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Prof. Marco Roffi,
Prof. Gilles Montalescot,
All the Scientific resources on ESC Congress 365
By Gilles MontalescotAlthough thienopyridine pre-treatment in Non ST-Elevation Acute Coronary syndrome (NSTE-ACS) is a class I recommendation, no large randomized study have been conducted to assess the risk/benefit as well as the optimal dosage and timing of a thienopyridine in this patient population.Prasugrel, a novel thienopyridine, provides predictably high and rapid inhibition of platelet aggregation.ACCOAST is a phase 3, randomized, double blind, event-driven study conducted in 171 centers throughout 19 countries in Europe and Canada, Israel and Turkey. The study compared prasugrel with placebo in patients presenting with NSTE-myocardial infarction (NSTE-MI) scheduled for coronary angiography.The primary end point was the composite of cardiovascular death, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa inhibitor bailout through 7 days from randomization. Follow-up continued through 30 days. 4033 patients were randomized to either an initial LD of prasugrel 30 mg after the diagnosis, followed by coronary angiography with an additional dose of prasugrel 30 mg given at the time of the PCI procedure (pretreatment), or placebo followed by a LD of prasugrel 60 mg given to patients undergoing PCI, at the time of the procedure (non-pretreatment). All patients undergoing PCI received daily prasugrel 5 or 10 mg. Key safety end points included TIMI major and minor bleeding complications.The demographics of the population are located in the table below.The results of the ACCOAST study will be presented at the meeting.Baseline Characteristics of Patients Enrolled in ACCOAST
Abbreviations: GRACE score=Global Registry of Acute Coronary Events score; LD=loading dose; MI=myocardial infarction; N=number of participants; PCI=percutaneous coronary intervention
Prof. Marco Roffi, FESC, Geneva, CHGilles Montalescot and co-investigators have to be congratulated for the performance of a randomized controlled trial seeking evidence for a practice established in many centers and supported by current guidelines, namely the pretreatment with a P2Y12 antagonist in patients with non-ST-elevation myocardial infarction (NSTEMI) undergoing early invasive strategy.The A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pretreatment At the time of diagnosis in patients with non-ST-elevation MI (ACCOAST) study included 4033 patients with NSTEMI scheduled for coronary angiography and, if appropriate, percutaneous coronary intervention (PCI) within 24 hours of enrollment. Patients were randomized to prasugrel pretreatment (i.e., 30 mg at randomization + 30 mg at the time of PCI) vs. standard prasugrel loading dose (60 mg) at the time of PCI.The primary endpoint was a composite of cardiovascular death, myocardial infarction (MI), stroke, urgent revascularization, or glycoprotein IIb/IIIa receptor inhibitor bailout at 7 days. The median time between loading dose and coronary angiogram was <4 ½ hours.Enrollment was stopped shortly before trial completion following the recommendation of an independent clinical endpoint committee because of an increased rate of major bleeding in the pretreatment arm in the absence of a benefit in terms of ischemic events. Accordingly, the primary endpoint occurred in 10.0% of patients in the pretreatment group vs. 9.8% of patients in the control group while the TIMI major bleeding rates were 2.6% and 1.4%, respectively (HR 1.9, 95% CI 1.19-3.02, P=0.006).The results of ACCOAST clearly challenge the Class I indication for P2Y12 pretreatment in NSTEMI in current guidelines.
Session Title: 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-Elevation Myocardial Infarction. 707
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