LATE-BREAKING ABSTRACT: The Sleep Apnea cardioVascular Endpoints (SAVE) study results – A trial of CPAP versus usual care in 2717 high cardiovascular risk patients with moderate-severe obstructive sleep apnea (OSA)

Background: Observational studies suggest continuous positive airway pressure (CPAP) treatment can reduce risks of serious cardiovascular (CV) events in people with OSA, but randomized data are lacking. We report results of the SAVE trial (ClinicalTrials.gov number NCT00738179) designed to close this evidence gap. Methods : SAVE was an investigator-initiated and conducted, international, multicentre, open-label, blinded endpoint, randomized controlled trial designed to test for superiority of CPAP plus usual care versus usual care alone on the primary efficacy composite endpoint of CV death, non-fatal myocardial infarction, non-fatal stroke, and any hospitalization for unstable angina, heart failure, or transient ischaemic attack. Eligibility criteria: age 45-75 years, prior cerebro- or coronary CV disease, OSA (≥4% oxygen desaturation index [ODI] ≥12/hr), Epworth sleepiness score (ESS) 3 hr/night over 1-2 week run-in phase. Results: 2717 patients were randomised between December 2008 and November 2013: 1359 to CPAP plus usual care and 1358 to usual care from 89 hospitals in 7 countries, with patient follow-up completed in January 2016. Groups were well balanced for baseline demographic/clinical characteristics (mean age 61 years, 81% male, 63% Asian) with BMI 28.6, ODI 28.2, snoring “almost every day” 83%, ESS 7.4. The main results will be presented at the conference. Conclusions: SAVE provides the first definitive randomised controlled trial evidence on the effectiveness of CPAP therapy on future CV events in patients with CV disease and co-occurring OSA.