Landmark REDUCE LAP-HF II trial demonstrates clinical benefit of Corvia Atrial Shunt in large segment of heart failure patients.- Corvia Medical

While the overall outcome of the trial was neutral, the data suggests patients with normal exercise pulmonary vascular resistance (PVR) and without a pacemaker, represent a responder group that derives significant clinical benefit, making atrial shunting the first implantable therapy to demonstrate effectiveness in HFpEF. Results were presented at the Technology and Heart Failure Therapeutics (THT) 2022 conference and primary results were published online in The Lancet. Publication of the responder group analysis is pending.

The REDUCE LAP-HF II trial is the world’s first phase III trial to evaluate an atrial shunt in heart failure patients to reduce HF symptoms, decrease HF-related hospitalizations and improve quality of life through a reduction in left atrial pressure (LAP). A total of 626 patients were randomized at 89 centers across the US, Canada, Europe, Australia, and Japan. Patients with normal exercise PVR, indicating the absence of pulmonary vascular disease (PVD), and without a pacemaker, derived significant clinical benefit, including a reduction in heart failure events compared to sham (0.12 vs. 0.22 events per patient-year, p=0.007) and a significant and clinically meaningful difference in health status improvement over sham (+5.5 points) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.

“Prior to this stud)y (REDUCE LAP-HF II trial, we knew patients with significant PVD would be very unlikely to benefit from atrial shunt treatment. However, we didn’t fully appreciate the critical role that invasive exercise phenotyping may have in uncovering the degree of PVD that allows patients to benefit from atrial shunting,” added Barry Borlaug, MD, Professor of Medicine and Director of Circulatory Failure Research at Mayo Clinic. “While further study is needed, with appropriate patient selection, atrial shunting may be a great option for HFpEF patients without any form of PVD. In REDUCE LAP-HF II, treated patients with normal pulmonary vasculature confirmed through exercise, had a significantly greater likelihood of clinical benefit than sham control, with a lower HF event rate and a significant and clinically meaningful KCCQ improvement.”

See-"Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial";The Lancet. Published: February 1, 2022 Sanjiv J Shah, Barry A Borlaug, Eugene S Chung, Donald E Cutlip, Philippe Debonnaire, Peter S Failand others.