Rivaroxaban Approved to Prevent CV Events in Patients with CAD or PAD

By Amy Orciari Herman

Edited by Susan Sadoughi, MD

Rivaroxaban (marketed as Xarelto) is now indicated to reduce the risk for major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD), the manufacturer announced late last week. The factor Xa inhibitor was previously approved to lower the risk for stroke in patients with atrial fibrillation and to treat venous thromboembolism, among other indications.

The new indication is based on findings from the COMPASS trial, in which patients with CAD or PAD were randomized to take rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily), rivaroxaban alone, or aspirin alone. Overall, patients taking rivaroxaban plus aspirin had a 24% reduction in risk for major CV events compared with those taking aspirin alone. Major bleeding was more common with combination therapy than with aspirin alone, but fatal or intracranial bleeds did not differ between the groups.

The new approval specifies that rivaroxaban is to be used in combination with aspirin.

Dr. Joel Gore originally covered the COMPASS trial for NEJM Journal Watch Cardiology in 2017, at which time he raised concerns about adoption of rivaroxaban for this indication on a routine basis. See the third link below for details.