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European Heart Journal Advance Access originally published online on January 9, 2006
European Heart Journal
2006 27(3):260-266; doi:10.1093/eurheartj/ehi721
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels

Julinda Mehilli1, Alban Dibra1, Adnan Kastrati1,*, Jürgen Pache1, Josef Dirschinger2, Albert Schömig1,2 for the Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators

1Deutsches Herzzentrum, Technische Universität, Lazarettstr. 36, 80636 Munich, Germany
2Medizinische Klinik rechts der Isar, Technische Universität, Munich, Germany

Received 12 December 2005; revised 24 December 2005; accepted 28 December 2005; online publish-ahead-of-print 9 January 2006.

* Corresponding author. Tel: +49 89 12184577; fax: +49 89 12184593. E-mail address: kastrati{at}dhm.mhn.de

Aims Sirolimus- and paclitaxel-eluting stents effectively reduce restenosis in small coronary vessels. The relative efficacy of these drug-eluting stents in this high-risk subset is not known.

Methods and results A total of 360 patients undergoing percutaneous coronary intervention for de novo lesions in native coronary vessels with a diameter of <2.80 mm received randomly paclitaxel-eluting stents (n=180) or sirolimus-eluting stents (n=180). The primary endpoint was in-stent late luminal loss. Secondary endpoints were angiographic restenosis and need of target lesion revascularization. The study intended to show that the paclitaxel-eluting stent is not inferior to the sirolimus-eluting stent with respect to the primary endpoint. The non-inferiority margin was set at 0.16 mm. Follow-up angiography was performed in 87% of the patients. In-stent late luminal loss in the paclitaxel-eluting stent group was 0.32 mm (upper 95% boundary, 0.42 mm), which was greater than that in the sirolimus-eluting stent group, failing to show the non-inferiority of the paclitaxel-eluting stent to the sirolimus-eluting stent (P>0.99). Angiographic restenosis was found in 19.0% of the lesions in the paclitaxel-eluting stent group and 11.4% of the lesions in the sirolimus-eluting stent group (P=0.047). Target lesion revascularization was performed in 14.7% of the lesions treated with paclitaxel-eluting stents and 6.6% of the lesions treated with sirolimus-eluting stents (P=0.008).

Conclusion The paclitaxel-eluting stent is associated with a greater late luminal loss and is less effective in reducing restenosis in small coronary vessels than the sirolimus-eluting stent.

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


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