European Heart Journal Advance Access originally published online on June 11, 2008
European Heart Journal 2008 29(16):1975-1982; doi:10.1093/eurheartj/ehn253
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Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis
Deutsches Herzzentrum and 1. Medizinische Klinik rechts der Isar, Technische Universität, Lazarettstrasse 36, 80636 Munich, Germany
Received 13 December 2007; revised 15 May 2008; accepted 23 May 2008; online publish-ahead-of-print 11 June 2008.
* Corresponding author. Tel: +49 89 1218 4577, Fax: +49 89 1218 4053, Email: kastrati{at}dhm.mhn.de
See page 1930 for the editorial comment on this article (doi:10.1093/eurheartj/ehn304)
Aims: The objective of this study was to assess the non-inferiority, in terms of anti-restenotic efficacy, of both biodegradable-polymer (BP) and polymer-free (PF) stents compared with permanent-polymer rapamycin-eluting (PP; Cypher) stent.
Methods and results: Patients with de novo coronary lesions in native vessels were randomly assigned to receive a BP stent, a PF stent or a PP stent. The primary endpoint was in-stent late lumen loss at follow-up angiogram.
A total of 605 patients were enrolled: 202 patients received BP stents, 202 were treated with PP stents, and 201 received PF stents. Repeat angiography was available for 492 patients (81.3%). Mean late lumen loss at 6–8-month angiographic follow-up was 0.17 ± 0.45 mm in the BP stent group, 0.23 ± 0.46 mm in the PP cohort, and 0.47 ± 0.56 mm in the PF stent group. The BP stent met pre-specified criteria for non-inferiority (P < 0.001), whereas the PF stent did not (P = 0.94). There were no differences in safety outcomes.
Conclusion: Both BP and PF stents have a 1-year safety profile similar to that of the PP stent. Whereas the PF stent provided an inferior efficacy, the BP stent is at least as effective as the PP stent in terms of anti-restenotic efficacy.
Key Words: Biodegradable Coronary restenosis Drug-eluting stents Polymer Rapamycin
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