Comparative Effectiveness of TAVI Platforms and Surgical Aortic Valve Replacement: A Network Meta-Analysis of Randomized Controlled Trials.

Abstract

Background: Evidence informing clinical guidelines assumes that all transcatheter aortic valve implantation (TAVI) devices have similar effectiveness, in other words, displaying a class effect across TAVI valves. We aimed to assess the comparative effectiveness of different TAVI platforms relative to other TAVI counterparts or surgical aortic valve replacement (SAVR).

Methods: MEDLINE/Embase/CENTRAL were searched from inception until April 2025, for randomized controlled trials comparing outcomes with different commercially available TAVI devices relative to other TAVI counterparts or SAVR. The certainty of the evidence was assessed following the Grading of Recommendations, Assessment, Development, and Evaluations approach. We performed a frequentist network meta-analysis to generate treatment effect estimates. All-cause, cardiovascular mortality, and stroke were considered critically important patient-centered outcomes.

Results: We identified 11 randomized controlled trials with 9946 participants and reporting outcomes between 1 to 10 years. TAVI with CoreValve-Evolut was associated with a similar risk of all-cause (absolute risk difference [ARD], 31/1000 from -12 to 79), and cardiovascular mortality (ARD, -8/1000 from -39 to 28) compared with SAVR (moderate certainty). Compared with SAVR, TAVI with SAPIEN and ACURATE neo were associated with an increased risk of all-cause (ARD, 109/1000 from 56 to 169, high certainty and ARD, 123/1000 from 9 to 277, moderate certainty, respectively) and cardiovascular mortality (ARD, 58/1000 from 18 to 105, high certainty and ARD, 105 from 7 to 247, moderate certainty, respectively). Moderate and high-certainty evidence showed that all TAVI platforms were associated with an increased risk of reinterventions and pacemaker implant versus SAVR. Compared with TAVI with CoreValve-Evolut, SAPIEN was associated with higher all-cause (ARD, 75/1000 from 13 to 147, high certainty) and cardiovascular mortality (ARD, 66/1000 from 15 to 130, high certainty), same scenario for ACURATE neo (ARD 113/1000 from 13 to 259, high certainty). TAVI with SAPIEN was associated with a higher risk of stroke compared with CoreValve-Evolut (ARD, 31/1000 from 5 to 65, high certainty), whereas CoreValve-Evolut showed higher rates of pacemaker implant compared with SAPIEN, ACURATE neo.

Conclusions: TAVI with CoreValve-Evolut is probably associated with similar mortality to SAVR. TAVI with SAPIEN and ACURATE neo were associated with increased risk of mortality compared with SAVR and CoreValve-Evolut. The current body of evidence from randomized controlled trials goes against the hypothesis of a class effect across TAVI valves.

Registration: URL: https://www.crd.york.ac.uk; Unique identifier: CRD42024512026.