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Meta-Analysis
. 2023 Nov 7;12(21):e030012.
doi: 10.1161/JAHA.123.030012. Epub 2023 Nov 6.

Midterm Survival of Low-Risk Patients Treated With Transcatheter Versus Surgical Aortic Valve Replacement: Meta-Analysis of Reconstructed Time-to-Event Data

Michel Pompeu Sá  1   2 , Xander Jacquemyn  3 , Jef Van den Eynde  3 , Derek Serna-Gallegos  1   2 , Danny Chu  1   2 , Marie-Annick Clavel  4   5 , Philippe Pibarot  4   5 , Ibrahim Sultan  4   5
Affiliations
Meta-Analysis

Midterm Survival of Low-Risk Patients Treated With Transcatheter Versus Surgical Aortic Valve Replacement: Meta-Analysis of Reconstructed Time-to-Event Data

Michel Pompeu Sá et al. J Am Heart Assoc. .

Abstract

Background We performed a meta-analysis of reconstructed time-to-event data from randomized controlled trials (RCTs) and propensity-score matched (PSM) studies comparing transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) to evaluate midterm outcomes in patients considered low risk for SAVR. Methods and Results Study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of RCTs and PSM studies published by December 31, 2022 was conducted. Eight studies (3 RCTs, 5 PSM studies) met our eligibility criteria and included 5444 patients; 2639 patients underwent TAVR, and 2805 patients underwent SAVR. TAVR showed a higher risk of all-cause mortality at 8 years of follow-up (hazard ratio [HR] 1.22, [95% CI, 1.03-1.43], P=0.018). Up to 2 years of follow-up, TAVR was not inferior to SAVR (HR, 1.08 [95% CI, 0.89-1.31], P=0.448); however, we observed a statistically significant difference after 2 years with higher mortality with TAVR (HR, 1.51 [95% CI, 1.14-2.00]; P=0.004). This difference was driven by PSM studies; our sensitivity analysis showed a statistically significant difference between TAVR and SAVR when we included only PSM studies (HR, 1.41 [95% CI, 1.16-1.72], P=0.001) but no statistically significant difference when we included only RCTs (HR, 0.89 [95% CI, 0.69-1.16], P=0.398). Conclusions In comparison with TAVR, SAVR appeared to be associated with improved survival beyond 2 years in low-risk patients. However, the survival benefit of SAVR was observed only in PSM studies and not in RCTs. The addition of data from ongoing RCTs as well as longer follow-up in previous RCTs will help to confirm if there is a difference in mid- and long-term survival between TAVR versus SAVR in the low-risk population.

Keywords: cardiac surgical procedures; cardiovascular surgical procedures; heart valve diseases; heart valve prosthesis implantation; meta‐analysis; transcatheter aortic valve replacement.

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Figures

Figure 1
Figure 1. Main analysis of overall survival up to 8 years, including all studies.
The solid lines represent the estimates, and the surrounding bands are 95% CI. HR indicates hazard ratio; SAVR, surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.
Figure 2
Figure 2. Analysis of time‐varying hazard ratios for mortality based on flexible parametric survival models with B‐splines.
HR indicates hazard ratio; SAVR, surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.
Figure 3
Figure 3. Restricted mean survival time over the entire follow‐up.
RMST indicates restricted mean survival time; SAVR, surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.
Figure 4
Figure 4. Landmark analysis.
HR indicates hazard ratio; SAVR, surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.
Figure 5
Figure 5. Sensitivity analysis.
A, Randomized controlled trials. B, Propensity‐score matched studies. HR indicates hazard ratio; SAVR, surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.
See this image and copyright information in PMC

Comment in

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