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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