Comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularization a randomized controlled trial
Thomas Pilgrim, Lorenz Räber, Andreas Limacher, Lukas Löffel, Peter Wenaweser, Stéphane Cook, Jean-Christophe Stauffer, Mario Togni, Rolf Vogel, Ali Garachemani, Aris Moschovitis, Ahmed A Khattab, Christian Seiler, Bernhard Meier, Peter Jüni, Stephan Windecker, Thomas Pilgrim, Lorenz Räber, Andreas Limacher, Lukas Löffel, Peter Wenaweser, Stéphane Cook, Jean-Christophe Stauffer, Mario Togni, Rolf Vogel, Ali Garachemani, Aris Moschovitis, Ahmed A Khattab, Christian Seiler, Bernhard Meier, Peter Jüni, Stephan Windecker
Abstract
Objectives: This study sought to compare the efficacy of passive stent coating with titanium-nitride-oxide (TiNO) with drug-eluting stents releasing zotarolimus (ZES) (Endeavor, Medtronic, Minneapolis, Minnesota).
Background: Stent coating with TiNO has been shown to reduce restenosis compared with bare-metal stents in experimental and clinical studies.
Methods: In an assessor-blind noninferiority study, 302 patients undergoing percutaneous coronary intervention were randomized to treatment with TiNO or ZES. The primary endpoint was in-stent late loss at 6 to 8 months, and analysis was by intention to treat.
Results: Both groups were well balanced with respect to baseline clinical and angiographic characteristics. The TiNO group failed to reach the pre-specified noninferiority margin for the primary endpoint (in-stent late loss: 0.64 ± 0.61 mm vs. 0.47 ± 0.48 mm, difference: 0.16, upper 1-sided 95% confidence interval [CI]: 0.26; p(noninferiority) = 0.54), and subsequent superiority testing was in favor of ZES (p(superiority) = 0.02). In-segment binary restenosis was lower with ZES (11.1%) than with TiNO (20.5%; p(superiority) = 0.04). A stratified analysis of the primary endpoint found particularly pronounced differences between stents among diabetic versus nondiabetic patients (0.90 ± 0.69 mm vs. 0.39 ± 0.38 mm; p(interaction) = 0.04). Clinical outcomes showed a similar rate of death (0.7% vs. 0.7%; p = 1.00), myocardial infarction (5.3% vs. 6.7%; p = 0.60), and major adverse cardiac events (21.1% vs. 18.0%, hazard ratio: 1.19, 95% CI: 0.71 to 2.00; p = 0.50) at 1 year. There were no differences in rates of definite or probable stent thrombosis (0.7% vs. 0%; p = 0.51) at 1 year.
Conclusions: Compared with TiNO, ZES was superior with regard to late loss and binary restenosis. The concept of passive stent coating with TiNO remains inferior to drug-eluting stent technology in reducing restenosis. ([TIDE] Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent: NCT00492908).
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed