Low-Dose Rivaroxaban Plus Aspirin in Patients With PAD Undergoing Lower Extremity Revascularization With and Without History of Prior Limb Revascularization: Insight From the VOYAGER-PAD Trial

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Abstract
BACKGROUND: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb events (MALE) and major adverse cardiovascular events. The VOYAGER-PAD trial (Vascular Outcomes Study of Acetylsalicylic Acid Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated that rivaroxaban 2.5 mg twice daily on top of antiplatelet therapy significantly reduced this risk. Whether the risk of major adverse cardiovascular events and MALE and the effect of rivaroxaban are consistent in patients with a history of prior LER versus those without has not been described. METHODS: VOYAGER-PAD randomized patients with symptomatic PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. The history of prior LER was collected at baseline. The primary end point was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. RESULTS: A total of 6564 patients were enrolled with 2336 (35.5%) having a prior history of LER. Patients with a history of prior LER had a higher rate of MALE relative to those without prior LER (3-year Kaplan-Meier cumulative rates, 12.9% versus 8.0%; hazard ratio [HR], 1.58 [95% CI, 1.25–1.99]). Compared with placebo, rivaroxaban reduced the primary efficacy end point with a numerically greater relative benefit in those with (HR, 0.73 [95% CI, 0.60–0.88]) versus without prior LER (HR, 0.94 [95% CI, 0.81–1.10]; P interaction =0.036). The relative increase in Thrombolysis in Myocardial Infarction major bleeding with rivaroxaban was consistent regardless of prior LER status (prior LER: HR, 1.08 [95% CI, 0.62–1.89]; no prior LER: HR, 1.88 [95% CI, 1.09–3.25]; P interaction =0.16). CONCLUSIONS: Patients with PAD with prior LER are at particularly high risk of MALE relative to those presenting without prior LER. Rivaroxaban reduces the risk of major adverse cardiovascular events and MALE after LER for symptomatic PAD with a greater relative benefit in those with prior LER. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02504216.

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