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2026, Number 4

Cir Card Mex 2026; 11 (4)

Questioning the interpretive hierarchy in the seven-year outcomes of the Evolut Low Risk trial

García-Villarreal, Ovidio A; Flores-García, J Andrés

ABSTRACT

The 7-year follow-up of the Evolut Low Risk Trial extends the comparison between transcatheter (TAVR) and surgical (SAVR) aortic valve replacement in low-risk patients, shifting the clinical question from early safety to long-term durability. While all-cause mortality and disabling stroke remain comparable, a significant divergence emerges in reintervention rates (9.8% vs 6.0%; subdistribution Hazard Ratio [sHR] 1.68; 95%CI: 1.10-2.58; p = 0.02), driven predominantly by structural regurgitation (5.6% vs 1.6%; sHR 3.39; 95%CI: 1.62-7.07; p < 0.001). Notably, approximately 65% of TAVR reinterventions required surgical explantation, underscoring an asymmetry in rescue strategies. Methodological concerns include substantial sponsor involvement, emphasis on as-treated analyses, incomplete late clinical followup during the critical durability phase, absence of adjudicated echocardiography at year six, and retrospective classification of procedural performance according to subsequent versions of the device’s instructions for use. The trial does not specify which surgical bioprostheses were used in the SAVR arm, which limits the rigorous interpretation of the long-term structural comparison. Moreover, narrative framing prioritizes mortality equivalence over structural divergence. In low-risk patients with long life expectancy, durability –not early survival– constitutes the decisive outcome. These findings confirm the short-term benefits of TAVR but also highlight persistent concerns about long-term valve durability and lifetime management, limiting their direct extrapolation to younger, low-risk patients.
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Keywords

aortic stenosis clinical trials low surgical risk transcatheter aortic valve replacement surgical aortic valve replacement




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Cirugía Cardiaca en México Vol. 11, Num. 4, Octubre-Diciembre 2026. Es una difusión con una periodicidad trimestral, editada por la Sociedad Mexicana de Cirugía Cardiaca, A.C., Juan Badiano 1-1º piso, Col. Sección XVI, Delegación Tlalpan, CP: 14080, Tel: (55)1315.0376, https://sociedadmexicanadecirugiacardiaca.com El correo electrónico revmexcircard@gmail.com. Editor responsable: Ovidio Alberto García Villarreal. Reserva de Derechos al Uso Exclusivo: 04-2019-041218174700-203, otorgado por el Instituto Nacional de Derecho de Autor. Para esta versión electrónica (web), ISSN: 2954-3320. Responsable de la última actualización de este número: Dr. Ovidio Alberto García Villarreal, Juan Badiano 1-1º piso, Col. Sección XVI, Delegación Tlalpan, CP: 14080. Fecha de última modificación, 8 de octubre de 2026.

 

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