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Vorapaxar in patients with coronary artery bypass grafting: Findings from the TRA 2°P-TIMI 50 trial
Ethan C Kosova1, Marc P Bonaca2, Mikael Dellborg3
11 Department of Medicine, Brigham and Women's Hospital, Boston, USA.
Insights
Vorapaxar significantly reduced cardiovascular events in patients with prior coronary artery bypass grafting (CABG). Bleeding risk during new CABG procedures while on vorapaxar was similar to placebo.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Vorapaxar is a protease-activated receptor-1 antagonist used to prevent cardiovascular events in stable patients with prior atherothrombosis.
- Patients with prior coronary artery bypass grafting (CABG) represent a high-risk population for recurrent atherothrombotic events.
Purpose of the Study:
- To evaluate the efficacy of vorapaxar in patients with severe coronary artery disease who previously underwent CABG.
- To assess the safety profile of vorapaxar in patients undergoing CABG while on the medication.
Main Methods:
- Analysis of data from the randomized, double-blinded, placebo-controlled TRA 2°P-TIMI 50 trial involving 26,449 patients.
- Specific investigation of vorapaxar's efficacy in 2,942 patients with a history of CABG prior to randomization.
- Assessment of safety in 367 patients who underwent a new CABG during the trial while receiving vorapaxar or placebo.
Main Results:
- Patients with prior CABG had a higher risk of cardiovascular death, myocardial infarction, or stroke compared to those without prior CABG (13.7% vs. 7.8%).
- Vorapaxar significantly reduced the risk of these events in patients with prior CABG (11.9% vs. 15.6%, HR 0.71, p=0.001).
- The rate of major bleeding during CABG in patients receiving vorapaxar was 6.3% compared to 4.1% in the placebo group (HR 1.53, p=0.39).
Conclusions:
- Vorapaxar demonstrates significant efficacy in reducing recurrent major cardiovascular events for patients with a history of CABG.
- The safety profile regarding bleeding risk during CABG appears comparable to the overall trial population when vorapaxar is administered.
Background:
Vorapaxar is a first-in-class protease-activated receptor-1 antagonist indicated for the reduction of cardiovascular death, myocardial infarction, and stroke in stable patients with prior atherothrombosis, who have not had a prior stroke or transient ischemic attack. The aims of this study were to investigate: 1) the role of vorapaxar in patients with severe coronary artery disease treated previously with coronary artery bypass grafting (CABG); and 2) safety in patients undergoing CABG while receiving vorapaxar.
Methods:
TRA 2°P-TIMI 50 was a randomized, double-blinded, placebo-controlled trial of vorapaxar in 26,449 stable patients with prior atherothrombosis followed for a median of 30 months. We 1) investigated the efficacy of vorapaxar among patients with a history of CABG prior to randomization ( n=2942); and 2) assessed the safety among 367 patients who underwent a new CABG during the trial.
Results:
Patients with a prior CABG were at higher risk for cardiovascular death, myocardial infarction, or stroke at three years compared with patients without a prior CABG (13.7% vs. 7.8%, p<0.001). Among patients with a prior CABG, vorapaxar significantly reduced the risk of cardiovascular death, myocardial infarction, or stroke (11.9% vs. 15.6%, hazard ratio 0.71, 95% confidence interval 0.58-0.88, p=0.001; number-needed-to-treat = 27). In patients undergoing CABG while receiving vorapaxar, the rate of Thrombolysis in Myocardial Infarction CABG major bleeding was 6.3% vs. 4.1% with placebo (hazard ratio 1.53, 95% confidence interval 0.58-4.01, p=0.39).
Conclusions:
In patients with a prior CABG, vorapaxar significantly reduced the risk of recurrent major cardiovascular events. In patients undergoing CABG while receiving vorapaxar, bleeding risk appeared similar to that seen in the overall trial population.
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