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European Heart Journal Advance Access originally published online on June 23, 2005
European Heart Journal
2005 26(15):1475-1481; doi:10.1093/eurheartj/ehi405
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org

Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating

Jörg Hausleiter1,*, Adnan Kastrati1, Rainer Wessely1, Alban Dibra1, Julinda Mehilli1, Thomas Schratzenstaller2, Isolde Graf1, Magdalena Renke-Gluszko2, Boris Behnisch3, Josef Dirschinger4, Erich Wintermantel2, Albert Schömig1,4 for the investigators of the Individualizable Drug-Eluting Stent System to Abrogate Restenosis Project

1Deutsches Herzzentrum München, Klinik an der Technischen Universität München, Lazarettstrasse 36, 80636 Munich, Germany
2Zentralinstitut für Medizintechnik; Technische Universität München, Garching, Germany
3Translumina Labs, Munich, Germany
4I. Medizinische Klinik des Klinikums rechts der Isar, Technische Universität, Munich, Germany

Received 9 May 2005; revised 3 June 2005; accepted 16 June 2005; online publish-ahead-of-print 23 June 2005.

* Corresponding author. Tel: +49 89 1218 4038; fax: +49 89 1218 4013. E-mail address: hausleiter{at}dhm.mhn.de

Aims Drug-eluting stents (DES) represent a major advance in interventional cardiology. Along with the success shown, current DES also present limitations related to the presence of polymer-coating, fixed drug, and dose used. With the ISAR (Individualized Drug-Eluting Stent System to Abrogate Restenosis) project, a DES system has been developed that permits individualized choice of the drug and dose to use for the given patient. The objective of this prospective dose finding study was to assess the feasibility, safety, and efficacy of a polymer-free on-site stent coating with increasing rapamycin doses.

Methods and results In this dose finding study, 602 patients were sequentially enrolled in four groups: microporous bare metal stent (BMS), DES stents coated with a 0.5, 1.0, and 2.0% rapamycin solution. The angiographic in-segment restenosis rate at follow-up angiography was the primary study endpoint. In-segment restenosis was significantly reduced from 25.9% with BMS to 18.9, 17.2, and 14.7% with 0.5, 1.0, and 2.0% rapamycin-eluting stents, respectively (P=0.024). Similarly, the need for target lesion revascularization at 1 year follow-up was reduced from 21.5% with BMS to 16.4, 12.6, and 8.8% with 0.5, 1.0, and 2.0% rapamycin-eluting stents, respectively (P=0.006).

Conclusion The placement of polymer-free stents coated on-site with rapamycin is feasible and safe. Furthermore, a dose-dependent efficacy in restenosis prevention is achievable with this new DES concept.

Key Words: Restenosis • Stents • Randomized • Rapamycin • Polymer


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