Dual-pathway inhibition with the XARELTO^® vascular dose*^1,2

PAD POST LER
CHRONIC PAD

The XARELTO^® vascular dose*: The FIRST and ONLY treatment approach indicated to help reduce risk^† in patients with PAD post LER^1,2

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 events^II

ARR = 19.9%-17.3% = 2.6%.

SUPERIOR RISK REDUCTION IN REPEAT REVASCULARIZATIONS AND REHOSPITALIZATIONS DUE TO LIMB EVENTS VERSUS PLACEBO^‡2

Secondary efficacy outcomes in patients with PAD revascularization

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 PAD^1-5

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.
^||Investigator-reported events.
^¶CV death includes coronary heart disease death, or death due to other CV causes or sudden cardiac arrest and unknown death.

Previous: PAD Clinical Trial

Next: PAD Safety Profile

General Tags:

PAD: Reduce the risk of major thrombotic vascular events

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

SUPERIOR RISK REDUCTION IN REPEAT REVASCULARIZATIONS AND REHOSPITALIZATIONS DUE TO LIMB EVENTS VERSUS PLACEBO‡2

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