = 0.002). This was driven largely by a higher need for TVR in the PCI group, however, there was a lower risk of stroke (0.6% vs. 2.2%; p = 0.003). The difference in MACE was greatest in patients with more complex coronary disease (SYNTAX score, 33).
In an observational study of 3,720 patients with multivessel disease, patients treated with DES had a higher 3-year rate of TVR, death, and MI (47). In contrast, Hlatky et al. (48) found no difference in long-term survival in a meta-analysis of 7,812 patients treated with PCI (37% BMS; 63% percutaneous transluminal coronary angioplasty) versus CABG; however, in patients with diabetes, mortality was lower in the CABG group.
Left main disease.
There is a growing body of evidence to support PCI for unprotected left main coronary artery disease. Several observational studies provided long-term outcome data with BMS and DES (49–52) (Table 2). In aggregate, DES seemed to reduce risk of TVR and MACE. Among patients with distal bifurcation disease, 2 observational studies demonstrated higher rates of adverse events when side-branch stenting was performed compared with main vessel stenting alone (51,52). Two studies (1 nonrandomized, 1 randomized) compared SES with paclitaxel-eluting stents (PES) and found similar outcomes between stent types (53,54). Park et al. (55) studied the role of intravascular ultrasound guidance in unprotected left main coronary artery stenting. In a propensity-matched analysis, patients receiving a DES had significantly lower 3-year mortality with intravascular ultrasound guidance versus angiography alone (4.7% vs. 16.0%; p = 0.048). For patients with DES restenosis, Sheiban et al. (56) found that most cases can be treated favorably with PCI. Palmerini et al. (57) studied the timing of cardiac events after unprotected left main coronary artery stenting (73% DES). In patients receiving dual antiplatelet therapy, the highest risk of events was in the first 6 months after PCI, especially among patients who initially had ACS. After clopidogrel discontinuation, the highest risk period was the first 90 days after stopping therapy.
Fractional flow reserve guidance.
The FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) study was an important highlight of the year (58). One thousand five patients with multivessel disease undergoing PCI were randomized to stenting guided by angiography alone or guided by fractional flow reserve (FFR) measurements (stent indicated if FFR  0.8). Fewer stents were used in the FFR group (1.9 vs. 2.7; p < 0.001). Importantly, the primary end point (death, MI, and TVR at 1 year) was significantly lower in the FFR group (13.2% vs. 18.3%; p = 0.02) compared with the angiography group, strongly supporting routine use of FFR in multivessel intervention.
High-risk PCI.
There are few data regarding the optimal management of high-risk patients undergoing PCI. The BCIS (Balloon Pump-Assisted Coronary Intervention Study) (the first randomized trial in this patient group) randomized 301 high-risk patients (EF 30%; jeopardy score 8) to elective versus provisional intra-aortic balloon pump (59). Twelve percent of patients required bailout intra-aortic balloon pump. There was no significant difference in MACE in either group at 30 days. This important study suggests that many patients with LV dysfunction can be treated safely without routine hemodynamic support, but did not specifically address what support strategy to use in very–high-risk patients in whom periprocedural circulatory support is considered essential. In other studies, use of the Impella 2.5 device (Abiomed, Danvers, Massachusetts) was found to be safe and feasible in high-risk patients (60,61).
Bifurcations.
Recent studies have demonstrated that a single main vessel stent strategy is the preferred technique in coronary bifurcations. In the CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) study, 350 patients were randomized to elective crush stenting versus stenting of the main vessel only with provisional side-branch T-stenting (62). At 6 months, the incidence of angiographic restenosis (main branch and side branch) and MACE was similar in the 2 groups. In a meta-analysis of 6 trials comparing single- or double-stent strategies, a higher incidence of periprocedural MI was observed with double stenting (63).
Kissing balloon dilatation often is used in main vessel stenting to optimize the side branch. In the Nordic-Baltic Bifurcation Study III (64), 477 patients with successful main vessel stenting (and side branch 2.25 mm) were randomized to final kissing balloon after dilatation or no post-dilation. At 6 months, there was no difference in clinical outcome between groups, suggesting that routine kissing balloon after dilatation is not necessary.
Among patients undergoing a planned 2-stent strategy, the Nordic Stent Technique Study demonstrated similar clinical outcomes between the crush and culotte techniques (using a SES); however, angiographic restenosis in the side branch was lower with culotte stenting (65).
The DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) study evaluated the Axxess (Devax Inc., Lake Forest, California) biolimus A9-eluting in 302 patients (66). At 9 months, there was a low rate of restenosis (3.6% parent vessel; 4.3% side branch) and MACE (7.7%) with this novel self-expanding stent.
Chronic occlusion.
Rathore et al. (67,68) reported outcomes in 904 patients with undergoing PCI for chronic coronary artery occlusion at a single center. With modern guidewire techniques, procedural success was 86.2%. Retrograde crossing was used in 7.2% of patients with a 65.6% success rate. Overall, a very low rate of in-hospital MACE (1.9%) was observed in this highly experienced center.
Outcomes.
In 2009, there were several interesting articles addressing outcomes after PCI. Resnic and Welt (69) provided a report on the potential negative impact of public reporting of PCI outcomes. In Massachusetts, a 47% decline in use of PCI for cardiogenic shock was observed after mandatory reporting was initiated in 2003. Khattab et al. (70) examined DES outcomes and hospital volume in 51 German centers. High-volume (>400 PCIs/year) centers had a significantly lower incidence of death and MI compared with intermediate- and low-volume centers. Hannan et al. (71) studied ad hoc procedures in New York State from 2003 through 2005 (83% PCI ad hoc). Ad hoc patients had lower baseline clinical risk. There was no difference in in-hospital mortality; however, ad hoc patients had lower 3-year mortality. Ryan et al. (72) examined health care costs in Medicare patients after the introduction of DES. Although total cardiovascular cost per revascularized patient decreased by approximately $1,680 after the introduction of DES, overall health care costs were significantly higher because of greater use of revascularization procedures.
Cell therapy.
In a 50-patient randomized double-blind trial, van Ramhorst et al. (73) evaluated intramyocardial injection of autologous bone marrow-derived mononuclear cells in patients with chronic myocardial ischemia. At 3 months, intramyocardial injection was associated with a significant improvement in myocardial perfusion, angina, and EF compared with placebo.
|
DES
|
|---|
DES healing.
An angiographic study of 1,197 patients receiving DES found that acquired aneurysms were rare, but occurred more frequently when a DES was implanted during AMI (74). Similarly, Gonzalo et al. (75) reported that primary PCI patients had higher frequency of stent malapposition and uncovered struts assessed by optical coherence tomography 6 months after DES, compared with elective DES patients. The type of stent also influences healing with angioscopic incidence of less neointimal coverage and more thrombus with PES compared with SES (76), and more restenosis but better endothelial function with BMS and zotarolimus-eluting stent (ZES) compared with SES (77).
DES thrombosis.
DES fracture is rarely reported in clinical series, but an autopsy study reported fracture in 51 (29%) of 177 stented lesions (78). Predictors of stent fracture included longer, overlapping stents and use of SES.
Late ST after DES continues to be of interest to cardiologists. A literature review of 161 ST cases found that 88% were not taking dual antiplatelet therapy (79). If both aspirin and clopidogrel were stopped, the median time to ST was 7 days; whereas if the aspirin was continued, ST occurred 122 days after clopidogrel was stopped. Likewise, Kimura et al. (80) reported in a registry of 10,000 SES-treated patients that discontinuation of both aspirin and clopidogrel greatly increased ST, but if aspirin was continued, thrombosis was so low that there was no apparent benefit of long-term clopidogrel. However, in a 7,500-patient Taxus registry, Lasala et al. (81) found that discontinuation of thienopyridine was associated with very late (>1 year) stent thrombosis. Similarly, a Dutch registry (82) of 437 patients with ST found a strong correlation between late ST and discontinuing clopidogrel at 6 months (hazard ratio: 5.9; 95% confidence interval: 1.7 to 19.8). This registry also reported high rates of death, MI, and recurrent ST, with poor outcomes occurring more frequently in patients with low EF, diabetes, complex lesions, long stent length, TIMI flow grade <3, and implantation of additional stents for treatment of the ST (83). Other studies have shown that lack of pretreatment thienopyridine (84) or clopidogrel hyporesponsiveness (85) contribute to the risk of DES thrombosis.
Late outcomes.
Several studies with up to 5 years of follow-up report lower TVR with first-generation DES compared with BMS with similar rates of death and MI (86–90). However, consistent with some of the randomized trial data, 1 large national registry suggested that PES had an increased risk of ST and MI compared to SES or BMS (91).
Second-generation DES may have a better long-term safety profile compared with PES or SES. The SPIRIT III (Clinical Evaluation of the Xience V Everolimus-Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) trial found improved event-free survival at 2 years with trends for reduced ST comparing Xience V (Abbott Vascular, Santa Clara, California) EES with Taxus (Boston Scientific, Natick, Massachusetts) PES (92). The larger (n = 3,687) SPIRIT IV trial confirmed that Xience was superior to Taxus Express with significant improvement in event-free survival and ST (93). Moreover, the COMPARE (Second-generation everolimus-eluting and paciltaxel-eluting stents in real-life practice) trial (n = 1,800) found significant reductions in TVR, MI, and ST with Xience compared with the new Taxus Liberté (94). Finally, the ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent versus Sirolimus-Eluting Stent and Paciltaxel-Eluting Stent for Coronary Lesions) trial randomized 2,640 patients to ZES, SES, or Taxus Liberté (Boston Scientific) and found that Cypher SES was superior to both ZES and PES at reducing TVR and stent thrombosis (95).
