Context Among patients with acute myocardial infarction, combination reperfusion
therapy with a platelet glycoprotein IIb/IIIa receptor inhibitor (abciximab)
and a half dose of a plasminogen activator (reteplase) did not significantly
reduce mortality at 30 days compared with a full dose of reteplase. Rates
of nonfatal ischemic complications were significantly diminished.
Objective To determine if the beneficial effects of abciximab and reteplase (combination
therapy) on early nonfatal complications would translate into a reduction
in the risk of death by 1 year.
Design, Setting, and Patients One-year follow-up of a randomized controlled trial (Global Use of Strategies
To Open Coronary Arteries [GUSTO] V). Of 16 588 patients who had been
treated in 820 community and referral hospitals in 20 countries between July
1999 and February 2001, mortality data were available for 16 453 (99.2%).
Intervention Patients were randomly assigned to receive (intravenously) a standard
dose of reteplase (two 10-U boluses, 30 minutes apart) or the combination
of a standard dose of abciximab (0.25 mg/kg bolus, 0.125 µg/kg per minute
infusion [maximum 10 µg/min for 12 hours]) and a half dose of reteplase
(two 5-U boluses, 30 minutes apart).
Main Outcome Measure One-year all-cause mortality rates.
Results All-cause mortality at 1 year occurred in 692 (8.38%) of 8260 patients
in the reteplase group and 698 (8.38%) of the 8328 patients in the combination
therapy group (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.90-1.11; P>.99). Reinfarction within the first 7 days occurred in
3.5% of patients in the reteplase group and 2.3% of patients in the combination
therapy group, and was significantly associated with 1-year mortality (22.6%
in patients with reinfarction vs 8.0% in patients without reinfarction; HR,
3.08; 95% CI, 2.53-3.75; P<.001). However, treatment
assignment did not significantly influence time of mortality regardless of
Conclusion Combination therapy (abciximab and reteplase) did not reduce mortality
over 1 year compared with fibrinolytic therapy with reteplase alone.