Canonico, Mario Enrico (2022) Low-dose Rivaroxaban plus Aspirin in Patients with Peripheral Artery Disease Undergoing Lower Extremity Revascularization with and without Concomitant Coronary Artery Disease: Insights from VOYAGER PAD. [Tesi di dottorato]

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Background Patients with peripheral artery disease (PAD) are at heightened risk of both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Rivaroxaban 2.5 mg BID with aspirin versus aspirin alone reduced major adverse limb and cardiovascular events in PAD patients after lower extremity revascularization (LER) in the VOYAGER PAD trial. The concomitant presence and related risk of known coronary artery disease (CAD) in PAD patients is not well understood leading differences in adverse event risk between PAD patients. Therefore, efficacy and safety of rivaroxaban 2.5 mg BID in PAD patients with and without CAD after LER has not yet been described. Methods VOYAGER PAD randomized patient with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin versus aspirin alone. The primary endpoint was a composite of acute limb ischemia, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was TIMI major bleeding. This is a pre- planned subgroup analysis investigating the contribution of concomitant CAD on efficacy and safety endpoints. Results Among 6,564 randomized patients, 2084 (32%) had CAD at baseline. In the placebo group, the 3-year Kaplan-Meier estimate of primary endpoint was 24.4% in those with concomitant PAD and CAD versus 17.9% in PAD only while MALE was 8.9% versus 10.2%, respectively. 3 Rivaroxaban decreased the rates of both MACE and MALE in each group particularly in those with concomitant PAD and CAD (HR 0.79, 95% CI 0.62-1.00) for MACE with a significant p- interaction of 0.03 considering MACE. The risk of bleeding was increased with rivaroxaban regardless of the presence of CAD. Conclusions In PAD patients underwent to LER, the presence of concomitant CAD leads to MACE events and confers an increased risk in PAD patients. Treatment with low-dose rivaroxaban and aspirin reduces the risk of MACE and MALE regardless of the presence of CAD; moreover, those with concomitant PAD and CAD derive a greater benefit with rivaroxaban in reducing MACE events versus those with PAD alone.

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