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GUSTO-V Trial: Global Utilization of Strategies to Open Occluded Coronary Arteries-V

GUSTO-V was a prospective, multicenter, randomized, open-label trial that found:

  • Combined low-dose of reteplase (5 U x 2 doses, 30 min apart) plus a 12-hour infusion of abciximab at 0.25 mg/kg bolus followed be 0.125 mcg/kg/min was not found to be superior to standard reteplase regimen.
  • The combination of low-dose reteplase and abciximab was associated with a reduction in the secondary end points, including infarction.
  • On the other hand, combination therapy was also associated higher non-intracranial bleeding complications and a trend towards an increased risk for intracranial hemorrhage, especially in patients > 75 years and resulted in a NNH (severe bleeding) in the combination group of 167.

GUSTO-V Trial: Global Utilization of Strategies to Open Occluded Coronary Arteries-V

  • GUSTO-V Trial: Global Utilization of Strategies to Open Occluded Coronary Arteries-V
    Study Design Prospective, multicenter, randomized, open-label trial.
    Sample Size n = 16,588 within 6 hours of onset of symptoms of acute MI, STEMI, or new left bundle branch block (LBBB)  
    Exclusion Criteria Patients with active bleeding, non-compressible vascular puncture site, blood pressure > 180/110 mm Hg, on oral anticoagulant therapy, stroke within the preceding 2 years, body weight >120 kg, or platelet count <100,000 cells/uL
    Interventions
        • n = 8,328: reteplase 10 U x 2 doss (30 minutes apart)
        • n = 8,328: abciximab 0.25 mg/kg bolus followed by 0.125 ug/kg/min for 12 hours + reteplase 5 U x 2 doses (30 minutes apart)
        Other Treatments
        • All patients received aspirin 150 mg on enrollment and daily thereafter (75-325 mg/d), intravenous heparin with a target aPTT of 50-70 seconds.
        • Coronary angiography and PCI or CABG were permitted.
        • The use of nonstudy abciximab for patients in the reteplase alone group was permitted if PCI was performed within 24 hours of enrollment and recommended if performed >24 hours after enrollment.
        Primary Endpoint To compare the effects of reteplase alone with a combination of a reduced dose of reteplase with abciximab in patients with ST segment elevation acute MI (STEMI).  
        Results
        • 24 hr-mortality was 2.3% in the reteplase only group and 2.2% in the reteplase + abciximab group (RR 0.96; 95% CI=0.78-1.18). 
        • 7-day mortality was 4.5% and 4.3%, respectively (RR 0.97; 95% CI=0.83-1.12).  
        • 30-day mortality was 5.9% in the reteplase group vs 5.6% in the reteplase + abciximab group (RR  0.95; 95% CI=0.84-1.08; p=0.37).
        • Reinfarction occurred in 3.5% of the patients in the reteplase group vs 2.3% in the combination group (p<0.0001).
        • 20.6% retelplase only vs 16.2% of the patients in the combination group died, experienced reinfarction or underwent urgent revascularization within the first 7 days (RR 0.75; 95% CI=0.69-0.81; p<0.0001).
        • Severe bleeding occurred in 0.5% in the reteplase group vs 1.1% in the combination group (p<0.0001), moderate bleeding in 1.8% vs 3.5%, respectively (p<0.0001), and 4.0% vs 5.7% of the patients, respectively, had transfusion (p<0.0001).
        •  Intracranial hemorrhage (ICH) occurred in 0.6% of the patients in the combination group (OR 0.76; 95% CI=0.43-1.37; p=0.37).  ICH occurred in 0.6% of the patients in each group (and patients > 75 years old, intracranial hemorrhage occurred in 1.1% of the patients in the reteplase group vs 2.1% in the combination group (OR 1.91; 95% CI=0.95-3.84; p=0.069), and in patients < 75 years of age, ICH occurred in 0.5 % vs 0.4%, respectively (OR 0.76; 95% CI=0.46-1.24; p=0.27).
        NNT/NNH Severe bleeding with combination therapy was = 167  
        Conclusions The combination of low-dose reteplase + a 12-hour infusion of abciximab was not found to be superior to standard reteplase regimen, but reduced secondary end points, including infarction. However, the combination therapy was also associated higher nonintracranial bleeding complications and a trend towards an increased risk for intracranial hemorrhage, mainly in patients > 75 years.

      MESH Terms & Keywords

      • GUSTO-V Trial, Thrombolytic Therapy for MI, Reteplase and Abciximab for MI