Clinical and anatomic subsets.
A small randomized trial reported lower rates of restenosis when SVG lesions were treated with PES compared with BMS (96). In another small randomized trial, a strategy of PES implantation for moderate vein graft lesions seemed to improve outcome compared with medical therapy (97). A registry of SES in chronic total occlusions showed safety and reduced restenosis (compared with historical controls with BMS) (98). Two large registries demonstrated that off-label use of DES had similar safety compared with BMS, yet was associated with lower TVR (99,100). A Taxus registry suggested similar angiographic and clinical outcomes between diabetics and nondiabetics (101). Among diabetics, ZES seems to be inferior to other DES (102,103). However, ZES may perform well in bifurcation lesions, given that side-branch occlusion (and periprocedural MI) occurred less frequently with ZES compared with PES (104).
The best management of DES restenosis is uncertain. ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Restenosis: Drug-Eluting Stents for In-Stent Restenosis) randomized 450 patients with SES restenosis to receive PCI with additional SES versus PES (105). They found repeat restenosis (19.0% vs. 20.6%) and clinical events were similar, suggesting no advantage in choosing a different stent for treatment of DES restenosis.
|
New Stents and Balloons
|
|---|
Drug-coated balloons.
It is unknown whether adverse events after DES placement are the result of the drug, polymer, or stent itself. New technologies on the horizon include drug-eluting balloons, polymer-free stents, and bioabsorbable polymer and stents. Unverdorben et al. (106) randomized 131 patients with in-stent restenosis to treatment with a paclitaxel-eluting balloon (PEB) versus PES. A significant reduction in late loss was observed in the PEB group with a trend for reduced restenosis, TVR, and MACE compared with PES. Similarly, Herdeg et al. (107) reported that local delivery of fluid paclitaxel after BMS placement reduced neointimal proliferation and MACE compared with BMS alone. Conversely, Hamm (108) randomized 637 patients to PEB and BMS versus Cypher DES and found that the PEB and BMS combination resulted in significant increases in stent thrombosis, MI, restenosis, and TVR.
New drugs, polymers, and stents.
A DES using the anti-inflammatory agent pimecrolimus was found to be inferior to BMS (109), PES (110), or dual elution of both drugs. Conversely, a biolimus-eluting stent with bioresorbable polymer was superior to PES at reducing late loss and restenosis (111). In a randomized trial of 1007 patients, Byrne et al. (112) found the ZES (Endeavor, Medtronic) stent was inferior (more late loss, restenosis, and TVR) to either SES or a novel dual-DES (polymer-free rapamycin and probucol-eluting stent). A Chinese registry (113) reported satisfactory results using an SES with biodegradable polymer; however, late loss was higher (0.21 ± 0.35 mm) than previously reported for the durable polymer SES.
Polymer-free rapamycin stents had improved neointimal coverage at 3 months (114), compared with durable polymer. Byrne et al. (115) randomized 2,603 patients to a rapamycin-eluting stent with biodegradable polymer to durable polymer stents (Cypher and Xience) and found similar angiographic and clinical outcomes. Therefore, to date, it seems that biodegradable polymers do not offer an advantage.
Other studies evaluated novel stent coatings designed to address the limitations of current stent platforms. Promising first-in-man results were seen with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low dose of sirolimus (116), as well as a nanothin polyzene-F–coated stent (117).
Bioabsorbable stents have been evaluated in small series and seem to have less scaffolding effect and decreased lumen size at 6 months; however, the long-term effects are favorable (118,119).
|
Pharmacotherapy
|
|---|
Clopidogrel.
Because clopidogrel does not have antiplatelet effect until it is converted by hepatic cytochrome P-450, its antiplatelet effect can be quite variable. There may be genetic predisposition to reduced clopidogrel responsiveness and higher MACE in patients with cytochrome P-450 polymorphisms (120–122). Moreover, drugs that affect cytochrome P-450 (particularly the proton pump inhibitor omeprazole) have been shown to reduce clopidogrel effectiveness and increase ischemic complications (123,124). Despite a Food and Drug Administration (FDA) advisory suggesting caution, other studies reported that the combined use of clopidogrel and omeprazole is safe (125,126) and provide reassurance. However, numerous investigators have shown a higher risk of ST in patients with clopidogrel hyporesponsiveness (85), and these patients may benefit from more potent antiplatelet agents such as a glycoprotein IIb/IIIa inhibitor (127,128).
Higher-dose clopidogrel also may improve clinical outcomes. In STEMI patients undergoing primary PCI, pretreatment with 600 mg clopidogrel was associated with a reduced rate of ST, MI, and death compared with a 300-mg dose (129). The CURRENT OASIS-7 (Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent Events/Optimal Antiplatelet Strategy for Interventions) trial randomized 17,000 ACS patients undergoing PCI to double dosing (600 mg load and 150 mg/day for 7 days followed by 75 mg/day) versus conventional dosing (130). The double-dose group had significant reductions in death, MI, and stroke and a 42% decrease in ST (Fig. 1). At our institution, we have used 600-mg loading doses for several years, but based on this study, we are now giving 150 mg clopidogrel for the first 7 days in all ACS and STEMI patients.
View larger version (23K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 1 Antiplatelet Agents Shown to Reduce Stent Thrombosis
Bar graph showing incidence of stent thrombosis (ST) in studies comparing conventional or potent antiplatelet therapies.
|
|
Although concern still exists regarding pretreatment with clopidogrel in ACS patients who ultimately may require CABG, the ACUITY trial reported a significant reduction in ischemic events in patients who received clopidogrel before CABG (131).
Prasugrel.
Results of the 3,534 STEMI patients within the TRITON–TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel–Thrombolysis in Myocardial Infarction 38) trial were published in 2009 (132). Patients were randomized to receive prasugrel (60 mg loading, 10 mg maintenance) or clopidogrel (300 mg loading, 75 mg daily). Only 27% patients received medication before PCI. At 30 days, patients treated with prasugrel had a significantly lower incidence of the primary end point, death/MI/stroke (6.5% vs. 9.5%; p = 0.0017), and ST (1.2% vs. 2.4%; p = 0.0084), without an increased risk of major bleeding. Further studies are needed to determine if prasugrel is beneficial compared to patients receiving higher clopidogrel dosing for STEMI. In a separate analysis from the trial, prasugrel was beneficial in ACS patients regardless of whether a glycoprotein IIb/IIIa inhibitor was used (133). Additionally, prasugrel was found to reduce both periprocedural and spontaneous MI (134).
Ticagrelor.
Ticagrelor is an oral reversible ADP inhibitor that has more rapid and consistent platelet inhibition than clopidogrel. The PLATO (Platelet Inhibition and Patient Outcomes) trial randomized 18,624 ACS patients to receive ticagrelor or clopidogrel (135). The overall trial demonstrated a significant reduction in death/MI/stroke at 12 months with ticagrelor, without an increase in major bleeding. Results of 2 planned substudies also were presented (136,137). In patients with STEMI (n = 8,430) and ACS patients with a planned invasive strategy (n = 13,408), ticagrelor was associated with significant reductions in death, MI, and ST. This represents an important step forward in oral antiplatelet therapy, and based on these results, ticagrelor likely will become the standard of care for ACS patients.
Cangrelor.
Intravenous cangrelor, a rapid-acting, reversible adenosine diphosphate (ADP) receptor antagonist, was evaluated in 2 large randomized trials (138,139). In one trial, clopidogrel 600 mg was given before PCI, and in the other trial, clopidogrel 600 mg was given after PCI. In both studies, cangrelor failed to improve the incidence of death/MI/ischemia-driven TVR at 48 h, but there was a lower incidence of ST in patients who were not pretreated with clopidogrel (138).
Cilostazol.
Addition of cilostazol to aspirin and clopidogrel results in greater ADP-induced platelet inhibition compared with dual antiplatelet therapy alone. In a randomized trial, Jeong et al. (140) demonstrated that patients with a suboptimal response to dual antiplatelet therapy have greater platelet inhibition when cilostazol is added compared with aspirin plus clopidogrel 150 mg daily. Triple antiplatelet therapy also seemed to improve clinical outcomes in a nonrandomized study of STEMI patients treated with a DES (141).
Glycoprotein (GP) IIb/IIIa inhibitors.
A wealth of information exists regarding the benefits of abciximab during primary PCI; however, these studies were conducted before the widespread use of clopidogrel and the cost constraints of our current health care system. Two meta-analyses comparing results of small molecule GP IIb/IIIa inhibitors with abciximab during primary PCI (142,143) did not demonstrate any difference in angiographic or clinical outcomes. The necessity of GP IIb/IIIa may be in question, with more randomized trials showing lack of benefit of pre-catheterization administration before (144–147). In patients who receive GP IIb/IIIa agents, it may be possible to reduce bleeding complications and cost by reducing the infusion duration to 2 h (148).
