Abciximab in addition to a high loading dose of clopidogrel does not improve outcomes in STEMI patients: Results from the BRAVE-3 Trial
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March 30, 2008 By Lauren Ciaglo [mailto: lciaglo@perfuse.org]
SCAI-ACCi2 08-Chicago, IL: Investigators from Germany report today that dual antiplatelet therapy with a high loading dose of clopidogrel (600 mg) and intravenous abciximab does not improve outcomes in ST-elevation myocardial infarction (STEMI) patients compared with clopidogrel therapy alone.
This study was presented by Dr. Julinda Mehilli at the SCAI-i2 summit Annual Scientific Sessions in Chicago today.
Early administration of glycoprotein IIb/IIIa inhibitors in the emergency room is associated with improved epicardial artery patency prior to primary angioplasty. Likewise, administration of a thienopyridine, such as clopidogrel (300 mg) has also been associated with improved outcomes when administered in conjunction with a fibrinolytic agent in the CLARITY-TIMI 28 trial. However, it is not clear, whether a high loading does of clopidogrel (600 mg) would negate the need for glycoprotein IIb/IIIa inhibition during primary PCI for STEMI.
The BRAVE-3 investigators studied 800 patients with acute STEMI. After receiving a 600 mg loading dose of clopidogrel, each patient was randomized to receive either a GP IIb/IIIa inhibitor (abciximab) (n=401) or placebo (n=399) as part of a primary PCI procedure. Abciximab was administered via the standard intravenous bolus and infusion regimen.
The primary endpoint for the study was final infarct size 5-10 days later as measured by nuclear single photon emission computed tomography (SPECT). The infarct size was calculated as the final perfusion defect at follow-up. The BRAVE-3 investigators demonstrated that there was no difference in the mean final infarct size between the abciximab group and the placebo group (15.7% vs. 16.6%, p=0.47). Similarly no difference in the median final infarct size was noted between the abciximab group and the placebo group (10% vs. 9%, p=0.76).
Additional endpoints included the 30 day composite of death, myocardial reinfarction (re-MI), urgent revascularization and stroke, bleeding, and thrombocytopenia. These results were also similar between the two groups (5% vs. 3.8%, respectively, p=0.53).
Source
- Late Breaking Clinical Trials Session: SCAI Annual Scientific Sessions in partnership with ACC i2 summit, March 29-April 1, 2008 Chicago
- SCAI-ACC i2 press release
- SCAI-ACC i2 Abstract: Pretreatment With a High Loading Dose of Clopidogrel and Value of Abciximab During Primary Coronary Intervention in Patients with Acute Myocardial Infarction. Results of the Randomized BRAVE-3 Trial. Late Breaking Clinical Trials II: Acute Myocardial Infarction Presentation Number 2404-7
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