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Gewalt, Senta M.; Helde, Sandra M.; Ibrahim, Tareq; Mayer, Katharina; Schmidt, Roland; Bott-Flügel, 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

Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women : Gender-Based Analysis of a Large Scale, Randomized Clinical Trial

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  • Medientyp: E-Artikel
  • Titel: Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women : Gender-Based Analysis of a Large Scale, Randomized Clinical Trial : Gender-Based Analysis of a Large Scale, Randomized Clinical Trial
  • Beteiligte: Gewalt, Senta M.; Helde, Sandra M.; Ibrahim, Tareq; Mayer, Katharina; Schmidt, Roland; Bott-Flügel, 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
  • Erschienen: Ovid Technologies (Wolters Kluwer Health), 2018
  • Erschienen in: Circulation: Cardiovascular Interventions, 11 (2018) 8
  • Sprache: Englisch
  • DOI: 10.1161/circinterventions.117.006074
  • ISSN: 1941-7640; 1941-7632
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: 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 ( P interaction =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.
  • Zugangsstatus: Freier Zugang