PAR-1.
Oral SCH 530 548, an oral platelet protease-activated receptor-1 antagonist, was developed to prevent thrombin-mediated platelet activation. In a trial of 1,030 patients undergoing cardiac catheterization, the agent was found to be safe and did not increase risk of TIMI bleeding, even when administered with aspirin and clopidogrel (149).
Bivalirudin.
Mehran et al. (150) published 1-year results of the HORIZONS AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial. Patients treated with bivalirudin had significantly improved outcomes at 1 year compared with those treated with heparin plus GP IIb/IIIa inhibitor: net adverse clinical events (15.6% vs. 18.3%; p = 0.022), major bleeding (5.8% vs. 9.2%; p < 0.001), and mortality (3.5% vs. 4.8%; p = 0.037).
Enoxaparin.
In a follow-up report from the STEEPLE (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients, an International Randomized Evaluation) trial, 1-year survival was similar in patients who received either enoxaparin or unfractionated heparin during initial elective PCI (151).
Statins.
Statin pretreatment seems to reduce periprocedural myocardial injury during PCI. In 668 statin-naïve patients, a single dose of atorvastatin 80 mg given the day before PCI significantly reduced the incidence of MI compared with no statin (9.5% vs. 15.8%; p = 0.014) (152). In another trial, Di Sciascio et al. (153) demonstrated that an atorvastatin reload (80 mg 12 h before PCI; 40 mg periprocedural) also improves results in patients receiving chronic statin therapy, with a significant reduction in periprocedural MI (13% vs. 24%; p = 0.017) and MACE (3.7% vs. 9.4%; p = 0.037). In ACS patients, intensive statin (atorvastatin 80 mg) therapy reduced recurrent events at 30 days compared with moderate-dose statin (pravastatin 40 mg) therapy (154).
Pioglitazone.
In a small randomized trial of 97 diabetic patients receiving BMS, pioglitazone was associated with a trend toward a lower in-stent neointimal volume by intravascular ultrasound at 6 months (155).
|
Contrast Nephropathy
|
|---|
Prevention.
Both short- and long-term prognosis after PCI is markedly impaired if contrast-induced nephropathy (CIN) develops. Jabara et al. (156) point out that the rate of CIN can vary from 3.3% to 10.2% in the same patient population depending on the definition. Currently, the most frequently used definition of CIN is an absolute 0.5 mg/dl increase in creatinine or a 25% increase over baseline. In a meta-analysis, Brown et al. (157) conclude that hydration with combination N-acetylcysteine (NAC) and sodium bicarbonate is the most effective treatment tested in large populations. Spargias et al. (158) randomized 208 patients with baseline creatinine of more than 1.4 mg/dl to placebo or infusion of iloprost at 1 ng/kg/min for 4 h. CIN occurred in 22% of control and 8% of treated patients (p = 0.005). This finding must be replicated in larger trials.
Contrast agents.
Controversy still exists regarding whether contrast media type influence the development of CIN. Mehran et al. (159) found that with a background of 70% use of NAC, no difference in incidence of CIN occurred when an ionic, low-osmolar agent (ioxaglate) was compared with a nonionic agent (iodixanol). In another randomized trial of 324 patients, there was no difference between iodixanol and iomeprol (160). A meta-analysis of 16 trials found that iodixanol was not associated with lower rates of CIN compared with low-osmolar agents (161). This entire question remains clouded in uncertainty. No acceptable animal model exists. Most trials are small and underpowered. Each trial has differences in hydration strategies; each had different background NAC and bicarbonate use. Most trials that do not specifically test contrast do not standardize the contrast agent used. Today, optimal preprocedure hydration, NAC pretreatment, and judicious use of total contrast volume remains the backbone of preventative efforts to decrease CIN.
|
Peripheral Vascular Disease
|
|---|
Renal sympathetic denervation.
In a landmark article, Krum et al. (162) presented the results of a study using radiofrequency catheter-based renal sympathetic denervation in 50 patients with resistant hypertension (systolic blood pressure 160 mm Hg with 3 or more medications). At the 1-year follow-up, there was a substantial and sustained improvement in blood pressure (approximately 27/13 mm Hg) with no evidence of deterioration in renal function. A prospective, randomized trial currently is underway to evaluate this exciting technology further.
Renal artery stenting.
In a large randomized trial, 806 patients with atherosclerotic renal artery stenosis were assigned to undergo renal revascularization plus medical therapy or to receive medical therapy alone (163). During the 5-year follow-up, there was no significant difference between the groups in renal function (the primary end point, measured by the reciprocal of the serum creatinine level), blood pressure, or renal events. These results undoubtedly will impact the use of renal revascularization therapy.
Carotid disease.
Gray et al. (164) studied 30-day clinical outcomes among 6,320 high surgical risk patients undergoing carotid artery stenting (CAS) in 2 recent prospective, multicenter registries. In patients younger than 80 years of age, the incidence of death or stroke was 5.3% for symptomatic patients and 2.9% for asymptomatic patients. These results demonstrate that CAS outcomes continue to improve and now meet American Heart Association standards for carotid endarterectomy in both symptomatic (<6%) and asymptomatic (<3%) lesions.
The role for CAS in patients older than 80 years has been questioned. Among 142 elderly patients, Chiam et al. found a more than 85% survival at 2 years, suggesting that CAS is a reasonable strategy in carefully selected patients (165).
Superficial femoral artery disease.
In a meta-analysis of 10 trials comparing stenting versus angioplasty for symptomatic SFA disease, there was a higher immediate success rate with stenting, but no difference in restenosis or repeat revascularization at follow-up (166).
|
Structural Heart Disease
|
|---|
Aortic valve.
Transcatheter aortic valve implantation (TAVI) for treatment of calcific aortic stenosis has generated enormous scientific and public interest. The year 2009 brought much more published information concerning the 2 currently available valves (Edwards-Sapien, Edwards, Irvine, California; CoreValve device, Medtronic, Minneapolis, Minnesota). Clavel et al. (167) carefully analyzed the hemodynamic results of 50 patients with successful Edwards valve implants compared with a matched control group of 50 patients with surgically implanted bioprosthetic valves. Although postoperative gradients were similar, patients with small outflows (annulus <22 mm) tended to have more prosthesis–patient mismatch with surgical implants. Conversely, patients with larger annulus sizes (>24 mm) tended to have a higher incidence of paravalvular leak with percutaneous aortic valve implantation (PAVI). These data suggest that with currently available valve sizes, hemodynamics is superior with PAVI in smaller annulus dimensions and superior with surgical implants in larger annulus sizes.
Himbert et al. (168) described a large French experience of 75 patients treated with the Edwards-Sapien valve (51 PAVI, 24 TAVI). In-hospital mortality was 10%, and the incidence of stroke was 4%. One-year survival was 78%. A definite learning curve exists: for the first 25 patients, the 1-year survival was 60%, compared with 93% for the last 50 patients. This fact has important implications for the current pivotal trial (PARTNER [Placement of Aortic Transcatheter Valve]) that has completed enrollment in the U.S. The large majority of patients enrolled in PARTNER were treated in centers with fewer than 25 patients, so this pivotal randomized trial (that will be definitive for U.S. FDA approval) is basically a trial of the learning curve of a new technology compared with a mature surgical approach. Webb et al. (169) similarly reported outcomes for 168 patients with the Edwards-Sapien valve in Vancouver. Again, operative mortality fell from 14% in the early experience to 8% in the later stage of investigation. In the PAVI group, mortality fell from 12% to 3%, and in the TAVI group, mortality fell from 25% to 11%. Paravalvular regurgitation was mild and stable over follow-up. At 3 years, no structural failure of the prosthetic valve occurred. Webb et al. (170) even more forcefully present the value of center and operator experience for this procedure. Here they describe their more recent experience in 25 high-risk aortic stenosis patients with aortic valve area of 0.59 ± 0.15 cm2 who underwent implantation with a new-generation Edwards-Sapien valve. Successful implantation occurred in 100% and 30-day survival was 100%. Finally, Détaint et al. (171) found that moderate to severe aortic regurgitation occurred in 40% of patients treated in the early experience at their center, compared with 15% in the later stages of experience. Overall, these studies make a strong argument for centralization of this procedure.
Mitral valve.
Feldman et al. (172) reported long-term outcomes in 107 patients treated with the Mitraclip device (Evalve, Inc., Menlo Park, California) for symptomatic mitral regurgitation resulting from functional or degenerative disease. Freedom from surgery at 3 years occurred in 76% of patients. In those patients who required surgery, 84% of patients initially eligible for valve repair were able to undergo successful valve repair rather than replacement. This study suggests that the procedure is durable in the medium term and that surgical correction is not eliminated as an option if recurrent mitral regurgitation occurs. This device is likely to receive FDA approval and will be the first commercially available device in the U.S. Sack et al. (173) and Schofer et al. (174) reported initial feasibility with novel coronary sinus mitral annuloplasty devices.
Left atrial appendage occlusion.
