| The PROFI Study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting) A Prospective Randomized Trial. | |
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MedLine Citation:
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PMID: 22284330 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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Klaudija Bijuklic; Andreas Wandler; Fadia Hazizi; Joachim Schofer |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-1-19 |
Journal Detail:
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Title: Journal of the American College of Cardiology Volume: - ISSN: 1558-3597 ISO Abbreviation: - Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2012-1-30 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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