New Data Confirm Rapid, Unpredictable Progression of Severe Aortic Stenosis and Need for Urgent Referral and Evaluation of Patients
Edwards Lifesciences (NYSE: EW) presented new scientific evidence at the American College of Cardiology's Annual Session, highlighting important findings about severe aortic stenosis (AS). The DETECT AS study, involving 939 patients and 285 physicians, showed that automatic electronic provider notifications increased aortic valve replacement rates by 11% overall and 14% for symptomatic patients.
The study revealed that 1 in 10 untreated patients with severe AS symptoms may die within five weeks. The EARLY TAVR trial demonstrated superior outcomes for asymptomatic severe AS patients treated with Edwards TAVR compared to watchful waiting. Additional research showed that cardiac biomarkers were not predictive of optimal treatment timing, emphasizing the unpredictable nature of the disease progression.
Edwards Lifesciences (NYSE: EW) ha presentato nuove evidenze scientifiche durante la Sessione Annuale dell'American College of Cardiology, evidenziando risultati importanti sulla stenosi aortica severa (AS). Lo studio DETECT AS, che ha coinvolto 939 pazienti e 285 medici, ha mostrato che le notifiche elettroniche automatiche ai fornitori hanno aumentato i tassi di sostituzione della valvola aortica dell'11% in generale e del 14% per i pazienti sintomatici.
Lo studio ha rivelato che 1 paziente su 10 non trattato con sintomi severi di AS potrebbe morire entro cinque settimane. Il trial EARLY TAVR ha dimostrato risultati superiori per i pazienti asintomatici con AS severa trattati con Edwards TAVR rispetto all'osservazione attenta. Ulteriori ricerche hanno mostrato che i biomarcatori cardiaci non erano predittivi del momento ottimale per il trattamento, sottolineando la natura imprevedibile della progressione della malattia.
Edwards Lifesciences (NYSE: EW) presentó nuevas evidencias científicas en la Sesión Anual del Colegio Americano de Cardiología, destacando hallazgos importantes sobre la estenosis aórtica severa (AS). El estudio DETECT AS, que involucró a 939 pacientes y 285 médicos, mostró que las notificaciones electrónicas automáticas a los proveedores aumentaron las tasas de reemplazo de válvula aórtica en un 11% en general y un 14% para los pacientes sintomáticos.
El estudio reveló que 1 de cada 10 pacientes no tratados con síntomas severos de AS podría morir en cinco semanas. El ensayo EARLY TAVR demostró resultados superiores para los pacientes asintomáticos con AS severa tratados con Edwards TAVR en comparación con la espera vigilante. Investigaciones adicionales mostraron que los biomarcadores cardíacos no eran predictivos del momento óptimo para el tratamiento, enfatizando la naturaleza impredecible de la progresión de la enfermedad.
에드워즈 라이프사이언스 (NYSE: EW)는 미국 심장학회 연례 회의에서 심각한 대동맥 협착증(AS)에 대한 중요한 발견을 강조하는 새로운 과학적 증거를 발표했습니다. DETECT AS 연구는 939명의 환자와 285명의 의사가 참여했으며, 자동 전자 제공자 알림이 대동맥 판막 교체율을 전반적으로 11%, 증상이 있는 환자에게는 14% 증가시켰음을 보여주었습니다.
이 연구는 심각한 AS 증상이 있는 치료받지 않은 환자 중 10명 중 1명이 5주 이내에 사망할 수 있음을 밝혔습니다. EARLY TAVR 시험은 에드워즈 TAVR로 치료받은 무증상 심각 AS 환자에게서 우수한 결과를 보여주었습니다. 추가 연구에서는 심장 바이오마커가 최적의 치료 시기를 예측할 수 없음을 보여주어 질병 진행의 예측 불가능한 특성을 강조했습니다.
Edwards Lifesciences (NYSE: EW) a présenté de nouvelles preuves scientifiques lors de la Session Annuelle du Collège Américain de Cardiologie, mettant en lumière des résultats importants concernant la sténose aortique sévère (AS). L'étude DETECT AS, impliquant 939 patients et 285 médecins, a montré que les notifications électroniques automatiques aux prestataires ont augmenté les taux de remplacement de la valve aortique de 11 % en général et de 14 % pour les patients symptomatiques.
L'étude a révélé qu'un patient non traité sur dix avec des symptômes sévères d'AS pourrait mourir dans les cinq semaines. L'essai EARLY TAVR a démontré des résultats supérieurs pour les patients asymptomatiques atteints de AS sévère traités avec Edwards TAVR par rapport à une observation attentive. Des recherches supplémentaires ont montré que les biomarqueurs cardiaques n'étaient pas prédictifs du moment optimal pour le traitement, soulignant la nature imprévisible de la progression de la maladie.
Edwards Lifesciences (NYSE: EW) präsentierte neue wissenschaftliche Erkenntnisse auf der Jahrestagung des American College of Cardiology und hob wichtige Ergebnisse zur schweren Aortenstenose (AS) hervor. Die DETECT AS-Studie, an der 939 Patienten und 285 Ärzte beteiligt waren, zeigte, dass automatische elektronische Benachrichtigungen an die Anbieter die Raten für Aortenklappenersatz insgesamt um 11 % und bei symptomatischen Patienten um 14 % erhöhten.
