Treating total occlusions, complex bifurcations, grossly calcified lesions or left main lesions via transradial approach is associated with significant reduction in access-site bleeding or vascular complications vs transfemoral approach. This kind of procedures have been typically excluded from studies randomizing patients to transradial vs transfemoral approach.
The COLOR study used the transradial bore-guiding catheter Glidesheath (produced by Terumo) with a much thinner wall that enables the use of 7 French devices in 6 French access sites.
Guidelines on both sides of the Atlantic recommend the transradial approach over the transfemoral because of its capacity to reduce bleeding, vascular complications and even mortality (RIFLE-STEACS y MATRIX).
Despite the latter, there are many operators that given the need for a larger bore-guiding catheter, opt for the transfemoral approach. Curiously, choosing one over the other varies according to center, country, and ever operator age.
The COLOR study was presented at EuroPCR 2021 scientific sessions and was simultaneously published in JACC: Cardiovascular Interventions. It included 388 patients with planned complex PCI requiring 7 French catheters.
Over half of these procedures were total occlusions (58%), followed by calcified lesions (19%), left main lesions (14%) and 2 stent bifurcations (9%).
Read also: EuroPCR 2021 | TVT Registry: Outcomes of TAVR in Low Surgical Risk Bicuspids.
Procedural success was around 90% in both arms and the use of a different approach to the one indicated by randomization (crossover rate) was low, and similar between arms.
The combined primary end point of BARC bleeding 2/3/5 or vascular complication requiring intervention, occurred in 19.1% of patients in the transfemoral group vs. 3.6% in the transradial group. The difference in bleeding was basically driven by BARC 2 bleeding (apparent bleeding, but with no clinical compromise). Vascular complications were 4.1% vs 0.5% respectively (p=0.04).
Major cardiovascular events at 30 days showed a tendency in favor of the femoral access (2.6% vs 6.7%; p=0.06). This should be interpreted with caution seeing as the COLOR did not reach the statistical power to show differences in clinical events.
Original Title: Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention.
Reference: Thomas A Meijers et al. JACC Cardiovasc Interv. 2021 May 7;S1936-8798(21)00513-6. Online ahead of print. doi: 10.1016/j.jcin.2021.03.041.
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