RATIONALE: @entity27 ( @entity27 ) is associated with increased risk of @entity65 . Continuous positive airway pressure (CPAP) delivered via a nasal mask during sleep immediately alleviates obstructive @entity386 and improves sleep quality and daytime somnolence. However, there is uncertainty as to whether such treatment can modify CV risk and disease. AIMS: The Sleep @entity65 Endpoints (SAVE) study aims to determine whether CPAP on top of best medical care compared to best medical care alone can reduce the risk of serious CV events in @entity1 with co-morbid @entity27 and established @entity66 . DESIGN: SAVE is an investigator initiated and conducted, international, multicenter, open, blinded endpoint, randomized controlled trial. @entity1 were randomised to either CPAP or usual care between 2008 and 2013 and will be followed up for an average of approximately 4 years. STUDY OUTCOME: The primary endpoint is a composite of @entity204 , @entity583 ( @entity583 , including @entity583 ), @entity64 , hospitalisation for @entity712 , hospitalisation for an acute @entity63 @entity299 ( @entity1459 ) or cerebral event (transient @entity63 event [TIA]). DISCUSSION: The pre-specified statistical analysis plan (SAP) for the main analyses is presented. This SAP was finalised before @entity1 follow-up was completed and before any unblinding of the data. The SAP outlines details of the primary, secondary and tertiary outcomes, together with planned subgroup and exploratory analyses.

Statistical analysis plan for the Sleep @entity65 Endpoints study: An international randomised controlled trial to determine whether continuous positive airways pressure treatment for @entity27 in XXXX with @entity66 prevents secondary cardiovascular events.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient', 'Participants'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke'] @entity712 :: ('MESH:D006333', 'Disease') :: ['heart failure'] @entity66 :: ('MESH:D004194', 'Disease') :: ['CV disease'] @entity63 :: ('MESH:D007511', 'Disease') :: ['ischemic'] @entity27 :: ('MESH:D020181', 'Disease') :: ['Obstructive sleep apnea', 'OSA'] @entity1459 :: ('MESH:D000789', 'Disease') :: ['unstable angina'] @entity299 :: ('MESH:D006331', 'Disease') :: ['cardiac event'] @entity583 :: ('MESH:D009203', 'Disease') :: ['silent MI', 'myocardial infarction', 'MI'] @entity204 :: ('MESH:D003643', 'Disease') :: ['CV death'] @entity65 :: ('MESH:D002318', 'Disease') :: ['Apnea Cardiovascular', 'cardiovascular disease'] @entity386 :: ('MESH:D001049', 'Disease') :: ['apneas']
@entity1 :: (9606,Species) :: ['patients']
