Clinical research

DOI: 10.4244/EIJ-D-22-01130

Ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of the randomised UNIVERSAL trial

Marc-André d'Entremont1,2, MD, MPH; Sulaiman Alrashidi3,4,5, MD; Omar Alansari3,4,5, MD; Bradley Brochu6, MD; Laura Heenan2, MSc; Elizabeth Skuriat2, MSc; Jessica Tyrwhitt2, BSc; Micheal Raco3,4,5, MD; Micheal Tsang3,4,5, MD, MSc; Nicholas Valettas3,4,5, MD, MASc; James L. Velianou3,4,5, MD; Tej N. Sheth2,3,4,5, MD; Matthew Sibbald3,4,5, MD, PhD; Shamir R. Mehta2,3,4,5, MD, MSc; Natalia Pinilla-Echeverri2,3,4,5, MD, MSc; Jon David Schwalm2,3,4,5, MD, MSc; Madhu K. Natarajan2,3,4,5, MD, MSc; Andrew Kelly3,4,5, MD; Elie Akl7, MD; Sarah Tawadros4, MBBCh; Mercedes Camargo4, MD, MASc; Walaa Faidi4, MSc; John Bauer4, BMRSc; Rachel Moxham4, BSc; James Nkurunziza3,4,5, MD; Gustavo Dutra3,4, MD; Jose Winter8, MD; Sanjit S. Jolly2,3,4,5, MD, MSc

Abstract

Background: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear.

Aims: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures.

Methods: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days.

Results: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US-...

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Volume 19 Number 1
May 12, 2023
Volume 19 Number 1
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