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Nuwellis Announces the Submission of the AVOID-HF Clinical Analysis as a Late Breaking Clinical Trial at HFSA
The Finkelstein-Schoenfeld Method of Win Ratios Analysis Provides New Insights Into Superiority of Ultrafiltration over Diuretics in Treating Fluid Overloaded
About this update from Nuwellis, Inc.
[{"type":"text","content":"The Finkelstein-Schoenfeld Method of Win Ratios Analysis Provides New Insights Into Superiority of Ultrafiltration over Diuretics in Treating Fluid Overloaded Heart Failure Patients Resistant to Diuretics\nMINNEAPOLIS, July 26, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) a commercial-stage company focused on improving the quality of life for people with fluid overload, today announced the submission of the AVOID-HF clinical study analysis using the Finkelstein-Schoenfeld method of Win-Ratios (WR) as a Late Breaking Clinical Trial at the Heart Failure Society of America’s (HFSA) 2022 Annual Scientific Meeting in September. The AVOID-HF (Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure) prospective, multicenter, randomized controlled trial tested the hypothesis that patients hospitalized for heart failure (HF) and treated with ultrafiltration would have a longer time to their first heart failure event within 90 days after hospital discharge compared to those receiving IV loop diuretics. The study was trending favorably when the study sponsor terminated it before reaching full enrollment for reasons unrelated to patient safety or clinical futility. At the time, analysis of the AVOID-HF trial data was inconclusive due to the lower-than-planned sample size. However, newer statistical methods like the Finkelstein-Schoenfeld method of hierarchical Win Ratios increase statistical precision to evaluate the clinical benefit and demonstrate significance between treatment arms with the added benefit of requiring a smaller study sample size. “The Finkelstein-Schoenfeld method of hierarchical Win Ratios provides a critical framework for evaluating the data obtained from the 221 patients enrolled in the AVOID-HF study,” said Dr. Sean Pinney, Professor of Medicine and Co-Director of the Heart and Vascular Center at The University of Chicago Medicine. “We were finally able to evaluate the role of ultrafiltration in treating these fluid overloaded heart failure patients and share our findings with the medical community.” Heart failure can disrupt normal kidney function and lower the ability to remove sodium from the body, resulting in excessive water retention that can ultimately lead to fluid overload. Over 1 million heart failure hospitalizations occur annually in the United States, and fluid overload i...