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J. Am. Coll. Cardiol. · Dec 2014
Randomized Controlled Trial Multicenter StudyEffect of prasugrel pre-treatment strategy in patients undergoing percutaneous coronary intervention for NSTEMI: the ACCOAST-PCI study.
- Gilles Montalescot, Jean-Philippe Collet, Patrick Ecollan, Leonardo Bolognese, Jurrien Ten Berg, Dariusz Dudek, Christian Hamm, Petr Widimsky, Jean-François Tanguay, Patrick Goldstein, Eileen Brown, Debra L Miller, LeRoy LeNarz, Eric Vicaut, and ACCOAST Investigators.
- ACTION Study Group, Institut de Cardiologie, UPMC Université Paris 6, INSERM UMRS-1166 Paris, Centre Hospitalier Universitaire Pitié-Salpêtriėre (AP-HP), Paris, France. Electronic address: gilles.montalescot@psl.aphp.fr.
- J. Am. Coll. Cardiol. 2014 Dec 23;64(24):2563-71.
BackgroundAfter percutaneous coronary intervention (PCI) for non-ST-segment elevation myocardial infarction (NSTEMI), treatment with a P2Y12 antagonist with aspirin is recommended for 1 year.ObjectivesThe oral P2Y12 antagonists ticagrelor and prasugrel have higher recommendations than clopidogrel, but it is unknown if administration before the start of PCI is beneficial.MethodsIn the randomized, double-blind ACCOAST (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction) trial, 4,033 patients were diagnosed with NSTEMI and 68.7% underwent PCI; 1,394 received pre-treatment with prasugrel (30-mg loading dose), and 1,376 received placebo. At the time of PCI, patients who received pre-treatment with prasugrel received an additional 30-mg dose of prasugrel, and those who received placebo received a 60-mg loading dose of prasugrel. Primary efficacy was a composite of cardiovascular death, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa bailout through 7 days from randomization. Investigators captured the presence of thrombus on initial angiography and during PCI.ResultsThe incidence of the primary endpoint through 7 days from randomization in the pre-treatment group versus the no pre-treatment group was 13.1% versus 13.1% (p = 0.93). Pre-treatment with prasugrel was not associated with decreases in any ischemic event, including total mortality. Patients with thrombus on angiography had a 3-fold higher incidence of the primary endpoint than patients without thrombus. There was no impact of pre-treatment with prasugrel on the presence of thrombus before PCI or on occurrence of stent thrombosis after PCI. There was a 3-fold increase in all non-coronary artery bypass graft Thrombolysis In Myocardial Infarction (TIMI) major bleeding and a 6-fold increase in non-coronary artery bypass graft life-threatening bleeding with pre-treatment with prasugrel; the same trends persisted in patients who had radial or femoral access even with use of a closure device.ConclusionsThese findings support deferring treatment with prasugrel until a decision is made about revascularization in patients with NSTEMI undergoing angiography within 48 h of admission. (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction [ACCOAST]; NCT01015287).Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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