| Paclitaxel-Coated Versus Uncoated Balloon Angioplasty Reduces Target Lesion Revascularization in Patients With Femoropopliteal Arterial Disease: A Meta-Analysis of Randomized Trials. | |
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MedLine Citation:
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PMID: 22851526 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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Salvatore Cassese; Robert A Byrne; Ilka Ott; Gjin Ndrepepa; Mateja Nerad; Adnan Kastrati; Massimiliano Fusaro |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-7-31 |
Journal Detail:
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Title: Circulation. Cardiovascular interventions Volume: - ISSN: 1941-7632 ISO Abbreviation: Circ Cardiovasc Interv Publication Date: 2012 Jul |
Date Detail:
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Created Date: 2012-8-1 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101499602 Medline TA: Circ Cardiovasc Interv Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Deutsches Herzzentrum, Technische Universität, Munich, Germany. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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