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/PAD1

*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 MORTALITY1

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‡ 2

*XARELTO® 2.5 mg twice daily with aspirin 100 mg once daily.

CHRONIC PAD

 

 

Major cardiovascular events were a composite of stroke, MI, and CV death.

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.


For VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

§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; HR = hazard ratio; ISTH = International Society on Thombosis and Haemostasis; NVAF = nonvalvular atrial fibrillation; PAD = peripheral artery disease.