The PROFI Study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting) A Prospective Randomized Trial

被引：206

作者：

Bijuklic, Klaudija ^{[1
]}

Wandler, Andreas ^{[1
]}

Hazizi, Fadia ^{[1
]}

Schofer, Joachim ^{[1
]}

机构：

[1] Univ Hamburg, Ctr Cardiovasc, Med Care Ctr Prof Mathey, D-22527 Hamburg, Germany

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2012年 / 59卷 / 15期

关键词：

carotid artery stenting; cerebral embolic protection; diffusion-weighted magnetic resonance imaging; DIFFUSION-WEIGHTED MRI; EMBOLIC PROTECTION; HIGH-RISK; ENDARTERECTOMY; STROKE; MICROEMBOLIZATION; ANGIOPLASTY; ISCHEMIA; DEVICES; UPDATE;

D O I：

10.1016/j.jacc.2011.11.035

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (J Am Coll Cardiol 2012;59:1383-9) (C) 2012 by the American College of Cardiology Foundation

引用

页码：1383 / 1389

页数：7

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