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| |  Benefit for Early Eptifibatide, Clopidogrel in Patients With Acute Coronary Syndrome: Presented at ACC By Walter Alexander ATLANTA -- March 18, 2010 -- In patients with non-ST-segment acute coronary syndrome (NSTE ACS) pretreated with clopidogrel, preprocedural (ie, percutaneous coronary intervention) eptifibatide may be associated with reduced 30-day mortality and myocardial infarction (MI). Analysis of the Early Versus Delayed Provisional Eptifibatide in Acute Coronary Syndromes (EARLY ACS) trial also showed increased bleeding risk with early eptifibatide. Tracy Wang, MD, Duke Clinical Research Institute, Durham, North Carolina, presented the results here on March 15 at the 59th Annual Scientific Sessions of the American College of Cardiology (ACC). Guidelines from the ACC, American Heart Association, and the European Society of Cardiology call for patients with NSTE ACS to be treated with an early invasive strategy with either clopidogrel or a glycoprotein 2b/3a inhibitor (GPI). They also recommend, in individuals with high-risk features, consideration of upstream use of both clopidogrel and a GPI. In results of the EARLY ACS trial, presented last year, the advantage for routine early eptifibatide over delayed provisional eptifibatide for the primary endpoint of combined death, reinfarction, recurrent ischaemia requiring urgent revascularisation or thrombotic bailout was not significant (10.0% vs 9.3%; P = .23). Similarly, the advantage for routine early eptifibatide use with the secondary endpoint of 30-day death or MI was nonsignificant (12.4% vs 11.2%; P = .079). Bleeding risk was significantly higher in patients randomised to the routine early eptifibatide strategy. Patients in EARLY ACS were randomised to eptifibatide or placebo 12 or more hours before angiography. In EARLY ACS, Dr. Wang noted, clopidogrel use and timing were determined by the treating physician. The current analysis examined whether upstream clopidogrel pretreatment influenced the benefit or safety of routine early eptifibatide use prior to angiography. Upstream clopidogrel use was reported in 75% of cases (n = 6,895; no upstream clopidogrel, n = 2,271). The adjusted difference in the primary endpoint between those receiving and those not receiving clopidogrel was marginal. For the endpoint of death/MI at 30 days, however, while the interaction was not statistically significant (P = .23), there was a 15% endpoint reduction in the routine early eptifibatide group (odds ratio [OR] = 0.85). Again, increased major bleeding with upstream eptifibatide was amplified in the presence of clopidogrel, as was the need for transfusions (OR for eptifibatide alone =1.23; with clopidogrel = 1.36). Kristin Newby, MD, also of Duke Clinical Research Institute, who led the EARLY ACS trial, commented in an interview, “Particularly in patients where you’re pretty certain they will be going to the cath lab, the combination of clopidogrel with eptifibatide looks good, with a modest increase in bleeding.” Fitting into a high-risk category, she said, would be patients who are marker-positive with refractory chest pain. Overall, she said, the findings are hypothesis generating. “This is a subanalysis of a big retrospective trial. It would be good to see it tested prospectively.” [Presentation title: Upfront Clopidogrel Use and the Efficacy and Safety of Early Eptifibatide Use in Patients With Acute Coronary Syndrome: An Analysis From the Early Versus Delayed Provisional Eptifibatide in Acute Coronary Syndromes (EARLY ACS) Trial. Abstract 0908-06]
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