In Asian patients with atrial fibrillation and eGFR <50, the ROCKET AF rivaroxaban dosage had a higher risk of major bleeding than the J-ROCKET AF dosage (HR 2.70; P=0.0445).
Cohort (n=5,215)
Yes
Does rivaroxaban following J-ROCKET AF dosage criteria compared to ROCKET AF dosage criteria or warfarin improve safety and efficacy in Asian patients with atrial fibrillation?
In Asian patients with atrial fibrillation, the lower-dose J-ROCKET AF rivaroxaban criteria provided similar efficacy but lower major bleeding risk in those with eGFR <50 mL/min per 1.73 m² compared to standard ROCKET AF criteria.
Effect estimate: HR 2.70
p-value: p=0.0445
Background The ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) evaluated rivaroxaban (20/15 mg/d) versus warfarin in patients with atrial fibrillation. A separate trial, J‐ ROCKET AF (Japanese ROCKET AF), compared rivaroxaban (15/10 mg/d) and warfarin in Japanese patients with atrial fibrillation. Data about rivaroxaban following J‐ ROCKET AF criteria compared with warfarin and ROCKET AF dosage were limited. Methods and Results This retrospective study used medical data from a multicenter healthcare provider in Taiwan that included 3162 patients taking rivaroxaban. Among 2320 patients with an estimated glomerular filtration rate ( eGFR ) ≥50 mL/min per 1.73 m 2 , 384 and 1936 patients followed the ROCKET AF (20 mg/d) and J‐ ROCKET AF (15 mg/d) recommendation, respectively. Among 842 patients with an eGFR <50 mL/min per 1.73 m 2 , 422 and 420 patients followed the ROCKET AF (15 mg/d) and J‐ ROCKET AF (10 mg/d) recommendation, respectively. A total of 2053 patients with atrial fibrillation receiving warfarin were identified. Rivaroxaban following either ROCKET AF or J‐ ROCKET AF dosage criteria was associated with a comparable risk of thromboembolism but a lower risk of bleeding than warfarin. For patients with an eGFR ≥50 mL/min per 1.73 m 2 , risks of clinical events did not differ significantly between the 2 dosage criteria of rivaroxaban. For patients with an eGFR <50 mL/min per 1.73 m 2 , the ROCKET AF dosage was associated with a higher risk of major bleeding compared with the J‐ ROCKET AF dosage (hazard ratio, 2.70; P =0.0445) without significant differences regarding the risk of ischemic events. Conclusions In Asian patients with atrial fibrillation, the J‐ ROCKET AF dosage was as effective as the ROCKET AF dosage irrespective of renal function. The risk of major bleeding was lower with the J‐ ROCKET AF dosage in patients with an eGFR <50 mL/min per 1.73 m 2 . Compared with warfarin, rivaroxaban following either dosage criteria was effective and even safer.
Chan et al. (2019) conducted a cohort in Atrial Fibrillation (n=5,215). Rivaroxaban vs. Warfarin was evaluated on Major bleeding (HR 2.70, p=0.0445). In Asian patients with atrial fibrillation and eGFR <50, the ROCKET AF rivaroxaban dosage had a higher risk of major bleeding than the J-ROCKET AF dosage (HR 2.70; P=0.0445).