Peripheral artery disease, or PAD, affects more than 8 million people in the US. Individuals can present in a multitude of ways, from being (1) asymptomatic: without any obvious symptomatic complaint, but usually with a functional impairment, (2) classic claudication: lower extremity symptoms confined to the muscles with a consistent onset with exercise and relief with rest, (3) “atypical” leg pain: lower extremity discomfort that is exertional, but that does not consistently resolve with rest, consistently limit exercise at a reproducible distance, or meet all “Rose questionnaire” criteria, (4) critical limb ischemia: ischemic rest pain, non-healing wound, or gangrene), or (5) acute limb ischemia: pain, pulselessness, pallor, paresthesias, paralysis which suggest potential major adverse limb events (MALE). Individuals with type 2 diabetes mellitus (T2DM) are at an increased risk for PAD, and specifically those with PAD have a substantially higher risk of major adverse cardiovascular events (MACE) and MALE. Dr. William Baker and colleagues sought to assess the effectiveness and safety of rivaroxaban versus warfarin for the prevention of MACE or MALE in patients with nonvalvular atrial fibrillation (NVAF) and T2DM.
Using MarketScan data from 2012-2017, Baker and team identified oral anticoagulant (OAC)-naïve NVAF patients with comorbid T2DM prior to OAC initiation. Baker stated… “we identified 10,700 rivaroxaban and 13,946 warfarin patients,” who were followed until a MACE, MALE or major bleeding event, OAC discontinuation or switch, insurance disenrollment or end of data availability occurred. The median age was 70 years, with a CHA2DS2-VASc score of 4, and the duration of available follow-up was 1.4 years. Eleven percent of patients had PAD, 1.4% had a prior MALE, including 0.3% with a history of major limb amputation at baseline. They found that rivaroxaban was associated with a 25% reduction in the risk of MACE, and 63% reduction in the risk of MALE compared to individuals taking warfarin, with no difference observed in major bleeding risk.
Baker had concluded “in the substantial proportion of NVAF patients who have comorbid T2DM, use of rivaroxaban seems to reduce risk of major adverse cardiovascular and limb events with similar bleeding risk when compared to use of warfarin. This includes reductions in major limb amputation and need for limb revascularization. In this high-risk population, optimal antithrombotic strategies suggest preferential use of a direct-acting oral anticoagulant such as rivaroxaban to lower the incidence of life-threatening events.”