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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Longest Available Clinical Outcomes After Drug-Eluting Stent Implantation for Unprotected Left Main Coronary Artery Disease

The DELFT (Drug Eluting stent for LeFT main) Registry

Emanuele Meliga, MD^_*,, Hector Manuel Garcia-Garcia, MD, MSc^_*, Marco Valgimigli, MD, PhD, Alaide Chieffo, MD, PhD, Giuseppe Biondi-Zoccai, MD, Andrew O. Maree, MD^||, Stephen Cook, MD^¶, Lindsay Reardon, MD^||, Claudio Moretti, MD, Stefano De Servi, MD^#, Igor F. Palacios, MD, FACC^||, Stephen Windecker, MD^¶, Antonio Colombo, MD, FACC, FESC, Ron van Domburg, PhD^_*, Imad Sheiban, MD and Patrick W. Serruys, MD, PhD, FACC, FESC^_*,_*

^_* Department of Interventional Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, the Netherlands
Department of Interventional Cardiology, S. Giovanni Battista Hospital, University of Turin, Turin, Italy
Department of Interventional Cardiology, S. Anna Hospital, University of Ferrara, Ferrara, Italy
Department of Interventional Cardiology, S. Raffaele Hospital, Milan, Italy
^|| Department of Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts
^¶ Department of Interventional Cardiology, University Hospital, Bern, Switzerland
^# Department of Cardiovascular Diseases, Ospedale Civile di Legnano, Legnano (Milan) Italy.

Manuscript received November 6, 2007; revised manuscript received February 28, 2008, accepted March 4, 2008.

^_* Reprint requests and correspondence: Dr. Patrick W. Serruys, Director of the Interventional Cardiology Department, Thoraxcenter, Erasmus Medical Center, Erasmus University, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands. (Email: p.w.j.c.serruys{at}erasmusmc.nl).

	Abstract

Top Abstract Methods Results Discussion Conclusions Appendix References

 
Objectives: The purpose of this study was to investigate the long-term safety and efficacy of percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for unprotected left main coronary artery (ULMCA) disease.

Background: Long-term clinical outcomes after DES implantation for ULMCA disease have not yet been ascertained.

Methods: From April 2002 to April 2004, 358 consecutive patients who underwent PCI with DES implantation for de novo lesions on ULMCA were retrospectively selected and analyzed in 7 European and U.S. tertiary care centers. No patients were excluded from the analysis, and all patients had a minimum follow-up of 3 years.

Results: Technical success rate was 100%. Procedural success rate was 89.6%. After 3 years, major adverse cardiovascular events (MACE)–free survival in the whole population was 73.5%. According to the Academic Research Consortium definitions, cardiac death occurred in 9.2% of patients, and reinfarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) occurred in 8.6%, 5.8%, and 14.2% of patients, respectively. Definite stent thrombosis occurred in 2 patients (specifically at 0 and 439 days). In elective patients, the 3-year MACE-free survival was 74.2%, with mortality, reinfarction, TLR, and TVR rates of 6.2%, 8.3%, 6.6%, and 16%, respectively. In the emergent group the 3-year MACE-free survival was 68.2%, with mortality, reinfarction, TLR, and TVR rates of 21.4%, 10%, 2.8%, and 7.1%, respectively.

Conclusions: Routine DES implantation in ULMCA disease seems encouraging, with favorable long-term clinical results.

Abbreviations and Acronyms   AMI = acute myocardial infarction   BMS = bare-metal stent(s)   CABG = coronary artery bypass grafting   CD = cardiac death   DES = drug-eluting stent(s)   EF = ejection fraction   EuroSCORE = European System for Cardiac Operative Risk Evaluation   HI = hemodynamic instability   IDDM = insulin-dependent diabetes mellitus   MACE = major adverse cardiac event(s)   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)   ST = stent thrombosis   TLR = target lesion revascularization   TVR = target vessel revascularization   ULMCA = unprotected left main coronary artery

The main goal of this study was to generate the longest available follow-up data and identify associated predictors for adverse outcomes in patients undergoing intervention with DES for ULMCA lesions in a "real-world'' setting with an international, multicenter, retrospective registry design.

