Document Detail


Paclitaxel-Coated Versus Uncoated Balloon Angioplasty Reduces Target Lesion Revascularization in Patients With Femoropopliteal Arterial Disease: A Meta-Analysis of Randomized Trials.
MedLine Citation:
PMID:  22851526     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: IN DISEASE OF THE FEMOROPOPLITEAL ARTERY, PACLITAXEL-COATED BALLOON (PCB) THERAPY IMPROVED ANGIOGRAPHIC OUTCOMES AS COMPARED WITH UNCOATED BALLOON (UCB) ANGIOPLASTY. NEVERTHELESS, IT REMAINS UNCERTAIN WHETHER PCB MAY REDUCE THE NEED FOR REINTERVENTION.METHODS AND RESULTS: WE SEARCHED MEDLINE, EMBASE, THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS (CENTRAL), SCIENTIFIC SESSION ABSTRACTS, AND RELEVANT WEB SITES FOR TRIALS OF PCB VERSUS UCB ANGIOPLASTY. KEY WORDS WERE: SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, ANGIOPLASTY, DRUG-ELUTING BALLOON, PACLITAXEL-ELUTING BALLOON, AND RANDOMIZED TRIAL. INCLUSION CRITERIA WERE: (1) RANDOMIZED DESIGN; (2) INTENTION-TO-TREAT ANALYSIS; AND (3) 6-MONTH FOLLOW-UP. EXCLUSION CRITERIA WERE: (1) VESSEL TREATED OTHER THAN FEMOROPOPLITEAL ARTERY; (2) DEVICE USED OTHER THAN PCB/UCB; AND (3) IRRETRIEVABLE OR DUPLICATED DATA. NO RESTRICTIONS (LANGUAGE, PUBLICATION DATE, OR STATUS) WERE APPLIED. THE PRIMARY END POINT WAS TARGET LESION REVASCULARIZATION. SECONDARY END POINTS WERE: ANGIOGRAPHIC BINARY RESTENOSIS AND LATE LUMEN LOSS AND ALL-CAUSE MORTALITY. A TOTAL OF 381 PATIENTS ENROLLED IN 4 RANDOMIZED TRIALS WERE INCLUDED (PCB, N=186 VERSUS UCB, N=195). MEDIAN FOLLOW-UP WAS 10.3 MONTHS. ANGIOPLASTY WITH PCB VERSUS UCB REDUCES TARGET LESION REVASCULARIZATION (12.2% VERSUS 27.7%; OR, 0.22; 95% CI, 0.130.38; P0.00001), ANGIOGRAPHIC RESTENOSIS (18.7% VERSUS 45.5%; OR, 0.26; 95% CI, 0.140.48; P0.0001), AND LATE LUMEN LOSS (RANGE, 0.05 TO 0.50 MM VERSUS 0.611.7 MM; WEIGHTED MEAN DIFFERENCE, 0.75 MM; 95% CI, 1.06 TO 0.45; P0.00001). NO MORTALITY DIFFERENCE WAS OBSERVED FOR PCB VERSUS UCB (2.1% VERSUS 3.2%; OR, 0.99; 95% CI, 0.392.49; P=0.98).CONCLUSIONS: In femoropopliteal arterial disease, PCB therapy is associated with superior antirestenotic efficacy as compared with UCB angioplasty with no evidence of a differential safety profile.
Authors:
Salvatore Cassese; Robert A Byrne; Ilka Ott; Gjin Ndrepepa; Mateja Nerad; Adnan Kastrati; Massimiliano Fusaro
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-7-31
Journal Detail:
Title:  Circulation. Cardiovascular interventions     Volume:  -     ISSN:  1941-7632     ISO Abbreviation:  Circ Cardiovasc Interv     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-8-1     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101499602     Medline TA:  Circ Cardiovasc Interv     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Deutsches Herzzentrum, Technische Universität, Munich, Germany.
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