A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

Abstract

Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been
compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is
no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis.
Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy
of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke,
requirement for second treatment, and death in patients with symptomatic intracranial stenosis.
Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional
techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of
medical treatment or severe stenosis (≥70%) with or without failure of medical treatment.
Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of
these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent
placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD])
was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty
followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was
very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement
continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on
post-procedure Day 2.
Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty
followed by stent placement is feasible. The immediate procedural outcomes with primary angioplasty are
comparable to stent placement and warrant further studies.