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TRISCEND II Six-Month Data for First 150 Patients Successfully Demonstrate Safety and Efficacy of Edwards Evoque System for Severe Tricuspid Regurgitation
SAN FRANCISCO -- Edwards Lifesciences Corporation today announced successful results from TRISCEND II, a randomized controlled pivotal trial designed to evaluate the safety and effectiveness of the groundbreaking EVOQUE tricuspid valve replacement system with optimal medical therapy (OMT) compared to OMT alone with 2:1 randomization.
The outcomes for the first 150 patients of the TRISCEND II trial achieved the primary safety endpoint at 30 days and both co-primary effectiveness endpoints at six months, demonstrating superiority to OMT alone. Results from the TRISCEND II trial were presented as a late-breaking clinical trial session at the 35th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
Patients enrolled in the TRISCEND II trial had at least severe tricuspid regurgitation (TR). The EVOQUE valve was successfully implanted in 95.8 percent of patients and the trial met all primary endpoints with:
- Major adverse event rate at 27.4 percent at 30 days;
- Significant TR grade reduction with 98.8 percent of patients achieving ≤ moderate TR and 93.8 percent achieving ≤ mild TR at six months; and
- Substantially superior quality-of-life and functional outcomes at six months for the composite endpoint including KCCQ, NYHA and 6MWD for the EVOQUE system plus OMT over OMT alone.
"We are excited by the safety and effectiveness data from the first 150 patients of the TRISCEND II pivotal trial," said Susheel Kodali, MD, director, Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and TRISCEND II Study Principal Investigator. "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."
An FDA Advisory Committee Meeting of the EVOQUE system is expected in Jan. 2024, followed by an anticipated US approval in mid-2024. In 2019, the EVOQUE system received FDA Breakthrough Designation, which is designed to provide patients with timely access to new devices for life-threatening or irreversibly debilitating conditions. As a result, the TRISCEND II trial was specifically designed to include a pre-specified analysis of the first 150 patients enrolled to evaluate the safety and effectiveness of the EVOQUE system. The full cohort of 400 patients is enrolled. Earlier this month, the EVOQUE system received CE Mark for the transcatheter treatment of eligible patients with TR.
"Patients suffering from severe tricuspid regurgitation endure debilitating symptoms and poor quality of life and are desperate for effective treatment, as evidenced by the rapid enrollment in this trial," said Daveen Chopra, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "These data build upon the promising foundation of results previously published from the single-arm TRISCEND study and add to our growing body of contemporary clinical evidence that enables more patients in need to receive treatment."
Edwards is committed to transforming the treatment of patients with mitral and tricuspid valve disease, supported by robust clinical evidence. The EVOQUE system is one of multiple transcatheter repair or replacement therapies in development by Edwards.
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