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.
Late-breaking data presented at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF), show that the use of the anticoagulant bivalirudin reduced net adverse clinical events (NACE) by 16% compared to the standard treatment. In addition, use of bivalirudin significantly reduced the major bleeding that occurs after angioplasty by 39% one year after the angioplasty was performed.
The use of bivalirudin also resulted in a significant 31% reduction in the 1-year rate of all cause mortality and a 43% reduction in the 1-year rate of cardiac mortality, with non-significant differences in the rate of repeat heart attack, stent thrombosis, stroke and target vessel revascularization (TVR) at 1 year.
"These 1-year results, which are even more impressive than the 30-day data reported at TCT one year ago, ensure that HORIZONS AMI will have a dramatic and lasting impact on the way that heart attack patients are treated during percutaneous coronary intervention," 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, and Principal Investigator of the HORIZONS-AMI trial. "The use of bivalirudin rather than heparin plus glycoprotein IIb/IIIa inhibitors reduced the rate of death and cardiac death by 1.4% and 1.7% respectively, which potentially could result in thousands of lives saved per year on a global basis."
"HORIZONS has demonstrated that the prevention of hemorrhagic complications after primary percutaneous coronary intervention in heart attack patients results in improved early and late survival," said Roxana Mehran, M.D., Joint Chief Scientific Officer of the Clinical Trials Center at CRF and Director of Outcomes Research, Data Coordination and Analysis at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center. She and her team conducted the study under an Investigational Device Exemption (IDE) from the Food and Drug Administration.
"Optimal drug selection and technique to minimize bleeding are essential to enhance outcomes for patients undergoing interventional therapies," Dr. Mehran said.
While previous studies of drug-eluting stents have often focused on their use in patients with stable or unstable chest pain, this is the largest study to focus on the appropriate use of anticoagulation medications and drug-eluting stents in patients experiencing the most dangerous form of heart attack (ST-elevation myocardial infarction).
Sponsored by the Cardiovascular Research Foundation, with research grant support from Boston Scientific Corporation and The Medicines Company, the HORIZONS AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trial enrolled over 3,600 patients presenting with a heart attack to hospitals in 11 countries. More than 120 national and international interventional cardiology centers participated in the trial. Patients undergoing angioplasty were randomly assigned to receive either the prior standard anticoagulant regimen of unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor or bivalirudin alone. The patients are to be followed for five years.
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