Identifying the highest risk vascular patients: Insights from the XATOA registry

Abstract

AimsPatients with coronary and peripheral artery disease (PAD) have a residual risk of major adverse cardiovascular and limb events despite standards of care. Among patients with coronary artery disease (CAD) and/or PAD selected for low dose rivaroxaban (2.5 mg BID) and aspirin, we sought to determine the highest risk vascular patients. MethodsXATOA is a single-arm registry of CAD and/or PAD patients. All participants were initiated on low dose rivaroxaban (2.5 mg BID) and aspirin. We report the incidence risk of MACE or MALE and major bleeding. A classification and regression tree analysis (CART) determined independent subgroups. ResultsBetween November 2018 and May 2020, 5,808 participants were enrolled in XATOA; 5,532 were included in the full analysis. The median follow-up (interquartile range) was 462 (371-577) days. The incidence risk per 100 pt-years of major adverse cardiovascular events (MACE) or major adverse limb events (MALE) was highest among participants with polyvascular disease (2 or more vascular beds affected, n=2889). The incidence risk was 9.16 versus 2.48 per 100 patient-years in polyvascular and non-polyvascular patients respectively. Other subgroups of high-risk patients included participants 75 years or older, with a history of diabetes, heart failure, or chronic renal insufficiency (CRI). Rates of major bleeding were low overall. A CART analysis showed that polyvascular disease was the most dominant factor separating higher from lower risk participants, and this was heightened with CRI or diabetes. ConclusionPatients with polyvascular disease represent a substantial subset of patients in clinical practice and should be prioritized to receive maximal medical therapy including low dose rivaroxaban (2.5 mg BID) and aspirin. Lay summaryPatients with coronary and peripheral artery disease have a residual risk of major adverse cardiovascular and limb events despite standards of care. In the XATOA registry, we determine the highest risk vascular patients and report the incidence risk of major adverse cardiovascular events, major adverse limb events, and major bleeding.Rates of major bleeding were low overall. Polyvascular disease was the most dominant factor and was heightened with CRI or diabetes.Patients with polyvascular disease should be prioritized to receive maximal medical therapy including low dose rivaroxaban (2.5 mg BID) and aspirin.