Objective: To compare the characteristics, management, and outcomes of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) who would have been eligible for inclusion in clinical trials of glycoprotein (GP) IIb/IIIa inhibitors with those of ineligible patients.
Design: Multinational, prospective, observational study (GRACE, Global Registry of Acute Coronary Events).
Setting: Patients hospitalised for a suspected acute coronary syndrome and enrolled in GRACE between April 1999 and December 2004.
Patients: 29 039 patients with NSTE ACS.
Main outcome measures: Characteristics and outcomes were compared for trial-eligible (75.0%) and trial-ineligible (25.0%) patients.
Results: GP IIb/IIIa inhibitors were administered to 20.0% of eligible and 15.3% of ineligible patients. Compared with eligible patients, ineligible patients who received GP IIb/IIIa inhibitors had significantly higher rates of hospital death (6.8% vs 3.7%) and major bleeding (4.9% vs 2.2%). After adjustment for their higher baseline risk, ineligible patients still experienced higher hospital death rates (adjusted odds ratio (OR) 1.60; 95% confidence interval (CI) 1.01 to 2.39), but not higher bleeding rates, than the eligible group. Use of GP IIb/IIIa inhibitors was associated with a trend towards lower 6-month mortality in eligible (OR 0.86, 95% CI 0.72 to 1.02) and ineligible (OR 0.82, 95% CI 0.65 to 1.05) patients compared with those in whom this therapy was not used.
Conclusions: GP IIb/IIIa inhibitors were markedly underused in the real-world population, irrespective of whether patients were trial-eligible or not. Despite the higher risk of ineligible patients, the benefits of GP IIb/IIIa inhibitors appear to be no less than in eligible patients.
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Competing interests: O H Dabbous: none; F A Anderson Jr: sanofi-aventis; J M Gore: sanofi-aventis; K A Eagle: Biosite, Bristol-Myers Squibb, Cardiac Sciences, Blue Cross Blue Shield of Michigan, Hewlett Foundation, Mardigian Fund, Pfizer, sanofi-aventis, Varbedian fund, National Heart, Lung & Blood NIH; K A A Fox: British Heart Foundation, Medical Research Council, The Wellcome Trust, Aventis, Sanofi-Synthelabo, GlaxoSmithKline, Bristol-Myers Squibb; R H Mehta: none; R J Goldberg: none; G Agnelli: sanofi-aventis; P G Steg: Boehringer Ingelheim, Bristol-Myers Squibb, GlaxaSmithKline, Merck Sharp & Dohme, Novartis, Nycomed, Sanofi-Aventis, Sankyo, Servier, ZLB-Behring, Pfizer, Takeda.
Funding: GRACE is funded by an unrestricted educational grant from sanofi-aventis (Paris, France) to the Center for Outcomes Research, University of Massachusetts Medical School (Worcester, MA, USA).