Purpose: To report a single-center, prospective randomized controlled trial that compared contrast use during ultrasound-assisted carotid artery stenting (CAS) to CAS procedures without ultrasound.
Methods: Between August 2010 and November 2011, 22 patients (18 men; mean age 72.8 years, range 62-84) with 25 severe symptomatic (n=3) or asymptomatic (n=22) carotid stenoses undergoing an endovascular intervention were randomly allocated (~1.1) to ultrasonography-assisted (n=13) or stand-alone (n=12) CAS. The primary endpoints were contrast use and number of selective cerebral injections. Secondary endpoints were procedure time, fluoroscopy time, any stroke, renal function assessment, major adverse cardiac events (MACE), and death.
Results: In the study period, 23 of 25 scheduled CAS procedures (12 ultrasound-assisted, 11 control) were completed in 20 patients; 2 procedures were aborted owing to friable plaque and difficult guidewire access, respectively. There were no deaths, stroke, MACE, or precipitation of dialysis-dependent renal failure in either group. Iodinated contrast usage was reduced by 61% (45.4±24.4 vs. 17.8±11.9 mL, p=0.002) and number of selective cerebral contrast injections by 49% (8.3 vs. 4.2, p=0.002). Neither time taken to complete the procedure (32.5 vs. 35.4 minutes, p=0.38) nor fluoroscopy time (14.5 vs. 13.9 minutes, p=0.54) differed significantly between the groups. Creatinine levels remained stable after CAS and did not differ between groups.
Conclusion: Ultrasonography-assisted CAS is feasible and safe. Its use can significantly lower the usage of iodinated contrast and the number of selective cerebral circulation injections while not prolonging the length of the procedure or the fluoroscopy time.