Rivaroxaban plus aspirin reduces total ischemic events in PAD after revascularization
Rivaroxaban plus low-dose aspirin reduced incidence of total severe CV and other adverse events in patients with peripheral artery disease who had lower-extremity revascularization, according to new data from the VOYAGER PAD trial.
“VOYAGER PAD showed that 1 in 5 patients undergoing lower-extremity revascularization experienced a CV or limb event in spite of the background treatment of aspirin in all patients and statin and clopidogrel use in half of the patients. But the rate of total and subsequent events after lower-extremity revascularization and the effect of rivaroxaban on the reduction of total events is unknown,” Rupert Bauersachs, MD, director of vascular medicine at the Darmstadt Clinic in Germany, said during a presentation.
Bauersachs said the objective of the prespecified analysis was to investigate the total burden of disease after lower-extremity revascularization and to evaluate the efficacy of rivaroxaban (Xarelto, Janssen/Bayer) on first and total events.
In the VOYAGER PAD trial, researchers analyzed 6,564 patients (median age, 67 years; 74% men) who had PAD and had undergone lower-extremity revascularization. Patients were assigned rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone.
In the trial, there were 4,714 total first and subsequent vascular events, including 1,614 primary endpoint events (acute limb ischemia, major amputation for vascular cause, MI, ischemic stroke or CV death) and 3,100 other vascular events.
At 3 years, rivaroxaban plus aspirin reduced total primary endpoint events by 14% (rivaroxaban plus aspirin, 25.9 events per 100 patients; aspirin alone, 30.3 events per 100 patients; HR = 0.86; 95% CI, 0.75-0.98; P =.02) and total vascular events by 14% (rivaroxaban plus aspirin, 75.9 events per 100 patients; aspirin alone, 88.4 events per 100 patients; HR = 0.86; 95% CI, 0.79-0.95; P = .003) compared with aspirin alone, according to the researchers.
An on-treatment analysis favored the rivaroxaban/aspirin group to a greater extent (HR for total primary endpoint events = 0.42; 95% CI, 0.37-0.49; HR for total vascular events = 0.63; 95% CI, 0.57-0.69), Bauersachs said during the presentation.
In the analysis, an estimated 4.4 primary events and 12.5 vascular events per 100 participants were avoided with rivaroxaban plus aspirin over 3 years, Bauersachs said.
Bauersachs said patients undergoing lower-extremity revascularization are at high risk for adverse limb and CV events, with a particularly high burden of total events, and that occurred despite current available medical treatment.
“The risk profile in patients with symptomatic PADs is dominated by adverse limb outcomes, particularly after lower-extremity revascularization, including major vascular amputation and recurrent revascularization. Rivaroxaban 2.5 mg twice daily reduced first and subsequent adverse limb events with an even greater benefit when considering all events. Rivaroxaban 2.5 mg twice daily reduced with aspirin should be considered as an adjunctive treatment after lower-extremity revascularization to reduce first and subsequent adverse outcomes,” Bauersachs said.
Reference:
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Bauersachs R, et al. Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).
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