• Interventional Techniques & Devices Clinical Trials
• Coronary Artery Disease

Drug-eluting stents (DES) confer no additional late cardiovascular risk in patients with stenting of large coronary arteries when compared with bare-metal stents (BMS), reported Christoph Kaiser, MD, University Hospital, Basel, Switzerland. Prof. Kaiser presented the results of the 24-month Basel Stent Cost-effectiveness Trial-PROspective Evaluation Examination (BASKET-PROVE; ISRCTN72444640).

The trial was designed to test the hypothesis that in large coronary arteries, first-generation DES provide only a small reduction in target vessel revascularization (TVR) and may increase late cardiac death/myocardial infarction (MI). This study was designed after a retrospective analysis of the single-center BASKET—Late Thrombotic Events (BASKET-LATE) trial, which examined the difference between first-generation DES and BMS among 826 patients, demonstrated that DES were associated with an increase in cardiac-related deaths or non-fatal MI after 6 months in patients with stenting of large vessels. Of note, no such association was found in patients with small vessels, however (Pfisterer M et al. Eur Heart J 2009), for which DES remain the stent of choice. A secondary aim of BASKET-PROVE was to determine whether a similar risk-benefit relationship would also be found for second-generation DES.

The study enrolled 2314 patients with vessels 3 mm in diameter and divided them into 3 groups: sirolimus-eluting (first-generation; SES) DES (n=775), everolimus-eluting (second-generation; EES) DES (n=774), and BMS (n=765). The mean patient age was 66 years, and 18% were diabetic. Patients represented a typical population that required stenting, with two-thirds presenting with acute coronary syndromes (34% with STEMI) and the remainder with stable chronic coronary artery disease. Patients were placed on aspirin therapy (75–100 mg daily) indefinitely and on clopidogrel 75 mg daily for a minimum of 1 year.

Compliance with dual antiplatelet therapy was high (82%) at 1 year. After 2 years, there was no significant difference in the primary endpoint of cardiac death or nonfatal MI between the groups (2.6% for SES, 3.2% for EES, and 4.8% for BMS; p=0.13 SES vs BMS and p=0.37 EES vs BMS).

Also, there were no significant differences in the secondary endpoints of total death, noncardiac death, or stent thrombosis. However, there was a statistically significant difference in non-MI-related TVR between the DES patients and those who received the BMS (SES, p=0.007; EES, p=0.002), although there was no statistically significant difference between the two DES groups. This resulted in a significant difference in the composite of cardiac death, nonfatal MI, and TVR (MACE), which was significantly reduced by both of the DES (SES, p=0.009; EES, p=0.005). Limitations of the study include low overall number of events, resulting in reduced power to detect differences between groups (the 2.2% absolute difference in the primary endpoint between SES and BMS was not statistically different despite representing an ∼85% relative increase), and unblinded adjudication of approximately one-third of reported events.

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Figure 1.

Kaplan-Meier Estimates of Composite Primary Endpoint at 24 Months.

Copyright © 2010 Massachusetts Medical Society. All rights reserved.

“In contemporaneous stenting of large coronary arteries, late safety problems with drug-eluting stents could not be confirmed, and there was even a trend in the opposite direction,” said Dr. Kaiser. The findings, he noted, should influence medical practice.

Results of this study were published simultaneously in The New England Journal of Medicine. Kaiser C et al. N Eng J Med 2010.

• © 2010 MD Conference Express