Transcatheter vs. Surgical Aortic Valve Replacement in Low- to Intermediate-Risk Patients: Do DEDICATE trial outcomes translate to real-world populations?

Authors

Edgar Daeter, Maaike M Roefs, Richard A J Post, Jurien Ten Berg, Pim A L Tonino, Dennis Van Veghel, Robert Klautz, Johanna J M Takkenberg, Kevin M Veen, Cardiothoracic Surgery Registration Committee of the Netherlands Heart Registration and DEDICATE author group

Published in

The Journal of thoracic and cardiovascular surgery. Sep 22, 2026. Epub Sep 22, 2026.

Abstract

To assess the transportability of the randomized DEDICATE trial results, comparing SAVR with TAVR in low- to intermediate-risk patients, to an external Dutch population derived from the Netherlands Heart Registration (NHR).
Data sources included the DEDICATE-RCT data (TAVR-trial, SAVR-trial) and the NHR (SAVR-registry). The primary endpoint was composite of all-cause mortality or stroke at one year; secondary endpoints were mortality and stroke. As-treated TAVR-trial and SAVR-trial patients were propensity-score (PS) matched to SAVR-registry patients. Model-based and weighting-based transportability analyses were performed.
After applying trial criteria, 3,389 SAVR-registry patients were eligible and 1,211 trial patients were included (654 TAVR; 557 SAVR). Trial-eligible SAVR-registry patients were younger and had fewer comorbidities. PS-matching of TAVR-trial to SAVR-registry yielded 1,150 patients, and matching of SAVR-trial to SAVR-registry yielded 892 patients. In PS-matched cohorts, SAVR-trial patients experienced more composite events (HR 1.63 [1.02-2.62],p=0.04) and strokes (HR 2.96 [1.37-6.37],p=0.01) than SAVR-registry patients, with comparable mortality (HR 1.15 [0.65-2.02], p=0.63). TAVR-trial (vs. SAVR-registry) patients had lower 1-year mortality (HR 0.46 [0.24-0.87], p=0.02). Transported absolute risk reduction (ARR) of 1-year mortality of TAVR was attenuated when the trial was reweighted to resemble the registry (ARR_transported: 2.2% [0.1-4.2]; ARR_trial: 3.7% [1.4-6.7]).
In PS-matched analyses, SAVR-registry patients showed lower combined mortality/stroke and stroke rates than SAVR-trial participants, suggesting caution in transporting trial-derived relative effects to this population. For mortality the relative trial-effects could be reproduced, but absolute benefit of TAVR was diminished in the registry population.

PMID:
42772371
Bibliographic data and abstract were imported from PubMed on 23 Sep 2026.

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