Risk of Bias in Randomized Clinical Trials Comparing Transcatheter and Surgical Aortic Valve Replacement: A Systematic Review and Meta-analysis

• Published in: JAMA network open 2023-01, Vol.6 (1), p.e2249321-e2249321
• Main Authors: Barili, Fabio, Brophy, James M, Ronco, Daniele, Myers, Patrick O, Uva, Miguel Sousa, Almeida, Rui M S, Marin-Cuartas, Mateo, Anselmi, Amedeo, Tomasi, Jacques, Verhoye, Jean-Philippe, Musumeci, Francesco, Mandrola, John, Kaul, Sanjay, Papatheodorou, Stefania, Parolari, Alessandro
• Format: Article
• Language: English
• Subjects: Aortic Valve - surgery; Bias; Clinical trials; Heart Valve Prosthesis Implantation - adverse effects; Humans; Internal validity; Meta-analysis; Online Only; Original Investigation; Randomized Controlled Trials as Topic; Risk Factors; Statistics and Research Methods; Systematic review; Thoracic surgery
• ISSN: 2574-3805; 2574-3805
• DOI: 10.1001/jamanetworkopen.2022.49321

Recent European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines highlighted some concerns about the randomized clinical trials (RCTs) comparing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. Quantification of these biases has not been previously performed. To assess whether randomization protects RCTs comparing TAVI and SAVR from biases other than nonrandom allocation. A systematic review of the literature between January 1, 2007, and June 6, 2022, on MEDLINE, Embase, and Cochrane Central Register of Controlled Trials was performed. Specialist websites were also checked for unpublished data. The study included RCTs with random allocation to TAVI or SAVR with a maximum 5-year follow-up. Data extraction was performed by 2 independent investigators following the PRISMA guidelines. A random-effects meta-analysis was used for quantifying pooled rates and differential rates between treatments of deviation from random assigned treatment (DAT), loss to follow-up, and receipt of additional treatments. The primary outcomes were the proportion of DAT, loss to follow-up, and patients who were provided additional treatments and myocardial revascularization, together with their ratio between treatments. The measures were the pooled overall proportion of the primary outcomes and the risk ratio (RR) in the TAVI vs SAVR groups. The search identified 8 eligible trials including 8849 participants randomly assigned to undergo TAVI (n = 4458) or SAVR (n = 4391). The pooled proportion of DAT among the sample was 4.2% (95% CI, 3.0%-5.6%), favoring TAVI (pooled RR vs SAVR, 0.16; 95% CI, 0.08-0.36; P