Sood Nitesh, Ashton Veronica, Bessada Youssef, Galli Katelyn, Bookhart Brahim K, Coleman Craig I
Arrhythmia Services, Southcoast Health, Massachusetts, United States.
Real World Value and Evidence, Janssen Scientific Affairs LLC, Titusville, New Jersey, United States.
TH Open. 2023 Mar 29;7(1):e82-e93. doi: 10.1055/a-2013-3346. eCollection 2023 Jan.
Obstructive sleep apnea (OSA) is associated with an increased incidence of atrial fibrillation (AF), hypertension, diabetes, heart failure, coronary heart disease, stroke, and death. We sought to evaluate the effectiveness and safety of rivaroxaban versus warfarin in nonvalvular AF (NVAF) patients with concomitant OSA. This was an analysis of electronic health record (EHR) data from November 2010 to December 2021. We included adults with NVAF and OSA at baseline, newly initiated on rivaroxaban or warfarin, and with ≥12 months of prior EHR activity. Patients with valvular disease, alternative indications for oral anticoagulation, or who were pregnant were excluded. The incidence rates of developing stroke or systemic embolism (SSE) and bleeding-related hospitalization were evaluated. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using propensity score-overlap weighted proportional hazards regression. Multiple sensitivity and subgroup analyses were performed. We included 21,940 rivaroxaban (20.1% at the 15 mg dose) and 38,213 warfarin (time-in-therapeutic range = 47.3 ± 28.3%) patients. Rivaroxaban was found to have similar hazard of SSE compared to warfarin (HR = 0.92, 95% CI = 0.82-1.03). Rivaroxaban was associated with a reduced rate of bleeding-related hospitalizations (HR = 0.85, 95% CI = 0.78-0.92) versus warfarin, as well as reductions in intracranial (HR = 0.76, 95% CI = 0.62-0.94) and extracranial (HR = 0.89, 95%CI = 0.81-0.97) bleeding. Upon sensitivity analysis restricting the population to men with a CHA DS VASc score ≥2 or women with a score ≥3, rivaroxaban was associated with a significant 33% risk reduction in SSE and 43% reduction in the risk of bleeding-related hospitalization. No significant interaction for the SSE or bleeding-related hospitalization outcomes was observed upon subgroup analyses. Among patients with NVAF and OSA, rivaroxaban had similar SSE risk versus warfarin but was associated with reductions in any intracranial and extracranial bleeding-related hospitalizations. Rivaroxaban was associated with significant reductions in SSE and bleeding-related hospitalizations when the study population was restricted to patients with a moderate-to-high risk of SSE. These data should provide prescribers with additional confidence in selecting rivaroxaban in NVAF patients who have OSA at the time of anticoagulation initiation.
阻塞性睡眠呼吸暂停（OSA）与心房颤动（AF）、高血压、糖尿病、心力衰竭、冠心病、中风及死亡的发病率增加相关。我们旨在评估利伐沙班与华法林在合并OSA的非瓣膜性房颤（NVAF）患者中的有效性和安全性。
这是一项对2010年11月至2021年12月电子健康记录（EHR）数据的分析。我们纳入了基线时患有NVAF和OSA、新开始使用利伐沙班或华法林且有≥12个月既往EHR活动记录的成年人。排除患有瓣膜病、口服抗凝治疗的其他适应证或怀孕的患者。评估发生中风或全身性栓塞（SSE）及出血相关住院的发生率。使用倾向得分重叠加权比例风险回归计算风险比（HR）和95%置信区间（CI）。进行了多项敏感性和亚组分析。
我们纳入了21,940名利伐沙班患者（15mg剂量组占20.1%）和38,213名华法林患者（治疗范围内时间=47.3±28.3%）。发现利伐沙班与华法林相比，SSE风险相似（HR=0.92，95%CI=0.82 - 1.03）。与华法林相比，利伐沙班与出血相关住院率降低相关（HR=0.85，95%CI=0.78 - 0.92），颅内出血（HR=0.76，95%CI=0.62 - 0.94）和颅外出血（HR=0.89，95%CI=0.81 - 0.97）也有所减少。在敏感性分析中，将研究人群限制为CHA₂DS₂ - VASc评分≥2的男性或评分≥3的女性时，利伐沙班使SSE风险显著降低33%，出血相关住院风险降低43%。亚组分析未观察到SSE或出血相关住院结局有显著交互作用。
在NVAF和OSA患者中，利伐沙班与华法林的SSE风险相似，但与任何颅内和颅外出血相关住院的减少相关。当研究人群限于SSE中高风险患者时，利伐沙班与SSE及出血相关住院的显著减少相关。这些数据应为开处方者在抗凝起始时患有OSA的NVAF患者中选择利伐沙班提供更多信心。
