Abstract 17939: Vorapaxar in Non-ST-Segment Elevation Acute Coronary Syndrome Patients With Peripheral Artery Disease: Results From TRACER
Background: In TRACER, vorapaxar, a PAR-1 antagonist, added to standard of care in non-ST-segment elevation acute coronary syndrome (NSTE ACS) patients modestly reduced ischemic events but significantly increased bleeding. A history of peripheral artery disease (PAD) was a risk enrichment inclusion criterion. We investigated the efficacy and safety of vorapaxar in patients with PAD.
Methods and Results: TRACER was a double-blind, randomized trial comparing vorapaxar with placebo in 12,944 patients. A total of 936 (7.2%) patients had a documented history of PAD. There was a higher incidence of ischemic events (cardiovascular [CV] death, myocardial infarction [MI], or stroke) among patients with PAD (25.3%) vs. no PAD (12.2%) (p<0.001) at final follow-up visit, and a higher incidence of GUSTO moderate or severe bleeding in PAD (9.1%) vs. no PAD (5.0%) (p<0.001) at the time of last dose of study medication. In patients with PAD treated with vorapaxar, there was a 21% reduction in the rate of CV death, MI, or stroke compared with placebo (p=0.787), with no significant interaction of treatment and PAD (Figure). PAD patients assigned to vorapaxar had a numerical reduction in the number of peripheral revascularization procedures (8.1% vs. 9.0%, p=0.158) and lower extremity amputation (0.9% vs. 1.5%, p=0.107) compared with placebo patients. Vorapaxar increased GUSTO moderate or severe bleeding with a similar magnitude in patients with PAD and no PAD (Figure).
Conclusions: NSTE ACS patients with PAD were at increased risk of ischemic events. In this exploratory analysis of PAD patients, we observed trends suggesting lower rates of ischemic endpoints, peripheral revascularization, and amputation with vorapaxar, warranting further investigation. Despite higher bleeding risk in PAD patients, vorapaxar did not appear to incrementally increase bleeding risk compared with non-PAD patients.
- © 2013 by American Heart Association, Inc.