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Evaluation of a novel mesh‐covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1‐year results of the SCAFFOLD trial
Author(s) -
Gray William A.,
Levy Elad,
Bacharach J. Michael,
Metzger David Christopher,
Randall Bryan,
Siddiqui Adnan,
Schonholz Claudio,
Alani Firas,
Schneider Peter A.
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28586
Subject(s) - medicine , stroke (engine) , stenosis , carotid stenting , restenosis , clinical endpoint , stent , endarterectomy , carotid endarterectomy , surgery , asymptomatic , population , myocardial infarction , cardiology , adverse effect , angiography , target lesion , clinical trial , percutaneous coronary intervention , mechanical engineering , environmental health , engineering
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).