Study Demonstrates Benefits of Edwards’ EVOQUE System

Edwards Lifesciences Corporation’s EVOQUE system is a better treatment than medical therapy alone, according to randomized, controlled study results.

TRISCEND II is a randomized controlled pivotal trial designed to study the company’s EVOQUE transcatheter tricuspid valve replacement (TTVR) system with optimal medical therapy (OMT) compared to OMT alone with a two-to-one randomization. The data included the full 400-patient cohort. The trial’s one-year primary endpoint outcomes will be simultaneously published in The New England Journal of Medicine, and TRISCEND II trial one-year quality-of-life (QoL) outcomes will be simultaneously published in the Journal of the American College of Cardiology.

“It is exciting to have the EVOQUE system available as a treatment option for patients who are very sick and otherwise have limited, if any, options,” said Susheel Kodali, M.D., Avanessians Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons and director of interventional echocardiography at the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Irving Medical Center and TRISCEND II study principal investigator. “The one-year outcomes from the TRISCEND II trial demonstrate the benefits of this therapy in these patients and the favorable trends in all-cause mortality and heart failure hospitalization are encouraging to see. We are pleased to see TTVR reach this stage after nearly a decade of development.”

Patients enrolled in the TRISCEND II trial had at least severe tricuspid regurgitation (TR). The EVOQUE valve was successfully implanted in 95.4% of patients, and of those who received the valve, nearly all (95.3%) achieved almost complete TR elimination with ≤ mild TR at one year, compared to 2.3% of patients receiving OMT alone. These TR reductions were associated with significant improvements in symptoms, function and QoL at one year, with favorable numerical outcomes in mortality and heart failure hospitalization.

“The TRISCEND II trial results also demonstrated sustained quality-of-life benefits for patients receiving the EVOQUE system,” said Suzanne Arnold, M.D., professor of Medicine at the University of Missouri-Kansas City (UMKC) School of Medicine, and clinical scholar at Saint Luke’s Mid America Heart Institute. “Patients receiving TTVR with the EVOQUE system were twice as likely to be alive with a good quality-of-life at one year, compared with the control group.”

The EVOQUE system is approved for use in both Europe and the United States, making it the world’s first and only approved TTVR system. The EVOQUE system includes four valve sizes (44mm, 48mm, 52mm and 56mm), with the 56mm valve recently approved in the United States.

“Edwards’ commitment to innovation is inspired by the millions of patients around the world suffering with debilitating symptoms and poor quality-of-life as a result of structural heart diseases and in desperate need of effective treatment options,” said Daveen Chopra, Edwards’ corporate vice president, Transcatheter Mitral and Tricuspid Therapies. “We are building a portfolio of transcatheter repair and replacement technologies for both the mitral and tricuspid valves, and we are dedicated to supporting those therapies with world-class evidence like what is being generated through the TRISCEND II trial.”

Edwards Lifesciences is a global structural heart innovation company developing breakthrough technologies and forming partnerships with clinicians and healthcare stakeholders.