Rivaroxaban plus aspirin reduced ischemic risk of the limb, brain, and heart in peripheral artery disease (PAD) after lower extremity revascularization (LER), according to an updated from the VOYAGER-PAD presented at the American Heart Association Scientific Session 2020.
These results support the use of rivaroxaban in addition to aspirin after endovascular intervention for PAD, according to study presenter Manesh R. Patel, MD, chief of the division of cardiology and the division of clinical pharmacology at Duke University School of Medicine.
Although dual antiplatelet therapy is often used following endovascular LER this strategy is not supported by any class 1A PAD guideline recommendations, Dr. Patel said.
“Despite high risk of events in these patients, there is no proven antithrombotic strategy to reduce limb and cardiovascular events in these patients,” he said.
The VOYAGER-PAD trial randomly assigned patients with PAD after LER to rivaroxaban 2.5 mg twice daily or matching placebo on background aspirin and followed them for a median of 28 months. The primary outcome was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, or cardiovascular death.
Dr. Patel presented results from a secondary analysis that attempted to define the risk profile of patients who underwent endovascular LER. Of the 6,564 patients randomized, about two-thirds were classified as endovascular LET and about one-third were classified as surgical. Patients undergoing endovascular LER tended to be older; 44% had diabetes, 64% had hyperlipidemia and about one-third had prior CAD.
Among endovascular treated patients, assignment to rivaroxaban resulted in a 10% risk reduction for the primary endpoint (17.9% vs. 16.2%; HR=0.90; 95% CI, 0.77 to 1.05). Major adverse limb events occurred in 7.5% of patients assigned placebo and 5.1% of patients assigned rivaroxaban. Rivaroxaban reduced risk for acute limb ischemia or major amputation of a vascular etiology by 33% compared with aspirin alone (HR=0.67; 95% CI, 0.52 to 0.87; P=0.0013). This translated into an absolute risk reduction of 2.4% with a number needed to treat of 42.
TIMI major bleeding – the primary safety endpoint – was higher regardless of the type of LER. For endovascular LER, the rate of TIMI major bleeding was 3.28% for rivaroxaban compared with 2.13% for placebo (HR=1.60 1.02 to 3.51; P=0.039). There was no increase in fatal or intracranial bleeding.
“The benefits of rivaroxaban twice daily with aspirin were not augmented by the use of concomitant clopidogrel,” Dr. Patel noted.