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Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: Insights from the VOYAGER PAD trial

European Heart Journal Aug 29, 2021

Krantz MJ, Debus SE, Hsia J, et al. - Based on the findings from the secondary analysis of the VOYAGER trial, researchers recommend considering low-dose rivaroxaban combined with aspirin in patients ≥ 75 years with peripheral artery disease (PAD) after lower extremity revascularization (LER).

  • The VOYAGER trial was performed to assess rivaroxaban 2.5 mg twice/day plus aspirin 100 mg/day in older adults.

  • For the secondary analysis, a composite of acute limb ischemia, major amputation, myocardial infarction, ischemic stroke, or cardiovascular death defined the primary endpoint.

  • Thrombolysis in myocardial infarction (TIMI) major bleeding analyzed by the pre-specified age cut-off of 75 years was the principal safety outcome.

  • Elderly vs non-elderly patients had higher absolute 3-year Kaplan–Meier cumulative incidence rates for primary efficacy (23.4% vs. 19.0%) and safety (3.5% vs 1.5%) endpoints.

  • No influence of age on efficacy of rivaroxaban (P-interaction 0.83) and safety (P-interaction 0.38) was evident. Patients >75 years showed no increased intracranial and fatal bleeding (2 rivaroxaban vs 8 placebo).

  • Overall, there were greater benefits (absolute risk reduction 3.8%, number needed to treat 26 for the primary endpoint) compared with risks (absolute risk increase 0.81%, number needed to harm 123 for TIMI major bleeding).

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