Comparison of Titanium-Nitride-Oxide–Coated stents with Zotarolimus-Eluting stents for coronary revascularization: a randomized controlled trial

Pilgrim, Thomas; Räber, Lorenz; Limacher, Andreas; Löffel, Lukas; Wenaweser, Peter; Cook, Stéphane; Stauffer, Jean-Christophe; Togni, Mario; Vogel, Rolf; Garachemani, Ali; Moschovitis, Aris; Khattab, Ahmed A.; Seiler, Christian; Meier, Bernhard; Jüni, Peter; Windecker, Stephan

doi:10.1016/j.jcin.2011.02.017

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Journal article

Comparison of Titanium-Nitride-Oxide–Coated stents with Zotarolimus-Eluting stents for coronary revascularization: a randomized controlled trial

Pilgrim, Thomas Department of Cardiology, Bern University Hospital, Bern, Switzerland
Räber, Lorenz Department of Cardiology, Bern University Hospital, Bern, Switzerland
Limacher, Andreas Clinical Trials Unit, Bern University Hospital, Bern, Switzerland
Löffel, Lukas Department of Cardiology, Bern University Hospital, Bern, Switzerland
Wenaweser, Peter Department of Cardiology, Bern University Hospital, Bern, Switzerland
Cook, Stéphane Department of Medicine, Cardiology unit, University of Fribourg, Switzerland
Stauffer, Jean-Christophe Department of Medicine, Cardiology unit, University of Fribourg, Switzerland
Togni, Mario Department of Cardiology, Bern University Hospital, Bern, Switzerland
Vogel, Rolf Department of Cardiology, Bern University Hospital, Bern, Switzerland
Garachemani, Ali Department of Cardiology, Clinic Sonnenhof, Bern, Switzerland
Moschovitis, Aris Department of Cardiology, Bern University Hospital, Bern, Switzerland
Khattab, Ahmed A. Department of Cardiology, Bern University Hospital, Bern, Switzerland
Seiler, Christian Department of Cardiology, Bern University Hospital, Bern, Switzerland
Meier, Bernhard Department of Cardiology, Bern University Hospital, Bern, Switzerland
Jüni, Peter Clinical Trials Unit, Bern University Hospital, Bern, Switzerland - Institute of Social and Preventive Medicine, University of Bern, Switzerland
Windecker, Stephan Department of Cardiology, Bern University Hospital, Bern, Switzerland - Clinical Trials Unit, Bern University Hospital, Bern, Switzerland

22.06.2011

Published in:

Journal of the American College of Cardiology: Cardiovascular Interventions. - 2011, vol. 4, no. 6, p. 672-682

titanium-nitride-oxide–coated stent(s)

English 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; 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.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)

Faculty

Faculté des sciences et de médecine

Department

Médecine 3ème année

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