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Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial.
MedLine Citation:
PMID:  22545894     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Abstract Purpose: To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). Methods: The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1±14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures). Results: Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006). Conclusion: PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.
Authors:
Konstantinos Katsanos; Dimitris Karnabatidis; Panagiotis Kitrou; Stavros Spiliopoulos; Nikolaos Christeas; Dimitris Siablis
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists     Volume:  19     ISSN:  1545-1550     ISO Abbreviation:  J. Endovasc. Ther.     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-05-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100896915     Medline TA:  J Endovasc Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  263-72     Citation Subset:  IM    
Affiliation:
Department of Diagnostic and Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
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