Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
Janssen Scientific Affairs, LLC, Titusville, NJ.
Am Heart J. 2019 Jun;212:113-119. doi: 10.1016/j.ahj.2019.02.001. Epub 2019 Feb 20.
There are limited data regarding clinical outcomes and healthcare resource utilization of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) who are morbidly obese (body mass index >40 kg/m or body weight >120 kg).
Using data from 2 US healthcare claims databases, we identified patients initiating rivaroxaban or warfarin who had ≥1 medical claim with an AF diagnosis, a diagnostic code for morbid obesity (ICD-9: 278.01, V85.4%; ICD-10: E66.01%, E66.2%, Z68.4%), and a minimum continuous enrollment of 12 months before and 3 months after treatment initiation. Patients were excluded if they had mitral stenosis, a mechanical heart valve procedure, an organ/tissue transplant, or an oral anticoagulant prescription prior to the index date. Rivaroxaban and warfarin patients were 1:1 propensity score matched. Conditional logistic regression was used to compare ischemic stroke/systemic embolism and major bleeding risk. Generalized linear models were used to compare healthcare resource utilization and costs.
A total of 3563 matched pairs of morbidly obese AF patients treated with rivaroxaban or warfarin were identified. The majority (81.4%) of patients in the rivaroxaban cohort were receiving the 20 mg dose. The rivaroxaban and warfarin cohorts were well balanced after propensity score matching. The risks of ischemic stroke/systemic embolism and major bleeding were similar for rivaroxaban and warfarin users (stroke/systemic embolism: 1.5% vs 1.7%; odds ratio [OR]: 0.88; 95% confidence interval [CI]: 0.60, 1.28; P = .5028; major bleeding: 2.2% vs 2.7%; OR: 0.80; 95% CI: 0.59, 1.08; P = .1447). Total healthcare costs including medication costs per patient per year (PPPY) were significantly lower with rivaroxaban versus warfarin ($48,552 vs $52,418; P = .0025), which was primarily driven by lower hospitalization rate (50.2% vs 54.1%; P = .0008), shorter length of stay (7.5 vs 9.1 days; P = .0010), and less outpatient service utilization (86 vs 115 visits PPPY; P < .0001).
Morbidly obese AF patients treated with rivaroxaban had comparable risk of ischemic stroke/systemic embolism and major bleeding as those treated with warfarin, but lower healthcare resource utilization and costs.
在病态肥胖（身体质量指数>40kg/m 或体重>120kg）的房颤（AF）患者中，直接口服抗凝剂（DOACs）的临床结局和医疗资源利用情况的数据有限。
我们使用来自 2 个美国医疗保健索赔数据库的数据，确定了开始使用利伐沙班或华法林的患者，这些患者有≥1 次与 AF 诊断相关的医疗索赔，病态肥胖的诊断代码（ICD-9：278.01，V85.4%；ICD-10：E66.01%、E66.2%、Z68.4%），并且在治疗开始前和治疗开始后 3 个月有至少 12 个月的连续入组。如果患者在指数日期之前有二尖瓣狭窄、机械心脏瓣膜手术、器官/组织移植或口服抗凝剂处方，则将其排除在外。利伐沙班和华法林患者按 1:1 比例进行倾向评分匹配。条件逻辑回归用于比较缺血性卒中和全身性栓塞以及大出血风险。广义线性模型用于比较医疗资源的利用和成本。
共确定了 3563 对接受利伐沙班或华法林治疗的病态肥胖 AF 患者进行匹配。利伐沙班组的大多数（81.4%）患者接受的是 20mg 剂量。经过倾向评分匹配后，利伐沙班组和华法林组之间的平衡情况良好。利伐沙班和华法林使用者的缺血性卒中和全身性栓塞以及大出血风险相似（卒中/全身性栓塞：1.5% vs 1.7%；比值比[OR]：0.88；95%置信区间[CI]：0.60，1.28；P=0.5028；大出血：2.2% vs 2.7%；OR：0.80；95% CI：0.59，1.08；P=0.1447）。利伐沙班的每位患者每年的总医疗费用（包括药物费用）（PPPY）明显低于华法林（48552 美元 vs 52418 美元；P=0.0025），这主要归因于住院率较低（50.2% vs 54.1%；P=0.0008），住院时间较短（7.5 天 vs 9.1 天；P=0.0010），以及门诊服务利用率较低（86 次就诊 vs 115 次就诊 PPPY；P<0.0001）。
接受利伐沙班治疗的病态肥胖 AF 患者缺血性卒中和全身性栓塞以及大出血的风险与接受华法林治疗的患者相似，但医疗资源的利用率和成本较低。
