Published online before print January 6, 2003, doi: 10.1161/01.CIR.0000046487.06811.5E
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(Circulation. 2003;107:437.)
© 2003 American Heart Association, Inc.
Clinical Investigation and Reports |
Long-Term Results After the Glycoprotein IIb/IIIa Inhibitor Abciximab in Unstable Angina
One-Year Survival in the GUSTO IV-ACS (Global Use of Strategies To Open Occluded Coronary Arteries IV—Acute Coronary Syndrome) Trial
From University Hospital Rotterdam (J.P.O., E.B., M.L.S.), Erasmus Medical Center, Rotterdam, the Netherlands; Division of Cardiology (P.A.), University of Alberta, Edmonton, Alberta, Canada; Centocor, Inc (E.S.B., J.S.C.), Malvern, Pa; Duke University Medical Center (E.M.O.), Durham, NC; Department of Cardiology (S.J., L.W.), Uppsala, Sweden; and The Cleveland Clinic Foundation (E.T.), Cleveland, Ohio.
Correspondence to Maarten L. Simoons, MD, Erasmus Medical Center, ROOM H 560, University Hospital Rotterdam, PO Box 2040, 3000 CA Rotterdam, The Netherlands. E-mail Simoons{at}tch.fgg.eur.nl
Background— This study was designed to investigate long-term effects of the glycoprotein IIb/IIIa inhibitor abciximab in patients with acute coronary syndrome without ST elevation who were not scheduled for coronary intervention.
Methods and Results— A total of 7800 patients were included with an acute coronary syndrome without ST elevation, documented by either elevated cardiac troponin or transient or persistent ST-segment depression. They were randomized to abciximab bolus and 24-hour infusion, abciximab bolus and 48-hour infusion, or matching placebo. The overall 1-year mortality rate was 8.3% (649 patients). One-year mortality was 7.8% in the placebo group and 8.2% in the 24-hour and 9.0% in the 48-hour abciximab infusion group. Compared with placebo, the hazard ratio for the 24-hour infusion of abciximab was 1.1 (95% CI 0.86 to 1.29), and for the 48-hour infusion, it was 1.2 (95% CI 0.95 to 1.41). The lack of benefit of abciximab was observed in every subgroup studied. Patients with negative troponin or elevated C-reactive protein had a higher mortality rate after treatment with abciximab for 48 hours than with placebo: 8.5% versus 5.8% in those with negative troponin (P=0.02), 16.3% versus 12.1% in those with elevated C-reactive protein (P=0.04).
Conclusions— Compared with placebo, abciximab did not provide any survival benefit at 1 year in patients admitted with an acute coronary syndrome with ST depression and/or elevated troponin who were not scheduled to undergo early coronary revascularization. In subgroups of patients, in particular those with low cardiac troponin or elevated C-reactive protein, abciximab was associated with excess mortality.
Key Words: coronary disease • acute coronary syndromes • prognosis
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