The eligibility criteria for the ELDERCARE‐AF trial included the following: age ≥80 years; CHADS2 risk score (congestive heart failure, hypertension, age ≥75 years, diabetes, and history of stroke) ≥2.
4 (link),
8 (link) All patients were of Japanese ethnicity and had to be considered ineligible for OACs such as warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban at the recommended therapeutic strength or the approved doses due to at least 1 of the following reasons: low creatinine clearance (15–30 mL/min); history of bleeding from a critical area/organ or gastrointestinal bleeding; low body weight (≤45 kg); ongoing use of nonsteroidal anti‐inflammatory drugs; and current use of an antiplatelet medication. Excluded from the study were patients with moderate–severe mitral stenosis and/or mechanical heart valves.
For this subanalysis, 45 kg was used as a cutoff to stratify patients into 2 body weight groups (ie, ≤45 and >45 kg). This cutoff was defined based on the design of the main ELDERCARE‐AF trial,
4 (link),
8 (link) in which a body weight of ≤45 kg was specified as one of the ineligibility criteria for OAC therapy at the recommended therapeutic strength or the approved doses. As a result of this enrollment criterion, many patients included in the overall ELDERCARE‐AF population had a body weight of 40 to 45 kg, thereby ensuring sufficient patient numbers in each body weight subgroup for comparative analysis. In addition, an exploratory analysis was performed with all patients divided into 4 subgroups based on quartiles of body weight: >57.9 kg, >49.0 to ≤57.9 kg, >42.0 to ≤49.0 kg, and ≤42.0 kg.
4 (link),
8 (link) All patients were of Japanese ethnicity and had to be considered ineligible for OACs such as warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban at the recommended therapeutic strength or the approved doses due to at least 1 of the following reasons: low creatinine clearance (15–30 mL/min); history of bleeding from a critical area/organ or gastrointestinal bleeding; low body weight (≤45 kg); ongoing use of nonsteroidal anti‐inflammatory drugs; and current use of an antiplatelet medication. Excluded from the study were patients with moderate–severe mitral stenosis and/or mechanical heart valves.
For this subanalysis, 45 kg was used as a cutoff to stratify patients into 2 body weight groups (ie, ≤45 and >45 kg). This cutoff was defined based on the design of the main ELDERCARE‐AF trial,
4 (link),
8 (link) in which a body weight of ≤45 kg was specified as one of the ineligibility criteria for OAC therapy at the recommended therapeutic strength or the approved doses. As a result of this enrollment criterion, many patients included in the overall ELDERCARE‐AF population had a body weight of 40 to 45 kg, thereby ensuring sufficient patient numbers in each body weight subgroup for comparative analysis. In addition, an exploratory analysis was performed with all patients divided into 4 subgroups based on quartiles of body weight: >57.9 kg, >49.0 to ≤57.9 kg, >42.0 to ≤49.0 kg, and ≤42.0 kg.
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