1. There was no significant difference between stenting versus carotid endarterectomy (CEA) for asymptomatic patients with carotid stenosis that were not at high risk for post-operative complications.
2. The study was discontinued prior to it reaching the number needed for 80% certainty due to the extended period of time for enrollment.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Prior studies had shown that among asymptomatic patients with carotid-artery stenosis of greater than 60% of the diameter of the artery, the risk of stroke or death was lower when immediate CEA was performed via surgery. However, revascularization can also be performed by means of stenting and removing the emboli. The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) found no significant difference between stenting and surgery. However, the study was not sufficiently powered. The Asymptomatic Carotid Trial (ACT) I study was prospective multicenter trial aimed to compare the outcomes of CEA versus stenting in asymptomatic severe carotid-artery stenosis patients that were at risk for surgical complications. It randomly assigned patients in a 3:1 ratio to undergo stenting or CEA. The results showed that at one-year CEA was not superior compared to stenting. There were no significant differences between the two procedures in regards to the rate of non-procedure-related stroke, all stroke, and survival at the 30 day to 5-year follow-up end point. The study is limited by a number of factors including termination prior to reaching the number needed for 80% certainty due to the long period of time it took for the study to enroll patients into the study.
Click to read the study, published today in NEJM
Relevant Reading: Stenting versus endarterectomy for treatment of carotid-artery stenosis
In-Depth [randomized controlled trial]: A total of 1453 patients were randomly assigned to undergo stenting or CEA in a 3:1 ratio. There were no significant differences between the two groups in regards to baseline clinical characteristics. Patients were confirmed to be asymptomatic prior to randomization and neurological assessments took place before and on the day of the procedure, and at 1, 6, and 12 months up to 5 years after the procedure. The primary end point was the collection of death, stroke (ipsilateral or contralateral), major or minor, or MI during the 30 days after the procedure or ipsilateral stroke during the 365 days after the procedure. At 1 year, the event rate was 3.8% in the stenting group vs. 3.4% in the CEA group, with a between group difference of 0.4 percentage points. There was no significant difference between the rate of stroke or death within 30 days between the two groups (2.9% in the stenting group vs. 1.7% in the CEA group; p=0.33). From 30 days to 5 years there were no significant differences between the two groups in regards to the rate of freedom from ipsilateral stroke (97.8% in the stenting group vs. 97.3% in the CEA group; p=0.51). The overall 5-year stroke-free survival rate was similar between the two groups (93.1% in the stenting group vs. 94.7% in the CEA group; p=0.44).
Image: PD
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