ZOLL® has announced today that a new analysis of data from the remedē® System Pivotal Trial suggests favorable outcomes for heart failure (HF) patients with central sleep apnea (CSA). The analysis was performed post-hoc using a hierarchical endpoint comprised of mortality, HF hospitalization, and health status. The new analysis was presented as a late-breaking clinical trial at the ESC Heart Failure 2024 conference in Lisbon, Portugal by Dr. William T. Abraham, College of Medicine Distinguished Professor, Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center, Columbus, Ohio.
The presented analysis re-evaluates the pivotal trial data using a win ratio to compare heart failure patients with central sleep apnea when treated with phrenic nerve stimulation (treatment group) versus patients with untreated CSA (control group). The win ratio of 4.92 (95% confidence interval 2.27-10.63, P<0.0001) suggests that patients in the treatment group were nearly five times more likely to experience a clinical benefit compared to those in the control group.1
“Win-ratio analysis is a valuable tool that is gaining traction in the medical community for more thoroughly assessing the clinical benefit of therapies. Win-ratio analysis goes a step beyond conventional analyses of composite endpoints by taking into consideration both the timing of events and the fact that some endpoints, like mortality, are more severe than others,” says Dr. Abraham. “The magnitude of effect reflected by the 4.92 win ratio is astonishing when you look across other studies in the heart failure population, though notably, this analysis is post-hoc. Importantly, the concordance of clinical benefit favoring phrenic nerve stimulation across the three components of survival, hospitalization rate, and quality of life supports the main finding.”
The analysis used three clinical benefit components in the following hierarchical order to compare all treated to all control patients: longest survival, lowest HF hospitalization rate, and ≥2-category difference in Patient Global Assessment at six months. The treatment group won in 4.1%, 11.6%, and 38.1% of comparisons, respectively, while the control group won in 2.2%, 4.2%, and 4.6% of comparisons. Ties accounted for the remaining pairs.1
“The win-ratio analysis provides new insights into the symptom-burden experienced by our patients with heart failure and central sleep apnea and the positive impact phrenic nerve stimulation has on these symptoms,” said Rami Khayat, Director of Sleep Medicine at the University of California-Irvine Health System. “The new analysis also highlights the importance of screening for central sleep apnea in patients with heart failure so effective therapies like phrenic nerve stimulation can be offered.”
References
- “Transvenous phrenic nerve stimulation to treat central sleep apnea in heart failure.” Late-breaking presentation from ESC Heart Failure 2024.
- Costanzo M.R., et al. The Lancet. 2016;388:974–82.
- Bekfani T, Abraham WT. Europace. 2016;18(8):1123–34. Epub 2016 May 26.
- Khayat R, et al. J Card Fail. 2012;18:534–40.
- Khayat, R et al. European Heart J. 2015;36 1463–69.
Source: Zoll
