Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries

Kaiser, Christoph M.D.
Galatius, Soeren M.D.
Erne, Paul M.D.
Eberli, Franz M.D.
Alber, Hannes M.D.
Rickli, Hans M.D.
Pedrazzini, Giovanni M.D.
Hornig, Burkhard M.D.
Bertel, Osmund M.D.
Bonetti, Piero M.D.
De Servi, Stefano M.D.
Brunner-La Rocca, Hans-Peter M.D.
Ricard, Ingrid Ph.D.
Pfisterer, Matthias M.D.

^*Members of the Basel Stent Kosten-Effektivitäts Trial-Prospective Validation Examination (BASKET-PROVE) Study Group are listed in the Supplementary Appendix, available at NEJM.org.
From University Hospital Basel, Basel (C.K., H.-P.B.-L., I.R., M.P.); State Hospital, Lucerne (P.E.); Triemli Hospital, Zurich (F.E.); State Hospital, St. Gallen (H.R.); Cardiocentro, Lugano (G.P.); Clara Hospital, Basel (B.H.); Cardiovascular Center Zurich, Zurich (O.B.); and State Hospital, Chur (P.B.) — all in Switzerland; Gentofte University Hospital, Hellerup, Denmark (S.G.); University Hospital, Innsbruck, Austria (H.A.); Ospedale Civile di Legnano, Milan, Italy (S.D.S.); and Maastricht University Medical Center, Maastricht, the Netherlands (H.-P.B.-L.). Address reprint requests to Dr. Kaiser at the Department of Cardiology, University Hospital, CH 4031 Basel, Switzerland, or at [email protected].
This article (10.1056/NEJMoa1009406) was published on November 16, 2010, at NEJM.org.

Supported by the Basel Cardiovascular Research Foundation and a grant from the Swiss National Foundation for Research (32003B-116382).

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

New England Journal of Medicine 363(24):p 2310-2319, December 9, 2010. | DOI: 10.1056/NEJMoa1009406

Background

Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether this increase in risk was also seen with second-generation drug-eluting stents.

Methods

We randomly assigned 2314 patients needing stents that were 3.0 mm or more in diameter to receive sirolimus-eluting, everolimus-eluting, or bare-metal stents. The primary end point was the composite of death from cardiac causes or nonfatal myocardial infarction at 2 years. Late events (occurring during months 7 to 24) and target-vessel revascularization were the main secondary end points.

Results

The rates of the primary end point were 2.6% among patients receiving sirolimus-eluting stents, 3.2% among those receiving everolimus-eluting stents, and 4.8% among those receiving bare-metal stents, with no significant differences between patients receiving either drug-eluting stent and those receiving bare-metal stents. There were also no significant between-group differences in the rate of late events or in the rate of death, myocardial infarction, or stent thrombosis. Rates of target-vessel revascularization for reasons unrelated to myocardial infarction were 3.7% among patients receiving sirolimus-eluting stents, 3.1% among those receiving everolimus-eluting stents, and 8.9% among those receiving bare-metal stents. The rate of target-vessel revascularization was significantly reduced among patients receiving either drug-eluting stent, as compared with a bare-metal stent, with no significant difference between the two types of drug-eluting stents.

Conclusions

In patients requiring stenting of large coronary arteries, no significant differences were found among sirolimus-eluting, everolimus-eluting, and bare-metal stents with respect to the rate of death or myocardial infarction. With the two drug-eluting stents, similar reductions in rates of target-vessel revascularization were seen. (Funded by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research; Current Controlled Trials number, ISRCTN72444640.)