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Design and Rationale of Routine U ltrasou N d Gu I dance for V ascular Acc E ss fo R Cardiac Procedure s : A Randomized Tria L (UNIVERSAL).
- Source :
-
CJC open [CJC Open] 2022 Aug 30; Vol. 4 (12), pp. 1074-1080. Date of Electronic Publication: 2022 Aug 30 (Print Publication: 2022). - Publication Year :
- 2022
-
Abstract
- Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce B leeding A cademic R esearch C onsortium (BARC) 2, 3, or 5 bleeding or major vascular complications.<br />Methods: The U ltrasou n d Gu i dance for V ascular Acc e ss fo r Cardiac Procedure s : A Randomized Tria l (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%.<br />Results: We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease.<br />Conclusions: The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide.<br /> (© 2022 The Authors.)
Details
- Language :
- English
- ISSN :
- 2589-790X
- Volume :
- 4
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- CJC open
- Publication Type :
- Academic Journal
- Accession number :
- 36562014
- Full Text :
- https://doi.org/10.1016/j.cjco.2022.08.011