The Sleep Apnea cardioVascular Endpoints (SAVE) Trial: Rationale, Ethics, Design, and Progress

Area of Science:

• Cardiology
• Sleep Medicine
• Clinical Trials

Background:

• Obstructive sleep apnea (OSA) is linked to cardiovascular disease.
• Continuous positive airway pressure (CPAP) is a common OSA treatment.
• The SAVE study aimed to clarify CPAP's role in preventing cardiovascular events in high-risk patients.

Purpose of the Study:

• To determine if CPAP treatment for OSA reduces major adverse cardiovascular events.
• To assess the impact of OSA treatment on patients with established cardiovascular disease.
• To provide evidence for global healthcare guidelines regarding OSA management.

Main Methods:

• Randomized controlled trial (RCT) design with blinded endpoints.
• International, multicenter recruitment across 89 sites in 6 countries.
• Randomization of 2,717 patients with OSA and established cardiovascular disease.
• Long-term patient follow-up (average >4 years) for cardiovascular outcomes.

Main Results:

• The article describes the study's design, rationale, and progress.
• It discusses challenges in recruitment, patient follow-up, and CPAP adherence.
• The revision of the initial sample size calculation is also detailed.

Conclusions:

• The SAVE study provides crucial data on CPAP's efficacy in reducing cardiovascular events in OSA patients.
• Findings will inform clinical practice and healthcare policy for managing OSA.
• The study highlights the importance of interdisciplinary collaboration in large-scale clinical research.