Edwards Lifesciences Evoque demonstrated superiority vs. medical therapy alone

Edwards Lifesciences (EW) announced that the EVOQUE system demonstrated superiority compared to medical therapy alone for the one-year primary endpoint of the TRISCEND II trial. TRISCEND II is a randomized controlled pivotal trial designed to study the groundbreaking EVOQUE transcatheter tricuspid valve replacement system with optimal medical therapy compared to OMT alone with 2:1 randomization. The data, presented during the late-breaking clinical trial sessions at the Transcatheter Cardiovascular Therapeutics meeting, included the full cohort of 400 patients. TRISCEND II trial 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 outcomes will be simultaneously published in the Journal of the American College of Cardiology. Patients enrolled in the TRISCEND II trial had at least severe tricuspid regurgitation. The EVOQUE valve was successfully implanted in 95.4 percent of patients, and of those who received the valve, nearly all achieved almost complete TR elimination with less than or equal to mild TR at one year, compared to 2.3 percent 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. “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, MD, 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.” The EVOQUE system is approved for use in both Europe and the US, making it the world’s first and only approved TTVR system. The EVOQUE system includes four valve sizes, with the 56mm valve recently approved in the US.