Improved PCI procedural methods have not changed bivalirudin’s edge over heparin, according to a study published in the Jan. 6 issue of the Journal of the American College of Cardiology.
The research team pooled data from the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) and EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trials to determine patient outcomes. Patients in both studies were randomized to receive either bivalirudin (Angiomax, The Medicines Company) or heparin. Among the heparin patients, 84.8 percent also received a glycoprotein IIb/IIIa inhibitor.
Gregg W. Stone, MD, from the Columbia University Medical Center in New York City, and colleagues found that among patients given bivalirudin, 30-day rates of major and minor bleeding, thrombocytopenia, transfusions and cardiac mortality were lower compared with those who received heparin. Acute stent thrombosis rates, however, were higher among patients taking bivalirudin as opposed to heparin (1.2 percent vs 0.2 percent, respectively).
While considered nonsignificant, the relative risk for 30-day all-cause mortality among patients on bivalirudin as opposed to heparin was 0.77; 30-day cardiac mortality risk was 0.7 among bivalirudin patients compared with heparin.
Major bleeding risk was 0.53 for patients on bivalirudin. Thrombocytopenia risk for bivalirudin was 0.48.
They noted nonsignificant differences between the two treatment arms for reinfarction, ischemia-driven revascularization and stroke.
While there was some influence on reduced complications with the use of radial vs. femoral access, prasugrel or ticagrelor, and other improvements to PCI procedure, bivalirudin made the greatest impact.
Stone et al did note that while their findings are in-line with others on the subject, they were not similar to the HEAT-PPCI (How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention) trial that published a much higher stent thrombosis rate (2.9 percent vs. 1.3 percent and 1.1 percent, for HEAT-PPCI, HORIZONS-AMI and EUROMAX, respectively).
“These results support the use of bivalirudin for anticoagulation of patients with STEMI undergoing primary PCI, independently of vascular access site, choice of P2Y12 inhibitor, and timing of drug initiation and discontinuation,” they wrote, but noted that more research should clarify changes as PCI refinements and innovations continue.