Introduction
: Background: Stenosis of the vertebral artery origin (VAOS), while under‐diagnosed, is common and may cause up to 25% of posterior circulation infarction. Stenting is widely employed as a secondary prevention strategy, but prospective clinical studies of safety and efficacy are limited.
Objective: To report periprocedural and 30‐day outcomes after stenting of the vertebral origin in the first 20 patients of the Vertebral Artery Origin Treatment by Endovascular Techniques Registry (VOTER).
Methods
: VOTER is a prospective, multicenter, cohort study of patients with symptomatic vertebral artery stenosis > = 50%. Demographic, clinical, and procedural data is collected via a RedCap constructed, cloud‐based, data entry portal. In addition, there is clinical follow‐up data collected at 30 days and 1 year. Lesion stenosis[OGS1] percentage along with representative images are collected pre‐stent, post‐stent, and at 1 year for validation by an independent core laboratory. The primary outcome is stroke and death at 30 days. The secondary outcome is restenosis > = 50% at 1 year follow‐up.
Results
: A total of 10 sites have been activated to enroll in the study. Of these, 3 sites have enrolled a total of 20 subjects. The median age was 64 (range 47–87) years; 14 (70%) were male, and 16 (80%) were white. 19 patients (95%) were hypertensive, with 5 patients (25%) having a history of ischemic heart disease. The median Modified Rankin score (mRS) at admission was 1 (range 0–3). Presenting symptoms included dizziness/vertigo (43%), visual field defects (14.3%), hemiparesis (14.3%), dysarthria (19.0%), diplopia (4.8%), ataxia (4.8%), and dysphasia (4.8%). All patients were treated with dual antiplatelet therapy. All stents utilized were drug eluting. The median pre‐stent stenosis was 80% (range 60–99%) with a median of 15% (range 0–33%) post‐stent residual. There were no periprocedural strokes, death, or technical complications. One month follow up was available in 15 patients (75%), with 2 reporting new neurological symptoms: 1 with blurred vision and 1 with dizziness and facial numbness. No new imaging confirmed infarctions occurred. Symptomatic improvement was noted in 40% of subjects although there was no change in the median 30 day mRS.
Conclusions
: VOTER is the first large prospective registry of vertebral origin stenting in North America. These early results from the first 20 subjects are consistent with procedural safety and the importance of continued study of stenting as a secondary prevention strategy for posterior circulation infarction in the setting of VAOS.