Edwards Evoque Valve for Tricuspid Regurgitation Evaluated at 6 Months in TRISCEND

November 6, 2021—Edwards Lifesciences Corporation announced that results from the TRISCEND clinical trial of the company's investigational Evoque transcatheter tricuspid valve replacement system demonstrated that favorable outcomes were sustained at 6 months in the treatment of patients with tricuspid regurgitation (TR).

According to Edwards, the prospective, single-arm, multicenter study is designed to evaluate the safety and performance of the Evoque device in treating TR.

The TRISCEND findings were presented 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.

Of 132 patients enrolled in the study, there are 56 patients with 6-month follow-up results that were reported at TCT. The study continues to enroll patients and additional patient follow-up will take place at 1 year and annually up to 5 years. The trial endpoints are device and procedural success, a composite of major adverse events at 30 days and TR reduction.

The company stated that patients who are enrolled in the TRISCEND study had symptomatic moderate or greater functional or degenerative TR despite optimal medical therapy. Positive 30-day outcomes were presented earlier this year.

The 6-month data (n = 56), which demonstrated significant TR reduction by core laboratory assessment, included the following findings:

• Significant reduction in TR severity, with 100% of patients with none/trace or mild TR in the 43 patients with paired echocardiographic data available
• Significantly improved functional and quality-of-life outcomes, including 89% of patients in New York Heart Association class I or II, and a 27-point increase in Kansas City Cardiomyopathy Questionnaire score over baseline
• High survival rate of 96% and freedom from heart failure hospitalization of 94%

Susheel Kodali, MD, who is from Columbia University Irving Medical Center in New York, New York, served as Principal Investigator of the TRISCEND study.

"Severe TR is becoming increasingly recognized to have a significant impact on quality of life and may be a predictor of increased mortality," commented Dr. Kodali in Edwards' press release. "Unfortunately, most patients with TR are at high risk for conventional surgery and there currently are no approved transcatheter options in the United States."

Dr. Kodali continued, "The 6-month results that we have seen with patients enrolled in the TRISCEND study who received the Evoque tricuspid valve replacement are truly remarkable and very promising for patients who suffer from TR."

The Evoque valve replacement system is an investigational device and is not available for sale in any country, advised Edwards Lifesciences.