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Title: | Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial | Authors: | Meijers, Thomas A. Nap, Alexander Aminian, Adel Schmitz, Thomas DENS, Jo Teeuwen, Koen van Kuijk, Jan-Peter van Wely, Marleen BATAILLE, Yoann Kraaijeveld, Adriaan O. Roolvink, Vincent Dambrink, Jan Henk E. Gosselink, A. T. Marcel Hermanides, Renicus S. Ottervanger, Jan Paul Tsilingiris, Ioannis van den Buijs, Deborah M. F. van Royen, Niels van Leeuwen, Maarten A. H. |
Issue Date: | 2024 | Publisher: | EUROPA EDITION | Source: | EuroIntervention, 20 (14) , p. e876 -e886 | 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 ultrasoundguided 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 fluoroscopyguided 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 largebore 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 | Notes: | van Leeuwen, MAH (corresponding author), Isala Heart Ctr, Dr van Heesweg 2, NL-8025 AB Zwolle, Netherlands. m.a.h.van.leeuwen@isala.nl |
Keywords: | complex PCI;CTO;large bore;ultrasound;vascular access | Document URI: | http://hdl.handle.net/1942/43619 | ISSN: | 1774-024X | e-ISSN: | 1969-6213 | DOI: | 10.4244/EIJ-D-24-00089 | ISI #: | 001272976700006 | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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