Transcatheter Aortic Valve Implantation vs 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 performed a meta-analysis and compared TAVI with surgical aortic valve replacement (SAVR) in trials that enrolled lower-risk patients.

Methods: We conducted a meta-analysis of randomized controlled trials and compared safety and efficacy outcomes between TAVI and SAVR among lower-risk patients (mean and/or median Society of Thoracic Surgeons [STS] score < 4). Point-estimate meta-analysis and reconstructed individual patient data 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 6 randomized controlled trials, totaling 2668 TAVI and 2573 SAVR patients, with a mean follow-up time of 3.02 years. TAVI was associated with lower risk of all-cause mortality (risk ratio, 0.68; 95% confidence interval, 0.52-0.88) and a composite of all-cause mortality or disabling stroke (risk ratio, 0.69; 95% confidence interval, 0.55-0.86) without a significant difference in stroke up to 2 years. Longer-term point-estimate analysis showed no difference. In reconstructed individual patient data, TAVI was associated with a lower risk of all-cause mortality, driven by an early advantage. Restricted mean survival time 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 to severe aortic regurgitation.

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