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

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...

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Autores: Sánchez de la Torre, Manuel, Sánchez de la Torre, Alicia, Bertran, Sandra, Abad Capa, Jorge, Durán Cantolla, Joaquín, Cabriada Nuño, Valentín, Mediano San Andrés, Olga, Masdeu Margalef, María José, Alonso, Mari Luz, Masa, Juan Fernando, Barceló, Antonia, De la Peña, Mónica, Mayos Pérez, Mercè, Coloma Navarro, Ramón, Montserrat Canal, Josep María, Chiner, Eusebi, Perelló, Salvador, Rubinós, Gemma, Mínguez Roure, Olga, Pascual, Lydia, Cortijo, Anunciación, Martínez González, Dolores, Aldomà, Albina, Dalmases, Mireia, McEvoy, R. Doug, Barbé Illa, Ferran
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universidad de Castilla-La Mancha
Repositorio:RUIdeRA. Repositorio Institucional de la UCLM
OAI Identifier:oai:ruidera.uclm.es:10578/41116
Acceso en línea:https://hdl.handle.net/10578/41116
Access Level:acceso abierto
Palabra clave:Acute coronary syndrome
Cardiovascular Events
Continuous Positive Airway Pressure
Obstructive sleep apnoea
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repository_id_str
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Sánchez de la Torre, Manuel
Acute coronary syndrome
Cardiovascular Events
Continuous Positive Airway Pressure
Obstructive sleep apnoea
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Sánchez de la Torre, Manuel
Sánchez de la Torre, Alicia
Bertran, Sandra
Abad Capa, Jorge
Durán Cantolla, Joaquín
Cabriada Nuño, Valentín
Mediano San Andrés, Olga
Masdeu Margalef, María José
Alonso, Mari Luz
Masa, Juan Fernando
Barceló, Antonia
De la Peña, Mónica
Mayos Pérez, Mercè
Coloma Navarro, Ramón
Montserrat Canal, Josep María
Chiner, Eusebi
Perelló, Salvador
Rubinós, Gemma
Mínguez Roure, Olga
Pascual, Lydia
Cortijo, Anunciación
Martínez González, Dolores
Aldomà, Albina
Dalmases, Mireia
McEvoy, R. Doug
Barbé Illa, Ferran
author Sánchez de la Torre, Manuel
author_facet Sánchez de la Torre, Manuel
Sánchez de la Torre, Alicia
Bertran, Sandra
Abad Capa, Jorge
Durán Cantolla, Joaquín
Cabriada Nuño, Valentín
Mediano San Andrés, Olga
Masdeu Margalef, María José
Alonso, Mari Luz
Masa, Juan Fernando
Barceló, Antonia
De la Peña, Mónica
Mayos Pérez, Mercè
Coloma Navarro, Ramón
Montserrat Canal, Josep María
Chiner, Eusebi
Perelló, Salvador
Rubinós, Gemma
Mínguez Roure, Olga
Pascual, Lydia
Cortijo, Anunciación
Martínez González, Dolores
Aldomà, Albina
Dalmases, Mireia
McEvoy, R. Doug
Barbé Illa, Ferran
author_role author
author2 Sánchez de la Torre, Alicia
Bertran, Sandra
Abad Capa, Jorge
Durán Cantolla, Joaquín
Cabriada Nuño, Valentín
Mediano San Andrés, Olga
Masdeu Margalef, María José
Alonso, Mari Luz
Masa, Juan Fernando
Barceló, Antonia
De la Peña, Mónica
Mayos Pérez, Mercè
Coloma Navarro, Ramón
Montserrat Canal, Josep María
Chiner, Eusebi
Perelló, Salvador
Rubinós, Gemma
Mínguez Roure, Olga
Pascual, Lydia
Cortijo, Anunciación
Martínez González, Dolores
Aldomà, Albina
Dalmases, Mireia
McEvoy, R. Doug
Barbé Illa, Ferran
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Acute coronary syndrome
Cardiovascular Events
Continuous Positive Airway Pressure
Obstructive sleep apnoea
topic Acute coronary syndrome
Cardiovascular Events
Continuous Positive Airway Pressure
Obstructive sleep apnoea
description 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.
publishDate 2019
dc.date.none.fl_str_mv 2019
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/10578/41116
url https://hdl.handle.net/10578/41116
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:RUIdeRA. Repositorio Institucional de la UCLM
instname:Universidad de Castilla-La Mancha
instname_str Universidad de Castilla-La Mancha
reponame_str RUIdeRA. Repositorio Institucional de la UCLM
collection RUIdeRA. Repositorio Institucional de la UCLM
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling 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 trialSánchez de la Torre, ManuelSánchez de la Torre, AliciaBertran, SandraAbad Capa, JorgeDurán Cantolla, JoaquínCabriada Nuño, ValentínMediano San Andrés, OlgaMasdeu Margalef, María JoséAlonso, Mari LuzMasa, Juan FernandoBarceló, AntoniaDe la Peña, MónicaMayos Pérez, MercèColoma Navarro, RamónMontserrat Canal, Josep MaríaChiner, EusebiPerelló, SalvadorRubinós, GemmaMínguez Roure, OlgaPascual, LydiaCortijo, AnunciaciónMartínez González, DoloresAldomà, AlbinaDalmases, MireiaMcEvoy, R. DougBarbé Illa, FerranAcute coronary syndromeCardiovascular EventsContinuous Positive Airway PressureObstructive sleep apnoeaBackground: 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.Elsevier202520252019info:eu-repo/semantics/articleapplication/pdfapplication/pdfhttps://hdl.handle.net/10578/41116reponame:RUIdeRA. Repositorio Institucional de la UCLMinstname:Universidad de Castilla-La ManchaInglésinfo:eu-repo/semantics/openAccessoai:ruidera.uclm.es:10578/411162026-05-27T07:36:41Z
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