Open AccessImpact of three major risk factors on clinical outcomes in patients with nonvalvular atrial fibrillation receiving rivaroxaban: Sub‐analysis from the XAPASS study
Author(s) -
Ikeda Takanori,
Ogawa Satoshi,
Kitazono Takanari,
Nakagawara Jyoji,
Minematsu Kazuo,
Miyamoto Susumu,
Murakawa Yuji,
Tachiiri Michiya,
Okayama Yutaka,
Sunaya Toshiyuki,
Hirano Kazufumi,
Hayasaki Takanori
Publication year - 2022
Publication title -
journal of arrhythmia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.463
H-Index - 21
eISSN - 1883-2148
pISSN - 1880-4276
DOI - 10.1002/joa3.12700
Subject(s) - medicine , atrial fibrillation , rivaroxaban , stroke (engine) , hazard ratio , myocardial infarction , risk factor , cardiology , warfarin , confidence interval , mechanical engineering , engineering
Background To evaluate the impact of three risk factors (age [≥75 years], renal impairment [creatinine clearance <50 ml/min], and low body weight [≤50 kg]) on the risk of any bleeding events, all‐cause mortality, and stroke, non‐central nervous system (non‐CNS) systemic embolism (SE), and myocardial infarction (MI) in patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban in a real‐world clinical setting. Methods The Xarelto Post‐Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) is a prospective, single‐arm, observational study. Enrolled patients were divided into four subgroups by the number of risk factors. Results Overall, 9823 patients were included: 4299 with low risk, 2816 with moderate risk, 1574 with high risk, and 1134 with very high risk. The hazard ratios (95% confidence interval) (reference: low risk) for the moderate‐, high‐, and very‐high‐risk groups were 1.62 (1.19, 2.21) ( p = 0.002), 2.15 (1.47, 3.15) ( p < 0.001), and 2.49 (1.60, 3.87) ( p <0.001) for major bleeding, and 1.98 (1.47, 2.66), 2.29 (1.59, 3.29), and 2.74 (1.81, 4.16) ( p <0.001 for all) for stroke/non‐CNS SE/MI, respectively. Conclusions Age ≥75 years and renal impairment, but not low body weight, were determinants for major bleeding. The accrual of three risk factors was associated with increased risk for major bleeding and stroke/non‐CNS SE/MI in patients with NVAF receiving rivaroxaban; there was no increase in the cumulative risk for these with an increasing number of risk factors.