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

Autor: Abel J Martínez García, Laura Abad, Sonia Castro, Noelia Sánchez-Rodríguez, Ma José Vázquez, Joaquín Durán Carro, Alicia Martín, Eusebi Chiner, David Diez, Dolores Martínez, Rocío Gallego, Jaime Marcos, Mercè Mayos, Francisco J Gómez de Terreros Caro, Carlos Egea, Almudena Fernández, Berenice Muria, Pilar Resano, Alicia Sánchez-de-la-Torre, Montserrat Martínez, Aida Muñoz, Gil Bonet, Jose L Rodríguez, Estefanía García-Ledesma, María Bienvenido-Villalba, Albina Aldomá, Ramón Arroyo-Espilguero, Nieves Mayoral, María J Mendoza, Sandra Bertran, Miguel Carrera, Gemma Rubinós, Patricia Peñacoba, Monique Suárez, Elisabet Zamora, Chechu Amibilia, Alfredo Bardají, Idoia Salinas, Ma Esther Viejo-Ayuso, Núria Farré, R. Doug McEvoy, Francisco J Rubio, Magdalena Campaner, Lara Navas, Juan F. Masa, Olga Minguez, Antonia Barceló, Silvia Ortega, Maricel Arbonés, Ma Isabel Valiente-Diaz, Jorge Ullate, Name Surname, Sandra Inglés, Josep M. Montserrat, Sofía Romera-Peralta, Concepción Rodríguez-García, Jorge Abad, Cristina Villena, Paloma Giménez, Salvador Perelló, Olga Mediano, Mari Luz Alonso, Laura Vigil, José Sancho, Ramón Coloma, Jose L Cabrero, Manuel Sánchez-de-la-Torre, Amaia Urrutia, Jaime Corral, Carmen Muñoz, Onintza Garmendia, Ana María Fortuna, Anna Mas, Mireia Dalmases, Marina Florés, Javier Piérola, Ruth Diez, Joaquín Durán-Cantolla, María José Masdeu, Ricardo Pereira, Elisabet Martínez, Leyre Serrano, María Piñar, Sergio García Castillo, Ignacio Vicente, Enriqueta Ramírez, Anna Villares, Estrella Ordax, Yunelsy Anta-Mejias, Anunciación Cortijo, Valentin Cabriada, Ana Martínez, Jose M Román-Sánchez, Estefanía Galera, Mónica de la Peña, Raul Labeaga, Lydia Pascual, Ferran Barbé
Rok vydání: 2020
Předmět:
Zdroj: The Lancet Respiratory Medicine. 8:359-367
ISSN: 2213-2600
Popis: Summary 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 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 Investigacion Sanitaria (Fondo Europeo de Desarrollo Regional), the Spanish Respiratory Society, the Catalonian Cardiology Society, Esteve-Teijin, Oxigen Salud, and ALLER.
Databáze: OpenAIRE
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