	Methods

Top Abstract Methods Results Discussion Conclusions Appendix References

 
Population.   Between April 2002 and April 2004, consecutive patients who underwent PCI with a sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) for de novo lesions in the ostium, shaft, or distal ULMCA were identified retrospectively and analyzed in 7 European and U.S. tertiary health care centers. All patients had confirmed myocardial ischemia related to ULMCA disease.

Patients were stratified into risk classes with the European System for Cardiac Operative Risk Evaluation (EuroSCORE) (13) (Table 1). Subjects with a EuroSCORE >6 were defined as high risk, and those with a EuroSCORE >9 as very high risk. Additional information about the risk of mortality and morbidity was generated with the Society of Thoracic Surgeons (STS) score. Data analysis was performed with the approval of the institutional ethics committees of the hospitals and/or universities involved.

All elective patients were pre-treated with aspirin, clopidogrel (75 mg/day 3 days before the procedure or 300-mg loading dose), and low-molecular-weight or unfractionated heparin (administered in the cath lab, before guidewire insertion). Heparin was titrated to maintain an activated clotting time >250 s. In general, patients who underwent emergent PCI received oxygen adjusted according to blood saturation before cardiac catheterization, aspirin 100 to 160 mg chewed, a 300-mg loading dose of clopidogrel, and intravenous heparin to maintain the activated clotting time >250 s.

Complete revascularization was attempted in all patients at the time of the index PCI. Significant lesions that were not treated during the index procedure were staged and treated generally within 1 month.

After the procedure, all patients were prescribed lifelong aspirin (75 to 100 mg/day), and prolonged (at least 6 months) dual antiplatelet therapy of aspirin + clopidogrel or aspirin + ticlopidine was recommended. Repeated revascularization was only performed if there was either symptom recurrence or inducible ischemia related to the ULMCA disease.

Angiographic follow-up was performed according to institutional guidelines, usually between 6 and 9 months after the procedure.

Definitions.   Technical success was defined as the successful deployment of the stent(s) in the target lesion.

Procedural success was defined as left main revascularization with a 30% residual diameter stenosis by quantitative coronary angiography, without major procedural or post-procedural adverse events (death, myocardial infarction [MI], emergency target vessel revascularization, or acute ST).

Hemodynamic instability (HI) was defined as the presence of hypotension (systolic blood pressure <90 mm Hg) associated with signs of global or regional hypoperfusion, without meeting all of the criteria for cardiogenic shock.

Emergency PCI was defined as a PCI in patients treated before the beginning of the next working day with cardiogenic shock, ST-segment elevation myocardial infarction, or unstable angina associated with signs of progressive HI unresponsive to standard medical treatment.

Death was classified as either cardiac death (CD) or noncardiac, according to the Academic Research Consortium (ARC) definitions (14). Deaths that could not be classified were considered cardiac.

Target lesion revascularization (TLR) was defined as any repeat percutaneous intervention of the target lesion or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

Target vessel revascularization (TVR) was defined as any repeat PCI of any segment of the target vessel, defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.

A major adverse cardiac event (MACE) was defined as the occurrence of CD, nonfatal MI, or TVR during the follow-up period.

Definite, probable, and possible stent thromboses were determined according to the ARC definitions (14). Stent thrombosis was defined as acute, subacute, late, and very late if the event occurred within 24 h, 30 days, <1 year, or >1 year, respectively, after the procedure.

Myocardial infarction was defined as a creatine kinase-MB mass increase >3 times the upper limit of normal, associated with chest pain lasting >30 min or with new evident electrocardiographic changes.

