December 17, 2013
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Vorapaxar may decrease ischemic events in patients with NSTEACS undergoing CABG

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Among patients with non-ST segment elevation ACS undergoing CABG, vorapaxar yielded a significant decrease in ischemic events, with no significant increase in perioperative bleeding, according to data from a subgroup analysis of the TRACER trial.

Researchers analyzed patients with acute symptoms of coronary ischemia within 24 hours prior to hospitalization who were randomly assigned to vorapaxar (40 mg loading dose and 2.5 mg subsequent daily maintenance dose) or matching placebo in the TRACER trial (n=12,944).

Correlations between treatment outcomes and ischemic and bleeding outcomes were evaluated using time-to-event analysis. Bleeding events were categorized using the TIMI and GUSTO scales. The study’s primary endpoint was a composite of death, MI, stroke, recurrent ischemia with hospitalization or emergency revascularization during index hospitalization.
During index hospitalization, 1,312 (10.1%) patients underwent CABG, and 78% were taking vorapaxar (Merck) at the time of surgery.

Among patients who underwent CABG, the primary endpoint occurred in 43 patients in the vorapaxar group and 70 in the placebo group, yielding a 45% reduction in ischemic events with vorapaxar (adjusted HR=0.55; 95% CI, 0.36-0.83).

The decrease in events after hospital discharge was greater among those who underwent CABG during index hospitalization (HR=0.46; 95% CI, 0.28-0.77) compared with those who did not undergo surgery during index hospitalization (HR=0.97; 95% CI, 0.87-1.08).

Although CABG-related TIMI major bleeding was numerically higher with vorapaxar, it was not significantly different between vorapaxar and placebo (9.7% vs. 7.3%; HR= 1.36; 95% CI, 0.92-2.02). The data also revealed no significant difference in fatal bleeding (0% vs. 0.3%) or need for reoperation (4.7% vs. 4.6%).
"These results should be considered exploratory, yet they suggest that PAR-1 antagonism could be a potentially attractive strategy to reduce recurrent ischemic events in CABG patients," the researchers wrote.

Disclosure: See the full study for a list of the researchers’ relevant financial disclosures.