Carotid artery stenting without embolic protection: A randomized multicenter trial (the CASWEP trial).

BACKGROUND: Carotid artery stenting (CAS) with a carotid protection device (CPD) has become the standard practice in patients with severe carotid stenosis and high surgical risk. However, the clinical efficacy and safety of CPDs are still controversial issues. We aimed to compare the clinical outcomes of the CAS without CPD with CAS combined with CPD.

METHODS: This is a multicenter randomized prospective study registered with https://clinicaltrials.gov (NCT02781181). After the exclusion, 279 patients were enrolled (139 patients in the CAS with CPD group and 140 patients in the CAS without CPD group). The primary outcome was a combination of peri-procedural in-hospital transient ischemic attack (TIA), ipsilateral stroke, or death. The secondary outcome was new ischemic brain lesions on post-procedural diffusion-weighted magnetic resonance imaging (DW-MRI).

RESULTS: Two patients died in CAS without CPD group, one patient died in CAS with CPD group. TIA was only seen in patients who underwent CAS under protection (n = 5). The combined primary outcome of TIA, ipsilateral stroke, and death rate was not different between groups (5.7% vs. 2.8%; p = 0.254). New defects were noted on the post-procedural DW-MRI in 28% of patients in the CPD group and 27% of patients in the no CPD group (p = 0.881).

CONCLUSIONS: This study suggests that CAS without CPD is not associated with higher rates of peri-procedural TIA, stroke, and death or new ischemic brain lesions on post-procedural DW-MRI compared to CAS with CPD in selected symptomatic and asymptomatic patients with significant carotid artery stenosis provided that there is no visible thrombus.