Drug-eluting stents prove more effective, equally as safe as bare-metal stentsMay 07, 2009The Cardiovascular Research Foundation (CRF) announced that its landmark study comparing the safety and efficacy of drug-eluting stents and bare-metal stents was published today in The New England Journal of Medicine. The study, HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction), showed that in heart attack patients undergoing angioplasty, the use of paclitaxel-eluting stents reduces rates of target lesion revascularization (TLR) and binary angiographic restenosis when compared to the use of bare-metal stents after 1 year. Additionally, the primary safety measure of major adverse cardiovascular events (MACE), including death, reinfarction, stent thrombosis and stroke established the non-inferiority of drug-eluting stents with respect to safety through 1 year. The study, led by Gregg W. Stone, M.D., of the Cardiovascular Research Foundation and professor of medicine at Columbia University Medical Center/New York-Presbyterian Hospital, was sponsored and managed by the Cardiovascular Research Foundation with research grant support from Boston Scientific Corporation and The Medicines Company. In the trial, the use of paclitaxel-eluting stents resulted in a significant reduction of ischemia-driven target-lesion revascularization (TLR) at 12 months (4.5% vs. 7.5%). TLR, which was the primary efficacy endpoint of the trial, refers to the rate at which a particular lesion re-narrows following stent implantation severely enough to require either a repeat angioplasty or bypass surgery operation. The use of paclitaxel-eluting stents also resulted in a significant reduction in binary restenosis after 13 months, which is the rate at which the artery re-narrows at least 50% following implantation of the stent, and was the secondary efficacy endpoint of the trial. The paclitaxel-eluting stent had a rate of 10.0% and the bare metal stent had a rate of 22.9%. "Outcomes from prior registry and randomized trials of drug-eluting stents compared to bare metal stents in heart attack patients have been conflicting. These results now provide definitive evidence that paclitaxel-eluting stents are superior in efficacy to bare metal stents and have a comparable safety profile at 1 year," said Dr. Stone. "The findings from the HORIZONS-AMI trial will have a major impact on how decisions are made regarding drug-eluting and bare metal stents in the highest risk patients, those in the early hours of a heart attack. This study removes much of the uncertainty and concern about the efficacy and safety of drug-eluting stents in this clinical setting. Moreover, all of the patients in this trial will be followed long-term to ensure that these favorable results are maintained." The HORIZONS-AMI trial, a prospective, open-label, multicenter, controlled study, enrolled 3,602 heart attack patients at 123 centers in 11 countries, 3,006 of whom were randomized to paclitaxel-eluting stents versus otherwise identical bare metal stents. Cardiovascular Research Foundation |
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| Related Drug-eluting Stents Current Events and Drug-eluting Stents News Articles Higher carotid arterial stenting rates associated with poorer clinical outcomes Among eligible Medicare beneficiaries, increased use of carotid arterial stenting (CAS) procedures to treat carotid stenosis-the narrowing of the carotid artery-is associated with higher rates of mortality and adverse clinical outcomes, including heart attack and stroke, according to researchers from the University of Pennsylvania School of Medicine. Drug-eluting stents better than bare-metal stents for heart attack patients Late-breaking data from the landmark HORIZONS-AMI clinical trial, presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, demonstrated that after two years, in heart attack patients, the use of a drug-eluting stent (paclitaxel) was safer and more effective than a bare-metal stent; and that the administration of the anticoagulant medication bivalirudin enhanced safety and efficacy compared to the use of heparin + GPIIb/IIIa inhibitors. SPIRIT IV trial shows everolimus stent sets new standard for event-free survival Late-breaking data from SPIRIT IV, a large-scale multi-center study of nearly 4,000 patients in the U.S., shows that an everolimus-eluting stent demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to a paclitaxel-eluting stent, and showed that "low late loss" may be achieved with drug-eluting stents without sacrificing safety. Drug-eluting stents safe, effective for treatment of chronic total occlusions A multicenter study in Asia found drug-eluting stents effective with a low rate of acute complications in patients with chronic total occlusions (CTOs) undergoing PCI. Results of the study will be presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF). Researchers find drug-eluting stents safe, effective for PCI in diabetics Results of a multicenter study in Asia, demonstrating that drug-eluting stents are effective with a low rate of complications in diabetic patients, will be presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF). Fast release of data leads to rapid changes in clinical practice for drug-eluting stents E-mail, search engines, smart phones and other new technologies that can disseminate new medical information quickly led to an almost immediate change in clinical practice for drug-eluting stents, according to a study reported in Circulation: Cardiovascular Quality and Outcomes. Analysis of drug-eluting stents data demonstrates safety, efficacy in on-and-off-label use The Cardiovascular Research Foundation (CRF) announced that results of the largest meta-analysis to date comparing mortality rates for drug-eluting stents (DES) versus bare metal stents (BMS) were published online June 15 in the journal Circulation. NEJM study finds drug-eluting stents more effective than bare-metal stents in heart attack patients NewYork-Presbyterian Hospital and Columbia University Medical Center, together with the Cardiovascular Research Foundation (CRF), announced that its landmark study comparing the safety and efficacy of drug-eluting stents and bare-metal stents was published in the May 7 New England Journal of Medicine. Drug-eluting stents found safe, superior to bare metal stents Drug-eluting stents were safe and superior to bare metal stents in preventing death and heart attacks among 262,700 "real-world" patients enrolled in a nationwide registry of cardiovascular disease, according to researchers from Duke University Medical Center. Promising 3-year data: Saving limbs with drug-eluting stents Attempts to treat critical limb ischemia in peripheral arterial disease (PAD) patients with below-the-knee angioplasty are still thwarted by restenosis (the re-narrowing of the artery at the site of angioplasty or stenting), the need for repeat treatments and the continued progression of atherosclerotic disease, leading to tissue death (gangrene) and amputation. More Drug-eluting Stents Current Events and Drug-eluting Stents News Articles |
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