Preliminary Results of SERVE-HF Trial Reveal Increased CV Mortality From ASV Therapy
The preliminary results from phase III of the ResMed’s SERVE-HF trial indicate that study participants who received Adaptive Servo-Ventilation (ASV) therapy as treatment for moderate to severe predominant central sleep apnea had an increased risk of cardiovascular mortality compared to the control group. The trial was designed to assess the efficacy of ASV therapy in reducing mortality and morbidity in patients with symptomatic chronic heart failure with reduced ejection fraction. It did not include participants with predominant obstructive sleep apnea, nor those receiving any other treatment modality such as continuous positive airway pressure (CPAP).
According to ResMed, there was a cardiovascular mortality rate of 10 percent per year in the group of patients that received ASV therapy, as compared to 7.5 percent per year in the control group. The company notes that they will continue to examine the trial data in order to better understand these preliminary results. In the meantime, ResMed has said it is working with global regulatory authorities "to proactively revise the labels and instructions for use for ResMed ASV devices to include a contraindication for people with symptomatic chronic heart failure (with left ventricular ejection fraction, LVEF, less than or equal to 45 percent). The company is also proactively informing health care providers, physicians, and patients of the cardiovascular safety signal observed in SERVE-HF."
“The results surprise me, given some of the previous data in this area, but this is another confirmation of the importance of performing well controlled and adequately powered clinical trials,” states David E. Lanfear, MD, MS, FACC, chair of the Mechanical Circulatory Support Work Group of the ACC’s Heart Failure Member Section. “I also think it’s worth applauding the study sponsor for being aggressive about quickly disseminating this important information to clinicians. Hopefully as the trial data gets more fully analyzed we can better understand what factors contributed to the adverse outcomes and perhaps where the treatment can be most helpful.”
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