Previous studies suggest that the left atrial appendage (LAA) is the source of emboli in many patients with atrial fibrillation. For this reason, percutaneous occlusion of the LAA has been studied avidly. Holmes et al. (175) describe the Watchman LAA system for embolic protection. They screened 4,998 patients with paroxysmal or chronic AF and randomized 707 warfarin-eligible patients to LAA occlusion and subsequent warfarin discontinuation or warfarin. Serious device-related events, including major bleeding, pericardial effusion, and device embolization, were more frequent in the active treatment group. The primary efficacy end point was a composite of death, stroke, and systemic embolism. LAA occlusion was noninferior to warfarin therapy. Thus, for patients who can tolerate warfarin, initial device-related complications were higher, but long-term efficacy in stroke prevention did occur. Ideally, clinicians really would like to use this device in patients at risk of cardiac emboli who cannot tolerate warfarin. These data are not yet available. Block et al. (176) also reported late outcomes of 64 patients treated with another LAA occlusion device. At 5 years, the annualized stroke/transient ischemic attack rate was 3.8%/year, which was less than expected.
Patent foramen ovale (PFO).
The interventional community has been accused of the Sir Edmund Hilary approach to PFO: "Close them because they are there!" In this regard, the year 2009 brought more discipline to this field. Ford et al. (177) presented the Mayo Clinic experience with PFO closure. Between 2001 and 2006, they implanted devices in 352 patients. Indications included 225 patients with cryptogenic stroke and 118 patients with transient ischemic attack. Recurrent stroke or transient ischemic attack occurred in 0.9% of patients at 1 year and in 2.8% of patients at 4 years. Of the 8 patients with recurrent stroke, 5 had factor V Leiden deficiency, protein C deficiency, or protein S deficiency. This experience suggests excellent efficacy for secondary prevention and also provides a strong argument for screening for thrombophilic disorders in these patients. Similarly, Wahl et al. (178) present the long-term Berne experience of 620 patients with PFO closure. They found an event-free survival of 97% at the 5-year follow-up. Despite these outstanding results, definitive proof of efficacy of PFO closure for secondary prevention does not exist. For this reason, O'Gara et al. (179) make an impassioned plea in an American Heart Association/American Stroke Association/American College of Cardiology Foundation Science Advisory for clinicians to enter their patients into ongoing pivotal randomized trials.
An even more contentious indication for PFO closure is migraine prevention. Previously, the MIST trial failed in its primary end point of prevention of migraine. Vigna et al. (180) report a systematic evaluation of closure in 82 patients with migraine and definite subclinical MRI abnormalities. Among 52 patients who underwent PFO closure and 29 (control) who did not, a 50% reduction in migraine frequency occurred in 87% of the treated patients, whereas only 17% of controls demonstrated reduction in migraine frequency (p < 0.001). Although the study is limited by its size and nonrandomized nature, it is very provocative with respect to efficacy. More will surely follow!
|
Footnotes
|
|---|
Dr. Dixon has received research grant support from Abbott Vascular, Inc., Abiomed, Inc., Boston Scientific, and InfraReDx, Inc. Dr. Grines is a consultant for Pfizer, Bristol-Myers Squibb, GlaxoSmithKline Global Cardiovascular Board, Abbott Vascular, InfraReDx, Possis Medical, CRF, Portola Pharma, Cordium Therapeutics, Sanofi-Aventis, and Svelte Medical Systems. Dr. O'Neill is a consultant for Medtronic and Byrne Healthcare Inc.
|
References
|
|---|
1. Kushner FG, Hand M, Smith Jr. SC, et al. 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Circulation 2009;120:2271-2306.[Free Full Text]2. Huynh T, Perron S, O'Loughlin J, et al. Comparison of primary percutaneous coronary intervention and fibrinolytic therapy in ST-segment-elevation myocardial infarction. Bayesian hierarchical meta-analyses of randomized controlled trials and observational studies. Circulation 2009;119:3101-3109.[Abstract/Free Full Text] 3. Cantor WJ, Fitchett D, Borgundvaag B, et al. Routine early angioplasty after fibrinolysis for acute myocardial infarction N Engl J Med 2009;360:2705-2718.[CrossRef][Medline] 4. Bohmer E, Hoffmann P, Abdelnoor M, et al. Efficacy and safety of immediate angioplasty versus ischemia-guided management after thrombolysis in acute myocardial infarction in areas with very long transfer distances. Results of the NORDISTEMI (NORwegian study on District treatment of ST-Elevation Myocardial Infarction). J Am Coll Cardiol 2010;55:102-110.[Abstract/Free Full Text] 5. Carver A, Rafelt S, Gershlick AH, et al. Longer-term follow-up of patients recruited to the REACT (Rescue Angioplasty Versus Conservative Treatment or Repeat Thrombolysis) trial J Am Coll Cardiol 2009;54:118-126.[Abstract/Free Full Text] 6. Ellis SG, Tendera M, de Belder MA, et al. 1-year survival in a randomized trial of facilitated reperfusion: results from the FINESSE (Facilitated Intervention With Enhanced Reperfusion Speed to Stop Events) trial J Am Coll Cardiol Intv 2009;2:909-916.[Abstract/Free Full Text] 7. Herrmann HC, Lu J, Brodie BR, et al. Benefit of facilitated percutaneous coronary intervention in high-risk ST-segment elevation myocardial infarction patients presenting to nonpercutaneous coronary intervention hospitals J Am Coll Cardiol Intv 2009;2:917-924.[Abstract/Free Full Text] 8. Brar SS, Leon MB, Stone GW, et al. Use of drug-eluting stents in acute myocardial infarction. A systematic review and meta-analysis. J Am Coll Cardiol 2009;53:1677-1689.[Abstract/Free Full Text] 9. Di Lorenzo E, Sauro R, Varricchio A, et al. Long-term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction Circulation 2009;120:964-972.[Free Full Text] 10. Di Lorenzo E, De Luca G, Sauro R, et al. The PASEO (Paclitaxel or sirolimus-eluting stent versus bare metal stent in primary angioplasty) randomized trial J Am Coll Cardiol Intv 2009;2:515-523.[Abstract/Free Full Text] 11. Stone GW, Lansky AJ, Pocock SJ, et al. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction N Engl J Med 2009;360:1946-1959.[CrossRef][Web of Science][Medline] 12. Stone GW. HORIZONS AMI. Two-year follow-up from a prospective, randomized trial of heparin plus glycoprotein IIb/IIIa inhibitors vs. bivalirudin and paclitaxel-eluting vs. bare metal stents in STEMI. Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 25, 2009; San Francisco, CA. 13. Tebaldi M, Arcozzi C, Campo G, et al. The 5-year clinical outcomes after a randomized comparison of sirolimus-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction J Am Coll Cardiol 2009;20:1900-1901. 14. Michels R. DEBATER. A comparison of drug-eluting stents and bare metal stents with or without abciximab in ST-segment elevation myocardial infarction. The Eindhoven reperfusion study. Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 25, 2009; San Francisco, CA. 15. Cervinka P, Bystron M, Spacek R, et al. Randomized comparison of Genous stent versus chromium-cobalt stent for treatment of ST-elevation myocardial infarction. 6-month clinical, angiographic and IVUS follow-up (GENIUS-STEMI). Paper presented at: American College of Cardiology; March 28, 2009; Orlando, FL. 16. Sardella G, Mancone M, Bucciarelli-Ducci C, et al. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size J Am Coll Cardiol 2009;53:309-315.[Abstract/Free Full Text] 17. Liistro F, Grotti S, Angioli P, et al. Impact of thrombus aspiration on myocardial tissue reperfusion and left ventricular functional recovery and remodeling after primary angioplasty Circ Cardiovasc Intervent 2009;2:376-383.[CrossRef] 18. Haeck JDE, Koch KT, Bilodeau L, et al. Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (Proximal embolic protection in acute myocardial infarction and resolution of ST-elevation study) J Am Coll Cardiol Intv 2009;2:934-943.[Abstract/Free Full Text] 19. Stone GW, Martin JL, de Boer M, et al. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction Circ Cardiovasc Intervent 2009;2:366-375.[CrossRef] 20. Sezer M, Cimen A, Aslanger E, et al. Effect of intracoronary streptokinase administered immediately after primary percutaneous coronary intervention on long-term left ventricular infarct size, volumes, and function J Am Coll Cardiol 2009;54:1065-1071.[Abstract/Free Full Text] 21. Ott I, Schulz S, Mehilli J, et al. Prospective, randomized, double-blind, placebo-controlled trial of erythropoietin in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (REVIVAL-3). Paper presented at: American College of Cardiology; March 30, 2009; Orlando, FL. 22. Fokkema ML, Vlaar PJ, Vogelzang M, et al. Effect of high-dose intracoronary adenosine administration during primary percutaneous coronary intervention in acute myocardial infarction. A randomized controlled trial. Circ Cardiovasc Intervent 2009;2:323-329.