Cerebral Embolic Protection Devices in Transcatheter Aortic Valve Implantation: Meta‐Analysis With Trial Sequential Analysis

Abstract

Background We aimed to reevaluate randomized controlled trial data on outcomes of cerebral embolic protection device use during transcatheter aortic valve implantation. A conventional meta‐analysis followed by trial sequential analysis was conducted to evaluate the strength of the current evidence. Methods and Results Databases were searched for randomized controlled trials. Primary outcomes included all stroke, disabling stroke, and all‐cause mortality. Conventional study‐level meta‐analysis was performed using random‐effects modeling. Trial sequential analysis was conducted to generate adjusted significance boundaries, futility boundaries, and the required information size considering a type I error of 5% and a power of 90%. Seven trials were included with a total of 4031 patients, of whom 2171 were treated with a device and 1860 were not. Conventional meta‐analysis showed no significant difference in all stroke (relative risk [RR], 0.85 [95% CI, 0.61–1.18]; P=0.339) and disabling stroke (RR, 0.59 [95% CI, 0.30–1.13]; P=0.113) with device use. The trial sequential analysis determined an absence of evidence for all stroke (required information size of 71 650 [5.6%]) and disabling stroke (required information size of 337 256 [1.2%]). Conventional meta‐analysis determined no significant difference in all‐cause mortality (RR, 1.03 [95% CI, 0.49–2.17]; P=0.928) with device use. The trial sequential analysis determined that the futility boundary was reached (required information size of 5772 [69.3%]). Conclusions There are insufficient randomized controlled trial data on cerebral embolic protection device use to provide conclusive meta‐analytic findings for stroke outcomes.

Keywords

• cerebral embolic protection devices
• meta‐analysis
• TAVI
• trial sequential analysis