Sleep Apnea Cardiovascular Endpoints - SAVE
Contribution To Literature:
The SAVE trial showed that CPAP as an addition to usual care was not superior to usual care alone for secondary prevention of CV events in patients with established CVD and OSA.
The goal of the trial was to assess the efficacy of continuous positive airway pressure (CPAP) in reducing cardiovascular (CV) events in patients with moderate to severe obstructive sleep apnea (OSA) and known CV disease (CVD).
Patients were randomized in a 1:1 fashion to either CPAP + usual care (n = 1,346) or usual care alone (n = 1,341).
- Total screened: 15,325
- Total number of enrollees: 2,687
- Duration of follow-up: mean 3.7 years
- Mean patient age: 61.3 years
- Percentage female: 19%
- Percentage type 2 diabetes mellitus (DM2): 30%
- Age 45-75 years
- Diagnosis of coronary artery disease (CAD) or CVD
- Moderate to severe OSA
- Severe daytime sleepiness (Epworth scale >15)
- Increased risk of an accident from falling asleep
- Severe hypoxemia
- Cheyne-Stokes respiration pattern
- Prior use of CPAP treatment for OSA
- Planned coronary or carotid revascularization within 6 months
- New York Heart Association class III/IV heart failure (HF)
Other salient features/characteristics:
- CAD: 50.8%, CVD: 49%
- Tobacco use: 15%
- Statin use: 58%, aspirin/antithrombotic use: 75%
- Body mass index: mean 28.6 kg/m2
- Apnea-hypopnea index: mean 29.3; Epworth Sleepiness Scale score: mean 7.4%
The primary outcome, CV death; myocardial infarction (MI); stroke; hospitalization for HF, unstable angina, or transient ischemic attack, for CPAP + usual care vs. usual care: 17.0% vs. 15.4% (hazard ratio 1.10, 95% confidence interval 0.91-1.32); p = 0.34
- CV death: 1.9% vs. 1.5%, p = 0.5
- MI: 3.1% vs. 2.9%, p = 0.8
Secondary outcomes for CPAP + usual care vs. CPAP:
- All-cause mortality: 3.0% vs. 3.2%, p = 0.67
- Revascularization procedure: 7.4% vs. 5.5%, p = 0.07
- Newly diagnosed DM2: 4.9% vs. 5.7%, p = 0.35
- Change in Epworth Sleepiness Scale score from baseline: -3.1 vs. -0.7, p < 0.0001
- Change in physical/mental components of Short Form-36 from baseline: 1.3/1.0 vs. 0.6/0, p < 0.01 for both
The results of this trial indicate that CPAP as an addition to usual care is not superior to usual care alone for secondary prevention of CV events in patients with established CAD and CVD and moderate to severe OSA. The use of CPAP did improve daytime sleepiness and health-related quality-of-life parameters. On adjusted propensity analyses, it appeared that there may be a benefit in patients using at least 4 hours of CPAP every night on average (mean in trial, 3.3 hours). This is hypothesis generating and will need to be confirmed in future trials. It is unclear if a longer follow-up may be necessary to observe a clinical benefit.
McEvoy RD, Antic NA, Heeley E, et al., on behalf of the SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med 2016;375:919-31.
Editorial: Mokhlesi B, Ayas NT. Cardiovascular Events in Obstructive Sleep Apnea — Can CPAP Therapy SAVE Lives? N Engl J Med 2016;375:994-6.
Presented by Dr. R. Doug McEvoy at the European Society of Cardiology Congress, Rome, Italy, August 28, 2016.
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