[CrossRef] 23. Atar D, Petzelbauer P, Schwitter J, et al. Effect of intravenous FX06 as an adjunct to primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction J Am Coll Cardiol 2009;53:720-729.[Abstract/Free Full Text] 24. Nikolsky E, Mehran R, Sadeghi M, et al. Prognostic impact of blood transfusion after primary angioplasty for acute myocardial infarction: analysis from the CADILLAC (Controlled Abciximab and device investigation to lower late angioplasty complications) trial J Am Coll Cardiol Intv 2009;2:624-632.[Abstract/Free Full Text] 25. Jolicoeur EM, O'Neill WW, Hellkamp A, et al. Transfusion and mortality in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention Eur Heart J 2009;30:2575-2583.[Abstract/Free Full Text] 26. Shishehbor MH, Madhwal S, Rajagopal V, et al. Impact of blood transfusion on short- and long-term mortality in patients with ST-segment elevation myocardial infarction J Am Coll Cardiol Intv 2009;2:46-53.[Abstract/Free Full Text] 27. Srinivas VS, Hailpern SM, Koss E, et al. Effect of physician volume on the relationship between hospital volume and mortality during primary angioplasty J Am Coll Cardiol 2009;53:574-579.[Abstract/Free Full Text] 28. Kumbhani DJ, Cannon CP, Fonarow GC, et al. Association of hospital primary angioplasty volume in ST-segment elevation myocardial infarction with quality and outcomes JAMA 2009;302:2207-2213.[Abstract/Free Full Text] 29. Lim HS, Farouque O, Andrianopoulos N, et al. Survival of elderly patients undergoing percutaneous coronary intervention for acute myocardial infarction complicated by cardiogenic shock J Am Coll Cardiol Intv 2009;2:146-152.[Abstract/Free Full Text] 30. Mehta R, Ou FS, Peterson ED, et al. Clinical significance of post-procedural TIMI flow in patients with cardiogenic shock undergoing primary percutaneous coronary intervention J Am Coll Cardiol Intv 2009;2:56-64.[Abstract/Free Full Text] 31. Wojakowski W, Tendera M, Kucia M, et al. Mobilization of bone marrow-derived Oct-4+ SSEA-4+ very small embryonic-like stem cells in patients with acute myocardial infarction J Am Coll Cardiol 2009;53:1-9.[Abstract/Free Full Text] 32. Herbots L, D'hooge J, Eroglu E, et al. Improved regional function after autologous bone marrow-derived stem cell transfer in patients with acute myocardial infarction: a randomized, double-blind strain rate imaging study Eur Heart J 2009;30:662-670.[Abstract/Free Full Text] 33. Tendera M, Wojakowski W, Ruzyllo W, et al. Intracoronary infusion of bone marrow-derived selected CD34+ CXCR4+ cells and non-selected mononuclear cells in patients with acute STEMI and reduced left ventricular ejection fraction: results of randomized, multicentre myocardial regeneration by intracoronary infusion of selected population of stem cells in acute myocardial infarction (REGENT) trial Eur Heart J 2009;30:1313-1321.[Abstract/Free Full Text] 34. Yousef M, Schannwell C, Köstering M, et al. Clinical benefit and long-term outcome after intracoronary autologous bone marrow cell transplantation in patients with acute myocardial infarction J Am Coll Cardiol 2009;53:2262-2269.[Abstract/Free Full Text] 35. Mehta SR, Granger CB, Boden WE, et al. Early versus delayed invasive intervention in acute coronary syndromes N Engl J Med 2009;360:2165-2175.[CrossRef][Medline] 36. Montalescot G, Cayla G, Collet JP, et al. Immediate vs delayed intervention for acute coronary syndromes: a randomized clinical trial JAMA 2009;302:947-954.[Abstract/Free Full Text] 37. Giugliano RP, White JA, Bode C, et al. Early versus delayed, provisional eptifibatide in acute coronary syndromes N Engl J Med 2009;360:2176-2190.[CrossRef][Medline] 38. Nikolsky E, Stone GW, Kirtane AJ, et al. Gastrointestinal bleeding in patients with acute coronary syndromes; incidence, predictors, and clinical implications J Am Coll Cardiol 2009;54:1293-1302.[Abstract/Free Full Text] 39. Mehran R, Nikolsky E, Lansky AJ, et al. Impact of chronic kidney disease on early (30-day) and late (1-year) outcomes of patients with acute coronary syndromes treated with alternative antithrombotic treatment strategies: an ACUITY (Acute catheterization and urgent intervention triage strategy) substudy J Am Coll Cardiol Intv 2009;2:748-757.[Abstract/Free Full Text] 40. Lopes RD, Alexander KP, Manoukian SV, et al. Advanced age, antithrombotic strategy, and bleeding in non-ST-segment elevation acute coronary syndromes J Am Coll Cardiol 2009;53:1021-1030.[Abstract/Free Full Text] 41. Prasad A, Gersh BJ, Bertrand ME, et al. Prognostic significance of periprocedural versus spontaneously occurring myocardial infarction after percutaneous coronary intervention in patients with acute coronary syndromes J Am Coll Cardiol 2009;54:477-486.[Abstract/Free Full Text] 42. Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 appropriateness criteria for coronary revascularization: a report of the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society of Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology Circulation 2009;119:1330-1352.[Free Full Text] 43. The BARI 2D study group A randomized trial of therapies for type 2 diabetes and coronary artery disease N Engl J Med 2009;360:2503-2515.[CrossRef][Medline] 44. Trikalinos TA, Alsheikh-Ali AA, Tatsioni A, et al. Percutaneous coronary interventions for non-acute coronary artery disease: a quantitative 20-year synopsis and a network meta-analysis Lancet 2009;373:911-918.[CrossRef][Web of Science][Medline] 45. Thiele H, Neumann-Schniedewind P, Jacobs S, et al. Randomized comparison of minimally invasive direct coronary artery bypass surgery versus sirolimus-eluting stenting in isolated proximal left anterior descending coronary artery stenosis J Am Coll Cardiol 2009;53:2324-2331.[Abstract/Free Full Text] 46. Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary artery bypass grafting for severe coronary artery disease N Engl J Med 2009;360:961-972.[CrossRef][Medline] 47. Li Y, Zheng Z, Xu B, et al. Comparison of drug-eluting stents and coronary artery bypass surgery for the treatment of multivessel coronary disease: three-year follow-up results from a single institution Circulation 2009;119:2040-2050.[Abstract/Free Full Text] 48. Hlatky MA, Boothroyd DB, Bravata DM, et al. Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease: a collaborative analysis of individual patient data from ten randomized trials Lancet 2009;373:1190-1197.[CrossRef][Web of Science][Medline] 49. Buszman PE, Buszman PP, Kiesz RS, et al. Early and long-term results of unprotected left main coronary artery stenting. The LE MANS (left main coronary artery stenting) registry. J Am Coll Cardiol 2009;54:1500-1511.[Abstract/Free Full Text] 50. Kim YH, Park DW, Lee SW, et al. Long-term safety and effectiveness of unprotected left main coronary stenting with drug-eluting stents compared with bare-metal stents Circulation 2009;120:400-407.[Abstract/Free Full Text] 51. Toyofuku M, Kimura T, Morimoto T, et al. Three-year outcomes after sirolimus-eluting stent implantation for unprotected left main coronary artery disease: insights from the J-Cypher registry Circulation 2009;120:1866-1874.[Abstract/Free Full Text] 52. Vaquerizo B, Lefèvre T, Darremont O, et al. Unprotected left main stenting in the real world: two-year outcomes of the French left main Taxus registry Circulation 2009;119:2349-2356.[Abstract/Free Full Text] 53. Lee JY, Park DW, Yun SC, et al. Long-term clinical outcomes of sirolimus- versus paclitaxel-eluting stents for patients with unprotected left main coronary artery disease J Am Coll Cardiol 2009;54:853-859.[Abstract/Free Full Text] 54. Mehilli J, Kastrati A, Byrne RA, et al. Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease J Am Coll Cardiol 2009;53:1760-1768.[Abstract/Free Full Text] 55. Park SJ, Kim YH, Park DW, et al. Impact of intravascular ultrasound guidance on long-term mortality in stenting for unprotected left main coronary artery stenosis Circ Cardiovasc Intervent 2009;2:167-177.[CrossRef] 56. Sheiban I, Sillano D, Biondi-Zoccai G, et al. Incidence and management of restenosis after treatment of unprotected left main disease with drug-eluting stents J Am Coll Cardiol 2009;54:1131-1136.[Abstract/Free Full Text] 57. Palmerini T, Marzocchi A, Tamburino C, et al. Temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery stenosis undergoing percutaneous coronary intervention J Am Coll Cardiol 2009;53:1176-1181.[Abstract/Free Full Text] 58. Tonino PAL, De Bruyne B, Pijls NHJ, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention N Engl J Med 2009;360:213-224.[CrossRef][Web of Science][Medline] 59. Redwood S. Balloon-pump assisted Coronary Intervention Study (BCIS-1). Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 25, 2009; San Francisco, CA. 60. Dixon SR, Henriques JPS, Mauri L, et al. A prospective feasibility trial investigating the use of the Impella 2.5 in patients undergoing high-risk percutaneous coronary intervention (the PROTECT I trial): initial US experience J Am Coll Cardiol Intv 2009;2:91-96.[Abstract/Free Full Text] 61. Sjauw KD, Konorza T, Erbel R, et al. Supported high-risk percutaneous coronary intervention with the Impella 2.5 device. The Europella Registry. J Am Coll Cardiol 2009;54:2430-2434.[Abstract/Free Full Text] 62. Colombo A, Bramucci E, Saccà, et al. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations Circulation 2009;119:71-78.[Abstract/Free Full Text] 63. Katritsis DG, Siontis GCM, Ioannidis JPA. Double versus single stenting for coronary bifurcation lesions. A meta-analysis. Circ Cardiovasc Intervent 2009;2:409-415.[CrossRef] 64. Niemela M. A prospective randomized trial of side branch dilatation strategies in patients with coronary bifurcation lesions undergoing treatment with a single stent (Nordic-Baltic Bifurcation Study III). Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 25, 2009; San Francisco, CA. 65. Erglis A, Kumsars I, Niemela, et al. Randomized comparison of coronary bifurcation stenting with the crush versus culotte technique using sirolimus eluting stents: the Nordic stent technique study Circ Cardiovasc Intervent 2009;2:27-34.[CrossRef] 66. Verheye S, Agostoni P, Dubois CL, et al. 9-month clinical, angiographic, and intravascular ultrasound results of a prospective evaluation of the Axxess self-expanding biolimus A9-eluting stent in coronary bifurcation lesions J Am Coll Cardiol 2009;53:1031-1039.[Abstract/Free Full Text] 67. Rathore S, Matsuo H, Terashima M, et al. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusion of coronary arteries 2002 to 2008: impact of novel guidewire techniques J Am Coll Cardiol Intv 2009;2:489-497.[Abstract/Free Full Text] 68. Rathore S, Katoh O, Matsuo H, et al. Retrograde percutaneous recanalization of chronic total occlusion of the coronary arteries Circ Cardiovasc Intervent 2009;2:124-132.[CrossRef] 69. Resnic FS, Welt FGP. The public health hazards of risk avoidance associated with public reporting of risk-adjusted outcomes in coronary intervention J Am Coll Cardiol 2009;53:825-830.[Abstract/Free Full Text] 70. Khattab AA, Hamm CW, Senges J, et al. Sirolimus-eluting stent treatment at high-volume centers confers lower mortality at 6-month follow-up Circulation 2009;120:600-606.[Abstract/Free Full Text] 71. Hannan EL, Samadashvili Z, Walford G, et al. Predictors and outcomes of ad hoc versus non-ad hoc percutaneous coronary interventions J Am Coll Cardiol Intv 2009;2:350-356.[Abstract/Free Full Text] 72. Ryan J, Linde-Zwirble W, Engelhart L, et al. Temporal changes in coronary revascularization procedures, outcomes, and costs in the bare-metal stent and drug-eluting stent eras: results from the US Medicare program Circulation 2009;119:952-961.[Abstract/Free Full Text] 73. van Ramhorst J, Bax JJ, Beeres SL, et al. Intramyocardial bone marrow cell injection for chronic myocardial ischemia: a randomized controlled trial JAMA 2009;301:1997-2004.[Abstract/Free Full Text] 74. Alfonso F, Pérez-Vizcayno MP, Ruiz M, et al. Coronary aneurysms after drug-eluting stent implantation. Clinical, angiographic, and intravascular ultrasound findings. J Am Coll Cardiol 2009;53:2053-2060.[Abstract/Free Full Text] 75. Gonzalo N, Barlis P, Serruys PW, et al. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography J Am Coll Cardiol Intv 2009;2:445-452.[Abstract/Free Full Text] 76. Awata M, Nanto S, Uematsu M, et al. Heterogeneous arterial healing in patients following paclitaxel-eluting stent implantation: comparison with sirolimus-eluting stents J Am Coll Cardiol Intv 2009;2:453-458.[Abstract/Free Full Text] 77. Kim JW, Seo HS, Park JH, et al. A prospective, randomized, 6-month comparison of the coronary vasomotor response associated with a zotarolimus- versus a sirolimus-eluting stent J Am Coll Cardiol 2009;53:1653-1659.[Abstract/Free Full Text] 78. Nakazawa G, Finn AV, Vorpahl M, et al. Incidence and predictors of drug-eluting stent fracture in human coronary artery. A pathologic analysis. J Am Coll Cardiol 2009;54:1924-1931.[Abstract/Free Full Text] 79. Eisenberg MJ, Richard PR, Libersan D, Filion KB. Safety of short-term discontinuation of antiplatelet therapy in patients with drug-eluting stents Circulation 2009;119:1634-1642.[Abstract/Free Full Text] 80. Kimura T, Morimoto T, Nakagawa Y, et al. Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation Circulation 2009;119:987-995.[Abstract/Free Full Text] 81. Lasala JM, Cox DA, Dobies D, et al. Drug eluting stent thrombosis in routine clinical practice Circ Cardiovasc Intervent 2009;2:285-293.[CrossRef] 82. van Werkum JW, Heestermans AA, Zomer AC, et al. Predictors of coronary stent thrombosis. The Dutch Stent Thrombosis Registry. J Am Coll Cardiol 2009;53:1399-1409.[Abstract/Free Full Text] 83. van Werkum JW, Heestermans AACM, de Korte FI, et al. Long-term clinical outcome after a first angiographically confirmed coronary stent thrombosis. An analysis of 431 cases. Circulation 2009;119:828-834.[Abstract/Free Full Text] 84. Aoki J, Lansky AJ, Mehran R, et al. Early stent thrombosis in patients with acute coronary syndromes treated with drug-eluting and bare metal stents Circulation 2009;119:687-698.[Abstract/Free Full Text] 85. Sibbing D, Braun S, Morath T, et al. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis J Am Coll Cardiol 2009;53:849-856.[Abstract/Free Full Text] 86. Caixeta A, Leon MB, Lansky AJ, et al. 5-year clinical outcomes after sirolimus-eluting stent implantation J Am Coll Cardiol 2009;54:894-902.[Abstract/Free Full Text] 87. Weisz G, Leon MB, Holmes DR, et al. Five-year follow-up after sirolimus-eluting stent implantation J Am Coll Cardiol 2009;53:1488-1497.[Abstract/Free Full Text] 88. Silber S, Colombo A, Banning AP, et al. Final 5-year results of the TAXUS II trial: a randomized study to assess the effectiveness of slow- and moderate-release polymer-based Paclitaxel-eluting stents for de novo coronary lesions Circulation 2009;120:1498-1504.[Abstract/Free Full Text] 89. James SK, Stenestrand U, Lindbäck J, et al. Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden N Engl J Med 2009;360:1933-1945.[CrossRef][Medline] 90. Kirtane AJ, Gupta A, Iyengar S, et al. Safety and efficacy of drug-eluting and bare metal stents. Comprehensive meta-analysis of randomized trials and observational studies. Circulation 2009;119:3198-3206.[Abstract/Free Full Text] 91. Kaltoft A, Jensen L, Maeng M, et al. 2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare metal coronary stents J Am Coll Cardiol 2009;53:658-664.[Abstract/Free Full Text] 92. Stone GW, Midei M, Newman W, et al. Two-year clinical follow-up from the clinical evaluation of the Xience V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions (SPIRIT) III trial Circulation 2009;119:680-688.[Abstract/Free Full Text] 93. Stone G. A prospective, randomized trial comparing an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease (SPIRIT IV). Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 23, 2009; San Francisco, CA. 94. Smits P. COMPARE: a prospective randomized trial of everolimus-eluting versus paclitaxel-eluting stents. Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 23, 2009; San Francisco, CA. 95. Park SJ. Comparison of the efficacy and safety of zotarolimus-eluting stent versus sirolimus-eluting stent and paclitaxel-eluting stent for coronary lesions (The ZEST trial). Paper presented at: American College of Cardiology; March 29, 2009; Orlando, FL. 96. Brilakis ES, Lichtenwalter C, et al. A randomized controlled trial of a paclitaxel-eluting stent versus a similar bare-metal stent in saphenous vein graft lesions J Am Coll Cardiol 2009;53:919-928.[Abstract/Free Full Text] 97. Rodés-Cabau J, Bertrand OF, Larose E, et al. Comparison of plaque sealing with paclitaxel-eluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions: the moderate vein graft lesion stenting with the Taxus stent and intravascular ultrasound (VELETI) pilot trial Circulation 2009;2:1978-1986120. 98. Kandzari DE, Rao SV, Moses JW, et al. Clinical and angiographic outcomes with sirolimus-eluting stents in total coronary occlusions: the ACROSS/TOSCA-4 (Approaches to chronic occlusions with sirolimus-eluting stents/total occlusion study of coronary arteries-4) trial J Am Coll Cardiol Intv 2009;2:97-106.[Abstract/Free Full Text] 99. Carlsson J, James SK, Lindbäck J, et al. Outcome of drug-eluting versus bare-metal stenting used according to on- and off-label criteria J Am Coll Cardiol 2009;53:1389-1398.[Abstract/Free Full Text] 100. Ko DT, Chiu M, Guo H, et al. Safety and effectiveness of drug-eluting and bare-metal stents for patients with off- and on-label indications J Am Coll Cardiol 2009;53:1773-1782.