Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women.

Gewalt, Senta M; Helde, Sandra M; Ibrahim, Tareq; Mayer, Katharina; Schmidt, Roland; Bott-Flugel, Lorenz; Hoppe, Katharina; Ott, Ilka; Hieber, Julia; Morath, Tanja; Byrne, Robert A; Kufner, Sebastian; Cassese, Salvatore; Hoppmann, Petra; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan; Schüpke, Stefanie

doi:10.1161/CIRCINTERVENTIONS.117.006074

2018

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Title:: Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women.
Document type:: Article; Journal Article
Author(s):: Gewalt, Senta M; Helde, Sandra M; Ibrahim, Tareq; Mayer, Katharina; Schmidt, Roland; Bott-Flugel, Lorenz; Hoppe, Katharina; Ott, Ilka; Hieber, Julia; Morath, Tanja; Byrne, Robert A; Kufner, Sebastian; Cassese, Salvatore; Hoppmann, Petra; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan; Schüpke, Stefanie
Abstract:: BACKGROUND: The value of vascular closure devices (VCD) in women undergoing transfemoral catheterization has not been sufficiently investigated. METHODS AND RESULTS: This is a sex-specific analysis of 1395 women enrolled in a large-scale, randomized, multicenter trial, in which patients undergoing transfemoral diagnostic coronary angiography were randomly assigned in a 1:1:1 ratio to arteriotomy closure with an intravascular VCD, extravascular VCD, or manual compression (MC). Primary objective was to assess the safety and efficacy of 2 different VCD compared with MC regarding vascular access-site complications at 30 days. A secondary comparison was between 2 different types of contemporary VCD. Overall, women were at higher risk for vascular access-site complications compared with men (9.0% versus 6.4%; P=0.002). Vascular access-site complications were comparable in women assigned to VCD and MC (8.6% versus 9.8%; P=0.451). There was no interaction of treatment effect and sex ( Pinteraction=0.970). Time to hemostasis was significantly shortened with VCD compared with MC (1 [interquartile range, 0.5-2.0] minutes) versus 11 [interquartile range, 10-15] minutes; P<0.001); however, more women with VCD required repeat MC (2.4% versus 0.6%; P=0.018). The use of the intravascular compared with the extravascular VCD was associated with a numerical reduction in vascular access-site complications (6.6% versus 10.7%; P=0.027) and significant reductions in time to hemostasis and VCD failure. CONCLUSIONS: In women undergoing diagnostic coronary angiography via the common femoral artery, VCD and MC provided comparable safety, while time to hemostasis was reduced with VCD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01389375.
Journal title abbreviation:: Circ Cardiovasc Interv
Year:: 2018
Journal volume:: 11
Journal issue:: 8
Fulltext / DOI:: doi:10.1161/CIRCINTERVENTIONS.117.006074
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/30354782
Print-ISSN:: 1941-7640
TUM Institution:: I. Medizinische Klinik und Poliklinik (Kardiologie); Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (Prof. Schunkert)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Lehr- und Forschungskooperationen mit den Kliniken und Instituten am Deutschen Herzzentrum Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (DHM) (Prof. Schunkert)2018

mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin I, Kardiologie (Prof. Laugwitz)2018