Paclitaxel Drug Coated Balloon Angioplasty for Medically Refractory Intracranial Atherosclerotic Disease: A U.S. Single-Center Experience with the AGENT balloon

BackgroundIntracranial atherosclerotic disease (ICAD) 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 to medical therapy alone. Drug coated balloon (DCB) angioplasty has emerged as a promising alternative, though its safety and durability remains uncertain. MethodsThis single-center retrospective study analyzed consecutive patients with refractory ICAD treated with AGENT DCB submaximal angioplasty. Patients were treated either for refractory large-vessel occlusion during thrombectomy (emergency rescue) or for recurrent ischemic symptoms from high-grade stenosis (elective primary). Technical success was defined as <50% residual stenosis without adjunctive stenting. Safety outcomes included hemorrhage, dissection, stroke, and death at three months. ResultsOf the 11 identified patients, nine underwent successful DCB angioplasty, five for emergent rescue therapy and four for elective primary therapy. There was a combined 78% technical success rate, with no major procedural complications. Mean stenosis reduction was 53.6% (paired Wilcoxon p=0.014; pre-procedure mean (SD) stenosis 90.8% ({+/-}8.6%) to post-procedure 37.3% ({+/-}33.4%)). Restenosis occurred in three of the four (75%) elective primary patients without recurrent ischemic events. Follow-up angiographic data for the emergent rescue cohort was unavailable, though no symptomatic ischemic events were reported. ConclusionPaclitaxel-coated AGENT drug-coated balloon (DCB) submaximal angioplasty was safe and yielded immediate improvements in luminal diameter. However, high rates of re-stenosis emphasize the need for innovative devices and larger prospective studies to define its therapeutic role for refractory ICAD.