A randomised comparison of transradial and transfemoral approach for carotid artery stenting: RADCAR (RADial access for CARotid artery stenting) study.

Abstract

Limited data exist on radial access in carotid artery stenting. This multicentre prospective randomised study was performed to compare the outcome and complication rates of transradial and transfemoral carotid artery stenting. The clinical and angiographic data of 260 consecutive patients with high risk for carotid endarterectomy, treated between 2010 and 2012 by carotid stenting with cerebral protection, were evaluated. Patients were randomised to transradial (n=130) or transfemoral (n=130) groups and several parameters were evaluated. Primary combined endpoint: major adverse cardiac and cerebral events, rate of access-site complications. Secondary endpoints: angiographic outcome of the procedure, fluoroscopy time and X-ray dose, procedural time, crossover rate to another puncture site and hospitalisation in days. Procedural success was achieved in all 260 patients (100%), the crossover rate was 10% in the TR and 1.5% in the TF group (p<0.05). A major access-site complication was encountered in one patient (0.9%) in the TR group and in one patient (0.8%) in the TF group (p=ns). The incidence of major adverse cardiac and cerebral events was 0.9% in the TR and 0.8% in the TF group (p=ns). Procedure time (1,620 [1,230-2,100] vs. 1,500 [1,080-2,100] sec, p=ns) and fluoroscopy time (540 [411-735] vs. 501 [378-702] sec, p=ns) were not significantly different, but the radiation dose was significantly higher in the TR group (195 [129-274] vs. 148 [102-237] Gy*cm2, p<0.05) by per-protocol analysis. Hospitalisation days were significantly lower in the TR group (1.17±0.40 vs. 1.25±0.45, p<0.05). By intention-to-treat analysis there was a significantly higher radiation dose in the TR group (195 [130-288] vs. 150 [104-241], p<0.05), but no difference in major events (0.9 vs. 0.8, p=ns) and length of hospitalisation in days (1.4±2.6 vs. 1.25±0.45, p=ns). The transradial approach for carotid artery stenting is safe and efficacious; however, the crossover rate is higher with transradial access. There are no differences in the total procedure duration and fluoroscopy time between the two approaches but the radiation dose is significantly higher in the radial group, and the hospitalisation is shorter with the use of transradial access by per-protocol analysis. By evaluating the patient data according to intention-to-treat analysis we found no difference in major adverse events and hospitalisation. In both groups, vascular complications rarely occurred.