Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena & Reggio Emilia, Modena University Hospital, Via del Pozzo 71, Modena, Italy.
TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.
Eur Heart J. 2019 May 14;40(19):1541-1550. doi: 10.1093/eurheartj/ehy861.
To investigate the relationship between body mass index (BMI) and outcomes in patients with atrial fibrillation (AF).
In the ENGAGE AF-TIMI 48 trial, patients with AF were randomized to warfarin (international normalized ratio 2.0-3.0) or edoxaban. The cohort (N = 21 028) included patients across BMI categories (kg/m2): underweight (<18.5) in 0.8%, normal (18.5 to <25) in 21.4%, overweight (25 to <30) in 37.6%, moderately obese (30 to <35) in 24.8%, severely obese (35 to <40) in 10.0%, and very severely obese (≥40) in 5.5%. In an adjusted analysis, higher BMI (continuous, per 5 kg/m2 increase) was significantly and independently associated with lower risks of stroke/systemic embolic event (SEE) [hazard ratio (HR) 0.88, P = 0.0001], ischaemic stroke/SEE (HR 0.87, P < 0.0001), and death (HR 0.91, P < 0.0001), but with increased risks of major (HR 1.06, P = 0.025) and major or clinically relevant non-major bleeding (HR 1.05, P = 0.0007). There was a significant interaction between sex and increasing BMI category, with lower risk of ischaemic stroke/SEE in males and increased risk of bleeding in women. Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >18.5 kg/m2, while time in therapeutic range for warfarin improved significantly as BMI increased (P < 0.0001). The effects of edoxaban vs. warfarin on stroke/SEE, major bleeding, and net clinical outcome were similar across BMI groups.
An increased BMI was independently associated with a lower risk of stroke/SEE, better survival, but increased risk of bleeding. The efficacy and safety profiles of edoxaban were similar across BMI categories ranging from 18.5 to >40.
探讨体重指数（BMI）与心房颤动（AF）患者结局的关系。
在 ENGAGE AF-TIMI 48 试验中，AF 患者被随机分配至华法林（国际标准化比值 2.0-3.0）或依度沙班治疗。该队列（N=21028）包含了 BMI 分类（kg/m2）的患者：低体重（<18.5）占 0.8%，正常体重（18.5-<25）占 21.4%，超重（25-<30）占 37.6%，中度肥胖（30-<35）占 24.8%，重度肥胖（35-<40）占 10.0%，极重度肥胖（≥40）占 5.5%。在调整分析中，较高的 BMI（连续，每增加 5kg/m2）与较低的卒中/全身性栓塞事件（SEE）风险显著相关（风险比 [HR] 0.88，P=0.0001），与缺血性卒中和 SEE（HR 0.87，P<0.0001）以及死亡风险（HR 0.91，P<0.0001）显著相关，但与大出血（HR 1.06，P=0.025）和大出血或临床相关非大出血风险（HR 1.05，P=0.0007）显著相关。BMI 类别与性别之间存在显著交互作用，男性缺血性卒中和 SEE 风险较低，而女性出血风险增加。依度沙班在>18.5kg/m2的 BMI 组中药物浓度和抗因子 Xa 活性相似，而华法林的治疗窗时间随着 BMI 的增加而显著改善（P<0.0001）。依度沙班与华法林在卒中/SEE、大出血和净临床结局方面的疗效和安全性相似，与 BMI 类别无关。
BMI 升高与卒中/SEE 风险降低、生存改善相关，但出血风险增加。依度沙班在 18.5-40kg/m2 范围内的 BMI 类别中疗效和安全性相似。
