Antithrombotic Strategies in Patients With Acute Coronary Syndromes Undergoing Early Invasive Management
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
- 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).
- Corresponding Author: Gregg W. Stone, MD, Cardiovascular Research Foundation, Columbia University Medical Center, 111 E 59th St, 11th Floor, New York, NY 10022 (gs2184{at}columbia.edu).
Abstract
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