[Abstract/Free Full Text] 101. Mahmud E, Ormiston JA, Turco MA, et al. TAXUS Liberté attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program J Am Coll Cardiol Intv 2009;2:240-252.[Abstract/Free Full Text] 102. Fröbert O, Lagerqvist B, Carlsson J, et al. Difference in restenosis rate with difference drug-eluting stents in patients with and without diabetes mellitus J Am Coll Cardiol 2009;53:1660-1667.[Abstract/Free Full Text] 103. Kirtane AJ, Patel R, O'Shaughnessy C, et al. Clinical and angiographic outcomes in diabetics from the ENDEAVOR IV trial: randomized comparison of zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease J Am Coll Cardiol Intv 2009;2:967-976.[Abstract/Free Full Text] 104. Popma JJ, Mauri L, O'Shaughnessy C, et al. Frequency and clinical consequences associated with sidebranch occlusion during stent implantation using zotarolimus-eluting and paclitaxel-eluting coronary stents Circ Cardiovasc Intervent 2009;2:133-139.[CrossRef] 105. Byrne RA. Prospective, randomized trial of paclitaxel-versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-eluting stents (ISAR DESIRE-2). Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 23, 2009; San Francisco, CA. 106. Unverdorben M, Vallbracht C, Cremers B, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary instent restenosis Circulation 2009;119:2986-2994.[Abstract/Free Full Text] 107. Herdeg C, Göhring-Frischholz K, Haase KK, et al. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation Circ Cardiovasc Intervent 2009;2:294-301.[CrossRef] 108. In: Hamm CW, editor. Paclitaxel-eluting PTCA-balloon in combination with the Coroflex Blue stent vs the sirolimus coated Cypher stent in the treatment of advanced coronary artery disease (PEPCAD III). Orlando, FL: American Heart Association; November 14, 2009Paper presented. 109. Ormiston JA, Webster MWI, Schwartz RS, et al. Feasibility, safety and efficacy of a novel polymeric pimecrolimus-eluting stent: traditional pre-clinical safety end points failed to predict 6-month clinical angiographic status J Am Coll Cardiol Intv 2009;2:1017-1024.[Abstract/Free Full Text] 110. Verheye S, Agostoni P, Dawkins KD, et al. The GENESIS (randomized, multicenter study of the pimecrolimus-eluting and pimecrolimus/paclitaxel-eluting coronary stent system in patients with de novo lesions of the native coronary arteries) trial J Am Coll Cardiol Intv 2009;2:205-214.[Abstract/Free Full Text] 111. Chevalier B, Silber S, Park SJ, et al. Randomized comparison of the Nobori biolimus A9-eluting coronary stent with the Taxus Liberté paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries Circ Cardiovasc Intervent 2009;2:188-195.[CrossRef] 112. Byrne RA, Mehilli J, Iijima R, et al. A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents Eur Heart J 2009;30:923-931.[Abstract/Free Full Text] 113. Han Y, Jing Q, Xu B, et al. Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in "real-world" practice: 18-month clinical and 9-month angiographic outcomes J Am Coll Cardiol Intv 2009;2:303-309.[Abstract/Free Full Text] 114. Moore P, Berlis P, Spiro J, et al. A randomized optical coherence tomography study of coronary stent strut coverage and luminal protrusion with rapamycin-eluting stents J Am Coll Cardiol 2009;2:437-444. 115. Byrne RA, Kastrati A, Kufner S, et al. Randomized, non-inferiority trial of 3 limus agent-eluting stents with different polymer coatings (ISAR-TEST 4) Eur Heart J 2009;20:2441-2449. 116. Costa JR, Abizaid A, Costa R, et al. 1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial J Am Coll Cardiol Intv 2009;2:422-427.[Abstract/Free Full Text] 117. Tamburino C, Manna A, Elena M, et al. First-in-man 1-year clinical outcomes of the Catania coronary stent system with nanothin polyzene-F in de novo native coronary artery lesions: the ATLANTA (Assessment of the latest non-thrombogenic angioplasty stent) trial J Am Coll Cardiol 2009;2:197-204. 118. Serruys PW, Ormiston JA, Onuma Y, et al. A Bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods Lancet 2009;373:897-910.[CrossRef][Web of Science][Medline] 119. Waksman R, Erbel R, Di Mario C, et al. Early and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries J Am Coll Cardiol Intv 2009;2:312-320.[Abstract/Free Full Text] 120. Mega JL, Close SL, Wiviott SD, et al. Cytochrome P450 polymorphisms and response to clopidogrel N Engl J Med 2009;360:345-362. 121. Shuldiner AR, O'Connell JR, Bliden KP, et al. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy JAMA 2009;302:849-857.[Abstract/Free Full Text] 122. Simon T, Verstuyft C, Mary-Krause M, et al. Genetic determinants of response to clopidogrel and cardiovascular events N Engl J Med 2009;360:363-375.[CrossRef][Web of Science][Medline] 123. Cuisset T, Frere C, Quilici J, et al. Comparison of omeprazole and pantoprazole influence on a high 150-mg clopidogrel maintenance dose J Am Coll Cardiol 2009;54:1149-1153.[Abstract/Free Full Text] 124. Ho PM, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome JAMA 2009;301:937-944.[Abstract/Free Full Text] 125. O'Donoghue ML, Braunwald E, Antman EM, et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomized trials Lancet 2009;374:989-997.[CrossRef][Web of Science][Medline] 126. Bhatt DL. The COGENT trial. Paper presented at Transcatheter Cardiovascular Therapeutics 2009; September 24, 2009; San Francisco, CA. 127. Gurbel PA, Bliden KP, Saucedo JF, et al. Bivalirudin and clopidogrel with and without eptifibatide for elective stenting: effects on platelet function, thromboelastographic indexes, and their relation to periprocedural infarction J Am Coll Cardiol 2009;53:648-657.[Abstract/Free Full Text] 128. Valgimigli M, Campo G, de Cesare N, et al. Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention Circulation 2009;119:3215-3222.[Abstract/Free Full Text] 129. Dangas G, Mehran R, Guagliumi G, et al. Role of clopidogrel loading dose in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty J Am Coll Cardiol 2009;54:1438-1446.[Abstract/Free Full Text] 130. Mehta SR. CURRENT-STEMI PCI: double-dose vs standard-dose clopidogrel in ACS patients undergoing PCI for STEMI. Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 24, 2009; San Francisco, CA. 131. Ebrahimi R, Dyke C, Mehran R, et al. Outcomes following pre-operative clopidogrel administration in patients with acute coronary syndromes undergoing coronary artery bypass surgery J Am Coll Cardiol 2009;53:1965-1972.[Abstract/Free Full Text] 132. Montalesoct G, Wiviott SD, Braunwald E, et al. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomized controlled trial Lancet 2009;373:723-731.[CrossRef][Web of Science][Medline] 133. O'Donoghue M, Antman E, Braunwald E, et al. The efficacy and safety of prasugrel with and without a glycoprotein IIb/IIIa inhibitor in patients with acute coronary syndromes undergoing percutaneous intervention J Am Coll Cardiol 2009;54:678-685.[Abstract/Free Full Text] 134. Morrow DA, Wiviott SD, White HD, et al. Effect of the novel thienopyridine prasugrel compared with clopidogrel on spontaneous and procedural myocardial infarction in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel Thrombolysis in Myocardial Infarction 38: an application of the classification system from the universal definition of myocardial infarction Circulation 2009;119:2758-2764.[Abstract/Free Full Text] 135. Wallentin L, Becker RC, Budaj A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes N Engl J Med 2009;361:1045-1057.[CrossRef][Medline] 136. Steg G. PLATO STEMI. Outcomes in patients with STEMI and planned PCI. Paper presented at: American Heart Association; November 15, 2009; Orlando, FL. 137. Cannon C. PLATO Invasive. Ticagrelor compared with clopidogrel in patients with acute coronary syndromes—the PLATelet Inhibition and patient Outcomes trial. Paper presented at: Transcatheter Cardiovascular Therapeutics 2009; September 24, 2009; San Francisco, CA. 138. Bhatt D, Lincoff AM, Gibson CM, et al. Intravenous platelet blockade with cangrelor during PCI N Engl J Med 2009;361:2330-2341.[CrossRef][Medline] 139. Harrington R, Stone GW, McNulty S, et al. Platelet inhibition with cangrelor in patients undergoing PCI N Engl J Med 2009;361:2318-2329.[CrossRef][Medline] 140. Jeong YH, Lee SW, Choi BR, et al. Randomized comparison of adjunctive cilostazol versus high maintenance dose clopidogrel in patients with high post-treatment platelet reactivity J Am Coll Cardiol 2009;53:1101-1109.[Abstract/Free Full Text] 141. Chen KY, Rha SW, Li YJ, et al. Triple versus dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention Circulation 2009;119:3207-3214.[Abstract/Free Full Text] 142. Gurm HS, Tamhane U, Meier P, et al. A comparison of abciximab and small-molecule glycoprotein IIb/III inhibitors in patients undergoing primary percutaneous coronary intervention. A meta-analysis of contemporary randomized controlled trials. Circ Cardiovasc Intervent 2009;2:230-236.