Randomized trial of predilation versus direct stenting for treatment of carotid artery stenosis

Background: A controversial aspect of carotid artery stenting (CAS) is the placement of a stent with or without predilation. The study was designed to test the hypothesis that direct stenting (DS) was not inferior to CAS with predilation. Methods: Elective CAS with filter protection was performed in 205 consecutive, unselected patients with carotid artery stenosis (>50% if symptomatic and >= 75% if asymptomatic by Doppler assessment) who were randomly assigned to CAS with predilation (n=100) or direct stenting (DS, n=105). Filter and stent selection were left to the operator's discretion. The study end-point was the angiographic success, defined as <= 30% angiographic residual stenosis after CAS without abnormal angiographic findings in cerebral circulation and without crossover to predilation in the DS group. Results: At baseline, patient clinical characteristics and stenosis anatomic features did not differ between groups. Angiographic success was 99% and 97%, p=0.33, in predilation and DS, respectively. No cross-over to predilation occurred in the DS group. Procedural time was shorter in DS as compared to predilation (24.3+/-7% versus 19.9+/-6%, p=0.001) and visible debris were more frequently captured in predilation as compared to DS (50% versus 36%, p=0.003). No peri-procedural and 30-day death or major stroke occurred in both groups. Minor stroke and TIA rates were similar in either group (2% versus 0% and 8% versus 5.7%, p=ns, respectively). Conclusion: In an unselected, consecutive series of patients submitted to CAS, DS is a feasible technique and is not inferior to CAS with predilation.