TRANSRADIAL AND TRANSFEMORAL ACCESS FOR CAROTID ARTERY STENTING WITH AN EMPHASIS ON THE DETECTION OF MICROEMBOLIZATION WITH DIFFUSION WEIGHTED MAGNETIC RESONANCE IMAGING (TACTILE TRIAL).

Aim.  To compare transradial (TR) and transfemoral (TF) approach for carotid artery stenting (CAS) with an emphasis on the detection of micro-embolization with diffusion-weighted magnetic resonance imaging (DW-MRI). Methods.  96 patients were included in the study in the period from January 2015 to October 2017 with further randomized 1 : 1 to the TR and TF groups. The inclusion criteria were the following: symptomatic stenosis ICA >70%; or asymptomatic stenosis ICA >80%. The positive history of stroke, myocardial infarction or open heart surgery <1 month were the exclusion criteria for the study. The primary endpoint was the incidence of new cerebral ischemic lesions as assessed by DW-MRI. All CAS procedures were performed by two experienced operators according to the approved protocol. Results.  Procedural success with TR approach was 46 (96%) versus 48 (100%) with TF approach (p = 0.495). Crossover rate was 4% in the TR group. The rate of primary endpoint in the TR and TF groups was 50 and 52%, respectively. The absolute risk difference was -2% (95% CI [-0.21, 0.17], p (non-inferiority) = 0.03). An «on-treatment» analysis revealed a tendency towards a reduced microembolic foci when intervening on the right ICA via TR approach compared to TF (44% vs. 68%, p = 0.478), and a reverse trend when intervening on the left ICA via TR compared to TF approach (57% versus 36%, respectively, p = 0.437). Conclusion.  Carotid stenting via transradial approach is noninferior for cerebral embolism to transfemoral approach. The rates of MACCE and vascular complications were similar in both groups. There was no significant difference in the procedural success rate in the transfemoral and transradial groups. The fluoroscopy time during transradial carotid stenting was higher in comparison with transfemoral carotid stenting, though the procedure duration was similar in both groups.