Data collection and follow-up.   All data relating to hospital admissions, procedures, and in-hospital outcomes were collected in each center with the hospital recording network. Information regarding clinical status was collected at clinic visits and by telephone interview. When the patient was not reachable, the information was sought from the referring physician, hospital electronic database, or Municipal Civil Registries. The data collection was carried out with a dedicated electronic case report form (CRF). All of the explored variables in the CRF were defined and number-coded before the CRF was sent to each participating center. At 3 years the clinical follow-up was 100%. This protocol was approved by the hospital ethics committees and is in accordance with the Declaration of Helsinki. Written informed consent was obtained from every patient.

Statistical analysis.   Continuous variables are expressed as mean ± SD, and categorical variables are expressed as counts and percentages.

The MACEs are reported hierarchically. Survival curves were generated by the Kaplan-Meier method, and survival among groups was compared with the log-rank test.

Bivariate and multivariate analyses were performed to identify independent predictors of adverse events. Specifically, all variables significantly associated with the clinical event of interest on bivariate analysis (p < 0.10) were entered into subsequent models. After appropriate checks for underlying assumptions, multiple variable Cox proportional hazard analyses were then performed, with the enter method for all pertinent covariates. Results of multiple variable Cox analyses are reported as hazard ratios with 95% confidence intervals and p values. All analyses were performed with SPSS version 12 statistical software (SPSS Inc., Chicago, Illinois). A 2-tailed p value < 0.05 was considered significant for hypothesis testing.

	Results

Top Abstract Methods Results Discussion Conclusions Appendix References

 
Baseline characteristics.   Baseline clinical characteristics are shown in Table 2.

In the emergent subgroup, mean EuroSCORE was 9.9 ± 3.5, and the most common diagnosis on admission was AMI (n = 31, 44.3%), followed by unstable angina with HI (n = 29, 41.4%) and cardiogenic shock (n = 10, 14.3%).

The risk of mortality and morbidity or mortality calculated by Society of Thoracic Surgeons (STS) score were 1.6 ± 0.7% and 13.5 ± 4.1% in the elective group and 22.3 ± 6.4% and 46 ± 11.3% in the emergent group, respectively.

Procedural and angiographic characteristics.   Procedural and angiographic characteristics are shown in Table 3. In brief, elective PCIs comprised 80.4%, and emergent PCIs comprised 19.6% of procedures. Sirolimus-eluting stents were deployed in 54.5% of patients, and paclitaxel-eluting stents were deployed in 45.5%. Baseline Thrombolysis In Myocardial Infarction (TIMI) flow assessment in the ULMCA was 0 to 1 in 17% of patients, 2 in 6.7%, and 3 in 76.3%. Lesions were more frequently distal (73.7%) than ostial/shaft (26.3%). The ULMCA was treated with multiple stents in 43.3% of cases, and crush stenting (26.5%) was favored over V-stenting (8.3%), Culotte (4.4%), and T-stenting (3.9%) techniques. Mean stent diameter was 3.23 ± 0.31 mm, mean stent length was 17.3 ± 6.7 mm, and the stents/patient ratio was 1.47. Mean post-procedural reference vessel diameter was 3.71 ± 0.54 mm, and mean minimal lumen diameter was 3.32 ± 0.57 mm. Multivessel treatment was performed in approximately one-half of the population (50.8%).

View larger version (17K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Kaplan-Meier Curves (A) Freedom from cardiac death (CD) and myocardial infarction (MI). (B) Freedom from major adverse cardiac events (MACE). (C) Freedom from target vessel revascularization (TVR). Solid lines = elective patients (Elec); solid bold lines = whole population (Whole); dashed lines = emergent patients (Emerg). The p value represents the difference between the elective and the emergent groups.

At 1 year, the incidence of CD was 6.7% and the incidence of MI, TLR, and TVR were 7.5%, 3.9%, and 10%, respectively. A MACE occurred in 24.3% of patients. The association with CD and MACE remained significant for emergent cases when compared with elective procedures (18.6% vs. 3.8%, p < 0.001, and 32.9% vs. 22.2%, p = 0.046).

