Respiratory Trials·org

Sleep medicine · Does CPAP prevent cardiovascular events?

SAVE

Sleep Apnea Cardiovascular Endpoints study

SAVE trial design and results
Design International, open-label, randomised controlled trial
Treatment CPAP plus usual care
Control Usual care alone
Population 2717 adults with moderate-to-severe obstructive sleep apnoea and established cardiovascular disease, most without significant sleepiness
Follow-up Mean 3.7 years
Primary endpoint Composite of cardiovascular death, myocardial infarction, stroke, or hospitalisation for unstable angina, heart failure or transient ischaemic attack
Result Mean CPAP adherence was 3.3 hours per night. The apnoea-hypopnoea index fell from 29.0 to 3.7 events per hour. Despite that, CPAP did not reduce the primary composite endpoint over a mean 3.7 years. Sleepiness, mood and quality of life did improve.
Secondary endpoints Individual cardiovascular endpoints, sleepiness, mood, quality of life, days off work

Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnoea and established cardiovascular disease.

The trial authors, in the published abstract

How it has aged

The defining negative trial in sleep medicine, and the one whose limitation is always raised: 3.3 hours a night is not a treated patient. It was designed in patients without significant sleepiness, so it does not challenge CPAP for symptomatic disease — only the claim that CPAP is cardiovascular prevention. Barbe 2012 found the same in non-sleepy patients.

Publications

CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea

McEvoy RD, Antic NA, Heeley E, et al. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med 2016 Sep 8;375(10):919-31.

  • No reduction in the composite cardiovascular endpoint over 3.7 years
  • Apnoea-hypopnoea index fell from 29.0 to 3.7 events per hour
  • Mean adherence only 3.3 hours per night
  • Sleepiness, mood and quality of life improved