Abstract
Objectives: Evaluate the effects of protease-activated-receptor 1 antagonist vorapaxar in NSTE ACS pts undergoing PCI during index hospitalization. Methods: This prespecified analysis of a post-randomization subgroup evaluated the effects of vorapaxar compared with placebo among TRACER pts undergoing PCI, focusing on implanted stent type (drug-eluting stent [DES] vs bare metal stent [BMS]). Results: Among 12,944 TRACER pts, 7479 (58%) underwent PCI during index hospitalization; 1576 (44.4%) of vorapaxar pts and 1484 (42.1%) of placebo pts received exclusively BMS implantation. During the treatment period with vorapaxar, the median duration of thienopyridine therapy was 133 (47-246) days with BMS and 221 (88-341) days with DES. At 1 yr, the primary endpoint (CV death, MI, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization) occurred in 10.4% of pts with vorapaxar vs 10.6% of pts with placebo (HR 0.96; 95% CI 0.83-1.10). The key secondary endpoint (CV death, MI, stroke) occurred in 6.8% with vorapaxar and 7.3% with placebo (HR 0.89; 95% CI 0.75-1.05). A trend of interaction was noted on CV death, MI, and stroke between treatment and type of implanted stent, with pts receiving BMS showing a relatively greater effect from vorapaxar (Figure). GUSTO moderate/severe bleeding was overall increased with vorapaxar with no statistical interaction, although the relative increase appeared less with BMS (HR 1.27; 95% CI 0.85-1.90) than with DES (HR 1.70; 95% CI 1.14-2.53). Conclusions: In this post-randomization subgroup analysis, the efficacy of vorapaxar among PCI pts is consistent with the overall TRACER results. The duration of dual antiplatelet therapy was shorter with BMS than with DES, and a noteworthy signal of increased efficacy and less bleeding liability was noted in BMS pts. These results point to further research opportunities to evaluate the potential clinical role of vorapaxar.
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