Research in context
Evidence before this study
Patients with peripheral artery disease are at high risk for major cardiovascular and limb events. The mainstay of treatment for patients with peripheral artery disease includes use of a single antiplatelet agent daily to prevent major adverse cardiovascular events. Other antithrombotic regimens have been tested in patients with peripheral artery disease including vitamin K antagonists and newer antiplatelet agents including P2Y12 antagonists used alone or in combination with aspirin, but none have been shown to be superior to antiplatelet therapy alone.
Added value of this study
The peripheral artery disease analysis of the COMPASS trial shows that use of low-dose rivaroxaban twice a day, together with aspirin 100 mg once a day, reduces cardiovascular death, myocardial infarction, stroke, and acute limb ischaemia and amputation, compared with aspirin alone. Although there is an increase in bleeding leading to more hospital admissions, there is no excess of fatal bleeding, intracranial bleeding, or bleeding into critical organs. Thus, the net clinical benefit favours the use of low-dose rivaroxaban plus aspirin.
Implications of all the available evidence
The combination of low dose rivaroxaban twice a day with aspirin could replace aspirin alone as standard of care in patients with stable peripheral artery disease who are not at high risk for bleeding.