On May 13, 2015, ResMed announced a safety alert ahead of publication of a large trial of their adaptive PAP system (“ASV”) for heart failure patients with central apnea [1]. The primary endpoint that the trial was designed to answer showed no effect of ASV. The unexpected finding came in an exploratory subset analysis (not the main goal of the trial): higher cardiovascular mortality in those using ASV (annual risk of 10% versus 7.5%). On May 15, the American Academy of Sleep Medicine posted their initial response to this announcement. In June 2015, the annual SLEEP conference hosted a special session in which cogent criticisms and concerns were raised in a balanced discussion about the trial, but the risk announcements had already been made public. A recent editorial detailed many points of uncertainty about the trial [2]. It remains unknown why the main outcome was negative, and why the subset analysis suggested increased cardiac risk with ASV use.
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