PDF: WEAVE
(2019)Objective
To evaluate the periprocedural safety of the Wingspan stent in patients with symptomatic intracranial atherosclerotic disease.
Study Summary
Intervention
Angioplasty and stenting with the Wingspan stent system in patients with 70–99% symptomatic ICAD, treated ≥8 days after qualifying stroke. Antiplatelet therapy (aspirin 325 mg and clopidogrel 75 mg) initiated ≥7 days prior to procedure.
Inclusion Criteria
Age 22–80 years, mRS ≤3, ≥2 strokes in the target territory (1 while on medical therapy), and 70–99% stenosis in a ≥2 mm intracranial artery; stenting ≥8 days from last stroke.
Study Design
Arms: Single Arm: Wingspan Stenting
Patients per Arm: 152 (on-label)
Outcome
Bottom Line
The WEAVE trial demonstrated a low periprocedural complication rate (2.6%) for the Wingspan stent in symptomatic intracranial atherosclerotic disease when used by experienced interventionalists following on-label usage guidelines, suggesting an excellent safety profile. This was the largest on-label, multicenter, prospective trial of the Wingspan stent system with the lowest reported complication rate to date.
Major Points
- A total of 152 consecutive patients meeting FDA on-label usage criteria were enrolled at 24 hospitals.
- On-label criteria included age 22-80 years, symptomatic intracranial atherosclerotic stenosis of 70%-99%, baseline modified Rankin Scale score ≤3, ≥2 strokes in the vascular territory of the stenotic lesion with at least 1 stroke while on medical therapy, and stenting of the lesion ≥8 days after the last stroke.
- The primary analysis assessed the periprocedural stroke, bleed, and death rate within 72 hours of the procedure.
- The trial was stopped early after interim analysis of 152 patients demonstrated a lower than expected 2.6% (4/152 patients) periprocedural stroke, bleed, and death rate, which was lower than the 4% safety benchmark set for the interim analysis.
- 97.4% (148/152) of patients were event-free at 72 hours.
- 1.3% (2/152) had nonfatal strokes, and 1.3% (2/152) of patients died.
- The mean target artery stenosis before the procedure was 83% and after stenting was 28%.
- Interventionalists with >50 Wingspan cases before the trial had a 0% periprocedural stroke and death rate in on-label cases, compared to 4.8% for those with <50 cases.
Study Design
- Study Type
- Prospective, single-arm, consecutive enrollment, postmarket surveillance trial (FDA mandated 522 study)
- Randomization
- No
- Sample Size
- 152
- Follow-up
- 72 hours (for primary analysis of periprocedural events)
- Centers
- 24
Primary Outcome
Definition: Periprocedural stroke, bleed, and death rate within 72 hours of the procedure.
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - | 2.6% (4/152 patients) | - | - |
Limitations & Criticisms
- The study is a single-arm, consecutive enrollment postmarket surveillance study, and therefore lacks a control group, which limits the ability to draw comparative conclusions about efficacy.
- The trial was stopped early when safety benchmarks were met, rather than completing the planned enrollment of 389 patients, which could affect the robustness of the findings.
- The results suggest that poor clinical results in previous trials like SAMMPRIS were due to inexperienced interventionalists, poor patient selection, and underdeveloped standards of practice, rather than problems with the stent itself. This is an interpretation by the authors and not directly compared in this single-arm trial.
- The study focuses solely on periprocedural safety (within 72 hours) and does not provide long-term efficacy data, leaving the long-term performance of the stent compared to medical therapy unknown.
- The trial's generalizability is limited to highly selected patients who meet strict on-label criteria and are treated by experienced interventionalists. It does not reflect broader clinical practice where off-label use or less experienced operators might be involved.
Citation
Stroke. 2019;50:889-894. DOI: 10.1161/STROKEAHA.118.023996.