Corvia Medical’s atrial shunt device did not reduce heart failure rates or improve health status in a 626-patient study published on The Lancet’s website.
The REDUCE LAP-HF II results appear to be bad news for Tewksbury, Massachusetts-based Corvia — as well as Edwards Lifesciences, which agreed in 2019 to pay $35 million for the rights to acquire the company.
The 626 patients in the Corvia-funded study were randomly assigned to either the atrial shunt device or sham procedure. The study were no differences between groups in the primary composite endpoint or in the individual components of the primary endpoint.
Corvia Medical in a news release focused instead on results involving the subgroup of patients who had no pacemaker and normal exercise pulmonary vascular resistance, which indicates the absence of pulmonary vascular disease (PVD). The subgroup saw a statistically significant reduction in heart failure events compared to sham (0.12 vs. 0.22 events per patient-year). There was also a significant and clinically meaningful difference in health status improvement over sham (+5.5 points).
“Prior to this study, 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,” said Dr. Barry Borlaug, 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,” said Borlaug said in the Corvia news release.