Analysis of ACT 1 Shows Carotid Stent Fractures Are Not Associated With Adverse Events
January 2, 2018—Findings from a study that sought to report the stent fracture rate and its association with in-stent restenosis and adverse outcomes in ACT 1 asymptomatic carotid trial were published by Ido Weinberg, MD, et al in Circulation. In September 2016, Dr. Weinberg presented the ACT 1 findings during a late-breaking trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which was sponsored by VIVA Physicians, Inc.
The prospective multicenter ACT 1 trial investigated carotid angioplasty and stenting versus endarterectomy in asymptomatic patients who were at standard risk for carotid endarterectomy with significant extracranial carotid stenotic disease. Patients were randomly assigned to carotid artery stenting with the Xact stent (Abbott Vascular) or carotid endarterectomy.
As summarized in Circulation, the primary endpoint was a composite of death, stroke, or myocardial infarction during the 30 days after the procedure or ipsilateral stroke during the 365 days after the procedure. After 771 patients were enrolled, successive randomly assigned patients were required to undergo annual radiographic (x-ray) analysis for stent fracture. Images were independently adjudicated by a core laboratory.
The investigators reported that of 1,021 patients treated with carotid artery stenting during a mean follow-up of 3.1 ± 1.6 years, 939 patients had at least one x-ray during the follow-up period. Stent fracture was reported in 51 (5.4%) patients. With a maximum follow-up period of 5 years, adverse clinical outcomes occurred in 39 (4.2%) patients with at least one x-ray during follow-up. Of 826 (80.9%) patients who underwent both duplex ultrasound and x-ray, 822 (99.5%) were interpretable. There was no association between stent fracture and the primary endpoint (P = .86) or with restenosis (P = .53).
In this large, independently adjudicated, multicenter study, the stent fracture rate was low and not associated with major adverse clinical events or in-stent restenosis, concluded the investigators in Circulation.