ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial
Thomas A Meijers1, Alexander Nap2, Adel Aminian3
1Department of Cardiology, Isala Heart Centre, Zwolle, The Netherlands.
Insights
Ultrasound-guided femoral artery puncture may reduce complications during complex percutaneous coronary intervention (PCI). This study compares ultrasound guidance to fluoroscopy guidance in 542 patients undergoing large-bore transfemoral PCI for complex lesions.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Imaging
Background:
- Transradial access (TRA) is favored for complex percutaneous coronary intervention (PCI), but transfemoral access (TFA) remains common, especially for chronic total occlusions (CTO).
- Ultrasound-guided femoral artery puncture may decrease access site complications in complex PCI, but evidence is limited.
Purpose of the Study:
- To evaluate the efficacy of ultrasound-guided puncture versus fluoroscopy-guided puncture in reducing access site complications during complex, large-bore transfemoral PCI.
- To compare the incidence of bleeding and vascular complications requiring intervention between the two guidance methods.
Main Methods:
- A randomized trial involving 542 patients undergoing complex PCI (CTO, bifurcation, calcified, or left main lesions) requiring 7-F or 8-F transfemoral access.
- Patients were randomized to either ultrasound-guided or fluoroscopy-guided femoral artery puncture.
- Primary outcome: composite of clinically relevant access site bleeding and/or vascular complications requiring intervention. Secondary outcomes include access site complications and major adverse cardiovascular events at 1 month.
Main Results:
- Primary outcome data are pending publication.
- Secondary outcome data on access site complications and MACE at 1 month are pending publication.
Conclusions:
- The study aims to provide robust evidence on the benefit of ultrasound guidance for femoral access in complex PCI.
- Findings will inform clinical practice regarding the optimal guidance technique for transfemoral access in high-risk PCI procedures.
Introduction:
Although recently published evidence favours transradial access (TRA) when using large-bore guiding catheters for percutaneous coronary intervention (PCI) of complex coronary lesions, the femoral artery will still be used in a considerate proportion of patients undergoing complex PCI, especially in PCI of chronic total occlusions (CTO). Ultrasound-guided puncture of the femoral artery may reduce clinically relevant access site complications, but robust evidence is lacking up to date.
Methods And Analysis:
A total of 542 patients undergoing complex PCI, defined as PCI of CTO, complex bifurcation, heavy calcified lesion or left main, in which the 7-F or 8-F transfemoral access is required, will be randomised to ultrasound-guided puncture or fluoroscopy-guided puncture. The primary outcome is the incidence of the composite end-point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Access site complications and major adverse cardiovascular events up to 1 month will also be compared between both groups.
Ethics And Dissemination:
Ethical approval for the study was granted by the local Ethics Committee ('Medisch Ethische Toetsing Commissie Isala Zwolle') for all Dutch sites, 'Comité Medische Ethiek Ziekenhuis Oost-Limburg' for Hospital Oost-Limburg, 'Comité d'éthique CHU-Charleroi-ISPPC' for Centre Hospilatier Universitaire de Charleroi and 'Ethik Kommission de Ärztekammer Nordrhein' for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ultrasound guided transfemoral access in complex large bore PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752.
Registration Details:
ClinicalTrials.gov identifier: NCT03846752.
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