European Heart Journal Advance Access originally published online on October 7, 2007
European Heart Journal 2007 28(22):2720-2725; doi:10.1093/eurheartj/ehm425
Randomized trial of rapamycin- and paclitaxel-eluting stents with identical biodegradable polymeric coating and design
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; online publish-ahead-of-print 7 October 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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 J. Mehilli, R. A. Byrne, A. Wieczorek, R. Iijima, S. Schulz, O. Bruskina, J. Pache, R. Wessely, A. Schomig, A. Kastrati, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis Eur. Heart J., August 2, 2008; 29(16): 1975 - 1982. [Abstract] [Full Text] [PDF]
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