Die Studie ergab, dass 1 von 10 unbehandelten Patienten mit schweren AS-Symptomen innerhalb von fünf Wochen sterben könnte. Die EARLY TAVR-Studie zeigte überlegene Ergebnisse für asymptomatische Patienten mit schwerer AS, die mit Edwards TAVR behandelt wurden, im Vergleich zur abwartenden Beobachtung. Weitere Forschungen zeigten, dass kardiale Biomarker nicht vorhersagbar für den optimalen Behandlungszeitpunkt waren, was die unvorhersehbare Natur des Krankheitsverlaufs betonte.
- DETECT AS study demonstrated significant improvement in treatment rates with echo alerts
- EARLY TAVR trial showed superior outcomes compared to watchful waiting
- SAPIEN valve platform has treated over 1 million patients worldwide
- Cardiac biomarkers failed to predict optimal treatment timing
- Study confirms rapid and unpredictable disease progression, complicating treatment planning
Insights
The clinical data unveiled at ACC strengthens Edwards Lifesciences' market position with multiple high-impact studies published in premier journals. The DETECT AS trial reveals that simple electronic notifications can increase treatment rates by
More strategically significant is the EARLY TAVR data published in The New England Journal of Medicine demonstrating superior outcomes with Edwards' TAVR versus watchful waiting in asymptomatic patients. This evidence could substantially expand the addressable market by validating treatment earlier in disease progression, before patients become symptomatic.
The biomarker study further strengthens Edwards' case by confirming that we lack reliable predictors of disease progression, undermining the watchful waiting approach that has traditionally market size. With their SAPIEN platform having treated over 1 million patients globally, Edwards possesses the clinical credibility, market presence, and manufacturing scale to capitalize on potential guideline changes resulting from these findings.
This body of evidence creates a compelling case for prompt evaluation upon AS diagnosis and could accelerate the shift from surgical to transcatheter approaches, where Edwards maintains technological leadership and significant market share.
These ACC presentations represent a significant advancement in aortic stenosis management. The DETECT AS trial elegantly demonstrates that systematic electronic notifications increase valve replacement rates by
The EARLY TAVR findings published in NEJM are particularly practice-changing. They provide level 1 evidence challenging the traditional "watchful waiting" approach for asymptomatic severe AS patients by demonstrating superior outcomes with immediate TAVR intervention. The follow-up analysis showing that waiting until symptom development carries risks further validates early intervention.
Most concerning is the data confirming the unpredictable disease progression, with 1 in 10 symptomatic patients dying within five weeks without treatment. The biomarker study's failure to identify reliable progression predictors underscores that our current monitoring approach is fundamentally flawed.
These studies collectively build an irrefutable case for prompt evaluation upon AS diagnosis rather than periodic surveillance. For a progressive, often rapidly fatal condition like severe AS, earlier intervention with technologies like Edwards' SAPIEN platform appears increasingly justified based on this robust evidence. The care pathway implications are substantial, potentially shifting treatment paradigms toward earlier TAVR evaluation for all severe AS patients.
Without treatment, 1 in 10 patients experiencing symptoms of severe aortic stenosis (AS) may die within five weeks. However, the symptoms of severe AS can be difficult to detect and may progress rapidly and unpredictably. New data presented at ACC underscore the importance of urgently referring patients to a heart team for evaluation once diagnosed.
Among the groundbreaking data were findings from the randomized, controlled DETECT AS study, the first to evaluate the impact of automatic electronic provider notifications (echo alerts) for patients with severe AS. In this trial involving 939 patients and 285 physicians, those who ordered an echo for severe AS were randomized to either receive an echo alert describing treatment guidelines or no notification. The findings revealed echo alerts increased aortic valve replacement (AVR) treatment rates by 11 percent for all patients with severe AS, and 14 percent for symptomatic severe AS patients. Echo alerts also significantly improved AVR treatment rates among older patients and women, thereby reducing age and gender disparities. The results were simultaneously published in Circulation.
“These data illuminate the persistent under-referral and under-treatment of severe AS patients and the significant impact a critical echo notification can have on improving treatment of this deadly disease,” said Sammy Elmariah, M.D., Interventional Cardiology Medical Director, Cardiac Catheterization Laboratory, and associate professor at the University of
Additional insights from the EARLY TAVR trial were also presented at ACC. The EARLY TAVR trial was the first randomized, controlled FDA pivotal study designed to determine the best strategy for treating asymptomatic severe AS and the benefits of timely intervention with TAVR. The data were published in The New England Journal of Medicine and demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared with guideline-recommended clinical surveillance (watchful waiting), with no clinical penalty for timely intervention.
The new study presented at ACC evaluated outcomes of patients treated in the EARLY TAVR trial segmented by the severity of their signs and symptoms once they converted to AVR. These data reiterate that watchful waiting is not an effective strategy for the management of severe AS.
In addition, it was hypothesized that cardiac biomarkers may be predictive of the best time for severe AS patients to go from watchful waiting to receiving treatment. Another new study presented at ACC showed that biomarkers were not predictive, further underscoring the rapid and unpredictable progression of the disease and urgency to refer patients to a heart team for evaluation and treatment. Results of the biomarkers study were simultaneously published in Circulation.
“The data from these new studies confirm that severe aortic stenosis is a complex disease and reiterate the need for urgent referral and evaluation of treatment for patients with or without symptoms,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “We remain committed to advancing high-quality science and delivering life-saving structural heart therapies for patients with our leading SAPIEN valve platform, which has been used to treat more than 1 million patients worldwide."
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. Wood and Dr. Elmariah and statements regarding expected product benefits, including patient outcomes, 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.
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Media Contact: Heather Bukant, 949-250-2753
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Source: Edwards Lifesciences Corporation
FAQ
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