Use of Rapamycin-Impregnated Stents in Coronary Arteries

ABSTRACT

We investigated the 2-year safety and efficacy of Sirolimus-eluting stents. Thirty patients had a single 18-mm sirolimus-eluting coronary stent implanted.Twentyeight patients underwent angiographic and intravascularultrasound follow-up at 2 years.No death occurred during the study period. No patient developed in-stent restenosis. One patient had a 52% in-lesion stenosis that required repeated revascularization and another patient underwent target vessel revascularization. Neointimal hyperplasia volume was minimal at 2 years in both groups. This study demonstrates the 2-year safety and efficacy of sirolimus-eluting stenting. The slow release formulation showed slight superiority over the fast-release formulation in preventing late lumen loss, which was minimal in both groups. RAVEL Trial. This-study was a randomized, double-blind study that included 238 patients at 19 medical centers (15 in Europe, 3 in Brazil, and 1 in Mexico). Patients were eligible for the study if they were between 18 and 85 years of age, and had been given a diagnosis of stable or unstable angina or silent ischemia. Additional eligibility criteria were presence of a single primary target lesion in a native coronary artery that was 2.5 to 3.5 mm in diameter and that could be covered by an 18-mm stent stenosis of 51% to 99% of the luminal diameter and a flow rate of grade 1 or higher according to the Thrombolysis in Myocardial Infarction. Results. One hundred twenty patients were randomly assigned to receive the sirolimuseluting stent, and 118 were assigned to receive the standard stent. At 6 months, the degree of neointimal proliferation, manifested as the mean ( SD) late luminal loss, was significantly lower in the sirolimus-stent group ( 0.01 0.33 mm) than in the standardstent group (0.80 0.53 mm, P .001). None of the patients in the sirolimus-stent group,as compared with 26.6% of those in the standard-stent group, had restenosis of 50% of the luminal diameter (P .001). There were no episodes of stent thrombosis. During a follow-up period of up to 1 year, the overall rate of major cardiac events was 5.8% in the sirolimus-stent group and 28.8% in the standard-stent group (P .001). The difference was due entirely to the higher rate of revascularization of the target vessel in the standard-stent group...