FIM STUDY: We investigated the 2-year safety and efficacy of @entity3446 -eluting stents. Thirty @entity1 had a single 18-mm @entity3446 -eluting coronary stent implanted. Twenty-eight @entity1 underwent angiographic and intravascular ultrasound follow-up at 2 years. No @entity204 occurred during the study period. No @entity1 developed in-stent @entity256 . One @entity1 had a 52% in-lesion stenosis that required repeated revascularization and another @entity1 underwent target vessel revascularization. Neointimal @entity1373 volume was minimal at 2 years in both groups. This study demonstrates the 2-year safety and efficacy of @entity3446 -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 @entity1 at 19 medical centers (15 in Europe, 3 in Brazil, and 1 in Mexico). @entity1 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 @entity951 or silent @entity63 . Additional eligibility criteria were presence of a single primary @entity75 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 @entity583 . RESULTS: One hundred twenty @entity1 were randomly assigned to receive the @entity3446 -eluting 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 @entity3446 -stent group (-0.01 +/- 0.33 mm) than in the standard-stent group (0.80 +/- 0.53 mm, P <.001). None of the @entity1 in the @entity3446 -stent group, as compared with 26.6% of those in the standard-stent group, had @entity256 of >/=50% of the luminal diameter (P <.001). There were no episodes of stent @entity715 . During a follow-up period of up to 1 year, the overall rate of major @entity299 was 5.8% in the @entity3446 -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. CONCLUSION: @entity1 with @entity951 who received @entity3446 -eluting stents for the treatment of single, primary lesions in native coronary arteries had no angiographic evidence of late luminal loss or in-stent @entity256 at 6 months, no episodes of @entity715 , and a very low rate of @entity299 at 1 year.

Use of XXXX -impregnated stents in coronary arteries.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity63 :: ('MESH:D007511', 'Disease') :: ['ischemia'] @entity75 :: ('MESH:D001927', 'Disease') :: ['target lesion'] @entity1373 :: ('MESH:D006965', 'Disease') :: ['hyperplasia'] @entity256 :: ('MESH:D023903', 'Disease') :: ['restenosis'] @entity3446 :: ('MESH:D020123', 'Chemical') :: ['sirolimus'] @entity951 :: ('MESH:D000787', 'Disease') :: ['angina'] @entity299 :: ('MESH:D006331', 'Disease') :: ['cardiac events'] @entity583 :: ('MESH:D009203', 'Disease') :: ['Myocardial Infarction'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity715 :: ('MESH:D013927', 'Disease') :: ['thrombosis']
@entity3446 :: (MESH:D020123,Chemical) :: ['rapamycin']
