Mortality at 1 Year With Combination Platelet Glycoprotein IIb/IIIa Inhibition and Reduced-Dose Fibrinolytic Therapy vs Conventional Fibrinolytic Therapy for Acute Myocardial Infarction. GUSTO V Randomized Trial - GUSTO V One Year Follow-up
The goal of this study was to assess the safety and efficacy of combination reperfusion therapy with a platelet glycoprotein IIb/IIIa receptor inhibitor (abciximab) and a half dose of a plasminogen activator (reteplase) in reduction of the risk of 1-year death in patients with acute ST elevation myocardial infarction
Patients Enrolled: 16588
Mean Follow Up: 1 year
ST elevation myocardial infarction treated in 820 community hospitals and referral hospitals between July 1999 and February 2001.
Patients with acute ST elevation myocardial infarction (STEMI, n=16,588) treated in 820 community and referral hospitals between July 1999 and February 2001, were randomized 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). While the primary endpoint was the 30 day moratlity, one year all cause mortality was also evaluated in the trial.
All-cause mortality at 1 year was similar between the reteplase group and the combination therapy group (8.38% vs. 8.38%, hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.90-1.11; P>.99). Reinfarction within the first 7 days was more common in the reteplase group compared to the combination therapy group (3.5% versus 2.3%, p <.001). Although reinfarction within first 7 days was associated with significantly higher 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), treatment assignment did not significantly influence time of mortality regardless of reinfarction status.
Among patients with STEMI, a combination of standard dose abciximab and half dose reteplase did not reduce mortality at 1 year compared with fibrinolytic therapy with reteplase alone. The lack of 1-year mortality benefit and the increased non-intracranial bleeding risk observed among patients treated with combination therapy (abciximab and reteplase) argues against the routine use of the combination therapy of abciximab and reteplase for management of STEMI. It remains to be determined whether combination therapy followed by early percutaneous coronary intervention (facilitated coronary angioplasty) would reduce mortality compared to primary percutaneous coronary intervention alone in patients with STEMI. The utlity of other combinations of agents also remains to be determined, although the combination of abciximab and TNK was not associated with benefits at one year in the ASSENT 3 trial.
Lincoff AM, Califf RM, Van de Werf F, et al. Mortality at 1 Year With Combination Platelet Glycoprotein IIb/IIIa Inhibition and Reduced-Dose Fibrinolytic Therapy vs Conventional Fibrinolytic Therapy for Acute Myocardial Infarction. GUSTO V Randomized Trial. JAMA 2002;288:2130-35.
Keywords: Thrombolytic Therapy, Myocardial Infarction, Platelet Aggregation Inhibitors, Hospitals, Community, Immunoglobulin Fab Fragments, Angioplasty, Platelet Membrane Glycoproteins, Percutaneous Coronary Intervention, Plasminogen, Recombinant Proteins, Tissue Plasminogen Activator, Platelet Glycoprotein GPIIb-IIIa Complex
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