XARELTO®: Efficacy profile in chronic CAD/PAD
XARELTO® 2.5 mg VASCULAR DOSE*:Significantly reduced major cardiovascular events† in combination with aspirin in patients with chronic CAD/PAD2
*XARELTO® 2.5 mg twice daily with aspirin 100 mg once daily.
CHRONIC CAD/PAD
‡Major cardiovascular events were a composite of stroke, myocardial infarction (MI), and cardiovascular (CV) death.
§Not adjusted for multiplicity.
REDUCTION IN ALL-CAUSE MORTALITY2
CHRONIC CAD/PAD
§Not adjusted for multiplicity.
XARELTO® 2.5 mg vascular dose†: Reduced major cardiovascular events‡ and ACUTE LIMB ISCHEMIA in combination with aspirin in patients with chronic PAD§3
CHRONIC PAD
‡Major cardiovascular events were a composite of stroke, MI, and CV death.
§Not adjusted for multiplicity.
§Not adjusted for multiplicity.
COMPASS1
COMPASS trial design: A phase 3, multicenter, double-dummy study of patients with a history of stable atherosclerotic vascular disease. Using a 1:1:1 randomization, patients received XARELTO® 2.5 mg twice daily plus aspirin 100 mg once daily (n=9152), rivaroxaban 5 mg twice daily (n=9117), or aspirin 100 mg once daily (n=9126).
Because the 5 mg dose alone was not superior to aspirin alone, only the data concerning the 2.5 mg dose plus aspirin are discussed.
COMPASS: Primary outcomes were a composite of cardiovascular death, stroke, and myocardial infarction. The principal safety outcome was a modification of the ISTH criteria for major bleeding and included fatal bleeding, symptomatic bleeding into a critical organ, bleeding into a surgical site requiring reoperation, and bleeding that led to hospitalization with or without an overnight stay.
§Cardiovascular death was defined as a death for which a definite noncardiovascular cause has not been identified. Uncertain causes of deaths are presumed to be cardiovascular unless proven otherwise.
||Acute limb ischemia was defined as limb-threatening ischemia with evidence of acute arterial obstruction by radiological criteria or a new pulse deficit leading to an intervention, such as surgery, thrombolysis, peripheral angioplasty, or amputation, within 30 days of symptoms onset.
ALI = acute limb ischemia; CAD = coronary artery disease; DOAC = direct oral anticoagulant; ESC = European Society of Cardiology; HR = hazard ratio; ISTH = International Society on Thombosis and Haemostasis; NVAF = nonvalvular atrial fibrillation; PAD = peripheral artery disease.