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European Heart Journal Advance Access published online on October 7, 2007
European Heart Journal, doi:10.1093/eurheartj/ehm425
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2007. For permissions please email: journals.permissions@oxfordjournals.org
The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that the original authorship is properly and fully attributed; the Journal, Learned Society and Oxford University Press are attributed as the original place of publication with correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org

Randomized trial of rapamycin- and paclitaxel-eluting stents with identical biodegradable polymeric coating and design

Rainer Wessely*, Adnan Kastrati, Julinda Mehilli, Alban Dibra, Jürgen Pache and Albert Schömig

Deutsches Herzzentrum and 1. Medizinische Klinik, Klinikum rechts der Isar, University of Technology, Lazarettstr. 36, 80636 Munich, Germany

Received 9 February 2007; revised 23 August 2007; accepted 30 August 2007.

* Corresponding author. Tel: +49 89 1218 1514; fax: +49 89 1218 4013. E-mail address: rwessely{at}web.de

Aims: This prospective, randomized study sought to directly compare the performance of paclitaxel and rapamycin on an otherwise identical, polymer-coated drug-eluting stent (DES) platform.

Methods and results: Stents with identical design and biodegradable polymeric coating that elute either rapamycin or paclitaxel over a 2 months time period were utilized. In this pilot trial that included 91 patients, both stent platforms proved safe with no case of death, Q-wave myocardial infarction or stent thrombosis within a 9 months follow-up period. Late-lumen loss was markedly greater in the paclitaxel-eluting stent group compared with the rapamycin-eluting stent group (0.96 ± 0.75 vs. 0.33 ± 0.46 mm, P < 0.0001). Likewise, the rate of angiographic restenosis was higher in the paclitaxel-eluting stent group compared with the rapamycin-eluting stent group [39.0 vs. 12.2%; relative risk (RR) 3.20 (95% confidence interval, 1.29–7.92), P = 0.005]. Concomitantly, the need for target lesion revascularization was higher in the paclitaxel-eluting stent group compared with the rapamycin-eluting stent group [26.7 vs. 8.7%; RR 3.07 (1.07–8.80), P = 0.02].

Conclusion: The results of this clinical trial that is the first to directly compare the performance of paclitaxel and rapamycin on a DES platform otherwise identical in design and polymeric coating imply that rapamycin is more effective for the prevention of coronary restenosis on a DES platform with mid-term drug release and less dependent on release kinetics than paclitaxel. Thus, to ensure efficacy, drug release from a paclitaxel-coating stent platform must be prolonged and well controlled to achieve results that are comparable with the FDA-approved paclitaxel-eluting stent platform.

Key Words: Drug-eluting stents • Rapamycin • Sirolimus • Paclitaxel • Restenosis • Coronary artery disease


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