Medtronic Evolut™ TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients
Medtronic (NYSE: MDT) has announced compelling five-year outcomes from the Evolut Low Risk Trial for its Evolut™ TAVR system. The study, involving 1,414 patients (730 TAVR, 684 surgery), demonstrated that TAVR patients experienced comparable rates of all-cause mortality or disabling stroke (15.5%) versus surgery (16.4%) at five years.
Key findings showed a numerically lower rate of cardiovascular mortality in TAVR patients (7.2%) compared to surgery (9.3%), along with significantly larger effective orifice areas and lower mean gradients. The trial evaluated patients with severe aortic stenosis who had a predicted 30-day mortality risk below 3%.
The results, presented at the American College of Cardiology's Annual Scientific Session & Expo, support Evolut's supra-annular, self-expanding TAVR as a durable and effective alternative to surgery for severe aortic stenosis patients, regardless of surgical risk.
Medtronic (NYSE: MDT) ha annunciato risultati significativi a cinque anni dallo Evolut Low Risk Trial per il suo sistema Evolut™ TAVR. Lo studio, che ha coinvolto 1.414 pazienti (730 TAVR, 684 interventi chirurgici), ha dimostrato che i pazienti TAVR hanno presentato tassi comparabili di mortalità per tutte le cause o ictus disabilitante (15,5%) rispetto alla chirurgia (16,4%) dopo cinque anni.
I risultati chiave hanno mostrato un tasso numericamente inferiore di mortalità cardiovascolare nei pazienti TAVR (7,2%) rispetto alla chirurgia (9,3%), insieme a aree di orifizio effettivo significativamente più grandi e gradienti medi più bassi. Il trial ha valutato pazienti con stenosi aortica severa che avevano un rischio di mortalità previsto a 30 giorni inferiore al 3%.
I risultati, presentati alla Sessione Scientifica Annuale & Expo del Collegio Americano di Cardiologia, supportano l'uso del TAVR Evolut, autoespandibile e supra-annulare, come un'alternativa duratura ed efficace alla chirurgia per i pazienti con stenosi aortica severa, indipendentemente dal rischio chirurgico.
Medtronic (NYSE: MDT) ha anunciado resultados impactantes a cinco años del Evolut Low Risk Trial para su sistema Evolut™ TAVR. El estudio, que involucró a 1.414 pacientes (730 TAVR, 684 cirugía), demostró que los pacientes TAVR experimentaron tasas comparables de mortalidad por todas las causas o accidente cerebrovascular discapacitante (15,5%) frente a la cirugía (16,4%) a cinco años.
Los hallazgos clave mostraron una tasa numéricamente más baja de mortalidad cardiovascular en pacientes TAVR (7,2%) en comparación con la cirugía (9,3%), junto con áreas de orificio efectivo significativamente más grandes y gradientes medios más bajos. El ensayo evaluó a pacientes con estenosis aórtica severa que tenían un riesgo de mortalidad a 30 días previsto por debajo del 3%.
Los resultados, presentados en la Sesión Científica Anual y Expo del Colegio Americano de Cardiología, respaldan el TAVR Evolut, autoexpandible y supra-anular, como una alternativa duradera y efectiva a la cirugía para pacientes con estenosis aórtica severa, independientemente del riesgo quirúrgico.
메드트로닉 (NYSE: MDT)은 Evolut™ TAVR 시스템에 대한 Evolut Low Risk Trial의 5년 결과를 발표했습니다. 이 연구는 1,414명의 환자(730명 TAVR, 684명 수술)를 포함하며, TAVR 환자들이 수술(16.4%)에 비해 모든 원인에 의한 사망률 또는 장애를 초래하는 뇌졸중의 비율이 비슷하게 나타났습니다(15.5%).
주요 결과는 TAVR 환자(7.2%)의 심혈관 사망률이 수술(9.3%)에 비해 수치적으로 낮았으며, 유효 개구 면적이 유의미하게 더 크고 평균 구배가 더 낮았음을 보여주었습니다. 이 시험은 30일 사망 위험이 3% 미만으로 예상되는 중증 대동맥 협착증 환자를 평가했습니다.
미국 심장학회 연례 과학 세션 및 엑스포에서 발표된 결과는 수술 위험과 관계없이 중증 대동맥 협착증 환자에게 내구성이 뛰어나고 효과적인 수술 대안으로서 Evolut의 초환형 자가 확장 TAVR을 지지합니다.
Medtronic (NYSE: MDT) a annoncé des résultats convaincants à cinq ans de l'Evolut Low Risk Trial pour son système Evolut™ TAVR. L'étude, impliquant 1.414 patients (730 TAVR, 684 chirurgies), a démontré que les patients TAVR avaient des taux comparables de mortalité toutes causes confondues ou d'accident vasculaire cérébral invalidant (15,5%) par rapport à la chirurgie (16,4%) après cinq ans.
Les résultats clés ont montré un taux de mortalité cardiovasculaire numériquement inférieur chez les patients TAVR (7,2%) par rapport à la chirurgie (9,3%), ainsi que des zones d'orifice effectif significativement plus grandes et des gradients moyens plus bas. L'essai a évalué des patients présentant une sténose aortique sévère ayant un risque de mortalité prédit à 30 jours inférieur à 3%.
