Background Prior studies evaluating the Wingspan stent for treatment of symptomatic intracranial atherosclerotic disease have included patients with a spectrum of both on-label and off-label indications for the stent. The WEAVE trial assessed 152 patients stented with the Wingspan stent strictly by its current on-label indication and found a 2.6% periprocedural stroke and death rate.
Objective This WOVEN study assesses the 1-year follow-up from this cohort.
Methods Twelve of the original 24 sites enrolling patients in the WEAVE trial performed follow-up chart review and imaging analysis up to 1 year after stenting. Assessment of delayed stroke and death was made in 129 patients, as well as vascular imaging follow-up to assess for in-stent re-stenosis.
Results In the 1-year follow-up period, seven patients had a stroke (six minor, one major). Subsequent to the periprocedural period, no deaths were recorded in the cohort. Including the four patients who had periprocedural events in the WEAVE study, there were 11 strokes or deaths of the 129 patients (8.5%) at the 1-year follow-up.
Conclusions The WOVEN study provides the 1-year follow-up on a cohort of 129 patients who were stented according to the current on-label use. It provides a more homogeneous patient group for analysis than prior studies, and demonstrates a relatively low 8.5% 1-year stroke and death rate in stented patients.
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Correction notice Since the online publication of this article, the title has been updated as 'Outcomes' was incorrectly spelt as 'utcomes'.
Contributors All the authors contributed to the data collection and manuscript review.
Funding The WOVEN Trial was a physician-initiated study without industry or public funding.
Disclaimer The WOVEN Trial sites and primary investigator interventionalists included SSM DePaul Medical Center (Ameer Alshekhlee), WellStar Health System (Rishi Gupta), Cedars Sinai Medical Center (Michael J. Alexander), The Cleveland Clinic (Gabor Toth), Multicare Medical Center (Brian Kott), Santa Barbara Cottage Hospital (Alois Zauner), University of Kentucky Medical Center (Justin Fraser), Central Baptist Health (Curtis Given II), Abington (Larami Mackenzie), Valley Baptist Medical Center – Harlingen (Ameer Hassan), Tennessee Interventional Associates (Blaise W. Baxter), Cadence Health Central DuPage (Harish Shownkeen). The research coordinators in the WOVEN study included: Vicki Manoukian, Gabriella Diaz, Janey Barnhart, Ashley Depalmo, Jennifer Isaacs, Laurie Preston, Erin Ross, Linda Breathitt, Kathy Hansen, Michelle Raymond, and Jacquie Johnson.
Competing interests MJA, AZ, RG, AEH, BWB, RCC and WY are scientific consultants for Stryker Neurovascular. No industry compensation was provided for this research or the production of this manuscript to any of the investigators.
Patient consent for publication Not required.
Ethics approval The WOVEN Trial was approved by the Cedars-Sinai institutional review board under identification number STUDY00000379.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. De-identified data access requires institutional review board approval and signed data usage agreement.