Why the study?
The transportability of randomized DEDICATE trial results comparing SAVR with TAVR in low- to intermediate-risk patients to real-world populations was uncertain.
Do TAVR and SAVR outcomes from the DEDICATE trial translate to a real-world, low- to intermediate-risk registry population?
Observational (n=4,600)
Yes
Do TAVR and SAVR outcomes from the DEDICATE trial translate to a real-world, low- to intermediate-risk registry population?
Hazard Ratio: 1.63 (95% CI 1.02–2.62)
p-value: p=0.04
The relative effects of TAVR over SAVR observed in the DEDICATE trial could be reproduced for mortality, but the absolute mortality benefit of TAVR was diminished when translated to a real-world registry population with lower baseline risk.
Indicates higher mortality/stroke risk with SAVR; extends DEDICATE by supporting TAVR preference in low- to intermediate-risk patients.
Objective 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). Methods 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. Results 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]). Conclusion 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.
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Daeter et al. (2026) conducted an observational in Aortic valve replacement in low- to intermediate-risk patients (n=4,600). SAVR in trial population vs. SAVR in registry population was evaluated on Composite of all-cause mortality or stroke at one year (HR 1.63, 95% CI 1.02-2.62, p=0.04).
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