TRISCEND, a single-arm, prospective, global, multi-center study, evaluates the Edwards Evoque system. Evoque, a transcatheter tricuspid valve replacement system, demonstrated favorable safety, efficacy and quality-of-life outcomes.
Edwards presented data during the late-breaking trials session at PCR London Valves 2022.
Patients enrolled in the trial had symptomatic moderate or greater functional or degenerative tricuspid regurgitation (TR). They had TR despite optimal medical therapy. The trial enrolled 176 patients. Edwards said in a news release that this represents the largest dataset among transcatheter tricuspid valve replacement therapies.
The company earlier reported positive 30-day and 6-month results. One-year outcomes demonstrated high survival of 90.1% and high freedom from heart failure hospitalization at 88.4%. Additionally, subjects showed significant and sustained TR reduction with 97.6% of patients demonstrating mild or trace TR.
Evoque also significantly improved functional and quality of life outcomes. Edwards reported 93% of patients in NYHA Class I or II compared to 26% at baseline. The company said it saw a 26-point increase in KCCQ score over baseline.
Study provides “important support” for Evoque
“Tricuspid regurgitation is prevalent, undertreated and has a significant impact on patients’ quality of life. With most TR patients at high risk for surgery, there is a great need for an approved transcatheter valve replacement treatment option,” said Dr. Didier Tchetche, Clinique Pasteur, Toulouse, France, and TRISCEND study co-primary investigator. “The one-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.”
Evoque is an investigational device. Edwards currently does not offer it for sale in any country. Its TRISCEND II randomized pivotal trial remains underway.
“We are encouraged by the sustained safety and performance outcomes demonstrated by the EVOQUE system at one year, as it represents a meaningful therapy in our portfolio of transcatheter therapies being developed to help improve the quality-of-life for patients with tricuspid and mitral valve diseases,” said Bernard J. Zovighian, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “Edwards’ eight data presentations included in this year’s PCR London Valves program deliver on our long-term investment in innovation and clinical evidence generation to meet the needs of patients and mark a new era for our company.”