ACCOAST-PCI: Prasugrel pretreatment did not benefit non-STEMI patients undergoing PCI
PARIS — Investigators of the ACCOAST-PCI study reported that prasugrel pretreatment compared with placebo in non-STEMI patients did not decrease thrombus burden at the time of the procedure, stent thrombosis, urgent revascularization or glycoprotein IIb/IIIa inhibitor use, but caused a significant risk for major bleeding.
“This study was a retrospective selection of patients once the coronary angiogram and PCI had been done; these patients are the ideal group for pretreatment because they have all received a stent,” Gilles Montalescot, MD, PhD, head of the cardiac intensive care unit at the Institut de Cardiologie, Paris, and ACCOAST trial investigator, told Cardiology Today’s Intervention. “Despite the fact that this is the ideal population, we did not see an ischemic benefit of pretreatment with prasugrel [Effient, Eli Lilly/Daiichi Sankyo] and instead saw a safety issue. This means that you do not have to give pretreatment in this patient population and other patients who are medically managed or going to the operating room because there is nothing to gain on the side of ischemia.”
Montalescot, who is a Cardiology Today’s Intervention Editorial Board member, reported at EuroPCR that the primary endpoint — CV death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor (GPI) bailout at 7 days — was almost identical between the two arms at 30 days (pretreatment, 14.1% vs. placebo, 13.8%; P=0.77). Similarly, there was no difference observed in the endpoint of CV death, MI or stroke at 30 days (pretreatment, 9.2% vs. placebo, 8.8%; P=.72).
However, the rate of non-CABG-related TIMI major or minor bleeding differed significantly between strategies, with a lower rate in the placebo arm (1.4% vs. 4.2%; P<.001).
Additional 30-day analysis showed that, compared with patients who had thrombus seen on angiography, patients whose thrombus was not seen on angiography had lower rates of CVD, MI, stroke, urgent revascularization or GPI bailout (10.4% vs. 26%; P<.001), MI (7.5% vs. 11.1%; P=.004), urgent revascularization (1.4% vs. 3.3%; P=.002) and GPI bailout (2.3% vs. 16.5%; P<.001); there was no difference in rates of CVD, stroke and definite or probable stent thrombosis.
Montalescot said prasugrel will likely receive a class IIIa indication for pretreatment as a result of the ACCOAST trial findings.
“Beyond that, we have data on clopidogrel, which is not very good for pretreatment,” he said. “Both the PRAGUE-8 and ARMYDA-5 trials were negative and a meta-analysis suggested that there was no benefit. The revascularization guidelines are the next guidelines to come out and they will probably change recommendations of pretreatment.”
The ACCOAST trial included roughly 4,100 patients with non-STEMI who were randomly assigned 1:1 in a double-blind fashion to pretreatment with 30-mg prasugrel or placebo. – by Brian Ellis
For more information:
Montalescot G. Hot line: Adjunctive pharmacology. Presented at: EuroPCR; May 20-23, 2014; Paris.
Disclosure: Montalescot reports no relevant financial disclosures.