NEJM -- Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents

Volume 363:136-146 July 8, 2010 Number 2

Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents

Patrick W. Serruys, M.D., Ph.D., Sigmund Silber, M.D., Ph.D., Scot Garg, M.B., Ch.B., M.R.C.P., Robert Jan van Geuns, M.D., Ph.D., Gert Richardt, M.D., Pawel E. Buszman, M.D., Ph.D., Henning Kelbæk, M.D., Adrianus Johannes van Boven, M.D., Ph.D., Sjoerd H. Hofma, M.D., Ph.D., Axel Linke, M.D., Ph.D., Volker Klauss, M.D., Ph.D., William Wijns, M.D., Ph.D., Carlos Macaya, M.D., Ph.D., Philippe Garot, M.D., Carlo DiMario, M.D., Ph.D., Ganesh Manoharan, M.B., B.Ch., M.D., F.R.C.P., Ran Kornowski, M.D., Thomas Ischinger, M.D., Ph.D., Antonio Bartorelli, M.D., Jacintha Ronden, Ph.D., Marco Bressers, M.Sc., Pierre Gobbens, B.Sc., Manuela Negoita, M.D., Frank van Leeuwen, M.D., and Stephan Windecker, M.D.


ABSTRACT

Background New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration.

Methods In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months.

Results At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (±SD) of in-stent stenosis (21.65±14.42% for zotarolimus vs. 19.76±14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27±0.43 mm in the zotarolimus-stent group versus 0.19±0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events.

Conclusions At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084 [ClinicalTrials.gov] .)



Source Information

From Erasmus Medical Center (P.W.S., S.G., R.J.G.) and Cardialysis (J.R., M.B., P. Gobbens) — both in Rotterdam; and Medisch Centrum Leeuwarden, Leeuwarden (A.J.B., S.H.H.) — all in the Netherlands; Kardiologische Praxis und Praxisklinik (S.S.), University Hospital Munich (Innenstadt) (V.K.) and Hospital Bogenhausen (T.I.) — all in Munich; Herz-Kreislauf-Zentrum, Segeberger Kliniken, Bad Segeberg (G.R.); and Herzzentrum Leipzig, Leipzig (A.L.) — all in Germany; Medical University of Silesia, Katowice, Poland (P.E.B.); Rigshospitalet, Copenhagen (H.K.); Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium (W.W.); Hospital Universitario, Madrid (C.M.); Institut Cardiovasculaire Paris-Sud, Quincy, France (P. Garot); Royal Brompton Hospital, London (C.D.); Royal Victoria Hospital, Belfast, United Kingdom (G.M.); Rabin Medical Center, Tel Aviv University, Tel Aviv (R.K.); Centro Cardiologico Monzino, Milan (A.B.); Medtronic, Santa Rosa, CA (M.N., F.L.); and Bern University Hospital, Bern, Switzerland (S.W.).

This article (10.1056/NEJMoa1004130) was published on June 16, 2010, at NEJM.org.

Address reprint requests to Dr. Serruys at the Department of Cardiology, Erasmus Medical Center, Molewaterplein 40, Ba-583, 3015 GD Rotterdam, the Netherlands, or at
p.w.j.c.serruys@erasmusmc.nl"p.w.j.c.serruys@erasmusmc.nl



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NEJM -- Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents