Dual-pathway inhibition with the XARELTO® vascular dose*1,2
The XARELTO® vascular dose*: The FIRST and ONLY treatment approach indicated to help reduce risk† in patients with PAD post LER1,2
SUPERIOR RISK REDUCTION IN A COMPOSITE OF MAJOR CV AND LIMB EVENTS VERSUS PLACEBO‡§1,2
- In VOYAGER, a phase 3 clinical trial (N=6564), the XARELTO® vascular dose* compared to placebo§ achieved a 15% RRR of major CV and limb eventsII
ARR = 19.9%-17.3% = 2.6%.
SUPERIOR RISK REDUCTION IN REPEAT REVASCULARIZATIONS AND REHOSPITALIZATIONS DUE TO LIMB EVENTS VERSUS PLACEBO‡2
ALI = acute limb ischemia; ARR = absolute risk reduction; CHD = coronary heart disease; CV = cardiovascular disease; KM = Kaplan-Meier; LER = lower extremity revascularization; MI = myocardial infarction; NNT = number needed to treat; PAD = peripheral artery disease; RRR = relative risk reduction.
*XARELTO® 2.5 mg twice daily plus aspirin (100 mg in clinical trial; 75 mg to 100 mg in practice) once daily.
†Reduction of a composite of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology in patients with PAD, including patients who have recently undergone an LER procedure due to symptomatic PAD.
‡Treatment schedule: XARELTO® 2.5 mg twice daily versus placebo; all patients received aspirin 100 mg once daily as background therapy.
§Patients on placebo received aspirin 100 mg once daily.
II18.2%-14.7% = 3.5%.
¶22.5%-20.0% = 2.5%.
#12.1%-8.7% = 3.4%.
The XARELTO® vascular dose*: The ONLY treatment approach indicated for reduction in the risk of major thrombotic vascular events† in patients with PAD1-5
RATES OF MAJOR Thrombotic vascular EVENTS VERSUS PLACEBO IN THE COMPASS PAD SUBGROUP†‡1,6
RATES OF ACUTE LIMB ISCHEMIA‡§1,6
RATES OF MAJOR VASCULAR AMPUTATIONS‡II1,6
RATES OF CV DEATH‡¶1,6
ARR = absolute risk reduction; BID = twice daily; CV = cardiovascular; MI = myocardial infarction; PAD = peripheral artery disease; QD = once daily; RRR = relative risk reduction.
*XARELTO® 2.5 mg twice daily plus aspirin 100 mg once daily.
†Reduction of a composite of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology.
‡Not adjusted for multiplicity.
§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.
¶CV death includes coronary heart disease death, or death due to other CV causes or sudden cardiac arrest and unknown death.