Background

• Despite the use of effective secondary prevention strategies, 5–10% of patients with cardiovascular disease have recurrent events each year

• The use of anticoagulants [anticoagulation] has not previously been widely recommended for patients in this context
   

Objective

• To test if rivaroxaban in combination with aspirin or given alone is more effective than aspirin alone in preventing major cardiovascular events, with acceptable safety, in patients with chronic atherosclerotic vascular disease
   

Study design

• Conducted at 602 centres in 33 countries

Endpoints

Primary efficacy outcome

• Composite of cardiovascular death, stroke or myocardial infarction

Primary safety outcomes

• Major bleeding using modified ISTH criteria including fatal bleeding, symptomatic bleeding into a critical organ, bleeding into a surgical site requiring reoperation, and bleeding that led to hospitalisation^§,

Secondary efficacy outcomes

• Composite of ischaemic stroke, myocardial infarction, acute limb ischaemia, or death from coronary heart disease

• Composite of ischaemic stroke, myocardial infarction, acute limb ischaemia, or cardiovascular death

• Death from any cause
   

Key Findings

• In patients with chronic CAD or PAD, dual pathway inhibition with rivaroxaban vascular dose 2.5 mg bid plus aspirin significantly lowered the risk of stroke, cardiovascular death and myocardial infarction versus aspirin alone

• As expected, risk of major bleeding was significantly higher in the rivaroxaban plus aspirin group compared with aspirin alone, but no significant increase in fatal, intracranial or critical organ bleeding was seen

• The rate of the net-clinical-benefit outcome was better with rivaroxaban plus aspirin than with aspirin alone

BID, twice daily; CAD, coronary artery disease; ISTH, International Society on Thrombosis and Haemostasis; OD, once daily; PAD, peripheral artery disease. * Patients who were not receiving a proton pump inhibitor were randomised to pantoprazole or pantoprazole placebo. † Patients treated according to local standard of care. ‡ ≤30 days of the required pre-specified number of events having occurred.
§ Included presentation to an acute care facility, without an overnight stay, which would not be considered major bleeding in other trials.

PP-XAR-ALL-1824-1