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Randomized Controlled Trial
. 2023 May 15;19(1):73-79.
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'Entremont  1   2 , Sulaiman Alrashidi  3   4   5 , Omar Alansari  3   4   5 , Bradley Brochu  6 , Laura Heenan  2 , Elizabeth Skuriat  2 , Jessica Tyrwhitt  2 , Micheal Raco  3   4   5 , Micheal Tsang  3   4   5 , Nicholas Valettas  3   4   5 , James L Velianou  3   4   5 , Tej N Sheth  2   3   4   5 , Matthew Sibbald  3   4   5 , Shamir R Mehta  2   3   4   5 , Natalia Pinilla-Echeverri  2   3   4   5 , Jon David Schwalm  2   3   4   5 , Madhu K Natarajan  2   3   4   5 , Andrew Kelly  3   4   5 , Elie Akl  7 , Sarah Tawadros  4 , Mercedes Camargo  4 , Walaa Faidi  4 , John Bauer  4 , Rachel Moxham  4 , James Nkurunziza  3   4   5 , Gustavo Dutra  3   4 , Jose Winter  8 , Sanjit S Jolly  2   3   4   5
Affiliations
Randomized Controlled Trial

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

Marc-André d'Entremont et al. EuroIntervention. .

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- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004).

Conclusions: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.

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Conflict of interest statement

J. Velianou reports receiving grants or contracts, consulting fees, and payment or honoraria for lectures, presentations, speakers’ bureaus, or educational events from Edwards Lifesciences; and reports receiving payment for participation on a Data Safety Monitoring Board or advisory board from Edwards Lifesciences. M. Sibbald reports receiving payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Abbott and Philips. S.S. Jolly reports receiving grants or contracts from Boston Scientific; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Penumbra. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. CONSORT diagram for the UNIVERSAL trial with vascular closure device subgroups.
TFA: transfemoral access; US: ultrasound; VCD: vascular closure device
Figure 2
Figure 2. Main outcomes.
CI: confidence interval; US: ultrasound; VCD: vascular closure device
See this image and copyright information in PMC

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