OS 12-02 SLEEP APNEA CARDIOVASCULAR ENDPOINTS (SAVE) STUDY: AN INTERNATIONAL RANDOMISED CONTROLLED TRIAL TO DETERMINE WHETHER CONTINUOUS POSITIVE AIRWAYS PRESSURE TREATMENT FOR OBSTRUCTIVE SLEEP APNEA IN PATIENTS WITH CV DISEASE PREVENTS SECONDARY CARDIOVASCULAR EVENTS.

OBJECTIVE: There is uncertainty over whether treatment of obstructive sleep apnea (OSA) can prevent serious cardiovascular (CV) events.

DESIGN AND METHOD: SAVE (NCT00738179; ACTRN12608000409370) was designed to determine whether treatment of OSA with CPAP reduces the risk of serious CV events in patients with established CV disease. Participants were centrally randomised to CPAP treatment or usual care between 2008 and 2013,with follow-up completed late 2015 and the results will be announced in August 2016. The primary endpoint is a composite of CV death, myocardial infarction, stroke, hospitalisation for heart failure, and hospitalisation for either an acute ischemic cardiac event or transient ischemic event (TIA). Sample size was set at 2500 to provide 90% power (alpha 0.05) to detect a 25% relative risk reduction in the primary endpoint in the CPAP group compared with the usual care group.

RESULTS: This international, prospective, open, randomised controlled clinical trial of CPAP for the prevention of major and minor CV events recruited 2717 participants with co-existing CV disease and moderate to severe OSA from clinics in Australia and New Zealand, China, India, Spain, and the USA. The main results will be presented at the conference.

CONCLUSIONS: SAVE will determine whether treatment of OSA in patiens with CV disease can prevent secondary major CV events, the results of which will have significant impact on clinical practice.