Comparison of vascular closure devices versus manual compression after femoral artery puncture in women gender-based analysis of a large scale, randomized clinical trial

Gewalt SM, Helde SM, Ibrahim T, Mayer K, Schmidt R, Bott-Fluegel L, Hoppe K, Ott I, Hieber J, Morath T, Byrne RA, Kufner S, Cassese S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Schuepke S (2018)

Publication Type: Journal article

Publication year: 2018

Journal

Circulation: Cardiovascular Interventions American Heart Association

Book Volume: 11

Article Number: e006074

Journal Issue: 8

DOI: 10.1161/CIRCINTERVENTIONS.117.006074

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.

Involved external institutions

Technische Universität München (TUM) DE Germany (DE) Krankenhaus des Hospitalordens des heiligen Johannes von Gott AT Austria (AT) Klinikum Landkreis Erding DE Germany (DE) Rotkreuzklinikum München DE Germany (DE)

How to cite

APA:

Gewalt, S.M., Helde, S.M., Ibrahim, T., Mayer, K., Schmidt, R., Bott-Fluegel, L.,... Schuepke, S. (2018). Comparison of vascular closure devices versus manual compression after femoral artery puncture in women gender-based analysis of a large scale, randomized clinical trial. Circulation: Cardiovascular Interventions, 11(8). https://doi.org/10.1161/CIRCINTERVENTIONS.117.006074

MLA:

Gewalt, Senta M., et al. "Comparison of vascular closure devices versus manual compression after femoral artery puncture in women gender-based analysis of a large scale, randomized clinical trial." Circulation: Cardiovascular Interventions 11.8 (2018).

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