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(Circulation. 2005;111:2617-2622.)
© 2005 American Heart Association, Inc.

Interventional Cardiology

Randomized Comparison of a Titanium-Nitride-Oxide–Coated Stent With a Stainless Steel Stent for Coronary Revascularization

The TiNOX Trial

Stephan Windecker, MD; Rüdiger Simon, MD; Markus Lins, MD; Volker Klauss, MD; Franz R. Eberli, MD; Marco Roffi, MD; Giovanni Pedrazzini, MD; Tiziano Moccetti, MD; Peter Wenaweser, MD; Mario Togni, MD; David Tüller, MD; Rainer Zbinden, MD; Christian Seiler, MD; Julinda Mehilli, MD; Adnan Kastrati, MD; Bernhard Meier, MD; Otto M. Hess, MD

From University Hospital Bern (S.W., P.W., M.T., D.T., R.Z., C.S., B.M., O.M.H.), University Hospital Zurich (F.R.E., M.R.), and Cardiocentro Lugano (G.P., T.M.), Switzerland; and University Hospital Munich (Innenstadt) (V.K.), University Hospital Kiel (R.S., M.L.), and German Heart Center and Technical University (J.M., A.K.), Munich, Germany.

Correspondence to Stephan Windecker, MD, Director, Invasive Cardiology, Department of Cardiology, University Hospital Bern, 3010 Bern, Switzerland. E-mail stephan.windecker{at}insel.ch

Received June 22, 2004; revision received November 3, 2004; accepted February 15, 2005.

Background— Stent coating with titanium-nitride-oxide has been shown to reduce neointimal hyperplasia in the porcine restenosis model. We designed a prospective, randomized, clinical study to investigate the safety and efficacy of titanium-nitride-oxide–coated stents compared with stainless steel stents.

Methods and Results— Ninety-two patients with de novo lesions were randomly assigned to treatment with titanium-nitride-oxide–coated stents (n=45) or stainless steel stents of otherwise identical design (n=47; control). Baseline characteristics were similar in both groups. At 30 days, no stent thromboses or other adverse events had occurred in either group. Quantitative coronary angiography at 6 months revealed lower late loss (0.55±0.63 versus 0.90±0.76 mm, P=0.03) and percent diameter stenosis (26±17% versus 36±24%, P=0.04) in lesions treated with titanium-nitride oxide–coated than in control stents. Binary restenosis was reduced from 33% in the control group to 15% in the titanium-nitride oxide–coated stent group (P=0.07). Intravascular ultrasound studies at 6 months showed smaller neointimal volume in titanium-nitride-oxide–coated stents than in control stents (18±21 versus 48±28 mm³, P<0.0001). Major adverse cardiac events at 6 months were less frequent in titanium-nitride-oxide–coated stents than in control stent–treated patients (7% versus 27%, P=0.02), largely driven by a reduced need for target-lesion revascularization (7% versus 23%, P=0.07).

Conclusions— Revascularization with titanium-nitride-oxide–coated stents is safe and effective in patients with de novo native coronary artery lesions. Titanium-nitride-oxide–coated stents reduce restenosis and major adverse cardiac events compared with stainless steel stents of otherwise identical design.

Key Words: stents • restenosis • revascularization

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