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Cardiovascular Outcomes in Adults with Coronary Artery Disease and Obstructive Sleep Apnea with versus without Excessive Daytime Sleepiness in the RICCADSA Clinical Trial

Eulenburg, Christine ; Celik, Yeliz ; Redline, Susan ; Thunström, Erik ; Glantz, Helena ; Strollo, Patrick J. and Peker, Yüksel LU (2023) In Annals of the American Thoracic Society 20(7). p.1048-1056
Abstract

Rationale: Recent randomized controlled trials did not show cardiovascular benefits of continuous positive airway pressure (CPAP) in adults with coronary artery disease (CAD) and obstructive sleep apnea (OSA) in intention-to-treat analyses. It has been argued that exclusion of patients with OSA with excessive daytime sleepiness (EDS), who may be most likely to benefit from CPAP treatment, may be a reason for the null results. Objectives: We addressed 1) the effect of concomitant EDS on adverse outcomes in patients with CAD and OSA; and 2) whether the cardiovascular benefit of CPAP adherence differs between individuals with versus without EDS. Methods: This was a secondary analysis of the RICCADSA (Randomized Intervention with CPAP in... (More)

Rationale: Recent randomized controlled trials did not show cardiovascular benefits of continuous positive airway pressure (CPAP) in adults with coronary artery disease (CAD) and obstructive sleep apnea (OSA) in intention-to-treat analyses. It has been argued that exclusion of patients with OSA with excessive daytime sleepiness (EDS), who may be most likely to benefit from CPAP treatment, may be a reason for the null results. Objectives: We addressed 1) the effect of concomitant EDS on adverse outcomes in patients with CAD and OSA; and 2) whether the cardiovascular benefit of CPAP adherence differs between individuals with versus without EDS. Methods: This was a secondary analysis of the RICCADSA (Randomized Intervention with CPAP in CAD and Obstructive Sleep Apnea) trial, conducted in Sweden between 2005 and 2013. Data were analyzed from 155 patients with CAD with OSA (apnea–hypopnea index > 15/h) and EDS (Epworth Sleepiness Scale score > 10), who were allocated to CPAP and 244 patients without EDS (ESS, 10), who were randomized to CPAP or no CPAP. Patients who were allocated to no CPAP or were nonadherent (CPAP usage, 4 h/night) were compared with adherent patients (CPAP usage > 4 h/night) at 1-year follow-up. Inverse probability of treatment weighting was applied to mimic randomization of EDS. The primary endpoint was the first event of repeat revascularization, myocardial infarction, stroke, or cardiovascular mortality. Results: The median follow-up was 52.2 months. The incidence of the primary endpoint did not differ significantly between the EDS versus no-EDS groups in the entire cohort. Within the adherent group, patients without EDS had a significantly decreased risk compared with patients with EDS (adjusted hazard ratio, 0.41; 95% confidence interval, 0.20–0.85; P = 0.02). Conclusions: Adverse cardiovascular outcomes did not differ by degrees of EDS for patients with CAD with OSA who were untreated or nonadherent to treatment. CPAP use, at least 4 h/night, was associated with reduced adverse outcomes in participants without EDS. Clinical trial registered with www.clinicaltrials.gov (NCT 00519597).

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cardiovascular outcomes, coronary artery disease, excessive sleepiness, obstructive sleep apnea
in
Annals of the American Thoracic Society
volume
20
issue
7
pages
9 pages
publisher
American Thoracic Society
external identifiers
  • pmid:36800433
  • scopus:85167479591
ISSN
2329-6933
DOI
10.1513/AnnalsATS.202208-676OC
language
English
LU publication?
yes
id
18949c33-b2e0-49a7-84ca-fc55b8079ec5
date added to LUP
2023-11-02 10:52:13
date last changed
2024-04-19 03:26:20
@article{18949c33-b2e0-49a7-84ca-fc55b8079ec5,
  abstract     = {{<p>Rationale: Recent randomized controlled trials did not show cardiovascular benefits of continuous positive airway pressure (CPAP) in adults with coronary artery disease (CAD) and obstructive sleep apnea (OSA) in intention-to-treat analyses. It has been argued that exclusion of patients with OSA with excessive daytime sleepiness (EDS), who may be most likely to benefit from CPAP treatment, may be a reason for the null results. Objectives: We addressed 1) the effect of concomitant EDS on adverse outcomes in patients with CAD and OSA; and 2) whether the cardiovascular benefit of CPAP adherence differs between individuals with versus without EDS. Methods: This was a secondary analysis of the RICCADSA (Randomized Intervention with CPAP in CAD and Obstructive Sleep Apnea) trial, conducted in Sweden between 2005 and 2013. Data were analyzed from 155 patients with CAD with OSA (apnea–hypopnea index &gt; 15/h) and EDS (Epworth Sleepiness Scale score &gt; 10), who were allocated to CPAP and 244 patients without EDS (ESS, 10), who were randomized to CPAP or no CPAP. Patients who were allocated to no CPAP or were nonadherent (CPAP usage, 4 h/night) were compared with adherent patients (CPAP usage &gt; 4 h/night) at 1-year follow-up. Inverse probability of treatment weighting was applied to mimic randomization of EDS. The primary endpoint was the first event of repeat revascularization, myocardial infarction, stroke, or cardiovascular mortality. Results: The median follow-up was 52.2 months. The incidence of the primary endpoint did not differ significantly between the EDS versus no-EDS groups in the entire cohort. Within the adherent group, patients without EDS had a significantly decreased risk compared with patients with EDS (adjusted hazard ratio, 0.41; 95% confidence interval, 0.20–0.85; P = 0.02). Conclusions: Adverse cardiovascular outcomes did not differ by degrees of EDS for patients with CAD with OSA who were untreated or nonadherent to treatment. CPAP use, at least 4 h/night, was associated with reduced adverse outcomes in participants without EDS. Clinical trial registered with www.clinicaltrials.gov (NCT 00519597).</p>}},
  author       = {{Eulenburg, Christine and Celik, Yeliz and Redline, Susan and Thunström, Erik and Glantz, Helena and Strollo, Patrick J. and Peker, Yüksel}},
  issn         = {{2329-6933}},
  keywords     = {{cardiovascular outcomes; coronary artery disease; excessive sleepiness; obstructive sleep apnea}},
  language     = {{eng}},
  number       = {{7}},
  pages        = {{1048--1056}},
  publisher    = {{American Thoracic Society}},
  series       = {{Annals of the American Thoracic Society}},
  title        = {{Cardiovascular Outcomes in Adults with Coronary Artery Disease and Obstructive Sleep Apnea with versus without Excessive Daytime Sleepiness in the RICCADSA Clinical Trial}},
  url          = {{http://dx.doi.org/10.1513/AnnalsATS.202208-676OC}},
  doi          = {{10.1513/AnnalsATS.202208-676OC}},
  volume       = {{20}},
  year         = {{2023}},
}