Published Online
on May 9, 2005

A more recent version of this article appeared on May 24, 2005

This Article Full Text (PDF) All Versions of this Article: 111/20/2617    most recent CIRCULATIONAHA.104.486647v1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Windecker, S. Articles by Hess, O. M. Search for Related Content PubMed PubMed Citation Articles by Windecker, S. Articles by Hess, O. M. Pubmed/NCBI databases Compound via MeSH Substance via MeSH Hazardous Substances DB TITANIUM TITANIUM DIOXIDE Related Collections Restenosis Catheter-based coronary and valvular interventions: other Catheter-based coronary interventions: stents Coronary circulation

Submitted on June 22, 2004
Revised on November 3, 2004
Accepted on February 15, 2005

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, and 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.

^* To whom correspondence should be addressed. E-mail: stephan.windecker{at}insel.ch.

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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