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 hospitalized 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 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] 1.01-2.39), but not higher bleeding rates, than the eligible group. Use of GP IIb/IIIa inhibitors was associated with a trend towards lower six-month mortality in eligible (OR 0.86, 95% CI 0.72-1.02) and ineligible (OR 0.82, 95% CI 0.65-1.05) 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 were no less than in eligible patients.
- acute coronary syndromes
- randomized clinical trial
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