![]() Benefit of rivaroxaban/aspirin was observed regardless of baseline clopidogrel use. Although the benefit of rivaroxaban/aspirin was consistent regardless of CAD status, the absolute benefit of this regimen appeared to be greater among those with both PAD and CAD. ![]() ![]() Rivaroxaban/aspirin was associated with a 2.6% absolute risk reduction in cardiovascular death, acute limb ischemia, major amputation, myocardial infarction, or stroke compared with placebo/aspirin at 3 years. placebo (p for interaction = 0.38)Īmong patients with lower extremity PAD undergoing revascularization, rivaroxaban/aspirin was associated with a reduction in major adverse limb and cardiovascular events compared with placebo/aspirin. Acute limb ischemia: 5.2% of the rivaroxaban/aspirin group compared with 7.8% of the placebo/aspirin group (p 75 years ):.Among diabetics, TIMI major bleeding occurred in 2.4% of the rivaroxaban/aspirin group compared with 1.0% of the placebo/aspirin group (p for interaction = 0.033). The primary safety outcome, Thrombolysis in Myocardial Infarction (TIMI) major bleeding, occurred in 2.7% of the rivaroxaban/aspirin group compared with 1.9% of the placebo/aspirin group (p = 0.069). This association was similar among various tested subgroups. The primary efficacy outcome, cardiovascular death, acute limb ischemia, major amputation, myocardial infarction, or stroke, occurred in 17.3% of the rivaroxaban/aspirin group compared with 19.9% of the placebo/aspirin group (p = 0.0085). Type of revascularization: surgical = 35%, endovascular or hybrid = 66%.Indication for revascularization claudication = 77%, critical limb ischemia = 23%.Need for long-term dual antiplatelet therapy.Need for antiplatelet or anticoagulation therapy other than aspirin and/or clopidogrel.Recent revascularization (Revascularization for asymptomatic disease.Successful lower extremity revascularization.Lower extremity PAD (documented by ischemic symptoms, imaging evidence of disease, and abnormal ankle-brachial index).Duration of follow-up: median 28 months.Patients with lower extremity PAD undergoing revascularization were randomized to rivaroxaban 2.5 mg twice daily/aspirin (n = 3,286) versus placebo/aspirin (n = 3,278).
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