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Observational Study
. 2020 Aug;35(8):1125-1134.
doi: 10.1007/s00380-020-01587-z. Epub 2020 Apr 6.

Impact of body mass index on real-world outcomes of rivaroxaban treatment in Japanese patients with non-valvular atrial fibrillation

Yuji Murakawa  1 , Takanori Ikeda  2 , Satoshi Ogawa  3 , Takanari Kitazono  4 , Jyoji Nakagawara  5   6 , Kazuo Minematsu  6   7 , Susumu Miyamoto  8 , Yasuhiro Hayashi  9 , Yoko Kidani  9 , Yutaka Okayama  10 , Toshiyuki Sunaya  11 , Shoichiro Sato  10 , Satoshi Yamanaka  9
Affiliations
Observational Study

Impact of body mass index on real-world outcomes of rivaroxaban treatment in Japanese patients with non-valvular atrial fibrillation

Yuji Murakawa et al. Heart Vessels. 2020 Aug.

Abstract

This sub-analysis of the XAPASS, a prospective, single-arm, observational study, aimed to evaluate relationships between body mass index (BMI) and safety (major bleeding and all-cause mortality) and effectiveness [stroke/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI)] outcomes in Japanese patients with non-valvular atrial fibrillation (NVAF) receiving rivaroxaban. Patients were categorized according to BMI (kg/m2) as underweight (< 18.5), normal weight (18.5 to < 25), overweight (25 to < 30), or obese (≥ 30). In total, 9578 patients with NVAF completed the 1-year follow-up and were evaluated; of these, 7618 patients had baseline BMI data. Overall, 542 (5.7%), 4410 (46.0%), 2167 (22.6%), and 499 (5.2%) patients were underweight, normal weight, overweight, and obese, respectively. Multivariable Cox regression analysis demonstrated that none of the BMI categories were independent predictors of major bleeding whereas being underweight was independently associated with increased all-cause mortality [hazard ratio (HR) 3.56, 95% confidence interval (CI) 2.40-5.26, p < 0.001]. The incidence of stroke/non-CNS SE/MI was higher in patients who were underweight than in those of normal weight (HR 2.11, 95% CI 1.20-3.70, p = 0.009). However, in multivariable analyses, being underweight was not identified as an independent predictor of stroke/non-CNS SE/MI (HR 1.64, 95% CI 0.90-2.99, p = 0.104). In conclusion, the high incidence of thromboembolic events and all-cause mortality in patients who were underweight highlights that thorough evaluation of disease status and comorbidities may be required in this population.

Keywords: Atrial fibrillation; Body mass index; Rivaroxaban; Stroke.

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Conflict of interest statement

YM, TI, SO, TK, JN, KM, and SM were advisory board members for Bayer Yakuhin, Ltd. YM received research grants from Bayer Yakuhin, Ltd., Boehringer Ingelheim, and Daiichi Sankyo, and honoraria from Bayer Yakuhin, Ltd., Boehringer Ingelheim, Bristol-Myers Squibb, and Daiichi Sankyo. TI received research grants from Bayer Yakuhin, Ltd., Bristol-Myers Squibb, Daiichi Sankyo, Medtronic Japan, and St. Jude Medical, and honoraria from Bayer Yakuhin, Ltd., Bristol-Myers Squibb, Daiichi Sankyo, Ono, and Pfizer; TI was an advisory board member for Bristol-Myers Squibb. TK received a research grant from Bayer Yakuhin, Ltd. JN received a research grant from Nihon Medi-Physics. KM received honoraria from Astellas, AstraZeneca, Bayer Yakuhin, Ltd., BMS, Boehringer Ingelheim, Daiichi Sankyo, Japan Stryker, Kowa, Mitsubishi-Tanabe, Nihon Medi-Physics, Nippon Chemiphar, Otsuka, Pfizer, Sawai, and Sumitomo Dainippon; KM was an advisory board member for CSL Behring and Medico’s Hirata. SM received research grants from Astellas, Brainlab, Bristol-Myers Squibb, Carl Zeiss Meditec, Chugai, CSL Behring, Daiichi Sankyo, Eisai, Medtronic, Meiji, Mitsubishi-Tanabe, MSD, Mizuho, Nihon Medi-Physics, Otsuka, Pfizer, Philips Electronics Japan, Sanofi, Siemens Healthcare, and Takeda. YH, YK, YO, TS, SS, and SY are employees of Bayer Yakuhin, Ltd.

Figures

Fig. 1
Fig. 1
Kaplan–Meier curves for the cumulative event rate of a major bleeding and b stroke/non-CNS SE/MI among four BMI categories*. BMI body mass index, CI confidence interval, CNS central nervous system, HR hazard ratio, MI myocardial infarction, SE systemic embolism. *BMI categories (kg/m2): underweight, < 18.5; normal, 18.5 to < 25; overweight, 25 to < 30; and obese, ≥ 30
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