Document Detail

Vascular remodeling and the local delivery of cytochalasin B after coronary angioplasty in humans.
MedLine Citation:
PMID:  10716458     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: This study sought to determine the safety, feasibility and outcome of local delivery of cytochalasin B at the site of coronary angioplasty. BACKGROUND: Previous failures in the pharmacologic prevention of restenosis may have been related to inadequate dosing at the angioplasty site as a result of systemic drug administration. Alternatively, although previous experimental protocols have typically targeted control of excess tissue growth (intimal hyperplasia), it now appears that overall arterial constriction (vascular remodeling) is the major contributor to late lumen loss. Cytochalasin B inhibits the polymerization of actin and has proved to be a potent inhibitor of vascular remodeling in animal models. METHODS: In this phase I, multicenter, randomized, controlled trial, cytochalasin B (or matching placebo) was administered to the site of a successful balloon angioplasty using a microporous local delivery infusion balloon. RESULTS: The rate of drug delivery at a constant infusion pressure varied significantly from patient to patient (range 1.7 to 20.2 ml/min), perhaps related to a variable constricting effect of the atherosclerotic plaque on the infusion balloon. The minimal stenosis diameter after the procedure was slightly better in the active drug group (1.86 +/- 0.44 vs. 1.49 +/- 0.63 mm, p < 0.03), but this difference was not seen at four to six weeks. Although the study was not powered for clinical outcomes (n = 43), the combined end point (death, nonfatal infarction or repeat revascularization) was encountered in 20% of the patients receiving cytochalasin B and in 38% of the patients receiving placebo. Clinical restenosis occurred in 18% of the treatment group and 22% of the placebo group. There were no significant differences between groups in biochemical or electrocardiographic variables. CONCLUSIONS: Cytochalasin B can be safely administered by local delivery after successful coronary angioplasty and warrants further study of its efficacy in reducing restenosis.
K G Lehmann; J J Popma; J A Werner; A J Lansky; R L Wilensky
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  35     ISSN:  0735-1097     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2000 Mar 
Date Detail:
Created Date:  2000-03-24     Completed Date:  2000-03-24     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  583-91     Citation Subset:  AIM; IM    
Division of Cardiology, University of Washington School of Medicine, Seattle, USA.
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MeSH Terms
Aged, 80 and over
Angioplasty, Transluminal, Percutaneous Coronary*
Catheterization, Peripheral*
Coronary Angiography
Coronary Disease / radiography,  therapy*
Coronary Vessels / drug effects*
Cytochalasin B / administration & dosage*,  therapeutic use
Drug Delivery Systems / methods*
Feasibility Studies
Infusions, Intra-Arterial / methods
Middle Aged
Myocardial Revascularization
Treatment Outcome
Reg. No./Substance:
14930-96-2/Cytochalasin B

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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