Open AccessRandomized Comparison of a Titanium-Nitride-Oxide–Coated Stent With a Stainless Steel Stent for Coronary Revascularization
Author(s) -
Stephan Windecker,
R. Simon,
Markus Lins,
Volker Klauß,
Franz R. Eberli,
Marco Roffi,
Giovanni Pedrazzini,
Tiziano Moccetti,
Peter Wenaweser,
Mario Togni,
David Tüller,
Rainer Zbinden,
Christian Seiler,
Julinda Mehilli,
Adnan Kastrati,
Bernhard Meier,
Otto M. Hess
Publication year - 2005
Publication title -
circulation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 7.795
H-Index - 607
eISSN - 1524-4539
pISSN - 0009-7322
DOI - 10.1161/circulationaha.104.486647
Subject(s) - medicine , restenosis , stent , stenosis , angioplasty , intravascular ultrasound , nitride , surgery , cardiology , materials science , layer (electronics) , composite material
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.