Continuous Positive Airway Pressure (CPAP) Treatment in Coronary Artery Disease and Sleep Apnea
Continuous Positive Airway Pressure (CPAP) Treatment in Coronary Artery Disease and Sleep Apnea
Obstructive sleep apnea (OSA) worsens the prognosis in patients with coronary artery disease
 (CAD). Many of these subjects do not report daytime sleepiness, and therefore, are not
 considered for OSA treatment with continuous positive airway pressure (CPAP). There is lack
 of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA.
 The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address
 if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction,
 stroke and cardiovascular mortality over mean follow-up period of 3-years in CAD patients
 with OSA without daytime sleepiness.Secondary outcomes include cardiovascular biomarkers,
 cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and
 1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy.
Rationale: OSA is a common condition in CAD with a poor prognosis.Many of these subjects do
 not report daytime sleepiness, and therefore, are not considered for OSA treatment with CPAP.
 There is lack of evidence regarding the impact of CPAP on the long-term prognosis of CAD
 patients with OSA.

 Objective: The RICCADSA trial is designed to address if CPAP treatment reduces the combined
 rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality
 over a mean follow-up period of 3-years in CAD patients with OSA (Apnea-Hypopnea-Index
 [AHI]>=15 per h) without daytime sleepiness (Epworth Sleepiness Scale [ESS]<10). Secondary
 outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and
 quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic
 findings and adherence to CPAP therapy.

 Patients and Methods: A sample of 511 CAD patients (122 non-sleepy OSA patients randomized to
 CPAP, 122 to non-CPAP; 155 sleepy OSA patients [ESS>=10] on CPAP, and 112 CAD patients
 without OSA [AHI <5 per h]) were included. The trial has 80% power to detect a risk reduction
 from an assumed composite end-point rate of 25% to 12% for the primary outcome at
 intention-to-treat basis.
Inclusion Criteria:

 -  Patients with angiographically-verified CAD who have newly undergone PCI or CABG
 treatment

 -  Written, informed study consent

 -  OSA (AHI>=15 per hour) or non-OSA (AHI<5 per hour) diagnosis on the unattended sleep
 recording at home

 Exclusion Criteria:

 -  Patients with already treated OSAS

 -  Patients presenting mainly central apneas (Cheynes-Stokes breathing)

 -  Patients with borderline OSA (AHI <15 and >=5 per hour) upon the unattended sleep
 recording at home