Purpose: Clinical trials use "time-to-first-event" analysis embedded often within the composite endpoint of cardiovascular death (CVD), MI, and stroke. However, many patients experienced nonfatal events before a fatal event and this method may not fully reflect patient benefit. We analyzed recurrent events in TRACER.
Methods: TRACER randomized 12,944 patients with ACS without ST-segment elevation. Vorapaxar did not reduce the primary endpoint but reduced the secondary endpoint of CVD, MI, and stroke; 14.7% vorapaxar vs 16.4% placebo, HR 0.89, 95% CI 0.81-0.98; nominal p=0.02. Analysis of vorapaxar's effect on recurrent CVD, MI, and stroke was prespecified using the Wei, Lin, and Weishield (WLW) approach.
Results: Only 1 event occurred in 10.1% vorapaxar vs 11.3% placebo. Recurrent events; n=348 occurred in 2.6% vorapaxar vs 2.8% placebo; p=0.6331. Vorapaxar significantly reduced the risk of recurrent CVD, MI and stroke after adjustment; HR 0.885; 95% CI 0.793–0.987; p=0.0284. Factors associated with risk of recurrent events are in the Table.
Conclusions: Vorapaxar reduced risk of "time-to-first" event and recurrent events broadening understanding of vorapaxar's potential to reduce recurrent events.