Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Jul 15;20(14):e876-e886.
doi: 10.4244/EIJ-D-24-00089.

Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial

Tom A Meijers  1 , Alexander Nap  2 , Adel Aminian  3 , Thomas Schmitz  4 , Joseph Dens  5 , Koen Teeuwen  6 , Jan-Peter van Kuijk  7 , Marleen van Wely  8 , Yoann Bataille  9 , Adriaan O Kraaijeveld  10 , Vincent Roolvink  1 , Jan-Henk E Dambrink  1 , A T Marcel Gosselink  1 , Renicus S Hermanides  1 , Jan Paul Ottervanger  1 , Ioannis Tsilingiris  4 , Deborah M F van den Buijs  5 , Niels van Royen  8 , Maarten A H van Leeuwen  1
Affiliations
Randomized Controlled Trial

Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial

Tom A Meijers et al. EuroIntervention. .

Abstract

Background: Transfemoral access is often used when large-bore guide catheters are required for percutaneous coronary intervention (PCI) of complex coronary lesions, especially when large-bore transradial access is contraindicated. Whether the risk of access site complications for these procedures may be reduced by ultrasound-guided puncture is unclear.

Aims: We aimed to show the superiority of ultrasound-guided femoral puncture compared to fluoroscopy-guided access in large-bore complex PCI with regard to access site-related Bleeding Academic Research Consortium 2, 3 or 5 bleeding and/or vascular complications requiring intervention during hospitalisation.

Methods: The ULTRACOLOR Trial is an international, multicentre, randomised controlled trial investigating whether ultrasound-guided large-bore femoral access reduces clinically relevant access site complications compared to fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions.

Results: A total of 544 patients undergoing complex PCI mandating large-bore (≥7 Fr) transfemoral access were randomised at 10 European centres (median age 71; 76% male). Of these patients, 68% required PCI of a chronic total occlusion. The primary endpoint was met in 18.9% of PCI with fluoroscopy-guided access and 15.7% of PCI with ultrasound-guided access (p=0.32). First-pass puncture success was 92% for ultrasound-guided access versus 85% for fluoroscopy-guided access (p=0.02). The median time in the catheterisation laboratory was 102 minutes versus 105 minutes (p=0.43), and the major adverse cardiovascular event rate at 1 month was 4.1% for fluoroscopy-guided access and 2.6% for ultrasound-guided access (p=0.32).

Conclusions: As compared to fluoroscopy-guided access, the routine use of ultrasound-guided access for large-bore transfemoral complex PCI did not significantly reduce clinically relevant bleeding or vascular access site complications. A significantly higher first-pass puncture success rate was demonstrated for ultrasound-guided access.

Clinicaltrials: gov identifier: NCT04837404.

PubMed Disclaimer

Conflict of interest statement

A. Aminian: consulting services for Terumo. A.O. Kraaijeveld: research grants from Xenios AG; lecture fees from Abiomed, Novartis, and Inari; and consultancy fees from Dekra and Boston Scientific. M.A.H. van Leeuwen: speaker/consulting services honoraria from Terumo, Daiichi Sankyo, and Abbott; and research grants from AstraZeneca, Top Sector Life Sciences & Health, Terumo, Top Medical B.V., and Abbott. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Enrolment flow diagram for the ULTRACOLOR Trial.
PCI: percutaneous coronary intervention; STEMI: ST-segment elevation myocardial infarction; TFA: transfemoral access
Figure 2
Figure 2. Subgroup analyses at discharge.
ACT: activated clotting time; BMI: body mass index; CI: confidence interval, CTO: chronic total occlusion; MDRD: Modification of Diet in Renal Disease; NSTE-ACS: non-ST-segment elevation acute coronary syndrome; OR: odds ratio
Central illustration
Central illustration. Outcomes of patients undergoing fluoroscopy-guided or ultrasound-guided large-bore femoral access in complex PCI − the ULTRACOLOR Trial.
A) Patient characteristics after randomisation. B) Main outcomes. BARC: Bleeding Academic Research Consortium; cath lab: catheterisation laboratory; CTO: chronic total occlusion; mins: minutes; PCI: percutaneous coronary intervention
See this image and copyright information in PMC

References

    1. Ikari Y, Nagaoka M, Kim JY, Morino Y, Tanabe T. The physics of guiding catheters for the left coronary artery in transfemoral and transradial interventions. J Invasive Cardiol. 2005;17:636–41. - PubMed
    1. Ghione M, Agudo P, Kilickesmez K, Estevez-Loureiro R, Zivelonghi C, Lindsay A, Foin N, Secco GG, Di Mario. Tools and techniques - clinical: catheter compatibility in CTO recanalisation. EuroIntervention. 2013;9:290–1. - PubMed
    1. Meijers TA, Aminian A, van Wely, Teeuwen K, Schmitz T, Dirksen MT, Rathore S, van der, Knaapen P, Dens J, Iglesias JF, Agostoni P, Roolvink V, Hermanides RS, van Royen, van Leeuwen. Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021;14:1293–303. - PubMed
    1. Gorgulu S, Kalay N, Norgaz T, Kocas C, Goktekin O, Brilakis ES. Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial. JACC Cardiovasc Interv. 2022;15:823–30. - PubMed
    1. Smilowitz NR, Kirtane AJ, Guiry M, Gray WA, Dolcimascolo P, Querijero M, Echeverry C, Kalcheva N, Flores B, Singh VP, Rabbani L, Kodali S, Collins MB, Leon MB, Moses JW, Weisz G. Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures. Am J Cardiol. 2012;110:177–82. - PubMed

Publication types

Associated data