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Routine Upstream Initiation vs Deferred Selective Use of Glycoprotein IIb/IIIa Inhibitors in Acute Coronary SyndromesThe ACUITY Timing Trial
Gregg W. Stone, MD;
Michel E. Bertrand, MD;
Jeffrey W. Moses, MD;
E. Magnus Ohman, MD;
A. Michael Lincoff, MD;
James H. Ware, PhD;
Stuart J. Pocock, PhD;
Brent T. McLaurin, MD;
David A. Cox, MD;
M. Zubair Jafar, MD;
Harish Chandna, MD;
Franz Hartmann, MD;
Franz Leisch, MD;
Ruth H. Strasser, MD;
Martin Desaga, MD;
Thomas D. Stuckey, MD;
Richard B. Zelman, MD;
Ira H. Lieber, MD;
David J. Cohen, MD;
Roxana Mehran, MD;
Harvey D. White, MD; for the ACUITY Investigators
JAMA. 2007;297:591-602.
Context In patients with moderate- and high-risk acute coronary syndromes (ACS) who undergo an early, invasive treatment strategy, current guidelines recommend administration of platelet glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitors, either upstream to all patients prior to angiography or deferred for selective use in the catheterization laboratory just prior to angioplasty. The preferred approach is undetermined.
Objective To determine the optimal strategy for the use of Gp IIb/IIIa inhibitors in patients with moderate- and high-risk ACS undergoing an early, invasive treatment strategy.
Design Prospective, randomized, open-label trial with 30-day clinical follow-up.
Setting Four hundred fifty academic and community-based institutions in 17 countries.
Patients A total of 9207 patients with moderate- and high-risk ACS undergoing an invasive treatment strategy.
Interventions Patients were randomly assigned to receive either routine upstream (n=4605) or deferred selective (n=4602) Gp IIb/IIIa inhibitor administration, respectively.
Main Outcome Measures The primary outcome was assessment of noninferiority of deferred Gp IIb/IIIa inhibitor use compared with upstream administration for the prevention of composite ischemic events (death, myocardial infarction, or unplanned revascularization for ischemia) at 30 days, using a 1-sided  level of .025. Major secondary end points included noninferiority or superiority of major bleeding and net clinical outcomes (composite ischemia or major bleeding).
Results Glycoprotein IIb/IIIa inhibitors were used more frequently (98.3% vs 55.7%, respectively) and for a significantly longer duration (median, 18.3 vs 13.1 hours; P<.001) in patients in the upstream group compared with the deferred group. Composite ischemia at 30 days occurred in 7.9% of patients assigned to deferred use compared with 7.1% of patients assigned to upstream administration (relative risk, 1.12; 95% confidence interval, 0.97-1.29; P = .044 for noninferiority; P = .13 for superiority); as such, the criterion for noninferiority was not met. Deferred use compared with upstream use resulted in reduced 30-day rates of major bleeding (4.9% vs 6.1%, respectively; P<.001 for noninferiority; P = .009 for superiority) and similar rates of net clinical outcomes (11.7% vs 11.7%; P<.001 for noninferiority; P = .93 for superiority).
Conclusions Among patients with moderate- and high-risk ACS undergoing an invasive treatment strategy, deferring the routine upstream use of Gp IIb/IIIa inhibitors for selective administration in the cardiac catheterization laboratory only to patients undergoing percutaneous coronary intervention resulted in a numerical increase in composite ischemia that, while not statistically significant, did not meet the criterion for noninferiority. This finding was offset by a significant reduction in major bleeding.
Trial Registration ClinicalTrials.gov Identifier: NCT00093158
Author Affiliations: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (Drs Stone, Moses, and Mehran); Hôpital Cardiologique, Lille, France (Dr Bertrand); Duke University Medical Center, Durham, NC (Dr Ohman); Cleveland Clinic, Cleveland, Ohio (Dr Lincoff); Harvard University, Boston, Mass (Dr Ware); London School of Hygiene and Tropical Medicine, London, England (Dr Pocock); AnMed Health, Anderson, SC (Dr McLaurin); Mid Carolina Cardiology, Charlotte, NC (Dr Cox); Hudson Valley Heart Center, Poughkeepsie, NY (Dr Jafar); Victoria Heart and Vascular Center, Victoria, Tex (Dr Chandna); Universitätsklilnik Schleswig-Holstein Campus Lübeck, Lübeck, Germany (Dr Hartmann); Allgemeines öffentl Krankenhaus der Landeshauptstadt Linz, Linz, Austria (Dr Leisch); Technische Universität Dresden, Dresden, Germany (Dr Strasser); Klinikum Dachau der Amper Kliniken AG, Dachau, Germany (Dr Desaga); Moses Cone Hospital and LeBauer Cardiovascular Research Foundation, Greensboro, NC (Dr Stuckey); Cape Cod Research Institute, Hyannis, Mass (Dr Zelman); North Houston Heart Center, Kingwood, Tex (Dr Lieber); St Luke's Hospital, Mid America Heart Institute, Kansas City, Mo (Dr Cohen); and Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (Dr White).
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