The aim of this study was to evaluate safety and clinically defined efficacy of the implantation of a new stent coated with diamond-like carbon (DLC stent), in a group of patients who underwent percutaneous transluminal coronary revascularization procedures in two hemodynamic centers. This study was an observational prospective nonrandomized study that included 196 patients with a total of 236 significant de novo atheromatous coronary lesions, in which 245 DLC stents were implanted. The primary end point of this study was a composite of major cardiovascular events (death or acute myocardial infarction with or without Q) and need for target lesion revascularization (TLR) or target vessel revascularization (TVR) procedure during the first 48 hours and at 6 months after the DLC stent implantation. All patients had a myocardial perfusion imaging study with Tl201 at 6 months after DLC stent implantation. Only patients with a myocardial perfusion imaging study indicative of myocardial ischemia were then submitted for a new coronary angiogram. No major cardiovascular event or emergency TVR occurred during hospitalization. At 6-month follow-up no major cardiovascular event occurred either, whereas the rate for TLR was 5.6% and that for TVR was 7.65%. This preliminary study provides enough clinical evidence that implantation of intracoronary bare metal stents coated with diamond-like carbon is associated with high success rates, safety, and efficacy, both in the hospital and at the 6-month follow-up after the interventional procedure.
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