The 3-year incidence of CD was 9.2%, and the incidence of MI, TLR, and TVR were 8.6%, 5.8%, and 14.2%, respectively. A MACE occurred in 32.1% of cases. Occurrence of CD (21.4% vs. 6.2%; p < 0.001) but not MACE (38.5% vs. 30.5%; p = 0.126) remained significantly higher in emergent cases relative to elective cases.

Data derived from the Kaplan-Meier survival curves are reported in Figure 1. Of note, the great majority of events occurred within 1 year in both groups of patients (72.7% and 85.4% in the elective and in the emergent group, respectively), whereas the cumulative event rate tended to stabilize over time.

Stent thrombosis.   The ST events are described in Table 5.

Acute ST occurred in a patient with acute coronary syndromes who underwent emergent PCI and received a single DES for a significant ostial lesion. Very late ST occurred in a patient with stable angina who underwent an elective PCI and received 3 DES for a significant lesion located in the distal left main. One-year dual antiplatelet therapy was recommended and thus, at the time of the ST event, was not ongoing. Both events occurred in patients who were classified as very-high-risk patients (EuroSCORE 9 and 11). No case of definite ST resulted in CD.

Multivariable analyses.   Results of multivariable analyses are presented in Table 6 and Online Tables 1 and 2. Of note, the following were identified as independent predictors of cardiac death (CD): age, shock, EuroSCORE, and impaired EF (<50%). The IDDM and EuroSCORE were significant predictors of MACE and IDDM; impaired EF and multiple stenting predicted the need for TVR.

	Discussion

Top Abstract Methods Results Discussion Conclusions Appendix References

General population and elective patients.   Very-long-term safety and efficacy data for DES used to treat ULMCA disease in unselected consecutive patients are lacking. Thus, it is difficult to put into perspective the results of our report.

In the bare-metal stent (BMS) era, patients with ULMCA disease treated percutaneously were carefully selected. Lee et al. (16) reported on 5-year follow-up patients (n = 187) with ULMCA disease that was treated percutaneously with BMS. All were elective and had normal EF and a low rate of distal left main involvement (37%). Moreover, when compared with our population, patients were significantly younger (56 ± 11 years vs. 66 ± 11 years) and had a lower incidence of hypertension (27% vs. 66%), hypercholesterolemia (30% vs. 64%), and diabetes (20% vs. 30%), and significantly higher post-procedural minimal lumen diameter (4.1 ± 0.7 mm vs. 3.3 ± 0.57 mm). A crude comparison of the 2 populations after 3-year follow-up shows a higher cumulative incidence of CD (9.2% vs. 2.3%) and lower MACE-free survival (73.5% vs. 77.5%) in our series relative to that of Lee et al. (16). After exclusion of emergent patients (n = 70) and elective patients with an EF <50% (n = 80), a repeat comparison of our cohort with that of Lee et al. (16) demonstrates a similar cumulative incidence of CD (1.2% vs. 2.3%) and rate of MACE-free survival (77.7% vs. 77.5%). Thus, treatment of ULMCA in higher-risk populations with DES achieves results similar to that of lower-risk populations treated with BMS.

Lee et al. (16) reported a cumulative incidence of TLR after 1 and 3 years (TVR rate not reported) of 18.8% and 20.7%, respectively, whereas the incidence in our comparable subpopulation was 2.9% and 6.7%, respectively. These data are consistent with published results from DES versus BMS randomized trials (17–20).

Recent reports (1,5) of DES use to treat ULMCA in selected populations showed considerable variability in the incidence of CD (range 0% to 11%), TVR (range 6% to 15%), and MACE (range 2% to 26%) at 1-year follow-up. This variability most likely represents relative differences in the inclusion and exclusion criteria applied and a lack of long-term follow-up results and makes comparison difficult. A study conducted by Sheiban et al. (3) reported excellent results in terms of death, TVR, and MACE at 12 and 24 months in a population of 85 consecutive unselected patients who underwent ULMCA revascularization with DES. Although from a small population derived from a single center, these results are in line with ours and suggest that DES implantation in "real-world" patients with ULMCA disease is both feasible and safe and effective over time.

