Author + information
- Received January 10, 2011
- Accepted February 18, 2011
- Published online June 1, 2011.
- Thomas Pilgrim, MD⁎,
- Lorenz Räber, MD⁎,
- Andreas Limacher, PhD†,
- Lukas Löffel, MD⁎,
- Peter Wenaweser, MD⁎,
- Stéphane Cook, MD∥,
- Jean-Christophe Stauffer, MD∥,
- Mario Togni, MD⁎,
- Rolf Vogel, MD, PhD⁎,
- Ali Garachemani, MD§,
- Aris Moschovitis, MD⁎,
- Ahmed A. Khattab, MD⁎,
- Christian Seiler, MD⁎,
- Bernhard Meier, MD⁎,
- Peter Jüni, MD†,‡ and
- Stephan Windecker, MD⁎,†,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Stephan Windecker, Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland
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)
Supported by the Inselspital Foundation. Dr. Jüni is an unpaid member of steering groups and planning committees of cardiovascular trials funded by Abbott Vascular, Biosensors, Cordis, Medtronic, and St. Jude Medical. Dr. Windecker received research grants from Abbott, Cordis, Medtronic, Biosensors, and Biotronik. All other authors have reported that they have no relationships to disclose. Drs. Pilgrim and Räber contributed equally to this work. Sotirios Tsimikas, MD, served as Guest Editor for this paper, and this paper was accepted before he became a new Associate Editor.
- Received January 10, 2011.
- Accepted February 18, 2011.
- American College of Cardiology Foundation