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

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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 cross-over 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.