Lisa Nainggolan

March 30, 2008

March 30, 2008 (Chicago, IL) – Use of the GP IIb/IIIa inhibitor abciximab in acute ST-elevation MI (STEMI) patients undergoing PCI after pretreatment with a loading dose of 600-mg clopidogrel does not add any measurable benefit, according to a new study presented here today at the American College of Cardiology 57th Annual Scientific Session/i2 Summit-SCAI Annual Meeting.

Dr Julinda Mehilli (Deutsches Herzzentrum, Munich, Germany) presented results of the BRAVE-3 trial in a late-breaking clinical-trials session, explaining that this is the first study to test the influence of high-dose clopidogrel on the value of abciximab exclusively in patients with acute STEMI. "Acute MI is a major medical problem, and the present study helps define the optimal treatment strategy," she said, adding that treatment without abciximab will be more cost-effective and reduce the risk of bleeding complications. "We are not going to use GP IIb/IIIa inhibitors anymore because the results of this trial were negative," she told heartwire .

Discussant of the trial, Dr Gregg Stone (Columbia University, New York), congratulated Mehilli and colleagues on "a beautifully done study that is important and insightful." He noted that abciximab plus heparin is still the standard of care in STEMI but hinted that the results may become outdated, given that more and more people are now using bivalirudin for the treatment of acute STEMI. But Mehilli said that bivalirudin is not yet being used in Europe for the treatment of STEMI, and press conference moderator Dr William Knopf (Atlanta Cardiology Group, GA) estimated that only around 10% to 15% of primary angioplasty procedures in the US currently employ bivalirudin, so the results of BRAVE-3 remain of great clinical relevance. "The key appears to be the high loading dose of clopidogrel," he noted.

No difference in infarct size between groups

The idea for BRAVE-3 was conceived when the new idea for acute STEMI was a high loading dose of clopidogrel, Mehilli explained. The trial was a randomized, multicenter, double-blind placebo-controlled trial of 800 patients with acute MI presenting within 24 hours of symptoms and undergoing PCI. All participants received aspirin 500 mg, unfractionated heparin (UFH) 5000 IU, and pretreatment with 600 mg of clopidogrel, and they were then assigned to either abciximab (usual bolus and perfusion regimen) or placebo.

Baseline and angiographic characteristics were similar between the two groups, and there was no difference between them in TIMI flow 3 after intervention. In both groups, 44% of patients received a drug-eluting stent, and 50% in each arm received a bare-metal stent.

The primary end point was left ventricular infarct size as determined by single-photon-emission computed tomography (SPECT) performed five to 10 days after enrollment. Secondary end points included the 30-day combined incidence of death, myocardial reinfarction, urgent revascularization, and stroke, as well as the incidence of bleeding and profound thrombocytopenia.

There was no difference between the two treatment arms in the primary end point or in most of the secondary end points (the 30-day combined incidence of death, myocardial reinfarction, urgent revascularization, and stroke was 5% in the abciximab group vs 3.8% in the placebo group). There was, however, a 1.5% incidence of profound thrombocytopenia in the abciximab group, and these patients also had a slightly higher rate of TIMI minor bleeding compared with the placebo group.

"For patients with acute STEMI undergoing primary coronary intervention after pretreatment with a 600-mg loading dose of clopidogrel, the additional use of abciximab is not associated with any measurable benefit after 30 days," Mehilli stated.

"The findings are important because they answerthe question of whether we need GP IIb/IIIa inhibitors anymore in the era of a loading dose of clopidogrel, and the answer is we don't," she told heartwire .

Stone reports receiving honoraria from Lilly and having interests in The Medicines Company and Therox.

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