Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial.

The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated.

Sentinel脑栓塞保护（CEP）装置已获批准用于在TAVR期间捕获和移除栓塞性物质，但其有效性一直存在争议。

Background

To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR.

探讨在行经导管主动脉瓣置换术（TAVR）的患者中，使用经导管瓣膜边缘成形术（CEP）与中风结果之间关联的地区差异。

DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022.

设计、设置和参与者：这是一项事后分析，对一项前瞻性、上市后随机临床试验进行评估，该试验评估了在2020年2月至2022年1月期间在美国、欧洲和澳大利亚的51家医院进行的经导管主动脉瓣置换术（TAVR），无论是否使用经导管瓣膜边缘成形术（CEP）。

Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included.

纳入了接受经股动脉TAVR治疗的症状性主动脉瓣狭窄患者。

Randomization was stratified according to center, operative risk, and intended TAVR valve type.

随机分组根据中心、手术风险和预期的TAVR瓣膜类型进行了分层。

Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device.

如果左颈总动脉或头臂干动脉狭窄超过70%，或者解剖结构妨碍了CEP装置的放置，则患者将被排除在外。

Data for this post hoc study were analyzed from August to October 2024.

这项事后研究的数据分析是从2024年8月到10月进行的。

intervention

TAVR with or without CEP.

TAVR 无论是否联合使用CEP。

main_outcomes_and_measures

The primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first.

主要终点是所有中风事件的发生率，在出院时或TAVR后72小时内，以先发生者为准。

Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes.

在基线和术后进行了神经系统检查，以识别中风、致残性中风和其他神经系统结果。

Results

The Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587).

中风保护与哨兵在经导管主动脉瓣置换术中的研究（PROTECTED TAVR）招募并随机分配了3000名患者（1803名[60.1%]为男性；平均[标准差]年龄为78.9[7.8]岁）：在美国队列中有1833名患者（仅TAVR：919名，TAVR与CEP：914名），在美国以外的队列中有1167名患者（仅TAVR：580名，TAVR与CEP：587名）。

Patients in the US cohort were younger, more predominantly male, had a lower prevalenceof atrial fibrillation, and had a higher prevalenceof bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort.

美国队列中的患者年龄更年轻，男性比例更高，房颤的患病率较低，而双叶主动脉瓣、糖尿病和周围血管疾病的患病率较高，与海外队列相比。

In the main trial, the incidenceof stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region.

在主要试验中，TAVR后72小时内或出院前的中风发生率在CEP组和对照组之间没有显著差异，且没有地理区域的交互作用。

In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort.

在这项事后分析中，与单独TAVR治疗相比，接受CEP治疗的美国队列患者总体中风风险相对降低了50%，致残性中风风险相对降低了73%；而在海外队列中，并未观察到CEP对中风风险降低的治疗效果。

conclusion_and_relevance

The PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidenceof periprocedural stroke during TAVR.

PROTECTED TAVR试验未能显示使用CEP对TAVR术中围手术期中风发生率有显著影响。

Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort.

尽管按地理区域划分没有显著的相互作用，但这项探索性的事后分析表明，美国队列中中风减少的趋势更为明显，而在其他国家/地区（OUS）队列中则没有这种趋势。

These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy.

这些发现是假设生成性的，需要进一步的研究来确定患者特征或程序实践的地区差异是否影响CEP的疗效。

trial_registration

ClinicalTrials.gov Identifier: NCT04149535.

临床试验注册号：NCT04149535。