Les résultats, présentés lors de la Session Scientifique Annuelle & Expo du Collège Américain de Cardiologie, soutiennent l'utilisation du TAVR Evolut, auto-expansible et supra-annulaire, comme une alternative durable et efficace à la chirurgie pour les patients atteints de sténose aortique sévère, quel que soit le risque chirurgical.
Medtronic (NYSE: MDT) hat überzeugende Fünfjahresergebnisse aus der Evolut Low Risk Trial für sein Evolut™ TAVR-System bekannt gegeben. Die Studie, an der 1.414 Patienten (730 TAVR, 684 Operationen) teilnahmen, zeigte, dass TAVR-Patienten vergleichbare Raten für die Gesamtmortalität oder behindernde Schlaganfälle (15,5%) im Vergleich zur Chirurgie (16,4%) nach fünf Jahren aufwiesen.
Wichtige Ergebnisse zeigten eine numerisch niedrigere Rate an kardiovaskulärer Mortalität bei TAVR-Patienten (7,2%) im Vergleich zur Chirurgie (9,3%), sowie signifikant größere effektive Öffnungsflächen und niedrigere mittlere Gradienten. Die Studie bewertete Patienten mit schwerer Aortenstenose, die ein vorhergesagtes 30-Tage-Mortalitätsrisiko von unter 3% hatten.
Die Ergebnisse, die auf der Jahrestagung und Expo des American College of Cardiology präsentiert wurden, unterstützen das supra-annulare, selbstexpandierende TAVR von Evolut als eine langlebige und effektive Alternative zur Chirurgie für Patienten mit schwerer Aortenstenose, unabhängig vom chirurgischen Risiko.
- Comparable 5-year mortality rates between TAVR (15.5%) and surgery (16.4%)
- Lower cardiovascular mortality trend in TAVR patients (7.2%) vs surgery (9.3%)
- Superior valve performance with larger orifice areas and lower mean gradients
- Demonstrated long-term durability and safety in low-risk patients
- None.
Insights
The five-year data from Medtronic's Evolut Low Risk Trial represents a significant milestone for the company's TAVR technology. The results showing comparable rates of all-cause mortality or disabling stroke between TAVR (
The numerically lower cardiovascular mortality rate (
From a competitive standpoint, these results strengthen Medtronic's position against Edwards Lifesciences in the expanding TAVR market. The low-risk segment represents the largest potential patient population, and durability data is crucial for physician decision-making when treating younger patients with longer life expectancies.
This trial validates Medtronic's self-expanding, supra-annular valve design approach, which appears to deliver excellent long-term hemodynamic performance. The data aligns with and reinforces the recently reported SMART trial results, creating a compelling body of evidence supporting Evolut TAVR as a first-line treatment option across risk categories.
The five-year Evolut Low Risk Trial data transforms the treatment paradigm for aortic stenosis. With mortality outcomes matching surgery and superior hemodynamics, interventional cardiologists now have robust evidence supporting TAVR as a durable option even for younger, healthier patients.
The clinical significance extends beyond the primary endpoint. While the all-cause mortality/disabling stroke composite endpoint showed numerical but non-statistically significant advantages (
The
These results will likely accelerate the ongoing shift from surgical to transcatheter approaches, particularly in the low-risk category where surgery has remained the default option. Physicians can now confidently recommend TAVR with Evolut to patients regardless of surgical risk classification, knowing the valve delivers durable performance through at least five years. This represents a substantial expansion of Medtronic's addressable patient population and positions their self-expanding valve technology favorably in this rapidly growing therapeutic area.
The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk <
"Results at five years support Evolut's supra-annular, self-expanding TAVR as a safe, effective, and durable alternative to surgery for patients with severe aortic stenosis, regardless of their surgical risk," said Michael J. Reardon, M.D., Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital and principal investigator of the trial. "The lower mortality risk and strong valve performance is meaningful for clinicians in evaluating treatment approaches that prioritize the overall well-being of patients."
Patients with severe aortic stenosis who were treated with either Evolut TAVR or surgery showed comparable rates of all-cause mortality or disabling stroke at 5 years (Evolut TAVR [
- Numerically lower rate of cardiovascular mortality (
7.2% Evolut TAVR vs.9.3% surgery; p=0.15) - Significantly larger effective orifice areas (EOA) and lower mean gradients in the TAVR vs. surgical arms
"At five years, Evolut has demonstrated lasting clinical outcomes comparable to surgery and a trend toward reduced cardiovascular mortality," said Kendra J. Grubb, M.D., M.H.A., M.Sc., vice president and chief medical officer of Structural Heart, which is part of the Medtronic Cardiovascular Portfolio. "These results reinforce the recently reported Evolut evidence from the SMART trial,[1] which emphasized superior hemodynamics and lower rates of valve dysfunction. The Evolut Low Risk data presented today will help clinicians make personalized treatment decisions for younger, lower-risk patients by considering each patient's unique needs, now acknowledging that data supports TAVR with Evolut as a safe and durable alternative to surgery."
About Medtronic
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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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1Herrmann H. Two-Year Outcomes of the Five-Year SMART Trial, presented at CRT 2025.
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