When Real-World Outcomes Do Not Meet the Results of Clinical Trials: Transfemoral Transcatheter vs. Surgical Aortic Valve Replacement in an Intermediate-Age Population (The Outstanding Italy Study)
Year: 2025
Type: article
Study design: Observational Study
Abstract: Objective: Aortic valve stenosis is the most common valvular heart disease in the elderly, and its treatment may be either surgical (SAVR) or transcatheter (TAVI). Although age is one of the main determinants of the therapeutic choice, current guidelines leave a “discrepancy area” between 65 and 75 years, with the American guidelines allowing TAVI for patients older than 65 years, while the European guidelines consider TAVI for patients older than 75 years. The present study addresses the outcomes of SAVR vs. TAVI in a real-world population aged 65 to 80 years, that is, one largely inclusive of the discrepancy area. Methods: This is a retrospective registry study based on data retrieved from administrative health databases of two large Italian regions (Lombardy and Puglia). Patients aged 65 to 80 years receiving either SAVR or a TAVI between 2018 and 2021 were selected. SAVR and TAVI outcomes (death, cardiac and non-cardiac events) were compared using a propensity-matching analysis, with a follow-up of 2 to 5 years and mortality as the primary outcome. Results: After propensity matching, two groups of 786 patients were compared in Lombardy and two groups of 321 patients were compared in Puglia. In both regions, at the end of follow-up, mortality was significantly (p < 0.001) lower in SAVR vs. TAVI (24.6% vs. 47.2% in Lombardy and 18.1% vs. 44.1% in Puglia). Conclusions: Our results are in contrast with the randomized controlled trials showing equivalence or even the superiority of TAVI vs. SAVR, but in agreement with other registry studies based on real-world data. With respect to the randomized controlled trials, the main difference is a better outcome in SAVR. Caution should be applied in addressing patients < 80 years with TAVI unless SAVR is contraindicated.
Source: Journal of Clinical Medicine
DOI: 10.3390/jcm14103471
Authors: Marco Ranucci, Lidia Staszewsky, Massimo Cartabia, Mauro Tettamanti, Vito Lepore, Fabio Robusto, Antonio Clavenna, Antonio D’Ettorre, Eloisa Arbustini, Damiano Baldassarre, Maria Teresa La Rovere, Matteo Montorfano, Gianfranco Parati, Roberto F. E. Pedretti, Giuseppe Maria Raffa, Francesco Santini, Giulio Stefanini, Maurizio Volterrani, Ida Fortino, Lucia Bisceglia, Lorenzo Menicanti, Roberto Latini
Institutions: IRCCS Policlinico San Donato, Mario Negri Institute for Pharmacological Research, Agenzia Regionale Sanitaria della Puglia, Policlinico San Matteo Fondazione, University of Milan, Centro Cardiologico Monzino, Istituti Clinici Scientifici Maugeri, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, IRCCS Istituto Auxologico Italiano, University of Milano-Bicocca, MultiMedica, Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione, University of Palermo, Ospedale Policlinico San Martino, University of Genoa, IRCCS Humanitas Research Hospital, San Raffaele University of Rome, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,137
Funder: Ministero della Salute
OpenAlex ID: W4410401374