Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, and colleagues examined the 1-year clinical outcomes of patients enrolled in the ACUITY trial. The randomized, open-label trial was conducted at 450 academic and community-based institutions in 17 countries. A total of 13,819 patients with moderate- and high-risk ACS undergoing invasive treatment were enrolled between August 2003 and December 2005. Patients were assigned to heparin plus GP IIb/IIIa inhibitors (n = 4,603), bivalirudin plus GP IIb/IIIa inhibitors (n = 4,604), or bivalirudin monotherapy (n = 4,612). Of these patients, 4,605 were assigned to routine upstream (prior to angiography) GP IIb/IIIa use and 4,602 were deferred to selective GP IIb/IIIa use.

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 monotherapy. 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. There were no significant differences in the rates of the individual components of death, MI, or unplanned revascularization for ischemia between the three groups.

“At 1 year, no statistically significant difference in rates of composite ischemia or mortality among patients with moderate- and high-risk ACS undergoing invasive treatment with the 3 therapies was found,” the authors conclude. “There was no statistically significant difference in the rates of composite ischemia between patients receiving routine upstream administration of GP IIb/IIIa inhibitors vs. deferring their use for patients undergoing PCI.”

(JAMA. 2007;298(21):2497-2506. Available pre-embargo to the media at www.jamamedia.org)

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