Transcatheter versus surgical aortic valve replacement in low- to intermediate-risk patients: Do DEDICATE trial outcomes translate to real-world populations?
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Full-root Aortic Valve Replacement by Stentless Aortic Xenografts in Patients with Small Aortic Roots
Published on: May 21, 2017
Edgar Daeter1, Maaike M Roefs2, Richard A J Post3
1Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
Objective:
To assess the transportability of the randomized DEDICATE (Randomized, Multicenter, Event-Driven Trial of TAVI versus SAVR in Patients with Symptomatic Severe Aortic-Valve Stenosis) trial results, comparing surgical aortic valve replacement (SAVR) with transcatheter aortic valve replacement (TAVR) in low- to intermediate-risk patients, with an external Dutch population derived from the Netherlands Heart Registration.
Methods:
Data sources included the DEDICATE-RCT data (TAVR-trial, SAVR-trial cohorts) and the Netherlands Heart Registration (SAVR-registry cohort). The primary end point was composite of all-cause mortality or stroke at 1 year; secondary end points 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 we applied trial criteria, 3389 patients from the SAVR registry were eligible and 1211 patients from the trial (654 TAVR; 557 SAVR) were included. Patients from the SAVR registry who were eligible for the trial were younger and had fewer comorbidities. PS matching of TAVR-trial to SAVR-registry cohorts yielded 1150 patients, and matching of the SAVR-trial to SAVR-registry cohorts yielded 892 patients. In PS-matched cohorts, SAVR-trial patients experienced more composite events (hazard ratio [HR], 1.63; 1.02-2.62, P = .04) and strokes (HR, 2.96; 1.37-6.37, P = .01) than SAVR-registry patients, with comparable mortality (HR, 1.15; 0.65-2.02, P = .63). TAVR-trial (vs SAVR-registry) patients had lower 1-year mortality (HR, 0.46; 0.24-0.87, P = .02). Transported absolute risk reduction (ARR) of 1-year mortality of TAVR was attenuated when the trial was reweighted to resemble the registry (ARRtransported: 2.2% [0.1-4.2]; ARRtrial: 3.7% [1.4-6.7]).
Conclusions:
In PS-matched analyses, patients from the SAVR registry showed lower combined mortality/stroke and stroke rates than participants in the SAVR trial, 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.
