Transcatheter aortic valve replacement versus surgery for symptomatic severe aortic stenosis: A reconstructed individual patient data meta-analysis.

OBJECTIVES

We wished to undertake a reconstructed individual patient data meta-analysis of randomized clinical trials comparing transcatheter aortic valve replacement (TAVR) and surgery for patients with severe symptomatic aortic stenosis.

BACKGROUND

TAVR and surgery are both well-established methods for treating patients with symptomatic severe aortic stenosis who are at low, intermediate, and high risk for surgery.

METHODS

Data were identified by searches of Medline, Embase, CENTRAL and ClinicalTrials.gov for all randomized clinical trials, which compared TAVR and surgery that had published at least 1 year of follow-up. Individual patient data were reconstructed from Kaplan-Meier curves.

RESULTS

A total of 7,770 patients from seven randomized clinical trials were included in this meta-analysis. At 1 year, TAVR was associated with a lower risk of death from any cause (hazard ratio [HR], 0.85, 95% confidence interval [CI], 0.73-0.98; p = .03), disabling stroke (HR, 0.71; 95% CI, 0.54-0.93; p = .01) and the composite end point of death or disabling stroke (HR, 0.79; 95% CI, 0.67-0.92; p = .002). Significant interactions were found for access suitability, with TAVR associated with a lower risk of these end points in patients suitable for transfemoral access. TAVR was associated with a lower risk of periprocedural events, whereas the risk of late events was similar between TAVR and surgery.

CONCLUSIONS

At 1 year, TAVR was associated with a lower risk of death, disabling stroke and the composite end point, when compared with surgery. These associations were strongest within the subgroup of patients in whom transfemoral access was feasible.