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. 2025 May 15;14(10):3471.
doi: 10.3390/jcm14103471.

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)

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 , Roberto Latini  2
Affiliations

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)

Marco Ranucci et al. J Clin Med. .

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; outcome; surgical aortic valve replacement; transcatheter aortic valve implantation.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Study flow-chart. SAVR: surgical aortic valve replacement; TAVI: transcatheter aortic valve implantation.
Figure 2
Figure 2
Kaplan–Meier curves of cumulative probability of death by any cause in Lombardy and Puglia. (A,B) From 0 to 1825 days of follow-up after aortic valve replacement. (C,D) From 31 to 1825 days follow-up. CI: confidence interval; HR: hazard ratio; SAVR: surgical aortic valve replacement; TAVI: transcatheter aortic valve implantation.
See this image and copyright information in PMC

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