Manuel Sánchez-de-la-Torre1, Alicia Sánchez-de-la-Torre1, Sandra Bertran1, Jorge Abad2, Joaquín Duran-Cantolla3, Valentín Cabriada4, Olga Mediano5, María José Masdeu6, Mari Luz Alonso7, Juan Fernando Masa8, Antonia Barceló9, Mónica de la Peña9, Mercè Mayos10, Ramón Coloma11, Josep M Montserrat12, Eusebi Chiner13, Salvador Perelló14, Gemma Rubinós15, Olga Mínguez16, Lydia Pascual16, Anunciación Cortijo16, Dolores Martínez16, Albina Aldomà17, Mireia Dalmases1, R Doug McEvoy18, Ferran Barbé19. 1. 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. 2. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain; Respiratory Department, Hospital Universitari Germans Trias I Pujol, Badalona, Barcelona, Spain. 3. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain; Servicio de Investigación OSI, Hospital Universitario Araba, IIS Bioaraba, Vitoria, Álava, Spain. 4. Respiratory Department, Hospital Universitario Cruces, Bizkaia, Spain. 5. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain; Respiratory Department, Hospital Universitario de Guadalajara, Guadalajara, Spain. 6. 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. 7. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain; Respiratory Department, Hospital Universitario de Burgos, Burgos, Spain. 8. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain; Respiratory Department, Hospital San Pedro Alcántara, Cáceres, Spain. 9. Clinic Analysis and Respiratory Services, Hospital Universitari Son Espases, Institut de investigació sanitaria de Palma (IdisPa), Palma de Mallorca, Spain. 10. 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. 11. Respiratory Department, Hospital General Universitario de Albacete, Spain. 12. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain; Respiratory Department, Hospital Clinic, Barcelona, Spain. 13. Respiratory Department, Hospital Universitari Sant Joan d'Alacant, Alicante, Spain. 14. Respiratory Department, Hospital Joan XXIII, Tarragona, Spain. 15. Respiratory Department, Hospital Universitario Central de Asturias, Oviedo, Spain. 16. Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Lleida, Spain. 17. Cardiology Department, Hospital Universitari Arnau de Vilanova, IRBLleida, Lleida, Spain. 18. Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia. 19. 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. Electronic address: febarbe.lleida.ics@gencat.cat.
Abstract
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 (90·01%) were recruited. 1264 (49·55%) patients had OSA and were randomly assigned to the CPAP group (n=633) or the UC group (n=631). 1287 (50·45%) patients did not have OSA, of whom 603 (46·85%) were randomly assigned to the reference group. Patients were followed up for a median of 3·35 years (IQR 1·50-5·31). The prevalence of cardiovascular events was similar in the CPAP and UC groups (98 events [16%] vs 108 events [17%]; hazard ratio [HR] 0·89 [95% CI 0·68-1·17]; p=0·40) during follow-up. Mean time of adherence to CPAP treatment was 2·78 h/night (SD 2·73). The prevalence of cardiovascular events was similar between patients in the reference group (90 [15%] events) and those in the UC group (102 (17%) events) during follow-up (1·01 [0·76-1·35]; p=0·93). 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 had1538 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. FUNDING: ResMed (Australia), Fondo de Investigación Sanitaria (Fondo Europeo de Desarrollo Regional), the Spanish Respiratory Society, the Catalonian Cardiology Society, Esteve-Teijin, Oxigen Salud, and ALLER.
RCT Entities:
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. OSApatients 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 (90·01%) were recruited. 1264 (49·55%) patients had OSA and were randomly assigned to the CPAP group (n=633) or the UC group (n=631). 1287 (50·45%) patients did not have OSA, of whom 603 (46·85%) were randomly assigned to the reference group. Patients were followed up for a median of 3·35 years (IQR 1·50-5·31). The prevalence of cardiovascular events was similar in the CPAP and UC groups (98 events [16%] vs 108 events [17%]; hazard ratio [HR] 0·89 [95% CI 0·68-1·17]; p=0·40) during follow-up. Mean time of adherence to CPAP treatment was 2·78 h/night (SD 2·73). The prevalence of cardiovascular events was similar between patients in the reference group (90 [15%] events) and those in the UC group (102 (17%) events) during follow-up (1·01 [0·76-1·35]; p=0·93). 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. FUNDING: ResMed (Australia), Fondo de Investigación Sanitaria (Fondo Europeo de Desarrollo Regional), the Spanish Respiratory Society, the Catalonian Cardiology Society, Esteve-Teijin, Oxigen Salud, and ALLER.
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