TRISCEND II Trial Demonstrates Superior Clinical and Quality-of-life Benefits With Edwards EVOQUE System for Severe Tricuspid Regurgitation
Edwards Lifesciences (NYSE: EW) announced superior one-year results for its EVOQUE transcatheter tricuspid valve replacement system in the TRISCEND II trial. The study, involving 400 patients with severe tricuspid regurgitation, showed 95.4% successful implantation rate. 95.3% of treated patients achieved near-complete tricuspid regurgitation elimination at one year, compared to just 2.3% in the control group receiving optimal medical therapy alone. The EVOQUE system, now approved in both Europe and US, demonstrated significant improvements in symptoms, function, and quality of life, with favorable trends in mortality and heart failure hospitalization.
Edwards Lifesciences (NYSE: EW) ha annunciato risultati superiori a un anno per il suo sistema di sostituzione della valvola tricuspide transcatetere EVOQUE nel trial TRISCEND II. Lo studio, che ha coinvolto 400 pazienti con grave rigurgito tricuspide, ha mostrato un 95,4% tasso di impianto riuscito. Il 95,3% dei pazienti trattati ha raggiunto un'eliminazione quasi completa del rigurgito tricuspide dopo un anno, rispetto solo al 2,3% del gruppo di controllo che riceveva solo terapia medica ottimale. Il sistema EVOQUE, ora approvato sia in Europa che negli Stati Uniti, ha dimostrato miglioramenti significativi nei sintomi, nella funzione e nella qualità della vita, con tendenze favorevoli in termini di mortalità e ospedalizzazione per insufficienza cardiaca.
Edwards Lifesciences (NYSE: EW) anunció resultados superiores a un año para su sistema de reemplazo de válvula tricúspide transcatéter EVOQUE en el ensayo TRISCEND II. El estudio, que involucró a 400 pacientes con regurgitación tricúspide severa, mostró una tasa de implantación exitosa del 95,4%. El 95,3% de los pacientes tratados logró una eliminación casi completa de la regurgitación tricúspide a un año, en comparación con solo el 2,3% en el grupo de control que recibió solo terapia médica óptima. El sistema EVOQUE, ahora aprobado tanto en Europa como en EE.UU., demostró mejoras significativas en los síntomas, la función y la calidad de vida, con tendencias favorables en la mortalidad y en la hospitalización por insuficiencia cardíaca.
에드워즈 라이프사이언스 (NYSE: EW)는 TRISCEND II 시험에서 EVOQUE 경피적 삼천치관 교체 시스템의 1년 우수 결과를 발표했습니다. 이 연구는 중증 삼천치관 역류 환자 400명을 포함했으며, 95.4%의 성공적인 이식률을 보였습니다. 치료받은 환자의 95.3%가 1년 후 삼천치관 역류를 거의 완전히 제거한 반면, 최적의 약물 치료만 받은 대조군은 2.3%에 불과했습니다. 현재 유럽과 미국에서 승인된 EVOQUE 시스템은 증상, 기능 및 삶의 질에서显著한 향상을 보였으며, 사망률 및 심부전 입원에 대한 긍정적인 경향을 나타냈습니다.
Edwards Lifesciences (NYSE: EW) a annoncé des résultats supérieurs à un an pour son système de remplacement de valve tricuspide par cathéter EVOQUE dans l'essai TRISCEND II. L'étude, impliquant 400 patients souffrant de régurgitation tricuspide sévère, a montré un taux d'implantation réussie de 95,4%. 95,3% des patients traités ont atteint une élimination quasi complète de la régurgitation tricuspide à un an, contre seulement 2,3% dans le groupe témoin recevant uniquement un traitement médical optimal. Le système EVOQUE, désormais approuvé en Europe et aux États-Unis, a démontré des améliorations significatives des symptômes, de la fonction et de la qualité de vie, avec des tendances favorables en matière de mortalité et d'hospitalisation pour insuffisance cardiaque.
Edwards Lifesciences (NYSE: EW) gab bekannt, dass die Ergebnisse nach einem Jahr für sein EVOQUE transkatheter Triusbialhersatzsystem im TRISCEND II-Test überlegen sind. In der Studie, die 400 Patienten mit schwerer Trikuspidalinsuffizienz umfasste, betrug die erfolgreiche Implantationsrate 95,4%. 95,3% der behandelten Patienten erreichten nach einem Jahr eine nahezu vollständige Eliminierung der Trikuspidalinsuffizienz, verglichen mit nur 2,3% in der Kontrollgruppe, die ausschließlich optimaler medizinischer Behandlung erhielt. Das EVOQUE-System, das jetzt sowohl in Europa als auch in den USA zugelassen ist, zeigte signifikante Verbesserungen in den Symptomen, der Funktion und der Lebensqualität, mit positiven Trends in der Sterblichkeit und der Hospitalisierung aufgrund von Herzinsuffizienz.
- 95.4% successful implantation rate of EVOQUE system
- 95.3% of treated patients achieved near-complete TR elimination vs 2.3% in control group
- First and only approved TTVR system worldwide (US and EU approval)
- Significant improvements in symptoms and quality of life outcomes
- Favorable trends in mortality and heart failure hospitalization
- None.
Insights
Patients enrolled in the TRISCEND II trial had at least severe tricuspid regurgitation (TR). The EVOQUE valve was successfully implanted in 95.4 percent of patients, and of those who received the valve, nearly all (95.3 percent) achieved almost complete TR elimination with ≤ mild TR at one year, compared to 2.3 percent of patients receiving OMT alone. These TR reductions were associated with significant improvements in symptoms, function and QoL at one year, with favorable numerical outcomes in mortality and heart failure hospitalization.
“It is exciting to have the EVOQUE system available as a treatment option for patients who are very sick and otherwise have limited, if any, options,” said Susheel Kodali, MD, Avanessians Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons and director of interventional echocardiography at the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Irving Medical Center and TRISCEND II Study Principal Investigator. “The one-year outcomes from the TRISCEND II trial demonstrate the benefits of this therapy in these patients and the favorable trends in all-cause mortality and heart failure hospitalization are encouraging to see. We are pleased to see TTVR reach this stage after nearly a decade of development.”
“The TRISCEND II trial results also demonstrated sustained quality-of-life benefits for patients receiving the EVOQUE system,” said Suzanne
The EVOQUE system is approved for use in both
“Edwards’ commitment to innovation is inspired by the millions of patients around the world suffering with debilitating symptoms and poor quality-of-life as a result of structural heart diseases and in desperate need of effective treatment options,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “We are building a portfolio of transcatheter repair and replacement technologies for both the mitral and tricuspid valves, and we are dedicated to supporting those therapies with world-class evidence like what is being generated through the TRISCEND II trial.”
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr. Chopra and statements regarding expected product benefits, patient outcomes, Edwards’ objectives, commitment and dedication in building a portfolio of technologies and evidence supporting those technologies, and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards EVOQUE, EVOQUE, TRISCEND, and TRISCEND II are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
Many Columbia University Vagelos College of Physicians and Surgeons physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance.
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Media Contact: Loree Bowen, 714-403-2475
Investor Contact: Mark Wilterding, 949-250-6826
Source: Edwards Lifesciences Corporation
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