Bivalirudin, compared with unfractionated heparin or enoxaparin, plus a glycoprotein (GP) IIb/IIIa inhibitor results in similar rates of composite ischemia and mortality at one year in moderate- and high-risk ACS patients undergoing PCI, according to a subset of the ACUITY trial in the Sept. 2 issue of the Journal of the American College of Cardiology (JACC).
The original ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial, published in Lancet, demonstrated that in moderate- and high-risk ACS patients undergoing PCI, bivalirudin (marketed as Angiomax by the Medicines Company) alone compared to unfractionated heparin (UFH) or enoxaparin plus a GP IIb/IIIa inhibitor resulted in less major bleeding by 41 percent and similar ischemic outcomes at 30 days, the researchers said. The impact of bivalirudin on one-year outcomes in acute coronary syndrome patients undergoing PCI is unknown.
In the ACUITY trial, the researchers enrolled 13,819 patients, 56.4 percent of whom underwent PCI. Composite ischemia (death, MI or unplanned revascularization) and mortality were assessed at one year.
Among patients undergoing PCI, the investigators randomized 2,561, 2,609 and 2,619 to UFH or enoxaparin (marketed as Lovenox or Clexane by Sanofi-Aventis) plus a GP IIb/IIIa inhibitor, bivalirudin plus a GP IIb/IIIa inhibitor and bivalirudin monotherapy, respectively.
At one year, Harvey D. White, MD, from the Green Lane Cardiovascular Service at the Auckland City Hospital in New Zealand, and colleagues found that there were no differences in composite ischemia (17.8 vs. 19.4 vs. 19.2 percent) or mortality (3.2 vs. 3.3 vs. 3.1 percent) among the three groups, respectively.
“These findings are important as the data suggest treatment with Angiomax provides similar protection against ischemia and death over standard therapy at one-year…Multiple studies have shown a significant association between bleeding complications in ACS and PCI with mortality,” White said. “The data from the ACUITY sub-analysis suggest treatment with Angiomax is an attractive antithrombotic therapeutic option for patients undergoing PCI.”