William A Gray1, Elad Levy2, J Michael Bacharach3, David Christopher Metzger4, Bryan Randall5, Adnan Siddiqui6, Claudio Schonholz7, Firas Alani8, Peter A Schneider9. 1. Lankenau Heart Institute, Main Line Health, Wynnewood, Pennsylvania. 2. Jacobs School of Medicine and Biomedical Sciences, SUNY University at Buffalo & Kaleida Health, 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, Inc., Flagstaff, Arizona. 6. Jacobs Institute, SUNY University at Buffalo & Kaleida Health, Buffalo, New York. 7. Division of Vascular & Interventional Radiology, Medical University of South Carolina, Charleston, South Carolina. 8. Covenant Healthcare System, Saginaw, Michigan. 9. Hawaii Permanente Medical Group and Kaiser Foundation Hospital, Honolulu, Hawaii.
Abstract
OBJECTIVE: The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year. BACKGROUND: SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population. METHODS: The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates. RESULTS: Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis. CONCLUSIONS: Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted).
OBJECTIVE: The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year. BACKGROUND: SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population. METHODS: The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates. RESULTS: Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis. CONCLUSIONS: Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted).
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