Reddy Rohin K, Ahmad Yousif, Arnold Ahran D, Howard James P
Cardiovascular Trials and Epidemiology Section, National Heart and Lung Institute, Imperial College London, London, United Kingdom.
Section of Cardiovascular Medicine, Yale University, New Haven, Connecticut.
J Soc Cardiovasc Angiogr Interv. 2023 Sep-Oct;2(5):None. doi: 10.1016/j.jscai.2023.101031.
Stroke is a feared complication of transcatheter aortic valve replacement (TAVR), which embolic protection devices (EPDs) may mitigate. This systematic review and meta-analysis synthesized randomized controlled trials (RCTs) to evaluate the effect of EPDs in TAVR.
All RCTs comparing EPDs with control during TAVR were systematically identified. Prespecified primary end points were all stroke, disabling stroke, nondisabling stroke, and all-cause mortality. Safety and neuroimaging parameters were assessed. Sensitivity analyses were stratified by EPD type. Study registration was a priori (CRD42022377939).
Eight trials randomizing 4043 patients were included. There was no significant difference between EPDs and control for all stroke (relative risk [RR], 0.88; 95% CI, 0.65-1.18; = .39; = 0%), disabling stroke (RR, 0.67; 95% CI, 0.31-1.46; = .32; = 8.6%), nondisabling stroke (RR, 0.99; 95% CI, 0.71-1.40; = .97; = 0%), or all-cause mortality (RR, 0.87; 95% CI, 0.43-1.78; = .71; = 2.3%). There were no differences in safety end points of bleeding, vascular complications, or acute kidney injury. EPDs did not result in differences in total lesion volume or the number of new lesions. The Sentinel EPD significantly reduced the risk of disabling stroke (RR, 0.42; 95% CI, 0.20-0.88; = .022; = 0%) but did not affect all stroke, nondisabling stroke, or all-cause mortality.
The totality of randomized data for EPDs during TAVR demonstrated no safety concerns or significant differences in clinical or neuroimaging end points. Analyses restricted to the Sentinel EPD demonstrated large, clinically meaningful reductions in disabling stroke. Ongoing RCTs may help validate these results.
中风是经导管主动脉瓣置换术（TAVR）令人担忧的并发症，而栓塞保护装置（EPD）可能会减轻这种并发症。本系统评价和荟萃分析综合了随机对照试验（RCT），以评估EPD在TAVR中的作用。
系统检索了所有在TAVR期间比较EPD与对照组的RCT。预先设定的主要终点为所有中风、致残性中风、非致残性中风和全因死亡率。评估了安全性和神经影像学参数。敏感性分析按EPD类型分层。研究注册为预先注册（CRD42022377939）。
纳入了8项试验，共4043例患者。EPD与对照组在所有中风（相对风险[RR]，0.88；95%可信区间[CI]，0.65 - 1.18；P = 0.39；I² = 0%）、致残性中风（RR，0.67；95%CI，0.31 - 1.46；P = 0.32；I² = 8.6%）、非致残性中风（RR，0.99；95%CI，0.71 - 1.40；P = 0.97；I² = 0%）或全因死亡率（RR，0.87；95%CI，0.43 - 1.78；P = 0.71；I² = 2.3%）方面无显著差异。在出血、血管并发症或急性肾损伤的安全性终点方面也无差异。EPD在总病变体积或新病变数量上没有导致差异。Sentinel EPD显著降低了致残性中风的风险（RR，0.42；95%CI，0.20 - 0.88；P = 0.022；I² = 0%），但不影响所有中风、非致残性中风或全因死亡率。
TAVR期间EPD的随机数据总体显示在临床或神经影像学终点方面没有安全问题或显著差异。仅限于Sentinel EPD的分析显示致残性中风有大幅的、具有临床意义的降低。正在进行的RCT可能有助于验证这些结果。