The survival curve showed that the main occurrence of adverse events—in terms of CD, MI, and TVR—was within the first 12 months, whereas thereafter, the curves showed a progressive tendency to flatten. In the overall population and in the elective subgroup, the 79.7% and 76.5% of all CDs and MIs, respectively, occurred within the first year of follow-up. Consistently, 70.9% (69.3% in the elective subgroup) of all TVRs and 75.7% (72.7% in the elective group) of all MACEs occurred within the first year, suggesting that the enhanced antiproliferative effect of DES is persistent and that, in this specific population, the so-called "catch-up" phenomenon seems not to occur at this point in time in this population. This is in line with the 2-year reports available so far (3).

In addition, our results suggest that treatment of elective patients with ULMCA disease with DES does not differ significantly from treatment of those with multivessel disease in terms of MACE. In fact, our findings are in line with those reported by Morice et al. (21) in the REALITY (Sirolimus versus Paclitaxel-eluting Stents in De Novo Coronary Artery Lesions) trial in 2006. The noncumulative incidence of MACE (matched for our definition of MACE) at 1-year follow-up in the REALITY trial was 14.75% (14.6% in the SES group; 14.9% in the PES group) compared with 22.2% in our cohort. Furthermore, the incidence of CD, MI, and TVR (matched with our definition of TVR) was 1.25%, 5.55%, and 7.95%, respectively, in the REALITY trial (average of the SES and PES groups) versus 3.8%, 7.3%, and 11.1% in our report.

Diabetes mellitus, multiple stenting, and impaired EF were found to be independent predictors of TVR in our population, which is consistent with a similar published analysis in other coronary lesion subsets (22).

Emergency PCI.   Percutaneous treatment of ULMCA disease in an emergent setting is not supported by current and prior American College of Cardiology/American Heart Association (ACC/AHA) guidelines for percutaneous coronary intervention (7) and reflects the lack of available data for the acute and long-term safety and efficacy of PCI in this particular subset of patients.

In the present study, at 30 days the incidence of MACE was significantly higher than in the elective group (24.3% vs. 8.3%, p < 0.001). At 3-year follow-up, however, the difference in MACE-free survival between the elective and the emergent group was only 6% (74.2% vs. 68.2%, respectively, p = 0.33). It is noteworthy that although TVR was over-represented among adverse events at 3-year follow-up in the elective group (52.3% of all adverse events), CD represented the major component in the emergent group (55.5% of all adverse events). Thereby, the 3-year incidence of TVR was shown to be significantly lower in the emergent group (p = 0.04), whereas conversely the incidence of CD and MI at 3 years was found to be significantly higher in these patients when compared with the elective group (p = 0.005).

As in the elective population, the survival curve showed that the vast majority of adverse events occurred within the first year of follow-up. In these patients, 86.6% of all CDs and MIs, 80.2% of all TVRs, and 85.4% of all MACEs occurred in the first 12 months. The incidence of CD and MI at 12 months was significantly lower in the elective PCI population compared with the emergent PCI population (risk ratio 2.11, 95% confidence interval 1.37 to 3.2). However, this early difference was no longer present after this point in time. This suggests that the increased risk is limited to the early post-treatment period and that patients who had an event-free survival at 1 year have comparable clinical outcomes at 3 years.

