Portal de Periódicos da CAPES

Comparison of Titanium-Nitride-Oxide–Coated Stents With Zotarolimus-Eluting Stents for Coronary Revascularization

2011; Elsevier BV; Volume: 4; Issue: 6 Linguagem: Inglês

10.1016/j.jcin.2011.02.017

1936-8798

Thomas Pilgrim, Lorenz Räber, Andreas Limacher, Lukas M. 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,

Cardiac Valve Diseases and Treatments

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). Stent coating with TiNO has been shown to reduce restenosis compared with bare-metal stents in experimental and clinical studies. 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. 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; pnoninferiority = 0.54), and subsequent superiority testing was in favor of ZES (psuperiority = 0.02). In-segment binary restenosis was lower with ZES (11.1%) than with TiNO (20.5%; psuperiority = 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; pinteraction = 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. 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)