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PROFI 研究(颈动脉支架置入术中近端球囊闭塞与滤器保护预防脑栓塞的前瞻性随机试验)。

The PROFI study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting): a prospective randomized trial.

机构信息

Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany.

出版信息

J Am Coll Cardiol. 2012 Apr 10;59(15):1383-9. doi: 10.1016/j.jacc.2011.11.035. Epub 2012 Jan 25.

DOI:10.1016/j.jacc.2011.11.035
PMID:22284330
Abstract

OBJECTIVES

The objective of this study was to compare the cerebral embolic load of filter-protected versus proximal balloon-protected carotid artery stenting (CAS).

BACKGROUND

Randomized trials comparing filter-protected CAS with carotid endarterectomy revealed a higher periprocedural stroke rate after CAS. Proximal balloon occlusion may be more effective in preventing cerebral embolization during CAS than filters.

METHODS

Patients undergoing CAS with cerebral embolic protection for internal carotid artery stenosis were randomly assigned to proximal balloon occlusion or filter protection. The primary endpoint was the incidence of new cerebral ischemic lesions assessed by diffusion-weighted magnetic resonance imaging. Secondary endpoints were the number and volume of new ischemic lesions and major adverse cardiovascular and cerebral events (MACCE).

RESULTS

Sixty-two consecutive patients (mean age: 71.7 years, 76.4% male) were randomized. Compared with filter protection (n = 31), proximal balloon occlusion (n = 31) resulted in a significant reduction in the incidence of new cerebral ischemic lesions (45.2% vs. 87.1%, p = 0.001). The number (median [range]: 2 [0 to 13] vs. 0 [0 to 4], p = 0.0001) and the volume (0.47 [0 to 2.4] cm(3) vs. 0 [0 to 0.84] cm(3), p = 0.0001) of new cerebral ischemic lesions were significantly reduced by proximal balloon occlusion. Lesions in the contralateral hemisphere were found in 29.0% and 6.5% of patients (filter vs. balloon occlusion, respectively, p = 0.047). The 30-day MACCE rate was 3.2% and 0% for filter versus balloon occlusion, respectively (p = NS).

CONCLUSIONS

In this randomized trial of patients undergoing CAS, proximal balloon occlusion as compared with filter protection significantly reduced the embolic load to the brain.

摘要

目的

本研究旨在比较滤器保护与近端球囊保护颈动脉支架置入术(CAS)的脑栓塞负荷。

背景

比较滤器保护的 CAS 与颈动脉内膜切除术的随机试验显示,CAS 后围手术期卒中发生率较高。与滤器相比,近端球囊闭塞在预防 CAS 期间脑栓塞方面可能更有效。

方法

对有脑保护装置的颈内动脉狭窄行 CAS 的患者进行随机分组,分别接受近端球囊闭塞或滤器保护。主要终点是通过弥散加权磁共振成像评估新的脑缺血性病变的发生率。次要终点是新的缺血性病变的数量和体积以及主要不良心脑血管事件(MACCE)。

结果

连续入选 62 例患者(平均年龄 71.7 岁,76.4%为男性),并随机分组。与滤器保护(n = 31)相比,近端球囊闭塞(n = 31)可显著降低新的脑缺血性病变的发生率(45.2%比 87.1%,p = 0.001)。新的缺血性病变的数量(中位数[范围]:2 [0 至 13]比 0 [0 至 4],p = 0.0001)和体积(0.47 [0 至 2.4] cm(3)比 0 [0 至 0.84] cm(3),p = 0.0001)也显著减少。29.0%和 6.5%的患者对侧半球有病变(分别为滤器和球囊闭塞,p = 0.047)。30 天 MACCE 发生率分别为 3.2%和 0%(滤器和球囊闭塞,p = NS)。

结论

在本项针对行 CAS 治疗的患者的随机试验中,与滤器保护相比,近端球囊闭塞可显著降低脑部栓塞负荷。

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