SAS CARE 2 - a randomized study of CPAP in patients with obstructive sleep disordered breathing following ischemic stroke or transient ischemic attack.

Autor:	Bernasconi C; Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland., Ott SR; Department of Pulmonary Medicine, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.; Sleep-Wake-Epilepsy Center, Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.; Pulmonary and Sleep Medicine, St. Claraspital, Basel, Switzerland., Fanfulla F; Sleep Medicine, Neurocenter of the Southern Switzerland, Regional Hospital of Lugano, Lugano, Switzerland.; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.; Sleep Medicine Unit, Istituti Clinici Scientifici Maugeri, Pavia, Italy., Miano S; Sleep Medicine, Neurocenter of the Southern Switzerland, Regional Hospital of Lugano, Lugano, Switzerland.; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland., Horvath T; Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland., Seiler A; Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland., Cereda CW; Stroke Center EOC, Neurocenter of the Southern Switzerland, Regional Hospital of Lugano, Lugano, Switzerland., Brill AK; Department of Pulmonary Medicine, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.; Sleep-Wake-Epilepsy Center, Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland., Young P; University Hospital Münster, Department of Neurology, Münster, Germany., Nobili L; Department of Neurology, Ospedale Niguarda, Milano, Italy.; DINOGMI, University of Genoa, Genoa, Italy., Manconi M; Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.; Sleep Medicine, Neurocenter of the Southern Switzerland, Regional Hospital of Lugano, Lugano, Switzerland.; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland., Bassetti CLA; Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.; Sleep-Wake-Epilepsy Center, Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.; Neurology Department, Sechenov First Moscow State Medical University, Moscow, Russia.
Jazyk:	angličtina
Zdroj:	Sleep medicine: X [Sleep Med X] 2020 Oct 09; Vol. 2, pp. 100027. Date of Electronic Publication: 2020 Oct 09 (Print Publication: 2020).
DOI:	10.1016/j.sleepx.2020.100027
Abstrakt:	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. Results: 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. Conclusion: 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. Competing Interests: None declared. The ICMJE Uniform Disclosure Form for Potential Conflicts of Interest associated with this article can be viewed by clicking on the following link: https://doi.org/10.1016/j.sleepx.2020.100027. (© 2020 The Authors.)
Databáze:	MEDLINE
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