Tom Meijers; Alexander Nap; Adel Aminian; Thomas Schmitz; Joseph Dens; Koen Teeuwen; Jan-Peter van Kuijk; Marleen van Wely; Yoann Bataille; Adriaan Kraaijeveld; Vincent Roolvink; Jan-Henk Dambrink; A.T. Marcel Gosselink; Renicus S. Hermanides; Jan Paul Ottervanger; Ioannis Tsilingiris; Deborah M.F van den Buijs; Niels van Royen; Maarten A.H. van Leeuwen

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. Meijers¹, MD; Alexander Nap², MD, PhD; Adel aminian³, MD; Thomas Schmitz⁴, MD, PhD; Joseph Dens⁵, MD, PhD; Koen Teeuwen⁶, MD, PhD; Jan-Peter van Kuijk⁷, MD, PhD; Marleen van Wely⁸, MD; Yoann Bataille⁹, MD, PhD; Adriaan O. Kraaijeveld¹⁰, MD, PhD; Vincent Roolvink¹, MD, PhD; Jan-Henk E. Dambrink¹, MD, PhD; A.T. Marcel Gosselink¹, MD, PhD; Renicus S. Hermanides¹, MD, PhD; Jan Paul Ottervanger¹, MD, PhD; Ioannis Tsilingiris⁴, MD, PhD; Deborah M.F van den Buijs⁵, MD; Niels van Royen⁸, MD, PhD; Maarten A.H. van Leeuwen¹, MD, PhD

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

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com