Bernasconi C, Ott S R, Fanfulla F, Miano S, Horvath T, Seiler A, Cereda C W, Brill A-K, Young P, Nobili L, Manconi M, Bassetti C L A
Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Department of Pulmonary Medicine, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Sleep Med X. 2020 Oct 9;2:100027. doi: 10.1016/j.sleepx.2020.100027. eCollection 2020 Dec.
OBJECTIVE/BACKGROUND: The benefit of Continuous Positive Airway Pressure (CPAP) treatment following ischemic stroke in patients with obstructive sleep-disordered breathing (SDB) is unclear. We set out to investigate this open question in a randomized controlled trial as part of the SAS-CARE study.
PATIENTS/METHODS: Non-sleepy patients (ESS < 10) with ischemic stroke or transient ischemic attack (TIA) and obstructive SDB (AHI ≥ 20) 3 months post-stroke were randomized 1:1 to CPAP treatment (CPAP+) or standard care. Primary outcome was the occurrence of vascular events (TIA/stroke, myocardial infarction/revascularization, hospitalization for heart failure or unstable angina) or death within 24 months post-stroke. Secondary outcomes included Modified Rankin Scale (mRS) and Barthel Index.
Among 238 SAS-CARE patients 41 (17%) non-sleepy obstructive SDB patients were randomized to CPAP (n = 19) or standard care (n = 22). Most patients (80%) had stroke and were males (78%), mean age was 64 ± 7 years and mean NIHSS score 0.6 ± 1.0 (range: 0-5). The primary endpoint was met by one patient in the standard care arm (a new stroke). In an intent-to treat analysis disregarding adherence, this corresponds to an absolute risk difference of 4.5% or an NNT = 22. mRS and Barthel Index were stable and similar between arms. CPAP adherence was sufficient in 60% of evaluable patients at month 24.
No benefit of CPAP started three months post-stroke was found in terms of new cardio- and cerebrovascular events over 2 years. This may be related to the small size of this study, the mild stoke severity, the exclusion of sleepy patients, the delayed start of treatment, and the overall low event rate.
目的/背景：阻塞性睡眠呼吸障碍（SDB）患者缺血性卒中后持续气道正压通气（CPAP）治疗的益处尚不清楚。作为SAS-CARE研究的一部分，我们开展了一项随机对照试验来研究这个开放性问题。
患者/方法：卒中后3个月的缺血性卒中或短暂性脑缺血发作（TIA）且无嗜睡症状（ESS<10）以及阻塞性SDB（AHI≥20）的患者按1:1随机分为CPAP治疗组（CPAP+）或标准治疗组。主要结局是卒中后24个月内发生血管事件（TIA/卒中、心肌梗死/血运重建、因心力衰竭或不稳定型心绞痛住院）或死亡。次要结局包括改良Rankin量表（mRS）和Barthel指数。
在238例SAS-CARE患者中，41例（17%）无嗜睡症状的阻塞性SDB患者被随机分为CPAP组（n = 19）或标准治疗组（n = 22）。大多数患者（80%）有卒中史，且为男性（78%），平均年龄为64±7岁，平均美国国立卫生研究院卒中量表（NIHSS）评分为0.6±1.0（范围：0 - 5）。标准治疗组有1例患者达到主要终点（新发卒中）。在不考虑依从性的意向性分析中，这相当于绝对风险差异为4.5%或需治疗人数（NNT）=22。两组间mRS和Barthel指数稳定且相似。在第24个月时，60%的可评估患者CPAP依从性良好。
卒中后3个月开始使用CPAP在2年的时间里，在预防新发心脑血管事件方面未发现益处。这可能与本研究样本量小、卒中严重程度较轻、排除嗜睡患者、治疗开始延迟以及总体事件发生率低有关。
