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July 31, 2014
RADCAR Study Compares Transradial and Transfemoral Approaches for CAS
August 1, 2014—Findings from the RADCAR study, a randomized comparison of transradial (TR) and transfemoral (TF) approaches for carotid artery stenting (CAS), were published by Zolta Ruzsa, MD, et al, in EuroIntervention (2014;10:381–391). Noting that limited data exist on radial access for CAS, the investigators conducted this multicenter, prospective, randomized study to compare the outcome and complication rates of TR and TF CAS.
As summarized in EuroIntervention, the investigators evaluated clinical and angiographic data from 260 consecutive patients considered high risk for carotid endarterectomy, who were treated between 2010 and 2012 by CAS with cerebral protection. Patients were randomized to TR (n = 130) or TF (n = 130) groups, and several parameters were evaluated. Primary combined endpoints were major adverse cardiac and cerebral events, rate of access site complications. Secondary endpoints were angiographic outcome of the procedure, fluoroscopy time and x-ray dose, procedural time, crossover rate to another puncture site, and hospitalization days.
The investigators reported that 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 < .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).
The investigators found that procedure time (1,620 [1,230–2,100] seconds vs 1,500 [1,080–2,100] seconds; P = NS) and fluoroscopy time (540 [411–735] seconds vs 501 [378–702] seconds, P = NS) were not significantly different, but the radiation dose was significantly higher in the TR group (195 [129–274] Gy cm2 vs 148 [102–237] Gy cm2; P < .05) by per-protocol analysis.
Additionally, hospitalization days were significantly lower in the TR group (1.17 ± 0.4 vs 1.25 ± 0.45; P < .05). By intention-to-treat analysis, there was a significantly higher radiation dose in the TR group (195 [130–288] Gy cm2 vs 150 [104–241] Gy cm2; P < .05), but no difference in major events (0.9 vs 0.8; P = NS) nor length of hospitalization days (1.4 ± 2.6 vs 1.25 ± 0.45; P = NS).
The investigators concluded that the TR approach for CAS is safe and efficacious; however, the crossover rate is higher with TR access. There were no differences in the total procedure duration and fluoroscopy time between the two approaches, but the radiation dose was significantly higher in the TR group, and the hospitalization time was shorter with the use of TR access by per-protocol analysis. By evaluating the patient data according to intention-to-treat analysis, neither difference in major adverse events nor hospitalization were found. In both groups, vascular complications rarely occurred, advised the investigators in EuroIntervention.
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