Coronary Artery Disease Clinical Trial
Official title:
Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea - RICCADSA Trial
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.
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