Outcomes with the use of glycoprotein IIb/IIIa inhibitors in non-ST-segment elevation acute coronary syndromes.

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.