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
ISSN: 22132600





LANCET RESPIRATORY MEDICINE
Editorial
ELSEVIER SCI LTD, THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND, Reino Unido
Tipo de documento: Article
Volumen: 8 Número: 4
Páginas: 359-367
WOS Id: 000522760200034
ID de PubMed: 31839558

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