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

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.

• Authors: Yuji Murakawa, Takanori Ikeda, Satoshi Ogawa, Takanari Kitazono, Jyoji Nakagawara, Kazuo Minematsu, Susumu Miyamoto, Yasuhiro Hayashi, Yoko Kidani, Yutaka Okayama, Toshiyuki Sunaya, Shoichiro Sato, Satoshi Yamanaka
• Journal: Heart and vessels (Heart Vessels) Vol. 35 Issue 8 Pg. 1125-1134 (Aug 2020) ISSN: 1615-2573 [Electronic] Japan
• PMID: 32253531 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Observational Study)

Chemical References

• Factor Xa Inhibitors
• Rivaroxaban

Topics

• Aged
• Aged, 80 and over
• Atrial Fibrillation (diagnosis, drug therapy, mortality)
• Body Mass Index
• Comorbidity
• Factor Xa Inhibitors (adverse effects, therapeutic use)
• Female
• Heart Disease Risk Factors
• Hemorrhage (chemically induced)
• Humans
• Incidence
• Japan (epidemiology)
• Male
• Middle Aged
• Myocardial Infarction (diagnosis, mortality, prevention & control)
• Obesity (diagnosis, mortality)
• Product Surveillance, Postmarketing
• Prospective Studies
• Risk Assessment
• Rivaroxaban (adverse effects, therapeutic use)
• Stroke (diagnosis, mortality, prevention & control)
• Thinness (diagnosis, mortality)
• Thromboembolism (diagnosis, mortality, prevention & control)
• Time Factors
• Treatment Outcome