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One-Year Results From the ACUITY Trial

Gregg W. Stone, MD; James H. Ware, PhD; Michel E. Bertrand, MD; A. Michael Lincoff, MD; Jeffrey W. Moses, MD; E. Magnus Ohman, MD; Harvey D. White, MD; Frederick Feit, MD; Antonio Colombo, MD; Brent T. McLaurin, MD; David A. Cox, MD; Steven V. Manoukian, MD; Martin Fahy, MSc; Tim C. Clayton, MSc; Roxana Mehran, MD; Stuart J. Pocock, PhD; for the ACUITY Investigators

JAMA. 2007;298(21):2497-2506.

Context  At 30-day follow-up, patients with moderate- and high-risk acute coronary syndromes (ACS) undergoing early invasive treatment in the ACUITY trial with bivalirudin monotherapy vs heparin plus glycoprotein (GP) IIb/IIIa inhibitors had noninferior rates of adverse ischemic events with reduced rates of major bleeding. Deferred upstream use of GP IIb/IIIa inhibitors for selective administration to patients undergoing percutaneous coronary intervention (PCI) resulted in a significant reduction in major bleeding, although a small increase in composite ischemia could not be excluded.

Objective  To determine 1-year ischemic outcomes for patients in the ACUITY trial.

Design, Setting, and Patients  A prospective, randomized, open-label trial with 1-year clinical follow-up 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 23, 2003, and December 5, 2005.

Interventions  Patients were assigned to heparin plus GP IIb/IIIa inhibitors (n = 4603), bivalirudin plus GP IIb/IIIa inhibitors (n = 4604), or bivalirudin monotherapy (n = 4612). Of these patients, 4605 were assigned to routine upstream GP IIb/IIIa administration and 4602 were deferred to selective GP IIb/IIIa inhibitor administration.

Main Outcome Measure  Composite ischemia (death, myocardial infarction, or unplanned revascularization for ischemia) at 1 year.

Results  Composite ischemia at 1 year occurred in 15.4% of patients assigned to heparin plus GP IIb/IIIa inhibitors and 16.0% assigned to bivalirudin plus GP IIb/IIIa inhibitors (compared with heparin plus GP IIb/IIIa inhibitors, HR, 1.05; 95% CI, 0.95-1.16; P = .35), and 16.2% assigned to bivalirudin monotherapy (HR, 1.06; 95% CI, 0.95-1.17; P = .29). Mortality at 1 year occurred in an estimated 3.9% of patients assigned to heparin plus GP IIb/IIIa inhibitors, 3.9% assigned to bivalirudin plus GP IIb/IIIa inhibitors (HR, 0.99; 95% CI, 0.80-1.22; P = .92), and 3.8% assigned to bivalirudin monotherapy (HR, 0.96; 95% CI, 0.77-1.18; P = .67). Composite ischemia occurred in 16.3% of patients assigned to deferred use compared with 15.2% of patients assigned to upstream administration (HR, 1.08; 95% CI, 0.97-1.20; P = .15).

Conclusions  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. 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.

Trial Registration  clinicaltrials.gov Identifier: NCT00093158

Author Affiliations: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York (Drs Stone, Moses, and Mehran, and Mr Fahy); Harvard University, Boston, Massachusetts (Dr Ware); Hôpital Cardiologique, Lille, France (Dr Bertrand); Cleveland Clinic, Cleveland, Ohio (Dr Lincoff); Duke University Medical Center, Durham, North Carolina (Dr Ohman); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (Dr White); New York University School of Medicine, New York (Dr Feit); Ospedale San Raphael, Milan, Italy (Dr Colombo); AnMed Health, Anderson, South Carolina (Dr McLaurin); Mid Carolina Cardiology, Charlotte, North Carolina (Dr Cox); Emory University School of Medicine, Atlanta, Georgia (Dr Manoukian); and London School of Hygiene and Tropical Medicine, London, England (Dr Pocock and Mr Clayton).

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