CORRECTING and REPLACING First All-Female TAVI Trial Shows Excellent Outcomes for Women Receiving Edwards Valves
Edwards Lifesciences (NYSE: EW) announced results from the RHEIA Trial, the first all-female study focused on transcatheter aortic valve implantation (TAVI) outcomes. The trial, presented at ESC Congress 2024, showed superior outcomes for women receiving Edwards SAPIEN 3 or SAPIEN 3 Ultra valves compared to surgical aortic valve replacement (SAVR).
Key findings include:
- TAVI was superior to SAVR in 1-year composite endpoints
- 8.9% of TAVI patients experienced death, stroke, or rehospitalization vs 15.6% in SAVR
- 443 female patients with an average age of 73 were included
- Study conducted across 48 sites in 12 European countries
The trial highlights the importance of valve selection for women, especially those with small annuli, to preserve options for future valve-in-valve procedures.
Edwards Lifesciences (NYSE: EW) ha annunciato i risultati del RHEIA Trial, il primo studio completamente femminile focalizzato sui risultati dell'impianto di valvole aortiche transcatetere (TAVI). Lo studio, presentato al Congresso ESC 2024, ha mostrato risultati superiori per le donne che ricevono le valvole Edwards SAPIEN 3 o SAPIEN 3 Ultra rispetto alla sostituzione chirurgica della valvola aortica (SAVR).
I risultati chiave includono:
- Il TAVI è risultato superiore al SAVR nei punti finali compositi a 1 anno
- L'8,9% dei pazienti TAVI ha subito morte, ictus o ri-hospitalizzazione rispetto al 15,6% nel SAVR
- Lo studio ha incluso 443 pazienti femminili con un'età media di 73 anni
- Studio condotto in 48 siti in 12 paesi europei
Il trial evidenzia l'importanza della selezione della valvola per le donne, soprattutto per quelle con anelli valvolari piccoli, per preservare le opzioni per futuri interventi valve-in-valve.
Edwards Lifesciences (NYSE: EW) anunció los resultados del RHEIA Trial, el primer estudio completamente femenino centrado en los resultados de la implantación de válvulas aórticas transcatéter (TAVI). El estudio, presentado en el Congreso ESC 2024, mostró resultados superiores para las mujeres que recibieron válvulas Edwards SAPIEN 3 o SAPIEN 3 Ultra en comparación con el reemplazo quirúrgico de la válvula aórtica (SAVR).
Los hallazgos clave incluyen:
- El TAVI fue superior al SAVR en los puntos finales compuestos a 1 año
- El 8,9% de los pacientes de TAVI experimentaron muerte, accidente cerebrovascular o readmisión, en comparación con el 15,6% en SAVR
- Se incluyeron 443 pacientes femeninas con una edad promedio de 73 años
- Estudio realizado en 48 sitios en 12 países europeos
El ensayo resalta la importancia de la selección de válvulas para las mujeres, especialmente aquellas con anillos pequeños, para preservar las opciones para futuros procedimientos de válvula en válvula.
에드워드 라이프사이언스(뉴욕증권거래소: EW)는 첫 여성 전용 연구인 RHEIA Trial의 결과를 발표하였습니다. 이 연구는 경피적 대동맥 판막 삽입술(TAVI) 결과에 초점을 맞추고 있습니다. ESC Congress 2024에서 발표된 이 연구에서는 에드워드 SAPIEN 3 또는 SAPIEN 3 Ultra 판막을 받은 여성들이 외과적 대동맥 판막 교체(SAVR)보다 더 우수한 결과를 나타냈다고 전했습니다.
주요 발견 사항은 다음과 같습니다:
- TAVI는 1년 복합 끝점에서 SAVR보다 우수했습니다
- TAVI 환자의 8.9%가 사망, 뇌졸중 또는 재입원 경험을 했으며, SAVR에서는 15.6%였습니다
- 평균 연령이 73세인 여성 환자 443명이 포함되었습니다
- 12개 유럽 국가의 48개 사이트에서 연구가 진행되었습니다
본 연구는 특히 작은 판막 고리를 가진 여성의 경우 향후 판막 대 판막 시술을 위한 선택지를 보존하기 위해 판막 선택의 중요성을 강조합니다.
