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European Heart Journal Advance Access originally published online on February 28, 2005
European Heart Journal 2005 26(13):1262-1268; doi:10.1093/eurheartj/ehi098
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org

Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial

Jürgen Pache1, Alban Dibra1, Julinda Mehilli1, Josef Dirschinger2, Albert Schömig2 and Adnan Kastrati1,*

1Deutsches Herzzentrum, Lazarettstrasse 36, 80636 Munich, Germany
2Medizinische Klinik rechts der Isar, Munich, Germany

Received 20 August 2004; revised 12 November 2004; accepted 25 November 2004; online publish-ahead-of-print 28 February 2005.

* Corresponding author. Tel: +49 89 12184577; fax: +49 89 12184593. E-mail address: kastrati{at}dhm.mhn.de

Aim Drug-eluting stents have considerably reduced restenosis. Their relative merits have been assessed on the basis of comparisons made with control bare stents with thick struts. However, increased strut thickness negatively affects restenosis. No direct comparisons between drug-eluting stents and bare stents with thin struts have been performed. The aim of this study was to evaluate the relative efficacy of sirolimus-eluting stents (CypherTM) as compared with that of bare stents with thin struts (BeStentTM 2).

Methods and results A total of 500 patients with coronary artery disease were randomly assigned to receive a Cypher stent or BeStent. The primary endpoint was angiographic restenosis defined as a stenosis diameter ≥50% at 6-month angiographic follow-up. The secondary endpoint was the need for target vessel revascularization (TVR) during the year following the procedure. Follow-up angiography was performed in 81.8% of the patients. Patients treated with Cypher stents had a lower angiographic restenosis rate [8.3 vs. 25.5%, relative risk, 0.33 (95% confidence interval, 0.19–0.56), P<0.001] and a lower incidence of TVR [7.2 vs. 18.8%, relative risk, 0.38 (0.22–0.66), P<0.001]. For smaller vessels (<2.8 mm), the angiographic restenosis rates were 7.0% with the Cypher stent and 34.2% with the BeStent (P<0.001). For larger vessels (≥2.8 mm), angiographic restenosis rates were 10.0% with the Cypher stent and 13.1% with the BeStent (P=0.52).

Conclusion The drug-eluting stent, Cypher, is associated with a significantly lower risk of restenosis compared with the bare thin-strut BeStent. The advantage of the Cypher stent is vastly reduced in large vessels.

Key Words: Drug-eluting stents • Restenosis • Sirolimus • Stents


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