Screening and treatment of obstructive sleep apnea in acute coronary syndrome. A randomized clinical trial.

BACKGROUND: We evaluated the effects of sleep-study guided multidisciplinary therapy (SGMT) of obstructive sleep apnoea (OSA) in patients presenting with acute coronary syndrome. METHODS: Eligible patients were randomized into (1) SGMT, comprised a sleep study during the index admission and continuous positive airway pressure and behavioral therapy for those with at least mild OSA or (2) standard therapy. The primary end point was the change in the plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) level from baseline to the 7-month follow-up. RESULTS: A total of 159 patients completed the trial. Of the 70 patients randomized to SGMT, 21 (30%), 15 (22%) and 27 (39%) were diagnosed with mild, moderate and severe OSA, respectively. Continuous positive airway pressure and a positional pillow were prescribed to 57 (91%) and 6 (9%) patients with OSA. Although plasma NT-proBNP levels were lower after 7 months compared to the baseline, the levels did not differ significantly between the SGMT and standard therapy groups at baseline (579 ±â€¯1117 vs. 611 ±â€¯899 pg/dL, p = .851) or at 7 months (90 ±â€¯167 vs. 93 ±â€¯174 pg/dL, p = .996). The changes in NT-proBNP levels from baseline to 7 months were similar with SGMT and standard therapy (-489 vs. -518 pg/dL, p = .726). Similar findings were observed for the plasma ST2 and hs-CRP levels. CONCLUSIONS: OSA screening and multifaceted treatment during the sub-acute phase of acute coronary syndrome did not further reduce the levels of cardiovascular biomarkers when compared with standard therapy. CLINICAL TRIAL REGISTRATION: clinicaltrial.gov NCT02599298.

Sleep study-guided multidisciplinary therapy (SGMT) for patients with acute coronary syndrome: Trial rationale and design.

Obstructive sleep apnea (OSA) is an emerging risk marker for acute coronary syndrome (ACS). This randomized trial aims to determine the effects of sleep study-guided multidisciplinary therapy (SGMT) comprising overnight sleep study, continuous positive airway pressure, and behavioral therapy for OSA during the subacute phase of ACS. We hypothesize that SGMT will reduce (1) the plasma levels of N-terminal pro brain natriuretic peptide and suppression of tumorigenicity 2; (2) the estimated 10-year risk of cardiovascular mortality as measured by the European Systematic Coronary Risk Evaluation (SCORE) algorithm; and (3) the cardiovascular event rate during a 3-year follow-up, compared with standard therapy. In the SGMT trial, 180 patients presenting with ACS will be randomly assigned to SGMT (n = 90) and standard therapy (n = 90) groups. Both groups will receive guideline-mandated treatment for ACS. Those assigned to SGMT will additionally undergo a sleep study and, if OSA is diagnosed, attend a multidisciplinary OSA clinic where they will receive personalized treatment including continuous positive airway pressure and behavioral/lifestyle counseling. The primary endpoint is the plasma N-terminal pro brain natriuretic peptide concentration at 7-month follow-up. This report presents the baseline characteristics of 117 patients (SGMT group: n =54; standard therapy group: n =63) who had been enrolled into the study as of August 31, 2017. The results of this trial will help us to understand whether active OSA diagnosis and treatment will improve the physiologic and clinical cardiovascular outcomes of this group of patients.