Edwards’ Evoque System’s 1-Year Data Presented From TRISCEND Study of Tricuspid Regurgitation

November 27, 2022—Edwards Lifesciences Corporation announced that 1-year results from patients treated in the TRISCEND study of the company’s Evoque transcatheter tricuspid valve replacement system demonstrated favorable safety, efficacy, and quality-of-life outcomes.

The single-arm, prospective, global, multicenter study enrolled 176 patients with symptomatic moderate or greater functional or degenerative tricuspid regurgitation (TR) despite optimal medical therapy.

The data were presented during the late-breaking trials session at the PCR London Valves 2022 course held November 27-29 in London, United Kingdom.

As summarized by Edwards Lifesciences, the 1-year outcomes demonstrated the following:

• 90.1% survival and 88.4% freedom from heart failure hospitalization
• Significant and sustained TR reduction with 97.6% of patients with mild or trace TR (n = 84)
• Significantly improved functional and quality-of-life outcomes, with 93% of patients in New York Heart Association class I or II compared to 26% at baseline (n = 89) and a 26-point increase in Kansas City Cardiomyopathy Questionnaire score over baseline (n = 102)

Professor Didier Tchetche, MD, of Clinique Pasteur in Toulouse, France, is Coprimary Investigator of the TRISCEND study.

“TR is prevalent, undertreated, and has a significant impact on patients’ quality of life,” commented Prof. Tchetche in the company’s press release. “With most TR patients at high risk for surgery, there is a great need for an approved transcatheter valve replacement treatment option.”

Prof. Tchetche continued, “The 1-year results for patients who received the Evoque tricuspid valve replacement as part of the TRISCEND study provide important support for our confidence in this therapy as an option for patients who suffer from tricuspid regurgitation.”

The company noted that positive 30-day and 6-month TRISCEND results for the Evoque system were previously revealed. The 6-month data were presented last year at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held November 4-6 online and in Orlando, Florida. In May 2021, the 30-day results were presented during the late-breaking clinical trials sessions at the virtual EuroPCR 2021 conference.

Edwards advised that the Evoque valve replacement system is an investigational device and is not available for sale in any country. The TRISCEND II randomized pivotal trial for the Evoque system is underway.