Complex Large-Bore Radial Percutaneous Coronary Intervention - COLOR
Contribution To Literature:
The COLOR trial showed that transradial access was associated with a significant reduction in access site-related bleeding among patients with complex coronary disease undergoing PCI.
Description:
The goal of the trial was to evaluate transradial access compared with transfemoral access among patients with complex coronary disease undergoing percutaneous coronary intervention (PCI) with a 7-Fr guiding catheter.
Study Design
- Randomized
- Parallel
- Open-label
Patients undergoing complex PCI with a 7-Fr guiding catheter were randomized to transradial access (n = 194) versus transfemoral access (n = 194).
- Total number of enrollees: 388
- Duration of follow-up: 33 days
- Mean patient age: 69 years
- Percentage female: 20%
- Percentage with diabetes: 28%
Inclusion criteria:
- Patients at least 18 years of age presenting with chronic coronary artery disease, unstable angina, or non–ST-segment elevation myocardial infarction (NSTEMI)
- Undergoing PCI, defined as left main, chronic total occlusion, bifurcation, or severe calcium
- Anticipated use of 7-Fr guiding catheter
Exclusion criteria:
- STEMI
- Cardiogenic shock
Other salient features/characteristics:
- Chronic total occlusion 58%, severe calcium 19%, left main disease 14%, and bifurcation lesions 9%
Principal Findings:
The primary outcome, access site–related clinically significant bleeding or vascular complications requiring intervention at discharge, occurred in 3.6% of the transradial access group compared with 19.1% of the transfemoral access group (p < 0.001).
Secondary outcomes:
- Crossover rate: 3.6% in the radial group compared with 2.6% in the femoral group (p = 0.56)
- Procedural success: 89.2% for the radial group compared with 86.0% for the femoral group (p = 0.29)
- Bleeding Academic Research Consortium (BARC 2) bleeding: 3.6% in the radial group compared with 16.5% in the femoral group (p < 0.001)
- Fewer vascular complications requiring intervention: 0.5% in the radial group compared with 4.1% in the femoral group (p = 0.04)
Interpretation:
Among patients with complex coronary artery disease undergoing PCI with a 7-Fr guiding catheter, radial access was feasible and safe. Radial access was associated with a reduction in clinically significant bleeding or vascular complications requiring intervention compared with femoral access. Procedural success was similar between treatment groups.
References:
Meijers TA, Aminian A, van Wely M, et al. Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention. JACC Cardiovasc Interv 2021;May 18:[Epub ahead of print].
Editorial Comment: Valgimigli M, Landi A. Large-Bore Radial Access for Complex PCI: A Flash of COLOR With Some Shades of Grey. JACC Cardiovasc Interv 2021;May 18:[Epub ahead of print].
Presented by Dr. Thomas A. Meiers at the EuroPCR Virtual Meeting (EuroPCR 2021), May 18, 2021.
Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Acute Heart Failure, Interventions and Coronary Artery Disease, Interventions and Vascular Medicine, Chronic Angina
Keywords: Angina, Unstable, Catheters, Coronary Artery Disease, Coronary Occlusion, Hemorrhage, Myocardial Ischemia, Patient Discharge, Percutaneous Coronary Intervention, Plaque, Atherosclerotic, Secondary Prevention, Shock, Cardiogenic, ST Elevation Myocardial Infarction, Vascular Diseases
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