Edwards Evoque System for Severe TR Studied in Initial 6-Month Data From TRISCEND II

October 26, 2023—Edwards Lifesciences announced successful results from TRISCEND II, a randomized controlled pivotal trial designed to evaluate the safety and effectiveness of the company’s Evoque tricuspid valve replacement system with optimal medical therapy (OMT) compared to OMT alone with 2:1 randomization. Patients enrolled in the TRISCEND II trial had at least severe tricuspid regurgitation (TR).

The outcomes for the first 150 patients of the TRISCEND II trial achieved the primary safety endpoint at 30 days and both coprimary effectiveness endpoints at 6 months, demonstrating superiority to OMT alone, reported the company.

The results from the TRISCEND II trial were presented during a late-breaking clinical trial session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

According to the company, the Evoque valve was successfully implanted in 95.8% of patients and the trial met all primary endpoints, including:

• Major adverse event rate of 27.4% at 30 days
• Significant TR grade reduction with 98.8% of patients achieving ≤ moderate TR and 93.8% achieving ≤ mild TR at 6 months
• Substantially superior quality-of-life and functional outcomes at 6 months for the composite endpoint including Kansas City Cardiomyopathy Questionnaire score, New York Heart Association class, and 6-minute walk distance for the Evoque system plus OMT versus OMT alone.

Susheel Kodali, MD, who is director, Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital in New York, New York, is the TRISCEND II study principal investigator.

“We are excited by the safety and effectiveness data from the first 150 patients of the TRISCEND II pivotal trial,” commented Dr. Kodali in Edwards’ press release. “With no predicate study of a novel transcatheter tricuspid valve replacement, these data and outcomes give us great hope in the Evoque system as an option to treat patients who are very sick and have few effective therapeutic options.”

On October 19, the company announced that the Evoque tricuspid valve replacement system received CE Mark approval for the transcatheter treatment of eligible patients with TR in Europe, where the Evoque valve will be available in three sizes, all delivered through a low-profile transfemoral 28-F system.

The Evoque system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the same bovine pericardial tissue as the company’s heart valves.

Edwards further noted that an FDA Advisory Committee Meeting of the Evoque system is expected in January 2024. The company anticipates approval in the United States in mid-2024.

In 2019, the Evoque system received FDA Breakthrough Device designation and, as a result, the TRISCEND II trial was designed to include a prespecified analysis of the first 150 patients enrolled to evaluate the safety and effectiveness of the device. The full cohort of 400 patients is enrolled, advised Edwards.