Drug-eluting stents more effective, equally as safe as bare metal stents in clinical trialOctober 16, 2008Late-breaking data from the HORIZONS AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trial reveal that after one year, use of a drug-eluting (paclitaxel) stent demonstrated significantly reduced rates of target lesion revascularization (TLR) and binary angiographic restenosis when compared to the use of a bare metal stent in heart attack patients. The results of the trial were presented at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF). 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. In the trial, the implantation of the drug-eluting stent resulted in a significant 41% reduction of ischemia-driven target lesion revascularization (TLR). TLR refers to the rate at which a particular lesion needs to be revascularized following angioplasty and was the primary efficacy endpoint of the trial.
Use of the drug-eluting stent also resulted in a significant 56% reduction in binary restenosis after 13 months, which is the rate at which the artery narrows following implantation of the stent, and was the secondary efficacy endpoint of the trial. The drug-eluting stent had a rate of 10.0% and the bare metal stent had a rate of 22.9%. "These results provide definitive evidence that drug-eluting stents are superior in efficacy to bare metal stents and have a comparable safety profile at 1 year," said Gregg W. Stone, M.D., CRF Chairman, Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at NewYork Presbyterian-Hospital/Columbia University Medical Center. Dr. Stone is the principal investigator of the HORIZONS AMI trial, which was sponsored by the Cardiovascular Research Foundation with research grant support from Boston Scientific Corporation and The Medicines Company. "Outcomes from prior registry studies of drug-eluting stents compared to bare metal stents have been conflicting; this is the first prospective, large, international randomized clinical trial and provides conclusive evidence on this subject," 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 for 5 years to ensure that these favorable results are maintained." The HORIZONS AMI trial enrolled approximately 3,600 heart attack patients in 11 countries, 3,006 of whom were randomized to paclitaxel-eluting TAXUS stents versus otherwise identical bare metal stents. More than 120 national and international interventional cardiology centers participated in the trial. Cardiovascular Research Foundation | |||||||||||||||||||||
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Related Drug-eluting Stents Current Events and Drug-eluting Stents News Articles Cardiac stent patients with diabetes may benefit from drug that counteracts the effects of leptin The naturally high levels of leptin in diabetic patients may reduce the effectiveness of drug-eluting stents used to treat heart blockages, but using a chemical that differs from the one commonly used to coat stents could counteract this effect. HORIZONS AMI will help set guidelines for drug and stent therapy The HORIZONS AMI clinical trial measuring the safety and efficacy of the use of the medication bivalirudin compared to standard drug therapy - heparin and glycoprotein IIb/IIIa inhibitors -- in heart attack patients who receive angioplasty, found that after 1 year, use of bivalirudin resulted in significantly lower rates of all-cause death, death from cardiac causes, and major bleeding. Triple antiplatelet therapy appears superior to dual antiplatelet therapy Results of five research studies and a clinical registry first-report presentation scheduled for the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF), suggest that triple antiplatelet therapy for patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents achieves greater platelet inhibition than conventional dual antiplatelet therapy. New devices used to reduce arterial occlusions, provide cardiac support, highlighted at TCT 2008 Research results highlighting three new devices used to reduce blockages in peripheral and coronary arteries and to provide cardiac support will be presented at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF). Potential treatment option for severe emphysema under study Emory University researchers are participating in a nationwide study to explore an investigational treatment for advanced widespread emphysema. Best use of drug-eluting stents Compared with bare metal stents, drug-eluting stents substantially reduce the risk of angiographic and clinical recurrence but do not affect mortality or the short term or long term risk of myocardial infarction. More patients with drug-coated cardiac stents survive, avoid costly follow-up procedures The more than ten million Americans who've received drug-eluting stents to open their blocked coronary arteries have a bright future, according to new research from the University of Pennsylvania School of Medicine. Landmark study reveals superiority of bivalirudin in heart attack patients at 30 days The Cardiovascular Research Foundation (CRF) announced today that the New England Journal of Medicine published results of the HORIZONS AMI trial which showed the use of the anticoagulant bivalirudin following angioplasty in heart attack patients reduced net adverse clinical events by 24 percent compared to the standard treatment, as well as reduced the risk of overall mortality by 33 percent and cardiac mortality by 38 percent. Henry Ford Hospital to study effectiveness of a new procedure that may help emphysema suffers Researchers at Henry Ford Hospital today announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial, an international, multi-center clinical trial to explore an investigational treatment that may offer a significant new option for those suffering with advanced emphysema. Researchers at Pulmonary Associates to study airway bypass procedure for severe emphysema Researchers at Pulmonary Associates today announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial, an international, multi-center clinical trial to explore an investigational treatment that may offer a new, minimally invasive option for those suffering with advanced widespread emphysema. More Drug-eluting Stents Current Events and Drug-eluting Stents News Articles |
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