Edwards Lifesciences’ TRISCEND II and CLASP IID Trials at TCT Enhance Company’s Position in Transcatheter Heart Valve Regurgitation and Set the Stage for EVOQUE approval in the U.S.
Edwards Lifesciences announced positive results from two additional major trial at this week’s Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium pertaining to its technologies for treating heart valve regurgitation.
The first study was the results from the TRISCEND II trial, a pivotal randomized controlled study evaluating the effectiveness and safety of the innovative EVOQUE tricuspid valve replacement system when used alongside optimal medical therapy (OMT) compared to OMT alone. The outcomes of the first 150 patients in the trial demonstrated the superiority of the EVOQUE system over OMT alone, achieving primary safety and effectiveness endpoints. Patients enrolled in the TRISCEND II trial had a diagnosis of at least severe tricuspid regurgitation (TR). The EVOQUE valve was successfully implanted in 95.8% of patients. Notably, the trial successfully met all primary endpoints, which included a major adverse event rate at 27.4% at 30 days. A significant TR grade reduction, with 98.8% of patients achieving mild TR and 93.8% achieving very mild TR at the six-month mark. 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 compared to OMT alone.
Dr. Susheel Kodali, director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and Principal Investigator of the TRISCEND II Study, expressed his excitement about the data. “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.”
The path forward for the EVOQUE system includes an FDA Advisory Committee Meeting scheduled for January 2024, with anticipated approval in the United States in mid-2024. In 2019, the EVOQUE system received FDA Breakthrough Designation. The company has previously received CE Mark approval for transcatheter treatment of eligible tricuspid regurgitation patients using EVOQUE this month. EVOQUE is the only transcatheter product currently on the market for treating tricuspid valve regurgitation.
In a second presentation, the company revealed one-year results from the CLASP IID trial, marking a significant milestone in the evaluation of transcatheter edge-to-edge repair (TEER) therapies for mitral valve regurgitation. TEER is a procedure that approximates the anterior and posterior mitral valve leaflets by grasping them with a clasping device, providing a less invasive approach to treating mitral regurgitation, which is a condition where blood flows backward into the heart due to a leaky mitral valve. It’s a technique that mimics a surgical treatment called the Alfieri stitch, allowing for improved patient outcomes and quality of life.
The study directly compared two contemporary TEER approaches and confirmed the clinical and quality-of-life benefits in patients with degenerative mitral regurgitation (DMR). The patients participating in the CLASP IID pivotal trial suffered from symptomatic DMR and were determined to be at high surgical risk. The CLASP IID trial also compared the safety and effectiveness of the PASCAL system to the MitraClip system from Abbott, enrolling 300 patients with 2:1 randomization (204 PASCAL / 96 MitraClip). The one-year results from the trial have shown that patients treated with the PASCAL system had freedom from major adverse events rate of 84.7% at one year and saw significant and sustained reduction in mitral regurgitation (MR), with 95.8% of patients achieving MR ≤2+ at one year. Additionally, 77.1% of PASCAL patients in the trial achieved a MR rate of ≤1+ at one year. This significant MR reduction is critical since evidence suggests it may be associated with better long-term patient outcomes. Moreover, the PASCAL system demonstrated sustained outcomes, including high survival rates, low heart failure hospitalization, and substantial improvements in patients’ quality of life.
Dr. Firas Zahr, director of Interventional Cardiology at Oregon Health & Science University and co-director of the Complex Heart Valve Program, highlighted the impact of these results. “These data from the CLASP IID randomized trial and registry further advance mitral edge-to-edge repair as an important treatment option for a wide range of very sick patients who suffer from debilitating symptoms. Patients receiving the PASCAL system experienced significant improvements in functional capacity and quality of life that were sustained for one year.”
The PASCAL Precision system is already approved for degenerative mitral regurgitation in the United States and Japan and has CE Mark for the treatment of mitral degenerative and functional regurgitation, as well as tricuspid regurgitation.