NEW YORK, NY -DECEMBER 4, 2007 - Patients with acute coronary syndromes (ACS) receiving early invasive treatment including angiography and percutaneous coronary intervention (PCI) have comparable results at 1 year in terms of mortality and ischemic outcomes no matter which of three different anticoagulant regimens they are on, according to a study in the December 5 issue of the Journal of the American Medical Association.
Researchers led by Gregg W. Stone, MD, Chairman of the Cardiovascular Research Foundation in New York and Professor of Medicine and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy, Columbia University Medical Center, looked at over 13,000 patients with ACS (unstable angina or less severe heart attacks known as non-ST-elevation myocardial infarctions) who were given either heparin plus glycoprotein (GP) IIb/IIIa inhibitors (4,603 patients), the thrombin (blood-clotting enzyme) inhibitor bivalirudin by itself (4,612 patients), or bivalirudin plus GB IIb/IIIa inhibitors (4,604 patients).
Anticoagulant drug regimens are normally given in patients undergoing PCI to reduce the bleeding and ischemic complications that can result from these procedures. In earlier research, the same group of investigators showed that patients with ACS who received an early invasive management strategy who received bivalirudin alone experienced similar rates of ischemic complications but significantly reduced rates of major bleeding at 30 days compared with similar patients receiving bivalirudin plus GP IIb/IIIa inhibitors. As a result, less blood transfusions were required in this group of patients, and hospital costs were reduced. However, the long-term effect of bivalirudin monotherapy on composite ischemia and death are unknown.
"In the short term, the optimal pharmacological regimen to support the invasive approach in ACS would ideally suppress adverse ischemic and thrombotic events while minimizing iatrogenic [induced by treatment] bleeding," Dr. Stone said.
Results from the recent study, called the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, showed that compared with the control group of heparin plus GP IIb/IIIa inhibitors in which the 1-year estimated rate of composite ischemia was 15.4 percent, composite ischemia occurred in 16.0 percent of patients assigned to bivalirudin plus GP IIb/IIIa inhibitors and in 16.2 percent of patients assigned to bivalirudin alone. Death at 1 year occurred in an estimated 3.9 percent of patients assigned to heparin plus GP IIb/IIIa inhibitors, 3.9 percent assigned to bivalirudin plus GP IIb/IIIa inhibitors, and 3.8 percent assigned to bivalirudin monotherapy. Between 30 days and 1 year, a trend was present for fewer deaths in the patients assigned to bivalirudin monotherapy compared to heparin plus IIb/IIIa inhibitors or bivalirudin plus IIb/IIIa inhibitors (96 vs. 114 vs. 105 deaths respectively).
"At 1 year, there were no statistically significant differences in the rates of composite ischemia or mortality among patients with moderate- and high-risk ACS undergoing invasive treatment with the three anticoagulant regimens," Dr. Stone said. "Thus, bivalirudin alone, which decreases bleeding and transfusions, as well as hospital costs, as well as simplifies and streamlines care compared to heparin plus IIb/IIIa inhibitors, should be favored in most patients with ACS undergoing early invasive treatment."
The Cardiovascular Research Foundation (CRF) in New York City is an independent, non-profit academic institution dedicated to improving the survival and quality of life of patients with cardiovascular disease through research and education. For more than 15 years, CRF has played a major role in realizing dramatic improvements in the lives of patients by establishing the safe use of new technologies and therapies in the subspecialty of interventional cardiology and endovascular medicine. CRF is affiliated with Columbia University Medical Center. For more information, please visit www.crf.org.