[CrossRef] 143. De Luca G, Ucci G, Cassetti E, Marino P. Benefits from small molecule administration as compared with abciximab among patients with ST-segment elevation myocardial infarction treated with primary angioplasty. A meta-analysis. J Am Coll Cardiol 2009;53:1668-1673.[Abstract/Free Full Text] 144. Bonnefoy E. Comparison of pre-hospital or cath lab administration of high dose tirofiban in patients undergoing primary angioplasty. The AGIR2 study. Paper presented at: American College of Cardiology; March 29, 2009; Orlando, FL. 145. Le May MR, Wells GA, Glover CA, et al. Primary percutaneous coronary angioplasty with and without eptifibatide in ST-segment elevation myocardial infarction (ASSIST) Circ Cardiovasc Intervent 2009;2:330-338.[CrossRef] 146. Hamm CW. Ongoing Tirofiban in Myocardial Infarction Evaluation (ONTIME). Paper presented at: American College of Cardiology; March 29, 2009; Orlando, FL. 147. Mehilli J, Kastrati A, Schulz S, et al. Abciximab in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention after clopidogrel loading: a randomized double-blind trial Circulation 2009;119:1933-1940.[Abstract/Free Full Text] 148. Fung AY, Saw J, Starovoytov A, et al. Abbreviated infusion of eptifibatide after successful coronary intervention J Am Coll Cardiol 2009;53:837-845.[Abstract/Free Full Text] 149. Becker RC, Moliterno DJ, Jennings LK, et al. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomized, double-blind, placebo-controlled phase II study Lancet 2009;373:919-928.[CrossRef][Web of Science][Medline] 150. Mehran R, Lansky A, Witzenbichler B, et al. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomized controlled trial Lancet 2009;374:1149-1159.[CrossRef][Web of Science][Medline] 151. Montalescot G, Gallo R, White HD, et al. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention: 1-year results from the STEEPLE (Safety and efficacy of enoxaparin in percutaneous coronary intervention patients, an international randomized evaluation) trial J Am Coll Cardiol Intv 2009;2:1083-1091.[Abstract/Free Full Text] 152. Briguori C, Visconti G, Focaccio A, et al. Novel approaches for preventing or limiting events (Naples II) trial J Am Coll Cardiol 2009;54:2157-2163.[Abstract/Free Full Text] 153. Di Sciascio G, Patti G, Pasceri V, et al. Efficacy of atorvastatin reload in patients in chronic statin therapy undergoing percutaneous coronary intervention J Am Coll Cardiol 2009;54:558-565.[Abstract/Free Full Text] 154. Gibson CM, Pride YB, Hochberg CP, et al. Effect of intensive statin therapy on clinical outcomes among patients undergoing percutaneous coronary intervention for acute coronary syndrome J Am Coll Cardiol 2009;54:2290-2295.[Abstract/Free Full Text] 155. Takagi T, Okura H, Kobayashi Y, et al. A prospective, multicenter, randomized trial to assess efficacy of pioglitazone on in-stent neointimal suppression in type 2 diabetes: POPPS (Prevention of in-stent neointimal proliferation by pioglitazone study) J Am Coll Cardiol Intv 2009;2:524-531.[Abstract/Free Full Text] 156. Jabara R, Gadesam RR, Pendyala LK, et al. Impact of the definition on the rate of contrast-induced nephropathy in percutaneous coronary intervention Am J Cardiol 2009;103:1657-1662.[CrossRef][Web of Science][Medline] 157. Brown JR, Block CA, Malenka DJ, et al. Sodium bicarbonate plus N-acetylcysteine prophylaxis: a meta-analysis J Am Coll Cardiol Intv 2009;2:1116-1124.[Abstract/Free Full Text] 158. Spargias K, Adreanides E, Demerouti E, et al. Iloprost prevents contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention Circulation 2009;120:1793-1799.[Abstract/Free Full Text] 159. Mehran R, Nikolsky E, Kirtane AJ, et al. Ionic low-osmolar versus iso-osmolar contrast media to obviate worsening nephropathy after angioplasty in chronic renal failure patients: the ICON (Ionic versus non-ionic contrast to obviate worsening nephropathy after angioplasty in chronic renal failure patients) study J Am Coll Cardiol Intv 2009;2:415-421.[Abstract/Free Full Text] 160. Wessely R, Koppara T, Bradaric C, et al. Choice of contrast medium in patients with impaired renal function undergoing percutaneous coronary intervention Circ Cardiovasc Intervent 2009;2:430-437.[CrossRef] 161. Reed M, Meier P, Tamhane UU, et al. The relative renal safety of iodixanol compared with low-osmolar contrast media: a meta-analysis of randomized controlled trials J Am Coll Cardiol Intv 2009;2:645-654.[Abstract/Free Full Text] 162. Krum H, Schlaich M, Whitbourn R, et al. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study Lancet 2009;373:1275-1281.[CrossRef][Web of Science][Medline] 163. The ASTRAL Investigators Revascularization versus medical therapy for renal-artery stenosis N Engl J Med 2009;361:1953-1962.[CrossRef][Web of Science][Medline] 164. Gray WA, Chaturvedi S, Verta P, et al. Thirty-day outcomes for carotid artery stenting in 6320 patients from 2 prospective, multicenter, high-surgical-risk registries Circ Cardiovasc Intervent 2009;2:159-166.[CrossRef] 165. Chiam PTL, Roubin GS, Panagopoulos S, et al. One-year clinical outcomes, midterm survival, and predictors of mortality after carotid stenting in elderly patients Circulation 2009;119:2343-2348.[Abstract/Free Full Text] 166. Kasapis C, Henke PK, Chetcuti SJ, et al. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials Eur Heart J 2009;30:44-45.[Abstract/Free Full Text] 167. Clavel MA, Webb JG, Pibarot P, et al. Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis J Am Coll Cardiol 2009;53:1883-1891.[Abstract/Free Full Text] 168. Himbert D, Descoutures F, Al-Attar N, et al. Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis J Am Coll Cardiol 2009;54:303-311.[Abstract/Free Full Text] 169. Webb JG, Altwegg L, Boone RH, et al. Transcatheter aortic valve implantation: impact on clinical and valve-related outcomes Circulation 2009;119:3009-3016.[Abstract/Free Full Text] 170. Webb JG, Altwegg L, Masson JB, et al. A new transcatheter aortic valve and percutaneous valve delivery system J Am Coll Cardiol 2009;53:1855-1858.[Abstract/Free Full Text] 171. Détaint D, Lepage L, Himbert D, et al. Determinants of significant paravalvular regurgitation after transcatheter aortic valve implantation: impact of device and annulus discongruence J Am Coll Cardiol Intv 2009;2:821-827.[Abstract/Free Full Text] 172. Feldman T, Kar S, Rinaldi M, et al. Percutaneous mitral repair with the MitraClip system J Am Coll Cardiol 2009;54:686-694.[Abstract/Free Full Text] 173. Sack S, Kahlert P, Bilodeau L, et al. Percutaneous transvenous mitral annuloplasty. Initial human experience with a novel coronary sinus implant device. Circ Cardiovasc Intervent 2009;2:277-284.[CrossRef] 174. Schofer J, Siminiak T, Haude M, et al. Percutaneous mitral annuloplasty for functional mitral regurgitation. Results of the CARILLON mitral annuloplasty device European Union study. Circulation 2009;120:326-333.[Abstract/Free Full Text] 175. Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomized non-inferiority trial Lancet 2009;374:534-542.[CrossRef][Web of Science][Medline] 176. Block PC, Burstein S, Casale PN, et al. Percutaneous left atrial appendage occlusion for patients in atrial fibrillation suboptimal for warfarin therapy: 5-year results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) study J Am Coll Cardiol Intv 2009;2:594-600.[Abstract/Free Full Text] 177. Ford MA, Reeder GS, Lennon RJ, et al. Percutaneous device closure of patent foramen ovale in patients with presumed cryptogenic stroke or transient ischemic attack: the Mayo Clinic experience J Am Coll Cardiol Intv 2009;2:404-411.[Abstract/Free Full Text] 178. Wahl A, Tai T, Praz F, et al. Late results after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism using the Amplatzer PFO occluder without intraprocedural echocardiography: effect of device size J Am Coll Cardiol Intv 2009;2:116-123.[Abstract/Free Full Text] 179. O'Gara PT, Messe SR, Tuzcu EM, et al. Percutaneous device closure of patent foramen ovale for secondary stroke prevention: a call for completion of randomized clinical trials: a science advisory from the American Heart Association/American Stroke Association and the American College of Cardiology Foundation Circulation 2009;119:2743-2747.[Abstract/Free Full Text] 180. Vigna C, Marchese N, Inchingolo V, et al. Improvement of migraine after patent foramen percutaneous closure in patients with subclinical brain lesions: a case-control study J Am Coll Cardiol Intv 2009;2:107-113.[Abstract/Free Full Text]
Related Article
-
Inside This Issue
J. Am. Coll. Cardiol. 2010 55: A34.
[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.,
December 14, 2010;
56(25):
2126 - 2138.
[Full Text]
[PDF]
|
|
|
|
Top
Focused Update
Acute Myocardial Infarction