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Pre-treatment with prasugrel -- more risk, no benefit: ACCOAST
Date:9/1/2013

gether, our findings suggest use of prasugrel should be considered only after the coronary anatomy has been defined."

Enrolment for ACCOAST was suspended by an independent data monitoring committee on November 16, 2012 when a planned interim analysis showed that pre-treatment with prasugrel was associated with an increased risk of major and life-threatening bleeding, although no increased rate of mortality.

The phase 3, randomized, double blind, event-driven study conducted in 171 centers and 19 countries in Europe, Canada, Israel and Turkey, randomized 4033 patients to either pre-treatment with prasugrel or placebo at the time of NTSE-ACS diagnosis (n=2037) followed by prasugrel given selectively after the coronary angiogram to patients with a confirmed indication for PCI (n=1996). Patients in both arms also received aspirin and standard of care.

Patients were to be scheduled to undergo coronary angiography/PCI within 48 hours from randomization.

Patients In the pre-treatment arm received a 30-mg loading dose (LD) of prasugrel at the time of randomization and, if PCI was indicated, an additional 30-mg at the time of PCI, while patients in the no pre-treatment arm got a placebo dose at randomization, and, if PCI was indicated, a 60-mg LD of prasugrel at the time of PCI.

Ultimately, PCI was performed in 68.7% of subjects, while in the 7 days post-randomization coronary artery bypass surgery (CABG) was chosen for 6.2% and medical management for 25.1%.

For the primary endpoint, a composite of cardiovascular death, myocardial infarction, stroke, urgent revascularization or GPIIb/IIIa bailout at 7 and 30 days post-randomization, there was no significant difference between the pre-treatment and no pre-treatment groups (10.0% vs 9.8%, p = 0.812, and 10.8 vs 10.8, p = 0.976, respectively).

However, the rate of all major bleeding, according to Thrombolysis in Myocardial Infarction (TIMI) criteria was almost double in the pre-treatment g
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Contact: ESC Press Office
press@escardio.org
44-773-005-7146
European Society of Cardiology
Source:Eurekalert

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