Edwards Lifesciences (NYSE: EW) a annoncé les résultats de l'Essai RHEIA, la première étude entièrement féminine axée sur les résultats de l'implantation de valves aortiques par cathéter (TAVI). L'essai, présenté au Congrès ESC 2024, a montré des résultats supérieurs pour les femmes recevant les valves Edwards SAPIEN 3 ou SAPIEN 3 Ultra par rapport au remplacement chirurgical de la valve aortique (SAVR).
Les résultats clés incluent :
- Le TAVI était supérieur au SAVR dans les points finaux composites à 1 an
- 8,9% des patients TAVI ont connu un décès, un AVC ou une ré-hospitalisation contre 15,6% dans le SAVR
- 443 patientes d'âge moyen 73 ans ont été incluses
- Étude réalisée dans 48 sites dans 12 pays européens
L'essai souligne l'importance du choix de la valve pour les femmes, en particulier celles ayant de petits anneaux, afin de préserver les options pour de futures procédures de valve dans la valve.
Edwards Lifesciences (NYSE: EW) gab die Ergebnisse der RHEIA-Studie bekannt, der ersten vollständig weiblichen Studie zu den Ergebnissen der transkatheter aortalen Klappenimplantation (TAVI). Die Studie, die auf dem ESC Congress 2024 vorgestellt wurde, zeigte überlegene Ergebnisse für Frauen, die Edwards SAPIEN 3 oder SAPIEN 3 Ultra Klappen erhielten im Vergleich zum chirurgischen aortalen Klappenersatz (SAVR).
Die wichtigsten Ergebnisse umfassen:
- TAVI war in den 1-Jahres-Komposit-Endpunkten überlegen im Vergleich zu SAVR
- 8,9% der TAVI-Patienten erlitten Tod, Schlaganfall oder Wiederaufnahme im Vergleich zu 15,6% bei SAVR
- Es wurden 443 weibliche Patienten mit einem Durchschnittsalter von 73 Jahren einbezogen
- Die Studie wurde an 48 Standorten in 12 europäischen Ländern durchgeführt
Die Studie hebt die Bedeutung der Klappenauswahl für Frauen hervor, insbesondere für jene mit kleinen Annuli, um zukünftige Optionen für Klappen-in-Klappen-Verfahren zu erhalten.
- None.
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The updated release reads:
FIRST ALL-FEMALE TAVI TRIAL SHOWS EXCELLENT OUTCOMES FOR WOMEN RECEIVING EDWARDS VALVES
Edwards Lifesciences (NYSE: EW) today announced the results from the RHEIA Trial, a first-of-its-kind trial focused exclusively on outcomes for women receiving transcatheter aortic valve implantation (TAVI). Presenting one-year results during a Hot Line session at the ESC Congress 2024, investigators reported superior outcomes for women receiving the Edwards SAPIEN 3 or SAPIEN 3 Ultra valves as compared to those receiving surgical aortic valve replacement (SAVR).
"Women are an underrepresented group in the diagnosis and treatment of severe aortic stenosis and this landmark study provides important insights into their treatment options,” said Hélène Eltchaninoff, M.D., head of the department of cardiology at the University Hospital of Rouen. “The transcatheter and surgical arms achieved remarkable results and the performance of the transcatheter valves adds to a growing body of evidence on the treatment options available to women.”
In the evaluation of composite 1-year endpoints, TAVI was found to be superior to SAVR with
“We are proud of this high-quality clinical research to inform patients’ decisions about the treatment of their heart valve failure,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “The outstanding success of the TAVI group points to the importance of valve selection for women undergoing aortic valve replacement – especially those women with small annuli – to preserve their options for a future valve-in-valve procedure, ensuring the lifetime management of their disease.”
Correcting the valve attribution from SAPIEN 3 Ultra RESILIA to SAPIEN 3 and correcting the patient population from 440 to 443. No further corrections were made.
About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn 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 Proxy Statement 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. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives 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 SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, RESILIA, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240831825338/en/
Media Contact: Howard Wright, 949-250-2790
Investor Contact: Mark Wilterding, 949-250-6826
Source: Edwards Lifesciences Corporation
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