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European Heart Journal Advance Access published online on June 11, 2008
European Heart Journal, doi:10.1093/eurheartj/ehn253
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org

Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis

Julinda Mehilli, Robert A. Byrne, Anna Wieczorek, Raisuke Iijima, Stefanie Schulz, Olga Bruskina, Jürgen Pache, Rainer Wessely, Albert Schömig, Adnan Kastrati for the Intracoronary Stenting and Angiographic Restenosis Investigators – Test Efficacy of Rapamycin-eluting Stents with Different Polymer Coating Strategies (ISAR-TEST-3)*

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.

* Corresponding author. Tel: +49 89 1218 4577, Fax: +49 89 1218 4053, Email: kastrati{at}dhm.mhn.de

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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