Abstract 10398: Vorapaxar in Patients With Diabetes and Prior MI: Findings From the TRA 2P - TIMI 50 Trial
Background: Vorapaxar reduces cardiovascular death (CVD), myocardial infarction (MI), or stroke in patients with prior MI. Patients with diabetes mellitus (DM) are at particularly high risk of recurrent thrombotic events despite standard therapy.
Methods: TRA 2°P-TIMI 50 was a randomized, double-blind, placebo controlled trial of vorapaxar vs. placebo in patients with stable atherosclerosis treated for an average of 2.5 years. We aimed to determine the efficacy and safety of vorapaxar in patients with (n=3936) and without DM (13,843) who qualified for TRA 2°P-TIMI 50 with a prior MI.
Results: The primary endpoint of CVD, MI or CVA occurred significantly more frequently in patients with DM than in patients without DM (14.1% vs. 7.4%, p<0.001). In patients with DM, vorapaxar significantly reduced the primary endpoint compared with placebo (12.6% vs. 15.7%, p=0.004; Figure). The relative reduction in CVD/MI/CVA with vorapaxar was similar in the lower risk patients without DM (p-interaction=0.51); but the absolute effect of vorapaxar was greater in patients with DM with a lower number needed to treat (NNT 30 vs. 76, Figure). The benefit of vorapaxar in patients with DM was driven by a reduction in MI (8.6% vs. 11.4%, HR 0.73, 95% CI 0.59-0.91, p=0.01, p-interaction=0.38), and severe recurrent ischemia (3.9% vs. 5.6%, HR 0.63, 95% CI 0.46-0.86, p=0.004, p-interaction=0.02). GUSTO moderate/severe bleeding was increased in diabetics treated with vorapaxar (4.7% vs. 2.8%, HR 1.59, 95% CI 1.09-2.32, p=0.02). There was no difference in this risk of bleeding with vorapaxar in patients with DM compared to patients without DM (3.0 vs. 1.9%, HR 1.62, 95% CI 1.27-2.06, p<0.001, p-interaction=0.95).
Conclusion: In patients with DM and prior MI, the addition of vorapaxar to standard therapy significantly reduced the risk of major vascular events with greater potential for absolute benefit in this group at high risk of recurrent ischemic events.
- © 2013 by American Heart Association, Inc.