Public Release:  Findings released from 1 of the largest percutaneous coronary intervention trials ever

Results show bivalirudin improves net clinical outcomes and increases survival in heart attack patients

Columbia University Medical Center

NEW YORK (May 23, 2008) - A study led by Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center/NewYork-Presbyterian and chairman of the Cardiovascular Research Foundation, has shown that heart attack patients who were administered the direct thrombin inhibitor bivalirudin during primary angioplasty had a reduced rate of adverse clinical events, a lower rate of major bleeding, and a lower mortality rate than those who were treated with a regimen of heparin and glycoprotein IIb/IIIa inhibitors (GPI).

In the landmark global trial, bivalirudin was compared to heparin plus GPI in more than 3,600 patients with ST-segment (a specific electrocardiogram wave) elevation myocardial infarction (STEMI), the most severe form of heart attack. The findings from the trial are presented in the May 22, 2008 issue of the New England Journal of Medicine.

The HORIZONS-AMI trial is a prospective, single-blind, randomized, multicenter study conducted in 11 countries. A total of 3,602 patients undergoing angioplasty were randomly assigned to receive either bivalirudin with provisional use of GPI or heparin plus GPI. The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) or major bleeding at 30 days. The secondary endpoint was major adverse cardiovascular events at 30 days. Those patients receiving bivalirudin within 30 days had significantly reduced net clinical adverse events by 24 percent, as well as reduced the risk of overall mortality by 33 percent and cardiac mortality by 38 percent, when compared to a regimen of heparin and GPI.

"The HORIZONS-AMI data show that using bivalirudin instead of heparin with a GPI during angioplasty increases survival in heart attack patients who are at high risk for death or disability," Dr. Stone said. "As the first multicenter randomized primary angioplasty trial since the introduction of balloon angioplasty to show improved survival, we expect HORIZONS-AMI to have an immediate impact on which drug therapy cardiologists choose for their patients with heart attack."

HORIZONS-AMI is the largest study ever to focus on the appropriate use of anticoagulant medications in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI). Only 7.2 percent of patients in the bivalirudin group received provisional GPI. The study also found that bivalirudin significantly reduced rates of major bleeding by 40 percent and demonstrated comparable rates of major cardiovascular adverse events. Bivalirudin has previously been shown to result in less bleeding and similar rates of composite ischemia compared to heparin plus GPI in patients undergoing angioplasty for stable angina, unstable angina and non-ST-elevation myocardial infarction (NSTEMI).

Dr. Stone emphasized the importance of reducing the risk of bleeding. "In multiple previous trials, major bleeding has been shown to be a strong predictor of short and long-term mortality in patients undergoing angioplasty and in those with acute coronary syndromes," he said.

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HORIZONS-AMI is sponsored and independently run by the Cardiovascular Research Foundation with funding by grants from The Medicines Company and Boston Scientific Corporation.

About ST-Segment Elevation Myocardial Infarction (STEMI)

STEMI is the most severe type of heart attack and carries a substantial risk of death and disability. STEMI involves myocardial injury, as indicated by a significant abnormality on the electrocardiogram (ECG) called ST-segment elevation. Guidelines recommend that STEMI patients be treated with rapid intervention such as primary angioplasty to help prevent further heart damage. According to the American Heart Association (AHA), an estimated 865,000 new and recurrent heart attacks occur every year, of which 400,000 are categorized as STEMI.

STEMI is part of a spectrum of acute coronary syndromes (ACS) caused by acute exacerbation of underlying coronary artery disease, and also includes non-ST elevation myocardial infarction (NSTEMI) and unstable angina (UA), chest pain due to inadequate circulation. Each year, about five million Americans seek emergency care for chest pain, of which an estimated 1.4 million are identified with ACS.

Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree. Among the most selective medical schools in the country, the school is home to the largest medical research enterprise in New York State and one of the largest in the country. For more information, please visit www.cumc.columbia.edu

NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million patient visits in a year, including more than 230,000 visits to its emergency departments -- more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S. News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital's mortality rates are among the lowest for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit www.nyp.org.

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