Authors
Montalescot G, Bolognese L, Dudek D, et al.
Title
Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes.
References
N Engl J Med. 2013 Sep 12;369(11):999-1010
Background
Although P2Y12 antagonists are effective in patients with non-ST-segment elevation (NSTE) acute coronary syndromes, the effect of the timing of administration--before or after coronary angiography--is not known.
Purpose
To evaluate the effect of administering the P2Y12 antagonist prasugrel at the time of diagnosis versus administering it after the coronary angiography if percutaneous coronary intervention (PCI) was indicated.
Design
Multicenter, randomized, controlled trial 4033 patients with non-STEMI acute coronary syndromes Coronary angiography between 2-48 post randomization Endpoint: First major cardiovascular event: Cardiovascular death, MI, stroke, urgent revascularization, GP IIb/IIIa bailout
Exclusion Criteria
Contraindication for treatment with Prasugrel.
Follow-Up
7 days post randomization (primary outcome), 30 days (secondary outcome)
Treatment Regimen
Pre-treamtent with prasugrel 30mg versus placebo In case of angioplasty, additional 30mg of prasugrel at time of procedure versus 60mg prasugrel in group pretreated with placebo
Results
Primary Endpoints: No difference for major cardiovascular event death, MI, stroke, urgent revasulrization: 10.0% Pre-treament group versus 9.8% no pre-treatment group (p=0.81) at 7 days Secondary Endpoints: No difference in endpoint at 30 days for each death, MI, stroke, urgent revascularization, GPIIb/IIIa bailout Increased TIMI major bleeding at 7 days (HR 1.90) and at 30 days (HR1.97) in the pre-treatment group
Summary
In NSTEMI patients scheduled for angiography, pre-treatment with Prasugrel does not reduce major ischemic cardiovascular events up to 30 days of follow-up, but it does increase TIMI major bleeding.
Implications
Clinicians were used to pre-treatment with clopidogrel, and the same practice was initially assumed for prasugrel. This study showed that pre-treatment with prasugrel has no benefit for the patient. The practice of prasugrel pre-treatment was abandoned.
Related Figures
None.