Concomitant Clopidogrel Shows No Benefit in VOYAGER-PAD Analysis

While the first day of the ACC’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) offered insights into the impact of rivaroxaban for lowering cardiac events in peripheral artery disease (PAD) patients after undergoing revascularization, a new analysis is revealing more about the effect of concomitant clopidogrel in these patients.

The VOYAGER-PAD subgroup analysis, which included more than 6500 patients, revealed the addition of clopidogrel with rivaroxaban and aspirin provided no additional to patients following lower extremity revascularization.

In short, investigators observed events in 508 receiving rivaroxaban and in 584 receiving placebo in the VOYAGER-PAD trial. Using Kaplan-Meier estimates, results indicated an incidence of 17.3% and 19.9%, respectively, at 3 years (HR, 0.85, 95% CI, 0.76-0.98; P=.009).

Results pointed to an increased rate of TIMI major bleeding in the rivaroxaban group—occurring in just 2.65% (n=62) of those receiving rivaroxaban compared to 1.87% (n=44) in the placebo group (HR, 1.43, 95% CI, 0.97-2.10; P=.07). Investigators also noted an increase in ISTH major bleeding occurring in 5.94% (n=140) patients in the rivaroxaban group compared to (4.06%) (n=100) in the placebo group (HR, 1.42, 95% CI, 1.10-1.84; P=.007).

In the subgroup analysis, available information indicated 3313 patients had been taking clopidogrel while 3234 were not taking clopidogrel. Comparison revealed little difference between the risk of primary outcome based on use of clopidogrel (With clopidogrel, HR, 0.85; 0.71-1.01; vs. without HR, 0.86; 0.73-1.01; P-interaction=.9163). Results of the analysis also indicated patients receiving clopidogrel had an increase in bleeding events, most notably among events with longer duration.

In a special edition ACC House Call, VOYAGER-PAD presenter Marc Bonaca, MD, MPH, cardiologist at Brigham and Women’s Hospital and executive director of CPC Clinical Research, discussed the results of this subgroup analysis and how it can help inform clinical decision-making for physicians.

This study, “VOYAGER PAD Efficacy and Safety of Rivaroxaban in Patients with PAD undergoing Revascularization with and without Clopidogrel,” was presented at ACC.20/WCC.