Abstract 19144: New Ischemic Stroke and Outcomes with Vorapaxar vs. Placebo: Results from TRA 2°P-TIMI 50 Trial
Vorapaxar is a potent platelet inhibitor that reduces thrombotic events in stable patients with a history of myocardial infarction (MI) or peripheral artery disease (PAD); however, this benefit is offset by increased bleeding including intracranial hemorrhage particularly in patients with established cerebrovascular disease (CVD). We investigated the outcomes in patients with MI or PAD experiencing a first ischemic stroke on vorapaxar.
METHODS: The TRA2P-TIMI 50 trial was a randomized, double-blind, placebo controlled trial of vorapaxar 2.5 mg daily in 26,449 patients with established atherosclerotic vascular disease. Patients were stratified at randomization by their qualifying atherosclerotic condition (MI, PAD, or CVD). After two years, the Data and Safety Monitoring Board recommended discontinuation of study treatment in those with prior stroke or incident stroke. We evaluated the risk of new ischemic stroke outcomes with vorapaxar in 20,170 patients with MI or PAD but no history of CVD.
RESULTS: In patients with MI or PAD and no history of CVD, vorapaxar significantly reduced ischemic stroke (HR 0.57, 95% CI 0.43 - 0.75, p<0.001)(Figure A). Overall there were numerically fewer hemorrhagic conversions in patients treated with vorapaxar who suffered a first ischemic stroke. The risk of hemorrhagic conversion (HR 1.19, 95% CI 0.49 - 2.91, p=0.70) or death (HR 1.09, 95% CI 0.57 - 2.07, p=0.79) during follow up was not significantly increased with vorapaxar. Although hemorrohagic stroke was increased (HR 2.78, 95% CI 1.00- 7.73, p=0.049) overall stroke was significantly reduced (HR 0.68, 95% CI 0.52 - 0.8, p=0.005) with vorapaxar (Figure B).
CONCLUSIONS: Vorapaxar reduces thrombotic events including ischemic stroke in stable patients with MI or PAD. There is no significant increase in the risk of hemorrhagic conversion or death in MI or PAD patients who experience a first ischemic stroke on vorapaxar. Hemorrhagic stroke is increased but all stroke is reduced.
- © 2012 by American Heart Association, Inc.