Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at lower surgical risk: meta-analysis of randomized trials.

Abstract

Background: The use of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is expanding to patients across the entire spectrum of surgical risk. We aimed to perform a meta-analysis comparing TAVI and surgical aortic valve replacement (SAVR) in trials enrolling lower risk patients.

Methods: We conducted a meta-analysis of randomized controlled trials (RCTs) comparing safety and efficacy outcomes between TAVI and SAVR among lower risk patients (mean/median STS score <4). Point-estimate meta-analysis and reconstructed individual patient data (RIPD) survival analysis were conducted. Primary outcomes included all-cause mortality, stroke, and a composite of all-cause mortality or disabling stroke (PROSPERO CRD42024541837).

Results: The analysis included six RCTs, totaling 2668 TAVI and 2573 SAVR patients, mean follow-up time of 3.02 years. TAVI was associated with lower risk of all-cause mortality (RR 0.68 [95%CI 0.52-0.88]) and a composite of all-cause mortality or disabling stroke (RR 0.69 [95%CI 0.55-0.86]) without a significant difference in stroke up to 2 years. Longer-term point-estimate analysis showed no difference. In RIPD, TAVI was associated with a lower risk of all-cause mortality, driven by an early advantage. Restricted mean survival time (RMST) differences for primary outcomes were <2.5 months and ≤1 month for all-cause mortality. TAVI was associated with a lower risk of bleeding, kidney injury and atrial fibrillation, but a higher risk of pacemaker implantation and moderate-severe aortic regurgitation.

Conclusion: In patients at lower surgical risk, TAVI was associated with improved short-term mortality. More data from long-term studies are needed.