Peter A Schneider1, Elad Levy2, J Michael Bacharach3, D Christopher Metzger4, Bryan Randall5, Andrew Garcia5, Adnan Siddiqui6, Claudio Schonholz7, William Gray8. 1. Division of Vascular Therapy, Hawaii Permanente Medical Group and Kaiser Foundation Hospital, Honolulu, Hawaii. Electronic address: peterschneidermd@aol.com. 2. Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, New York. 3. North Central Heart Institute, Sioux Falls, South Dakota. 4. Wellmont CVA Heart and Vascular Institute, Kingsport, Tennessee. 5. W.L. Gore & Associates, Flagstaff, Arizona. 6. Jacobs Institute & Kaleida Health, State University of New York at Buffalo, Buffalo, New York. 7. Medical University of South Carolina, Charleston, South Carolina. 8. Lankenau Heart Institute, Main Line Health, Wynnewood, Pennsylvania.
Abstract
OBJECTIVES: The primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days. BACKGROUND: Rates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA). The study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates. METHODS: The SCAFFOLD trial, a prospective, multicenter, single-arm clinical trial evaluating the GORE carotid stent (GCS), enrolled patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥50% or asymptomatic ≥80%). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint, the composite of death, stroke, and MI through 30 days. RESULTS: A total of 312 patients were enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, of which 265 were included in the primary analysis population. The 30-day rate of death, stroke, or MI was 3.0% (95% confidence interval: 1.3% to 5.9%) and the stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The 2 deaths in the study were not stroke related. CONCLUSIONS: Low death, stroke, or MI rates were demonstrated with GCS in patients at high risk for CEA. 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.
OBJECTIVES: The primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days. BACKGROUND: Rates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA). The study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates. METHODS: The SCAFFOLD trial, a prospective, multicenter, single-arm clinical trial evaluating the GORE carotid stent (GCS), enrolled patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥50% or asymptomatic ≥80%). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint, the composite of death, stroke, and MI through 30 days. RESULTS: A total of 312 patients were enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, of which 265 were included in the primary analysis population. The 30-day rate of death, stroke, or MI was 3.0% (95% confidence interval: 1.3% to 5.9%) and the stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The 2 deaths in the study were not stroke related. CONCLUSIONS:Low death, stroke, or MI rates were demonstrated with GCS in patients at high risk for CEA. 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.
Authors: Damian R Maciejewski; Łukasz Tekieli; Mariusz Trystuła; Tomasz Tomaszewski; Roman Machnik; Jacek Legutko; Marek Kazibudzki; Robert Musiał; Marcin Misztal; Piotr Pieniążek Journal: Postepy Kardiol Interwencyjnej Date: 2020-12-29 Impact factor: 1.426
Authors: Adam Mazurek; Krzysztof Malinowski; Kenneth Rosenfield; Laura Capoccia; Francesco Speziale; Gianmarco de Donato; Carlo Setacci; Christian Wissgott; Pasqualino Sirignano; Lukasz Tekieli; Andrey Karpenko; Waclaw Kuczmik; Eugenio Stabile; David Christopher Metzger; Max Amor; Adnan H Siddiqui; Antonio Micari; Piotr Pieniążek; Alberto Cremonesi; Joachim Schofer; Andrej Schmidt; Piotr Musialek Journal: J Clin Med Date: 2022-08-17 Impact factor: 4.964