December 11, 2018
Thirty-Day Results Published From SCAFFOLD Trial of Mesh-Covered Gore Carotid Stent
December 12, 2018—The 30-day results from the SCAFFOLD trial demonstrated a low rate of a composite of major adverse events (MAEs) including death, stroke, or myocardial infarction after carotid artery stenting (CAS) with the Gore carotid stent (GCS; Gore & Associates) in patients at high risk for carotid endarterectomy (CEA). Peter A. Schneider, MD, et al published the findings from this first-in-human evaluation of the GCS in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11:2396–2404).
According to the investigators, the primary purpose of this study was the composite of MAEs through 30 days after the index procedure or ipsilateral stroke from 30 days to 1 year. The investigators hypothesized that the GCS with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates.
As summarized in JACC: Cardiovascular Interventions, the prospective, multicenter, single-arm SCAFFOLD clinical trial was composed of 312 patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥ 50% stenosis or asymptomatic ≥ 80% stenosis). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint of MAEs through 30 days.
Of the 312 patients enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, 265 were included in the primary analysis population. The 30-day MAE rate was 3% (95% confidence interval, 1.3%–5.9%). The stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The two deaths in the study were not stroke related.
"The 30-day stroke rate of 1.1% suggests that the carotid stent mesh covering may reduce the neurologic events associated with CAS when used in appropriately selected patients," concluded the investigators in JACC: Cardiovascular Interventions.