Efficacy Of Sirolimus-eluting Stents Research Articles

Primary stenting of occluded native coronary arteries II—Rationale and design of the PRISON II study: A randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions

Primary intracoronary stent placement after successfully crossing chronic total occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation will be compared with sirolimus-eluting stent implantation for the treatment of CTO. A total of 200 patients will be followed up for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is the binary angiographic restenosis and reocclusion rate.

Drug-eluting stents: cost versus clinical benefit.

The publication in January 2001 of the first-in-man results showing zero restenosis after sirolimus-eluting stent implantation produced enormous excitement in the cardiological community.1 The long-awaited tool—a safe, restenosis-proof, easy-to-use stent—had been found. It was not too long thereafter that paclitaxel-eluting stents also demonstrated their capability to decrease restenosis. Today, both sirolimus- and paclitaxel-eluting stents have been shown in randomized trials to reduce restenosis as compared with conventional metallic stents (Figure 1).2–6 Most of these studies have been recently released in the form of abstracts during medical meetings and are still unpublished.3,5,6 In addition to sirolimus and paclitaxel, other agents have shown promising early results in recent studies, enlarging the body of evidence demonstrating the potential benefits of what are known as drug-eluting stents.7 Regulatory agencies have been very active in evaluating some of these devices in the United States, Europe, South America, and Asia. The sirolimus-eluting stent has been available for routine use in Europe, South America, and Asia since the first half of 2002 and received approval from the US Food and Drug Administration to be marketed in April 2003. Paclitaxel-eluting stents have also received CE (Conformite Europeenne) marking for commercialization in Europe and are now beginning to be commercialized. Figure 1. Randomized trials showing reduction of binary restenosis with drug-eluting stents.2–6 The case seemed to be closed. Restenosis, the Achilles’ heel of percutaneous revascularization, appeared defeated. However, since the sirolimus-eluting stents became available, very little has changed in the everyday life of almost all interventional laboratories in Europe. Why? Has the new treatment presented any undesirable effect? Was the desire to defeat restenosis not as great as supposed? The answer is none of the above. The limitation currently impeding more widespread use of the new technology is nontechnical, nonmedical, and nonbiological. The …

Use of rapamycin-impregnated stents in coronary arteries

FIM study We investigated the 2-year safety and efficacy of sirolimus-eluting stents. Thirty patients had a single 18-mm sirolimus-eluting coronary stent implanted. Twenty-eight patients underwent angiographic and intravascular ultrasound 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 sirolimus-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 sirolimus-stent group (−0.01 ± 0.33 mm) than in the standard-stent 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. Conclusion Patients with angina who received sirolimus-eluting stents for the treatment of single, primary lesions in native coronary arteries had no angiographic evidence of late luminal loss or in-stent restenosis at 6 months, no episodes of thrombosis, and a very low rate of cardiac events at 1 year.

Safety and efficacy of sirolimus-eluting stent (cypher) in acute myocardial infarction: A substudy of the Rapamycin-Eluting Stent Evaluation at Rotterdam Cardiology Hospital (RESEARCH) study

Safety and efficacy of sirolimus-eluting stent (cypher) in acute myocardial infarction: A substudy of the Rapamycin-Eluting Stent Evaluation at Rotterdam Cardiology Hospital (RESEARCH) study