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Randomized comparison of percutaneous coronary intervention with titanium-nitride-oxide-coated stents versus stainless steel stents in patients with coronary artery disease: RIO trial

BACKGROUND: Stent coating with titanium-nitride oxide (Titan) has been shown to reduce neointimal hyperplasia in both animals and humans. A prospective, randomized, clinical study was designed to compare the incidence of major adverse cardiac events (MACE) after two years in patients with the Titan stent versus the stainless steel stent. METHODS: Two hundred patients (228 stenosis) submitted to stent implantation between October 2005 and May 2006 were randomized into two groups: I) Bare metal stent (100); II) Titan (100) and followed clinically. MACE was defined as a composite of death, acute myocardial infarction or clinically driven revascularization of target lesion. MACE and angina free survival after 2 years were compared between the two groups. RESULTS: All procedures were successful in both groups. Baseline clinical and angiographic characteristics were similar in both groups. Mean follow-up period was 482 ± 264 days. After 30 days, MACE was 2% in group I and 1% in group II (P = 0.32). MACE free survival at 2 years was significantly better in the Titan group than in the bare metal stent group (93.6% vs. 82.4%; P = 0.036) as well as angina free survival (84% vs. 71%; P = 0.02). CONCLUSIONS: Revascularization with Titan stent in chronic coronary artery disease is safe, effective, and reduces the incidence of MACE and angina after two years when compared with the bare metal stent.

Stents; Drug-eluting stents; Coronary restenosis


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