TRISCEND II SIX-MONTH DATA FOR FIRST 150 PATIENTS SUCCESSFULLY DEMONSTRATE SAFETY AND EFFICACY OF EDWARDS EVOQUE SYSTEM FOR SEVERE TRICUSPID REGURGITATION

Excerpt from the Press Release:

SAN FRANCISCO, Oct. 26, 2023 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW) 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 35^th 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.”

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