EC Approves Rivaroxaban Plus Aspirin Regimen for CAD, PAD

Megan Brooks


August 27, 2018

The European Commission (EC) has approved a regimen of rivaroxaban (Xarelto, Bayer) 2.5 mg twice daily plus acetylsalicylic acid (ASA) 75 to 100 mg once daily for the prevention of atherothrombotic events in adults with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischemic events.

Rivaroxaban is the only non–vitamin K antagonist oral anticoagulant with this indication, the company said in a news release.  

The approval is based on data from the phase 3 COMPASS study, which showed that rivaroxaban 2.5 mg twice daily plus ASA 100 mg once daily was associated with a 24% reduced risk for the composite of stroke, cardiovascular death, and myocardial infarction compared with ASA 100 mg once daily alone in patients with CAD or PAD.

The results were presented last August at the European Society of Cardiology (ESC) 2017 Congress by John Eikelboom, MD, McMaster University, Hamilton, Ontario, Canada, simultaneously published online in the New England Journal of Medicine, and reported by | Medscape Cardiology.

"Despite many advances in the area of cardiovascular care, CAD and PAD have remained an area of unmet need. Even with currently available treatments for secondary prevention, patients remain at an unacceptable high risk of thrombotic events which can lead to disability, loss of limb and death," Eikelboom said in a company news release. 

"The approval of this combination approach of the vascular dose of an anticoagulant plus an antiplatelet provides physicians and patients with a much-needed improved treatment option."

Data from the COMPASS study on this indication are under review by the US Food and Drug Administration, as part of a supplemental new drug application.

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