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ACCOAST: Prasugrel pretreatment increases major bleeding, does not benefit ischemic events
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AMSTERDAM — Patients with non-ST-elevation ACS who were scheduled to undergo catheterization and given pretreatment with prasugrel did not have a reduction in ischemic events at 30 days, but had an increased risk for major bleeding complications, according to results of the ACCOAST trial.
“The results are consistent among patients undergoing PCI, supporting treatment with prasugrel once the coronary anatomy has been defined,” Gilles Montalescot, MD, professor at the Institut de Cardiologie, Hôpital la Pitié-Salpêtrière, Paris, and trial investigator, said during a press conference at ESC Congress 2013.
The phase 3, randomized, double blind ACCOAST trial involved patients with non-ST-elevation ACS (NSTEACS) and a positive troponin level who were scheduled to undergo coronary angiography within 2 to 48 hours of randomization (n=4,033). Patients were randomly assigned 1:1 to prasugrel 30 mg (Effient, Daiichi-Sankyo/Eli Lilly) before angiography or a matching placebo.
Gilles Montalescot
The primary endpoint was a composite of CV death, MI, stroke, urgent revascularization and glycoprotein IIb/IIIa bailout through 7 days, while the primary safety endpoint was all TIMI major bleeding episodes through 7 days.
Researchers observed that the primary efficacy endpoint did not differ between groups (pretreatment HR=1.02; 95% CI, 0.84-1.25).
However, there was a statistically significant difference with regard to the safety endpoint, suggesting an increased risk for bleeding in the pretreatment arm (HR=1.9; 95% CI, 1.19-3.02). Specifically, the rate of non–CABG-related TIMI major bleeding was increased by a factor of three and life-threatening bleeding by a factor of six.
“At this time, reappraisal of routine pretreatment strategies in NSTEACS is needed,” Montalescot said.
In an editorial accompanying the study in The New England Journal of Medicine, John F. Keaney Jr., MD, from the division of cardiovascular medicine, department of medicine, University of Massachusetts Medical School, Worcester, wrote that pretreatment with prasugrel afforded maximal platelet inhibition at the time of vascular access, which explains why excess procedural bleeding occurred.
“Overall, these results indicate that patients with non-STEMI who are selected for an early invasive strategy will be best served by administration of prasugrel only after angiographic definition of their coronary anatomy," Keaney wrote. "It remains to be seen whether a similar strategy could be applied to ticagrelor [Brilinta, AstraZeneca], the other high-potency P2Y12 antagonist currently available. – by Brian Ellis
For more information:
Montalescot G. Hot line II: Late breaking trials on intervention and devices. Presented at: the European Society of Cardiology Congress; Aug. 31-Sept. 4, 2013; Amsterdam.
Montalescot G. N Engl J Med. 2013;doi:10.1056/nejmoa1308075.
Keany JF. N Engl J Med. 2013;doi:10.1056/nejme1308820.
Disclosure:The study was supported by Daiichi-Sankyo/Eli Lilly. See the study for a full list of researcher disclosures.
Perspective
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Spencer B. King III, MD
The main question this study tries to answer is whether pretreatment with prasugrel is worthwhile clinically, and, in this case, it clearly is not. My thesis as to why this is the case is because a stent is a very good antithrombotic. It has a very potent effect by opening the artery and getting good laminar flow, and acute thrombosis in that setting is very low, plus all the people are on aspirin by this time.
In terms of how this will impact practice, it will depend on what people are doing. If people are routinely giving prasugrel upstream they might be dissuaded from doing that. If people are just giving it in the cath lab, they will continue to do it with some reassurance that they are doing the right thing. I suspect you won’t see any huge shift in what interventional cardiologists do as a result of these data.
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