If their potential is realized, they will fulfill an important clinical need, researchers say.
The use of drug-coated balloons (DCBs) to treat severe intracranial atherosclerotic disease is showing promise in an early single-center series published online October 18, 2018, ahead of print in the Journal of NeuroInterventional Surgery.
The study authors, led by Ju Han, MD (Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan, China), report that since both SAMMPRIS and VISSIT demonstrated negative outcomes for stenting in symptomatic intracranial stenosis, there is no universally accepted treatment approach for this condition.
“The discouraging results were mainly attributed to perioperative complications and a high incidence of restenosis or in-stent restenosis (ISR), which is thought to be caused by intimal hyperplasia,” they write.
“In recent years,” they continue, “[balloons] coated with antiproliferative drugs have been well recognized for their ability to inhibit intimal hyperplasia. During DCB dilatation, the drug can penetrate into the vessel wall. Previous studies have shown that DCB dilatation can effectively prevent and treat ISR and shows promise in newly formed lesions of coronary and peripheral small arteries.”
Earlier in 2018, a single-center, open-label study also published in JNIS, compared the outcomes of eight patients treated using the Neuro Elutax SV paclitaxel-eluting balloon (Aachen Resonance), the first device of its kind designed for intracranial use, with those of 11 patients who received the Wingspan/Gateway stent system (Boston Scientific/ Stryker Neurovascular). All 19 patients had symptomatic atherosclerotic intracranial high-grade stenosis. After a follow-up period of approximately 10 months, the incidence of the compound endpoint of ischemic re-event and/or restenosis was 13% with the Elutax and 64% using the Wingspan (P = 0.03).
“Since it is a small pilot study, [only] safety and feasibility, without any complications of DCB use in intracranial stenosis, could be shown,” Philipp Gruber, MD (Cantonal Hospital, Aarau, Switzerland), lead author of that earlier report, told Neurovascular Exchange in an email. “Further, DCB offer the advantage of uniform local drug delivery and no residual foreign body compared to drug-eluted stent systems.”
To further elucidate the role of drug-coated balloons in the setting of severe intracranial atherosclerosis, Han and colleagues retrospectively collected data on 30 patients with 31 arteries treated using a paclitaxel-coated balloon originally designed for use in coronary arteries (SeQuent Please; B. Braun) for symptomatic severe intracranial atherosclerotic disease (≥ 70% stenosis or chronic total occlusion) between September 2016 and September 2017. All patients had experienced a recurrent transient ischemic attack or ischemic stroke after standard medical therapy with a combination of antithrombotic agents and risk control.
Lesions were predilated with conventional balloons, a necessary step when using a balloon designed for larger coronary arteries, and all arteries were successfully dilated using drug-eluting balloons. Overall, 29 (93.5%) arteries achieved good antegrade perfusion, with remedial stenting needed in only two arteries. Two patients presented with new ischemic stroke after the procedure.
Over a follow-up period of 9.8 ± 2.6 months, there were no cases of recurrent ischemic symptoms. Repeat vascular imaging was performed at 7.0 ± 1.1 months, consisting of cerebral angiography in 24 patients (25 arteries) and MR angiography in six patients (six arteries). Only one artery (3.2%) showed signs of angiographic asymptomatic restenosis.
“This single-center series study shows that the use of DCBs may be feasible and safe for the treatment of symptomatic severe intracranial atherosclerotic disease,” conclude the authors. “Further prospective randomized studies with larger patient numbers are mandatory to establish the clinical efficacy and indications.”
According to Gruber, the new study lends support to their earlier findings on feasibility and outcome.
However, he added, there are two major differences worth noting.
“First, we used a DCB specifically dedicated for intracranial use. Thus, [their] DCB might be more rigid compared to our DCB,” Gruber explained. “Second, regarding safety we prefer to perform a submaximal angioplasty technique using only DCB, without [using] predilatation of the culprit lesion with a conventional angioplasty balloon, as our colleagues did. We think that too many intracranial manipulations with devices increases the risk of periprocedural complications. Further, even a low dilation rate of the stenosis degree might optimize the local stenosis situation for the patients and might additionally lower the risk of vessel dissections.”
Han J, Zhang J, Zhang X, et al. Drug-coated balloons for the treatment of symptomatic intracranial atherosclerosis: Initial experience and follow-up outcome. J NeuroIntervent Surg. 2018;Epub ahead of print.
Gruber P, Garcia- Esperon C, Berberat J, et al. Neuro Elutax SV drug-eluting balloon versus Wingspan stent system in symptomatic intracranial high-grade stenosis: a single-center experience. J NeuroIntervent Surg. 2018;Epub ahead of print.
Han and Gruber report no relevant conflicts of interest.