Edwards’ Evoque System Evaluated in TRISCEND II for Clinical and QoL Benefits in Severe TR

November 7, 2024—Edwards Lifesciences Corporation recently announced that the company’s Evoque system demonstrated superiority compared to optimal medical therapy (OMT) alone for the 1-year primary endpoint of the TRISCEND II trial in the full cohort of 400 patients.

TRISCEND II is a randomized controlled pivotal trial designed to study the Evoque transcatheter tricuspid valve replacement (TTVR) system with OMT compared to OMT alone with 2:1 randomization. The Evoque system is approved for use in both Europe and the United States. The device includes four valve sizes: 44 mm, 48 mm, 52 mm, and 56 mm.

The findings were presented during the late-breaking clinical trial sessions at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

Simultaneously, the 1-year primary endpoint outcomes from the TRISCEND II trial were published by Rebecca T. Hahn, MD, et al in The New England Journal of Medicine. Additionally, the 1-year quality-of-life (QoL) outcomes from the trial were published Suzanne V. Arnold, MD, et al in Journal of the American College of Cardiology.

According to Edwards, patients enrolled in TRISCEND II 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, 95.3% achieved almost complete TR elimination with ≤ mild TR at 1 year, compared to 2.3 % of patients receiving OMT alone.

The study showed that TR reductions were associated with significant improvements in symptoms, function, and QoL at 1 year, with favorable numerical outcomes in mortality and heart failure hospitalization, stated the company.

Dr. Arnold and Susheel Kodali, MD, the study’s principal investigator, discussed the TRISCEND II findings in Edwards’ press release.

“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,” stated Dr. Kodali. “The 1-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.”

Dr. Arnold added, “The TRISCEND II trial results also demonstrated sustained QoL benefits for patients receiving the Evoque system. Patients receiving TTVR with the Evoque system were twice as likely to be alive with a good QoL at 1 year, compared with the control group.”

Dr. Arnold is Professor of Medicine at the University of Missouri-Kansas City School of Medicine, and Clinical Scholar at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri.

Dr. Kodali is the 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 in New York, New York.