Abstract 6: Interim Report of the Weave Trial: First 102 Consecutive on Label Patients
Purpose: The initial FDA approval trial of the self-expanding Wingspan stent for symptomatic intracranial atherosclerotic disease demonstrated a 4.5% periprocedural complication rate. Subsequently, similar on-label registry data was reported. The WEAVE Trial is a prospective, consecutive enrollment, single-arm, post-market surveillance trial evaluating periprocedural outcomes in patients with the revised FDA indications for use.
Methods: Data for the first 102 on-label patients for which completed data is available are included in this report. The primary analysis endpoints included periprocedural stroke, death, or symptomatic bleed within 72 hours of the stenting procedure in patients who were treated on label. A subgroup of the participating sites included anti-platelet therapy resistance testing and correction, if needed, in their treatment of the patient. All patient outcomes were separately adjudicated by a stroke Neurologist by 72 to 96 hours post procedure.
Results: In the initial 122 consecutive patients enrolled with completed data, 102 patients were treated on label and are included in the primary analysis, and 20 patients were treated off label and were part of secondary analyses. The mean stenosis in the primary analysis group was 83% with target artery break down as follows: 40.2% MCA, 25.5% ICA, 19.6% Basilar, 14.7% Vertebral or VB junction. Of the 102 patients in the primary analysis, 3 patients (2.9%) reached a primary endpoint of stroke, symptomatic bleed, or death within 72 hours. In the off label group, 4 of the 20 patients (20%) reached a primary endpoint within that period.
Conclusions: The early interim analysis of the first 102 patients of WEAVE trial has demonstrated a very low periprocedural morbidity and mortality of 2.9%. This is lower than the high periprocedural event rate in the SAMMPRIS trial, and statistically better than the outcomes in the off label group (Fisher’s Exact test p value 0.014). This early data provides impetus to continue to collect data in this trial, and lends support to the concept that refined patient selection criteria and establishment of best practice techniques and management for these patients can substantially decrease the peri-procedural risk of intracranial stenting.
Author Disclosures: M.J. Alexander: Consultant/Advisory Board; Modest; Stryker Neurovascular. J.C. Chaloupka: Consultant/Advisory Board; Modest; Stryker Neurovascular. A. Zauner: None. B. Baxter: None. R. Callison: None. W. Yu: None.
- © 2017 by American Heart Association, Inc.