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(Circulation. 2006;113:273-279.)
© 2006 American Heart Association, Inc.

Interventional Cardiology

Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Reduction of Late Lumen Loss

Julinda Mehilli, MD; Adnan Kastrati, MD; Rainer Wessely, MD; Alban Dibra, MD; Jörg Hausleiter, MD; Birgit Jaschke, PhD; Josef Dirschinger, MD; Albert Schömig, MD, for the Intracoronary Stenting and Angiographic Restenosis–Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators

From the Deutsches Herzzentrum (J.M., A.K., R.W., A.D., J.H., B.J., A.S.) and Medizinische Klinik I rechts der Isar (J.D., A.S.), Technische Universität, Munich, Germany.

Correspondence to Albert Schömig, MD, Deutsches Herzzentrum, Lazarettstrasse 36, 80636 Munich, Germany. E-mail aschoemig{at}dhm.mhn.de

Received July 14, 2005; revision received October 4, 2005; accepted November 7, 2005.

Background— Although drug-eluting stents (DESs) constitute a major achievement in preventing restenosis, concerns remain regarding the increased inflammatory and thrombogenic responses associated with the polymers used. Recently, we showed that a nonpolymer on-site coating with rapamycin not only is feasible and safe but also leads to a dose-dependent reduction in restenosis.

Methods and Results— To assess whether polymer-free stents coated on-site with 2% rapamycin solution are inferior to polymer-based paclitaxel-eluting stents for the prevention of restenosis, we randomly assigned a total of 450 patients with de novo lesions in native coronary vessels, excluding the left main trunk, to either the polymer-free, rapamycin-coated Yukon DES (rapamycin stent) or the polymer-based, paclitaxel-eluting Taxus stent (paclitaxel stent). The primary end point was in-stent late lumen loss. Secondary end points were angiographic restenosis and target lesion revascularization. The study was designed to test the noninferiority of the rapamycin stent compared with the paclitaxel stent with respect to late lumen loss according to a noninferiority margin of 0.13 mm. Follow-up angiography was completed in 81% of the patients. The mean difference in in-stent late lumen loss between the rapamycin-stent group and the paclitaxel-stent group was 0.002 mm, and the upper limit of the 1-sided 95% confidence interval was 0.10 mm (P=0.02 from test for noninferiority). No significant differences were observed regarding angiographic restenosis rates (14.2% with the rapamycin stent and 15.5% with the paclitaxel stent) and target lesion revascularization rates due to restenosis (9.3% in both groups).

Conclusions— The polymer-free, rapamycin-coated stent has an antirestenotic effect that is not inferior to that observed with the polymer-based paclitaxel-eluting stent.

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