A First-in-Human Evaluation of a Novel Mesh-Covered Stent for Treatment of Carotid Stenosis in Patients at High Risk for Endarterectomy30-Day Results of the SCAFFOLD Trial
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Author + information
- Peter A. Schneider, MDa,∗ (peterschneidermd{at}aol.com),
- Elad Levy, MD, MBAb,
- J. Michael Bacharach, MD, MPHc,
- D. Christopher Metzger, MDd,
- Bryan Randall, MSe,
- Andrew Garcia, BSe,
- Adnan Siddiqui, MD, PhDf,
- Claudio Schonholz, MDg and
- William Gray, MDh
- aDivision of Vascular Therapy, Hawaii Permanente Medical Group and Kaiser Foundation Hospital, Honolulu, Hawaii
- bJacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, New York
- cNorth Central Heart Institute, Sioux Falls, South Dakota
- dWellmont CVA Heart and Vascular Institute, Kingsport, Tennessee
- eW.L. Gore & Associates, Flagstaff, Arizona
- fJacobs Institute & Kaleida Health, State University of New York at Buffalo, Buffalo, New York
- gMedical University of South Carolina, Charleston, South Carolina
- hLankenau Heart Institute, Main Line Health, Wynnewood, Pennsylvania
- ↵∗Address for correspondence:
Dr. Peter A. Schneider, Division of Vascular Therapy, Hawaii Permanente Medical Group/Kaiser Foundation Hospital, 3288 Moanalua Road, Honolulu 96819, Hawaii.
Graphical abstract
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.
- carotid artery disease
- carotid artery stent
- carotid endarterectomy
- clinical studies
- GORE carotid stent
- high risk
- stent design/structure/coatings
- stroke
Footnotes
Dr. Schneider has served on the advisory board for Abbott, Boston Scientific, Medtronic, and Cardiovascular Systems Inc., served as a consultant for Silk Road Medical; has received royalties from Cook Medical; and served as a member of the screening committee for the SCAFFOLD trial (W.L. Gore & Associates). Dr. Levy owns shares in Intratech Medical Ltd., NeXtGen Biologics, Rapid Medical Ltd., Claret Medical, Cognition Medical, Imperative Care (formerly the Stroke Project), Rebound Therapeutics, StimMed, and Three River Medical; has served as the National Principal Investigator for the Medtronic (formerly Covidien Neurovascular) Steering Committees for the U.S. SWIFT PRIME and SWIFT Direct Trials; has received honoraria from Medtronic; has served as a consultant for Claret Medical, GLG Consulting, Guidepoint Global, Imperative Care (formerly the Stroke Project), Medtronic (formerly Covidien Neurovascular), Rebound, and StimMed; has served on the Acute Ischemic Stroke clinical advisory board for Stryker, NeXtGen Biologics, MEDX, Cognition Medical, and Endostream Medical; has served as a principal investigator for Microvention (CONFIDENCE study); and has rendered medical/legal opinions as an expert witness. Dr. Bacharach has served on the Speakers Bureau for Boston Scientific, Bristol-Myers Squibb, Cook Medical, and W.L. Gore & Associates; and has served as a consultant for W.L. Gore & Associates; and as a board member for IAC. Dr. Metzger has served on as a co-principal investigator for and on the steering committee of the Confidence, CANOPY, and SAPPHIRE WW trials (unpaid); and received honoraria from Abbott, W.L. Gore & Associates, and Boston Scientific. Dr. Siddiqui has served as a consultant or on the advisory board for Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Cerenovus, Claret Medical, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Medtronic, MicroVention, Northwest University (data safety and monitoring board chair for the HEAT trial), Penumbra, Rapid Medical, Rebound Therapeutics Corporation, Serenity Medical, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, and W.L. Gore & Associates; has a financial interest, is an investor, or owns stock in Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical, Imperative Care, International Medical Distribution Partners, Rebound Therapeutics Corporation, Serenity Medical, Inc., Silk Road Medical, StimMed, Synchron, Three Rivers Medical, and Viseon Spine; has served as a national principal investigator or on the steering committee for the Cerenovus LARGE trial and ARISE II trial, Medtronic SWIFT PRIME and SWIFT DIRECT trials, MicroVention FRED Trial and CONFIDENCE study, MUSC POSITIVE trial, Penumbra 3D Separator trial, COMPASS trial, and INVEST trial; and has served on the screening committee for the SCAFFOLD trial (W.L. Gore & Associates). Dr. Schonholz has served on the scientific advisory board for W.L. Gore & Associates; and on the screening committee for the SCAFFOLD trial (W.L. Gore & Associates). Dr. Gray has served as a consultant for Abbott Vascular, Boston Scientific, Cook Medical, Medtronic, Shockwave Medical, and W.L. Gore & Associates; has received research grant support from Abbott Vascular, Boston Scientific, Intact Vascular, Shockwave Medical, and W.L. Gore & Associates; owns stock in Biocardia, Contego Medical, and Silk Road Medical; and has served on the screening committee for the SCAFFOLD trial (W.L. Gore & Associates). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 4, 2018.
- Revision received July 19, 2018.
- Accepted July 24, 2018.
- 2018 American College of Cardiology Foundation
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