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Article

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)

by
Marco Ranucci
1,*,
Lidia Staszewsky
2,
Massimo Cartabia
3,
Mauro Tettamanti
3,
Vito Lepore
4,
Fabio Robusto
5,
Antonio Clavenna
6,
Antonio D’Ettorre
5,
Eloisa Arbustini
6,
Damiano Baldassarre
7,8,
Maria Teresa La Rovere
9,
Matteo Montorfano
10,11,
Gianfranco Parati
12,13,
Roberto F. E. Pedretti
14,15,
Giuseppe Maria Raffa
16,17,
Francesco Santini
18,
Giulio Stefanini
19,
Maurizio Volterrani
20,21,
Ida Fortino
22,
Lucia Bisceglia
23,
Lorenzo Menicanti
24 and
Roberto Latini
2add Show full author list remove Hide full author list
1
Department of Cardiovascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, 20097 Milan, Italy
2
Department of Acute Brain and Cardiovascular Injury, Lab Clinical Research in Brain and Cardiovascular Injury, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, 20156 Milan, Italy
3
Laboratory of Geriatric Neuropsychiatry, Dept of Health Policy, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, 20156 Milan, Italy
4
Department of Public Health, Laboratory of Medical Research and Consumer Involvement, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, 20156 Milan, Italy
5
Puglia Health System, Medonline-Statte, ASL-TA, 74010 Taranto, Italy
6
Scientific Department, Centre for Inherited Cardiovascular Diseases, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
7
Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy
8
Department of Medical Biotechnology and Translational Medicine, Università degli Studi di Milano, 20129 Milan, Italy
9
Department of Cardiology, Istituti Clinici Scientifici Maugeri, Montescano Institute-IRCCS, 27040 Montescano, Italy
10
School of Medicine, Vita-Salute San Raffaele University, 20132 Milan, Italy
11
Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy
12
Istituto Auxologico Italiano, S. Luca Hospital, University of Milan-Bicocca, 20126 Milan, Italy
13
Department of Medicine and Surgery, University of Milano-Bicocca, Piazza dell’Ateneo Nuovo, 20126 Milan, Italy
14
School of Medicine and Surgery, University of Milano Bicocca, 20126 Milano, Italy
15
Cardiovascular Department, IRCCS MultiMedica, 20099 Sesto San Giovanni, Italy
16
Department for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation, IRCCS-ISMETT, 90127 Palermo, Italy
17
Cardiac Surgery Unit, Department of Precision Medicine in Medical Surgical and Critical Area (Me.Pre.C.C.), University of Palermo, 90133 Palermo, Italy.
18
Cardiac Surgery, Ospedale Policlinico San Martino, University of Genoa, 16126 Genoa, Italy
19
IRCCS Istituto Clinico Humanitas, 20089 Rozzano, Italy
20
Cardiopulmonary Department, IRCCS San Raffaele Roma, 00166 Rome, Italy
21
Exercise Medicine and Science, San Raffaele Open University, 00166 Rome, Italy
22
Puglia Health System, Agenzia Regionale Strategica per la Salute ed il Sociale, AReSS Puglia, Area Epidemiologia e Care Intelligence, 70121 Bari, Italy
23
Laboratory for Pharmacoepidemiology, Department of Public Health, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, 20156 Milan, Italy
24
Department of Cardiac Surgery, IRCCS Policlinico San Donato, 20097 Milan, Italy
 
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*
Author to whom correspondence should be addressed.
J. Clin. Med. 2025, 14(10), 3471; https://doi.org/10.3390/jcm14103471
Submission received: 10 March 2025 / Revised: 18 April 2025 / Accepted: 8 May 2025 / Published: 15 May 2025
(This article belongs to the Special Issue Current Clinical Treatments and Challenges for Cardiovascular Diseases)
Versions Notes

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.
Keywords: Aortic valve stenosis; transcatheter aortic valve implantation; surgical aortic valve replacement; outcome Aortic valve stenosis; transcatheter aortic valve implantation; surgical aortic valve replacement; outcome

Share and Cite

MDPI and ACS Style

Ranucci, M.; Staszewsky, L.; Cartabia, M.; Tettamanti, M.; Lepore, V.; Robusto, F.; Clavenna, A.; D’Ettorre, A.; Arbustini, E.; Baldassarre, D.; et al. 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). J. Clin. Med. 2025, 14, 3471. https://doi.org/10.3390/jcm14103471

AMA Style

Ranucci M, Staszewsky L, Cartabia M, Tettamanti M, Lepore V, Robusto F, Clavenna A, D’Ettorre A, Arbustini E, Baldassarre D, et al. 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). Journal of Clinical Medicine. 2025; 14(10):3471. https://doi.org/10.3390/jcm14103471

Chicago/Turabian Style

Ranucci, Marco, Lidia Staszewsky, Massimo Cartabia, Mauro Tettamanti, Vito Lepore, Fabio Robusto, Antonio Clavenna, Antonio D’Ettorre, Eloisa Arbustini, Damiano Baldassarre, and et al. 2025. "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)" Journal of Clinical Medicine 14, no. 10: 3471. https://doi.org/10.3390/jcm14103471

APA Style

Ranucci, M., Staszewsky, L., Cartabia, M., Tettamanti, M., Lepore, V., Robusto, F., Clavenna, A., D’Ettorre, A., Arbustini, E., Baldassarre, D., La Rovere, M. T., Montorfano, M., Parati, G., Pedretti, R. F. E., Raffa, G. M., Santini, F., Stefanini, G., Volterrani, M., Fortino, I., ... Latini, R. (2025). 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). Journal of Clinical Medicine, 14(10), 3471. https://doi.org/10.3390/jcm14103471

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