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Positive airway pressure fails to improve CV outcomes in sleep apnea
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Positive airway pressure for the treatment of patients with sleep apnea did not reduce risk for CV outcomes or death, according to a study published in JAMA.
Jie Yu, MD, of the department of cardiology at Peking University in Beijing, and colleagues analyzed data from 7,266 adults (mean age, 61 years; 80.5% men) from 10 randomized trials who were assigned continuous positive airway pressure, adaptive servo-ventilation or sham positive airway pressure. The patients had central sleep apnea or obstructive sleep apnea.
The composite outcomes of interest included major adverse CV events with hospitalization for unstable angina and major adverse CV events (nonfatal acute ACS, CV death and nonfatal stroke). Cause-specific outcomes were defined as fatal or nonfatal stroke, fatal or nonfatal ACS, fatal or hospitalized HF and hospitalization for unstable angina. Researchers also studied CV death, all-cause death and non-CV death.
Adverse CV events
Among the cohort, there were 635 major adverse CV events with hospitalization for angina, 356 major adverse CV events and 613 deaths, the researchers reported.
Positive airway pressure was not linked to major adverse CV events (RR = 0.77; 95% CI, 0.53-1.13; risk difference [RD] = –0.01; 95% CI, –0.03 to 0.01), major adverse CV events with hospitalization for unstable angina (RR = 0.92; 95% CI, 0.71-1.2; RD = –0.01; 95% CI, –0.03 to 0.01), CV death (RR = 1.15; 95% CI, 0.88-1.5; RD = 0; 95% CI, –0.02 to 0.02) and all-cause death (RR = 1.13; 95% CI, 0.99-1.29; RD = 0; 95% CI, –0.01 to 0.01). Stroke (RR = 0.9; 95% CI, 0.66-1.21; RD = 0; 95% CI, –0.02 to 0.01), ACS (RR = 1; 95% CI, 0.65-1.55; RD = 0; 95% CI, –0.02 to 0.01) and HF (RR = 1.03; 95% CI, 0.92-1.16; RD = 0; 95% CI, –0.01 to 0.01) were also not associated with positive airway pressure.
Associations did not differ between continuous positive airway pressure and adaptive servo-ventilation (all P value homogeneity > .24). Meta-regressions did not determine links between positive airway pressure and outcomes for follow-up duration, levels of apnea severity or adherence to treatment (all P values > .13).
Positive airway pressure recommendations
“Based on the available evidence, it is reasonable to recommend [positive airway pressure] therapy for the improvement of symptoms in patients with [obstructive sleep apnea], but not for protection against vascular disease or death,” Yu and colleagues wrote. “It is possible that an enhanced evidence base able to better explore effects in patient subgroups might identify protective effects of [positive airway pressure] treatment for some patient subsets. In the meantime, these data emphasize the importance of proven therapies, such as [BP] lowering, lipid lowering and antiplatelet therapy in patients with sleep apnea, who should be treated according to established guidelines for patients at elevated [CV] risk.”
In a related editorial, Daniel J. Gottlieb, MD, MPH, associate professor of medicine at Harvard Medical School, associate physician in the division of sleep and circadian disorders in Brigham and Women’s Hospital and director of the Sleep Disorders Center at VA Boston Healthcare System, wrote: “Aside from limited clinical situations such as resistant hypertension, the principal indication for [obstructive sleep apnea] treatment at this time is control of [obstructive sleep apnea] symptoms. The lack of clear [CV] benefit should alleviate ethical concerns about withholding [positive airway pressure] therapy, even from severely affected individuals, in the context of clinical trials with informed consent.” – by Darlene Dobkowski
Disclosures: Yu reports no relevant financial disclosures. Gottlieb reports receiving personal fees from Vivus. Please see the full study for a list of the other researchers’ relevant financial disclosures.
Perspective
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Ajay V. Srivastava, MD, FACC
Although not a randomized controlled trial, this meta-analysis of 10 randomized controlled trials explores the effect of positive airway pressure on CV outcomes. While there is evidence to show the many effects of positive airway pressure on pulmonary and CV systems, the effect on CV outcomes directly is yet to be proven. This paper attempts to answer this question.
These findings allow health care providers to answer a common question raised by patients, namely, “Will positive airway pressure help me live longer?” In this meta-analysis of randomized controlled trials, there were no significant associations between positive airway pressure treatment and a range of CV events or death.
This study does not directly answer the more common question raised by patients, “Will positive airway pressure help me sleep better and improve daytime alertness?” Based on the available evidence, it is reasonable to recommend positive airway pressure therapy for the improvement of sleep symptoms in patients with obstructive sleep apnea. It also showed a BP reduction in patients using positive airway pressure.
I would like to see studies specifically examining the role of long-term use of positive airway pressure of atrial fibrillation, a disease that is an epidemic in patients older than 65 years.
In the subgroup analysis, there was a trend towards benefit (not powered for statistical significance) in patients who wore positive airway pressure devices for more than 4 hours per day. This study also shows that overall, patients are not wearing positive airway pressure at night as much as they should. Findings also emphasize the importance of proven therapies, such as BP lowering, lipid lowering and antiplatelet therapy in patients with sleep apnea.
This study highlights the lack of good quality randomized controlled trials in this area, perhaps due to the cost involved in following patients long-term to assess for benefits.
The sample size of randomized controlled trials included in the meta-analysis are probably not powered to assess for hard CV outcomes such as death.
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