Comparison of baseline characteristics and outcomes of on-label full dose (20mg) and off-label reduced dose (15mg) rivaroxaban in patients with atrial fibrillation in Asian elderly patients

Abstract

Abstract Introduction In ROCKET-AF trial, rivaroxaban 20mg was on label dose and dose reduction criteria for rivaroxaban is creatinine clearance (CrCl) less than 50ml/min. Some Asian countries using reduced doses label compared with other global regions according to the J-ROCKET trial. Purpose The aim of this study was to assess the patients characteristic and outcomes of on-label full dose rivaroxaban and off-label reduced dose rivaroxaban in Asian elderly patients. Methods This study is a multi-center, prospective, non-interventional observational study to evaluate the efficacy and safety of rivaroxaban in atrial fibrillation patients older than 65 years old with or without renal impairment. Results A total of 1098 patients (mean age 72.8±5.8 years, 691[62.9%] males) was included and 265 patients received on label full does (20mg) rivaroxaban and 560 patients received off label reduced dose (15mg) rivaroxaban. Off label group showed older, more female patients, lower body weight, impaired CrCl and higher CHADS-VASc score. There showed no significant differences between two groups in major and minor bleeding, stroke and net-clinical outcomes. Conclusions Physicians prefer to prescribe off-label reduced dose rivaroxaban in patients with older and frail patients in Asia real world practice. There showed no differences in outcomes in these patients. Off label 15mg of rivaroxaban might be consider in specific populations.