Eulenburg Christine, Celik Yeliz, Redline Susan, Thunström Erik, Glantz Helena, Strollo Patrick J, Peker Yüksel
Department for Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Koc University Research Center for Translational Medicine, Istanbul, Turkey.
Ann Am Thorac Soc. 2023 Jul;20(7):1048-1056. doi: 10.1513/AnnalsATS.202208-676OC.
Recent randomized controlled trials did not show cardiovascular benefits of continuous positive airway pressure (CPAP) in adults with coronary artery disease (CAD) and obstructive sleep apnea (OSA) in intention-to-treat analyses. It has been argued that exclusion of patients with OSA with excessive daytime sleepiness (EDS), who may be most likely to benefit from CPAP treatment, may be a reason for the null results. We addressed ) the effect of concomitant EDS on adverse outcomes in patients with CAD and OSA; and ) whether the cardiovascular benefit of CPAP adherence differs between individuals with versus without EDS. This was a secondary analysis of the RICCADSA (Randomized Intervention with CPAP in CAD and Obstructive Sleep Apnea) trial, conducted in Sweden between 2005 and 2013. Data were analyzed from 155 patients with CAD with OSA (apnea-hypopnea index ⩾ 15/h) and EDS (Epworth Sleepiness Scale score ⩾ 10), who were allocated to CPAP and 244 patients without EDS (ESS < 10), who were randomized to CPAP or no CPAP. Patients who were allocated to no CPAP or were nonadherent (CPAP usage < 4 h/night) were compared with adherent patients (CPAP usage ⩾ 4 h/night) at 1-year follow-up. Inverse probability of treatment weighting was applied to mimic randomization of EDS. The primary endpoint was the first event of repeat revascularization, myocardial infarction, stroke, or cardiovascular mortality. The median follow-up was 52.2 months. The incidence of the primary endpoint did not differ significantly between the EDS versus no-EDS groups in the entire cohort. Within the adherent group, patients without EDS had a significantly decreased risk compared with patients with EDS (adjusted hazard ratio, 0.41; 95% confidence interval, 0.20-0.85; = 0.02). Adverse cardiovascular outcomes did not differ by degrees of EDS for patients with CAD with OSA who were untreated or nonadherent to treatment. CPAP use, at least 4 h/night, was associated with reduced adverse outcomes in participants without EDS. Clinical trial registered with www.clinicaltrials.gov (NCT00519597).
近期的随机对照试验在意向性分析中未显示持续气道正压通气（CPAP）对患有冠状动脉疾病（CAD）和阻塞性睡眠呼吸暂停（OSA）的成年人有心血管益处。有人认为，排除那些可能最有可能从CPAP治疗中获益的白天过度嗜睡（EDS）的OSA患者，可能是得出阴性结果的一个原因。我们研究了：）合并EDS对CAD和OSA患者不良结局的影响；以及）CPAP依从性对有或没有EDS的个体心血管益处的差异。这是对2005年至2013年在瑞典进行的RICCADSA（CAD和阻塞性睡眠呼吸暂停的CPAP随机干预）试验的二次分析。分析了155例患有CAD和OSA（呼吸暂停低通气指数⩾15次/小时）且有EDS（爱泼华嗜睡量表评分⩾10）并被分配接受CPAP治疗的患者，以及244例没有EDS（ESS<10）并被随机分配接受CPAP或不接受CPAP治疗的患者的数据。在1年随访时，将被分配不接受CPAP治疗或不依从（CPAP使用<4小时/晚）的患者与依从患者（CPAP使用⩾4小时/晚）进行比较。应用治疗权重的逆概率来模拟EDS的随机化。主要终点是再次血管重建、心肌梗死、中风或心血管死亡的首次事件。中位随访时间为52.2个月。在整个队列中，EDS组和无EDS组的主要终点发生率没有显著差异。在依从组中，没有EDS的患者与有EDS的患者相比，风险显著降低（调整后的风险比，0.41；95%置信区间，0.20 - 0.85；P = 0.02）。对于未接受治疗或不依从治疗的CAD合并OSA患者，不良心血管结局在不同程度的EDS患者中没有差异。每晚至少使用4小时CPAP与没有EDS的参与者不良结局减少相关。临床试验已在www.clinicaltrials.gov注册（NCT00519597）。
