Document Detail


A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett).
MedLine Citation:
PMID:  12132030     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: We compared the safety and efficacy of three closure devices (Angioseal, Vasoseal and Duett) used to close arterial puncture sites in patients who underwent coronary percutaneous procedures.
METHODS: A prospective randomized, single-center trial was carried out of consecutive patients who underwent coronary angiography [705 patients: Angioseal (243),Vasoseal (228) and Duett (234)] or angioplasty [146 patients:Angioseal (47), Vasoseal (52) and Duett (47)].
RESULTS: In the angiography patients the device deployment rates were similar, with the Angioseal been significantly slower in achieving hemostasis (p = 0.0001) but resulting in earlier ambulation (p = 0.0001). In the coronary angioplasty patients the deployment rates were similar to those for angiography: time to hemostasis was longer for the Angioseal (p = 0.003), while ambulation times were not different, although prolonged compared with angiography (p = 0.0001). The three devices had similar major complication rates. The Vasoseal had a higher major complication rate after angioplasty than after angiography (p = 0.004). The incidence rate of peripheral embolization was lower when the Angioseal was utilized. Severe complications were mainly seen in patients who received abciximab.
CONCLUSIONS: The three closure devices had high rates of successful deployment and were relatively safe. The Angioseal resulted in earlier ambulation after angiography. Utilization of closure devices after abciximab administration possibly increased the complications.
Authors:
Lampros K Michalis; Michael R Rees; Demetrios Patsouras; Christos S Katsouras; John Goudevenos; Spyridon Pappas; Eleni Sourla; Theophilos Kolettis; Lampros Sioros; Paraskevi Zotou; Panoraia Gartzou-Matsouka; Dimitris A Sideris
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial     Date:  2002-07-23
Journal Detail:
Title:  Cardiovascular and interventional radiology     Volume:  25     ISSN:  0174-1551     ISO Abbreviation:  Cardiovasc Intervent Radiol     Publication Date:    2002 Sep-Oct
Date Detail:
Created Date:  2002-11-26     Completed Date:  2003-03-07     Revised Date:  2013-05-24    
Medline Journal Info:
Nlm Unique ID:  8003538     Medline TA:  Cardiovasc Intervent Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  423-9     Citation Subset:  IM    
Affiliation:
Cardiac Department, University Hospital of Ioannina, Ioannina, Greece. lmihalis@cc.uoi.gr
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MeSH Terms
Descriptor/Qualifier:
Analysis of Variance
Angioplasty / adverse effects*
Antibodies, Monoclonal / adverse effects
Anticoagulants / adverse effects
Coronary Angiography / adverse effects*
Early Ambulation
Equipment Failure
Female
Hemostatic Techniques / adverse effects*,  instrumentation*
Humans
Immunoglobulin Fab Fragments / adverse effects
Male
Middle Aged
Prospective Studies
Punctures / adverse effects
Radiography, Interventional / adverse effects,  instrumentation
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Anticoagulants; 0/Immunoglobulin Fab Fragments; X85G7936GV/abciximab

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


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