Effect of obstructive sleep apnoea and its treatment with continuous positive airway pressure on the prevalence of cardiovascular events in patients with acute coronary syndrome (ISAACC study): a randomised controlled trial
Por:
Sanchez-de-la-Torre, M, Sanchez-de-la-Torre, A, Bertran, S, Abad, J, Duran-Cantolla, J, Cabriada, V, Mediano, O, Masdeu, MJ, Alonso, ML, Masa, JF, Barcelo, A, de la Pena, M, Mayos, M, Coloma, R, Montserrat, JM, Chiner, E, Perello, S, Rubinos, G, Minguez, O, Pascual, L, Cortijo, A, Martinez, D, Aldoma, A, Dalmases, M, McEvoy, RD, Barbe, F
Publicada:
1 abr 2020
Resumen:
Background Despite the improvement in the prognosis of acute coronary syndrome (ACS), substantial morbidity and mortality remain. We aimed to evaluate the effect of obstructive sleep apnoea (OSA) and its treatment with continuous positive airway pressure (CPAP) on the clinical evolution of patients with ACS.
Methods We designed a multicentre, open-label, parallel-group, randomised controlled trial of patients with ACS at 15 hospitals in Spain. Eligible non-sleepy patients were men and women aged 18 years and older, admitted to hospital for documented symptoms of ACS. All patients underwent respiratory polygraphy during the first 24-72 h after admission. OSA patients were randomly assigned (1:1) to CPAP treatment plus usual care (CPAP group) or usual care alone (UC group) by a computerised system available 24 h a day. A group of patients with ACS but without OSA was also included as a reference group. Because of the nature of the intervention, the trial intervention could not be masked to either investigators or patients. Patients were monitored and followed for a minimum of 1 year. Patients were examined at the time of inclusion; after 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months; and every 12 months thereafter, if applicable, during the follow-up period. The primary endpoint was the prevalence of a composite of cardiovascular events (cardiovascular death or non-fatal events [Acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisations for unstable angina or transient ischaemic attack]) in patients followed up for a minimum of 1 year. The primary analysis was done according to the intention-to-treat principle. This study is registered with Clinicaltrials.gov, NCT01335087 and is now closed.
Findings Between April 25, 2011, and Feb 2, 2018, a total of 2834 patients with ACS had respiratory polygraphy, of whom 2551 (90 center dot 01%) were recruited. 1264 (49 center dot 55%) patients had OSA and were randomly assigned to the CPAP group (n=633) or the UC group (n=631). 1287 (50 center dot 45%) patients did not have OSA, of whom 603 (46 center dot 85%) were randomly assigned to the reference group. Patients were followed up for a median of 3 center dot 35 years (IQR 1 center dot 50-5 center dot 31). The prevalence of cardiovascular events was similar in the CPAP and UC groups (98 events [16%] vs 108 events [17%]; hazard ratio [HR] 0 center dot 89 [95% CI 0 center dot 68-1 center dot 17]; p=0 center dot 40) during follow-up. Mean time of adherence to CPAP treatment was 2 center dot 78 h/night (SD 2 center dot 73). The prevalence of cardio-vascular events was similar between patients in the reference group (90 [15%] events) and those in the UC group (102 (17%) events) during follow-up (1 center dot 01 [0 center dot 76-1 center dot 35]; p=0 center dot 93). The prevalence of cardiovascular events seem not to be related to CPAP compliance or OSA severity. 464 (74%) of 629 patients in the CPAP group had 1538 serious adverse events and 406 (65%) of 626 patients in the UC group had 1764 serious adverse events.
Interpretation Among non-sleepy patients with ACS, the presence of OSA was not associated with an increased prevalence of cardiovascular events and treatment with CPAP did not significantly reduce this prevalence. Copyright (c) 2019 Elsevier Ltd. All rights reserved.
Filiaciones:
Sanchez-de-la-Torre, M:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Sanchez-de-la-Torre, A:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Bertran, S:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Abad, J:
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Hosp Badalona Germans Trias & Pujol, Resp Dept, Barcelona, Spain
Duran-Cantolla, J:
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Hosp Univ Araba, Serv Invest OSI, IIS Bioaraba, Vitoria, Spain
Cabriada, V:
Hosp Univ Cruces, Resp Dept, Bizkaia, Spain
Mediano, O:
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Hosp Univ Guadalajara, Resp Dept, Guadalajara, Spain
Masdeu, MJ:
Univ Autonoma Barcelona, Resp & Sleep Dept, Hosp Univ Pan Tauli, Inst Invest & Innovacio Parc Tauli, Sabadell, Spain
Alonso, ML:
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Hosp Univ Burgos, Resp Dept, Burgos, Spain
Masa, JF:
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Hosp San Pedro Alcantara, Resp Dept, Caceres, Spain
Barcelo, A:
Hosp Univ Son Espases, Inst Invest Sanitaria Palma IdisPa, Clin Anal & Resp Serv, Palma De Mallorca, Spain
de la Pena, M:
Hosp Univ Son Espases, Inst Invest Sanitaria Palma IdisPa, Clin Anal & Resp Serv, Palma De Mallorca, Spain
Mayos, M:
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Hosp Santa Creu & Sant Pau, Dept Resp Med, Sleep Unit, Barcelona, Spain
Coloma, R:
Hosp Gen Univ Albacete, Resp Dept, Albacete, Spain
Montserrat, JM:
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
Hosp Clin Barcelona, Resp Dept, Barcelona, Spain
Chiner, E:
Hosp Univ St Joan dAlacant, Resp Dept, Alicante, Spain
Perello, S:
Hosp Joan 23, Resp Dept, Tarragona, Spain
Rubinos, G:
Hosp Univ Cent Asturias, Resp Dept, Oviedo, Spain
Minguez, O:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Pascual, L:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Cortijo, A:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Martinez, D:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Aldoma, A:
Hosp Arnau Vilanova, Cardiol Dept, IRBLleida, Lleida, Spain
Dalmases, M:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
McEvoy, RD:
Flinders Univ S Australia, Coll Med & Publ Hlth, Adelaide Inst Sleep Hlth, Adelaide, SA, Australia
Barbe, F:
Hosp Univ Arnau Vilanova Santa Maria, IRB Lleida, Translat Res Resp Med, Lleida, Spain
Ctr Invest Biomed Red Enfermedades Resp, Madrid, Spain
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