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:
Sánchez-de-la-Torre M, Sánchez-de-la-Torre A, Bertran S, Abad J, Duran-Cantolla J, Cabriada V, Mediano O, Masdeu MJ, Alonso ML, Masa JF, Barceló A, de la Peña M, Mayos M, Coloma R, Montserrat JM, Chiner E, Perelló S, Rubinós G, Mínguez O, Pascual L, Cortijo A, Martínez D, Aldomà A, Dalmases M, McEvoy RD, Barbé F and Spanish Sleep Network
Publicada:
1 abr 2020
Ahead of Print:
12 dic 2019
Categoría:
Pulmonary and respiratory medicine
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:
Sánchez-de-la-Torre M:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Sánchez-de-la-Torre A:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Bertran S:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Abad J:
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Respiratory Department, Hospital Universitari Germans Trias I Pujol, Badalona, Barcelona, Spain
Duran-Cantolla J:
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Servicio de Investigación OSI, Hospital Universitario Araba, IIS Bioaraba, Vitoria, Álava, Spain
Cabriada V:
Respiratory Department, Hospital Universitario Cruces, Bizkaia, Spain
Mediano O:
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Respiratory Department, Hospital Universitario de Guadalajara, Guadalajara, Spain
Masdeu MJ:
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Respiratory and Sleep Department, Hospital Universitari Parc Taulí, Institut Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain
Alonso ML:
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Respiratory Department, Hospital Universitario de Burgos, Burgos, Spain
Masa JF:
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Respiratory Department, Hospital San Pedro Alcántara, Cáceres, Spain
Barceló A:
Clinic Analysis and Respiratory Services, Hospital Universitari Son Espases, Institut de investigació sanitaria de Palma (IdisPa), Palma de Mallorca, Spain
de la Peña M:
Clinic Analysis and Respiratory Services, Hospital Universitari Son Espases, Institut de investigació sanitaria de Palma (IdisPa), Palma de Mallorca, Spain
Mayos M:
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Sleep Unit, Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Coloma R:
Respiratory Department, Hospital General Universitario de Albacete, Spain
Montserrat JM:
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Respiratory Department, Hospital Clinic, Barcelona, Spain
:
Respiratory Department, Hospital Universitari Sant Joan d'Alacant, Alicante, Spain
Perelló S:
Respiratory Department, Hospital Joan XXIII, Tarragona, Spain
Rubinós G:
Respiratory Department, Hospital Universitario Central de Asturias, Oviedo, Spain
Mínguez O:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Pascual L:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Cortijo A:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Martínez D:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Aldomà A:
Cardiology Department, Hospital Universitari Arnau de Vilanova, IRBLleida, Lleida, Spain
Dalmases M:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
McEvoy RD:
Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia
Barbé F:
Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
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