Transcatheter versus surgical aortic valve replacement for severe aortic valve stenosis: Meta-analysis with trial sequential analysis

Xander Jacquemyn; Michel Pompeu Sá; Filip Rega; Peter Verbrugghe; Bart Meuris; Derek Serna-Gallegos; James A Brown; Marie-Annick Clavel; Philippe Pibarot; Ibrahim Sultan

doi:10.1016/j.jtcvs.2024.04.007

Transcatheter versus surgical aortic valve replacement for severe aortic valve stenosis: Meta-analysis with trial sequential analysis

J Thorac Cardiovasc Surg. 2024 Apr 28:S0022-5223(24)00294-0. doi: 10.1016/j.jtcvs.2024.04.007. Online ahead of print.

Affiliations

¹ Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.
² Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pa; UPMC Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pa.
³ Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium; Department of Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium.
⁴ Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec City, Québec, Canada; Department of Medicine, Faculty of Medicine, Université Laval, Québec City, Québec, Canada.
⁵ Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pa; UPMC Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address: sultani@upmc.edu.

PMID: 38688452
DOI: 10.1016/j.jtcvs.2024.04.007

Abstract

Objectives: Randomized controlled trials comparing transcatheter aortic valve implantation with surgical aortic valve replacement demonstrate conflicting evidence, particularly in low-risk patients. We aim to reevaluate the evidence using trial sequential analysis, balancing type I and II errors, and compare with conventional meta-analysis.

Methods: Databases were searched for randomized controlled trials, which were divided into higher-risk and lower-risk randomized controlled trials according to a pragmatic risk classification. Primary outcomes were death and a composite end point of death or disabling stroke assessed at 1 year and maximum follow-up. Conventional meta-analysis and trial sequential analysis were performed, and the required information size was calculated considering a type I error of 5% and a power of 90%.

Results: Eight randomized controlled trials (n = 5274 higher-risk and 3661 lower-risk patients) were included. Higher-risk trials showed no significant reduction in death at 1 year with transcatheter aortic valve implantation (relative risk, 0.93, 95% CI, 0.81-1.08, P = .345). Lower-risk trials suggested lower death risk on conventional meta-analysis (relative risk, 0.67, 95% CI, 0.47-0.96, P = .031), but trial sequential analysis indicated potential spurious evidence (P = .116), necessitating more data for conclusive benefit (required information size = 5944 [59.8%]). For death or disabling stroke at 1 year, higher-risk trials lacked evidence (relative risk, 0.90, 95% CI, 0.79-1.02, P = .108). In lower-risk trials, transcatheter aortic valve implantation indicated lower risk in conventional meta-analysis (relative risk, 0.68, 95% CI, 0.50-0.93, P = .014), but trial sequential analysis suggested potential spurious evidence (P = .053), necessitating more data for conclusive benefit (required information size = 5122 [69.4%]). Follow-up results provided inconclusive evidence for both primary outcomes across risk categories.

Conclusions: Conventional meta-analysis methods may have prematurely declared an early reduction of negative outcomes after transcatheter aortic valve implantation when compared with surgical aortic valve replacement.

Keywords: aortic valve replacement; cardiac surgical procedures; cardiovascular surgical procedures; heart valve diseases; heart valve prosthesis implantation; meta-analysis.