BACKGROUND: Intracranial atherosclerotic disease is associated with up to 10% of ischemic strokes and a high risk of recurrence. Endovascular treatments including percutaneous transluminal angioplasty and stenting have failed to demonstrate improved outcomes compared with medical therapy alone. Drug-coated balloon (DCB) angioplasty has emerged as a promising alternative, though its safety and durability remain uncertain. METHODS: This single-center retrospective study analyzed consecutive patients with refractory intracranial atherosclerotic disease treated with AGENT drug-coated balloon submaximal angioplasty. Stenosis was quantified according to the WASID criteria (Warfarin-Aspirin Symptomatic Intracranial Disease). Patients were treated either for refractory large-vessel occlusion during thrombectomy (emergency rescue) or for recurrent ischemic symptoms from high-grade stenosis (elective primary). Primary outcome was technical success, defined as <50% residual stenosis after DCB angioplasty without the need for adjunctive percutaneous transluminal angioplasty and stenting. Safety outcomes included periprocedural intracranial hemorrhage, vessel dissection, symptomatic reocclusion, ischemic stroke, and mortality at 1 month and 3 months. RESULTS: Of the 11 identified patients, 9 underwent successful DCB angioplasty, 5 for emergent rescue therapy, and 4 for elective primary therapy. There was a combined technical success rate of 78%, with no major procedural complications. Mean stenosis reduction was 53.6% (paired Wilcoxon P =0.014; preprocedure mean SD stenosis 90.8% ±8.6% to postprocedure 37.3% ±33.4%). Restenosis occurred in 3 of the 4 (75%) elective primary patients on follow-up imaging at a mean of 64 days postprocedure, without recurrent ischemic events. Follow-up angiographic data for the emergent rescue cohort was unavailable, though no symptomatic ischemic events were reported. CONCLUSIONS: Paclitaxel-coated AGENT DCB submaximal angioplasty was safe and yielded immediate improvements in luminal diameter. However, high rates of restenosis emphasize the need for innovative devices and larger prospective studies to define its therapeutic role for refractory intracranial atherosclerotic disease.
Chaudhari et al. (Wed,) studied this question.