Department of Cardiology, Rikshospitalet.
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Am J Respir Crit Care Med. 2021 Sep 1;204(5):573-582. doi: 10.1164/rccm.202011-4133OC.
Sleep apnea (SA) is highly prevalent in patients with atrial fibrillation (AF), and both conditions are associated with adverse cardiovascular outcomes. To determine the effect of continuous positive airway pressure (CPAP) on AF burden. This open-label, parallel-group, randomized controlled trial included patients with paroxysmal AF and moderate to severe SA (apnea-hypopnea index ⩾15). A computerized system randomized eligible patients (1:1) to 5 months' treatment with CPAP plus usual care (CPAP, = 55) or usual care alone (control, = 54). The outcome assessment was blinded. The planned primary outcome was the difference between CPAP treatment and control groups in change of AF burden (percentage of time in AF) as measured by implantable loop recorder. A total of 579 patients with paroxysmal AF had respiratory polygraphy, of whom 244 (42%) had moderate to severe SA. Of these, 158 (65%) participated in the CPAP run-in period, of whom 39 (25%) patients did not tolerate the treatment. A total of 108 patients were available for the primary analysis. The mean time in AF decreased from 5.6% at baseline to 4.1% during the last 3 months of CPAP intervention and from 5.0% to 4.3% in the control group. The adjusted between-group difference at follow-up was -0.63 (95% confidence interval, -2.55 to 1.30) percentage points ( = 0.52). Seven serious adverse events (13%) occurred in the CPAP group, and two (4%) occurred in the control group. In patients with paroxysmal AF and SA, treatment with CPAP did not result in a statistically significant reduction in the burden of AF.Clinical trial registered with www.clinicaltrials.gov (NCT02727192).
睡眠呼吸暂停(SA)在心房颤动(AF)患者中非常普遍,这两种疾病都与不良心血管结局相关。为了确定持续气道正压通气(CPAP)对 AF 负担的影响。这项开放标签、平行组、随机对照试验纳入了阵发性 AF 和中重度 SA(呼吸暂停-低通气指数 ⩾15)的患者。一个计算机系统将符合条件的患者(1:1)随机分为 5 个月 CPAP 加常规护理(CPAP,n=55)或单纯常规护理(对照组,n=54)。结果评估是盲法的。主要结局是通过植入式环路记录仪测量的 AF 负担(AF 时间百分比)在 CPAP 治疗组与对照组之间的差异。共有 579 例阵发性 AF 患者进行了呼吸多导图检查,其中 244 例(42%)有中重度 SA。其中,158 例(65%)参加了 CPAP 预试验,其中 39 例(25%)患者无法耐受治疗。共有 108 例患者可用于主要分析。AF 时间从基线时的 5.6%下降到 CPAP 干预的最后 3 个月的 4.1%,对照组从 5.0%下降到 4.3%。随访时的组间差值为 -0.63(95%置信区间,-2.55 至 1.30)个百分点( = 0.52)。CPAP 组发生 7 例严重不良事件(13%),对照组发生 2 例(4%)。在阵发性 AF 和 SA 患者中,CPAP 治疗并未显著降低 AF 负担。临床试验在 www.clinicaltrials.gov 注册(NCT02727192)。