Christiansen et al. (23) recently reported clinical outcomes among patients undergoing emergency PCI for AMI in patients with ULMCA (n = 27). Compared with our series, the population had similar baseline characteristics and a similar surgical risk score but did not receive DES routinely, and in 1 patient plain old balloon angioplasty alone was performed. The MACE rate at 6-month follow-up in Christiansen's report and in our group was 41% and 30%, respectively. Interestingly, CD was the most prominent component of MACE, consistent with our findings. In our series, the very-high-risk profile of patients in whom CD occurred (EuroSCORE 13 ± 3, mean EF 38 ± 11%, CS as diagnosis at admission in 8 of 15 patients) and absence of procedure-related or ST-related CDs suggest that CD occurred owing to the clinical presentation and comorbidities rather than the procedure or "performance" of the device implanted.

Comparison with CABG.   Current ACC/AHA guidelines for PCI recommend surgical revascularization as the primary procedure for patients with ULMCA disease (6). The main reason for this recommendation is that long-term outcomes of surgical revascularization, including in the subpopulation with ULMCA disease, are available (24,25,26), whereas few data exist to allow evaluation of long-term safety and efficacy of PCI with DES for ULMCA disease, and no randomized trial has been published that compares the 2 treatments. Results of the ongoing SYNTAX (SYNergy Between PCI With TAXUS and Cardiac Surgery) and COMBAT (Comparison of Bypass Surgery and Angioplasty Using Sirolimus-Eluting Stents in Patients With Unprotected Left Main Coronary Artery Disease) studies are awaited.

Three-year cumulative survival of elective patients with ULMCA disease enrolled in the CASS (Collaborative Study in Coronary Artery Surgery) study was 91% for the surgical group (24), which is in line with the cumulative survival rate in our elective group (93.4%).

Recent retrospective studies (27,28) reported 1-year follow-up outcomes of patients undergoing CABG for ULMCA disease. The range of incidence of death, MI, TVR, and MACE was 5.2% to 8.5%, 15% to 32.4%, 5.5% to 5.7%, and 24.8% to 46.6%, respectively. Compared with our population, this represents a similar incidence of death and lower incidence of TVR but an apparently higher incidence of MI and MACE. In these studies, the average risk score and the proportion of patients stratified as at low- or high-risk scores are similar to the population in our study. However, because the assessment was performed with different risk score systems, caution should be taken while interpreting and comparing the outcomes of the aforementioned studies. The 3-year follow-up outcomes of CABG in elective patients with isolated ULMCA disease were recently described by d'Allonnes et al. (25). At 3 years, cumulative survival and freedom from MACE were 92% and 87%, respectively. Compared with our series, survival was comparable but our incidence of MACE was higher, mainly owing to the higher rate of TVR.

Stent thrombosis.   In this registry, the definite ST occurred only in 2 cases. The patient in whom definite acute ST occurred was taking dual antiplatelet therapy, whereas the patient with very late ST was only taking aspirin at the time of the adverse event. Index PCI was performed in the context of acute coronary syndromes (unstable angina, emergent PCI) in the acute ST case, whereas in the other case the procedure was elective, performed in a patient with stable angina.

In our study, definite ST was not associated with CD, and the overall incidence was as low as in other high-risk DES populations. Real-world DES registries with long-term follow-up (15) have reported an overall incidence of mortality related to ST of <10%, and most recently, in the ERACI (Argentine Randomized Study: Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Multivessel Disease) III ST analysis (29), death related to "confirmed ST" occurred only in 1 of 5 patients (subacute ST in a patient who stopped clopidogrel 3 days before the event).

	Conclusions

Top Abstract Methods Results Discussion Conclusions Appendix References

 
Very-long-term follow-up of patients with ULMCA disease treated with DES demonstrated a satisfactory rate in both single and composite outcomes. The progressive reduction of incidence of adverse events over time suggests that DES are persistently effective. Elective PCI patients had an excellent event-free survival over the 3-year period. The PCIs in emergent patients, although hampered by an early lower event-free survival, also had a favorable long-term clinical success rate. In terms of safety, the definite ST rate was lower than in other high-risk lesion subsets.

	Appendix

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For supplementary tables, please see the online version of this article.

	References

Top Abstract Methods Results Discussion Conclusions Appendix References

 
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