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European Heart Journal Advance Access published online on February 28, 2005
European Heart Journal, doi:10.1093/eurheartj/ehi098
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved

Clinical research

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

Jürgen Pache 1, Alban Dibra 1, Julinda Mehilli 1, Josef Dirschinger 2, Albert Schömig 2, and Adnan Kastrati 1*

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

* To whom correspondence should be addressed.
Adnan Kastrati, E-mail: kastrati{at}dhm.mhn.de


  Abstract

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.

Keywords: Drug-eluting stents; Restenosis; Sirolimus; Stents.
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