Mortality in low-risk patients with aortic stenosis undergoing transcatheter or surgical aortic valve replacement: a reconstructed individual patient data meta-analysis.

ABSTRACT

OBJECTIVES: Although the standard of care for patients with severe aortic stenosis at low-surgical risk has included surgical aortic valve replacement (SAVR) since the mid-1960s, many clinical studies have investigated whether transcatheter aortic valve implantation (TAVI) can be a better approach in these patients. As no individual study has been performed to detect the difference in mortality between these 2 treatment strategies, we did a reconstructive individual patient data analysis to study the long-term difference in all-cause mortality. METHODS: Randomized clinical trials and propensity score-matched studies that included low-risk adult patients with severe aortic stenosis undergoing either SAVR or TAVI and with reports on the mortality rates during the follow-up period were considered. The primary outcome was all-cause mortality of up to 5 years. RESULTS: In the reconstructed individual patient data analysis, there was no statistically significant difference in all-cause mortality between TAVI and SAVR at 5 years of follow-up [30.7% vs 21.4%, hazard ratio (HR) 1.19, 95% confidence interval (CI) 0.96-1.48; P = 0.104]. However, landmark analyses in patients surviving up to 1 year of follow-up showed significantly higher all-cause mortality at 5 years of follow-up (27.5% vs 17.3%, HR 1.77, 95% CI 1.29-2.43; P < 0.001) in patients undergoing TAVI compared to patients undergoing SAVR, respectively. CONCLUSIONS: This reconstructed individual patient data analysis in low-risk patients with severe aortic stenosis demonstrates that the 5-year all-cause mortality rates are higher after TAVI than after SAVR, driven by markedly higher mortality rates between 1 and 5 years of follow-up in the TAVI group. The present results call for caution in expanding the TAVI procedure as the treatment of choice for the majority of all low-risk patients until long-term data from contemporary randomized clinical trials are available.