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      Drug-coated balloons for the treatment of symptomatic intracranial atherosclerosis: initial experience and follow-up outcome

      , , , , , , , ,
      Journal of NeuroInterventional Surgery
      BMJ

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          Abstract

          Background

          The optimal treatment for patients with symptomatic severe intracranial atherosclerotic disease is not well established. Angioplasty and stenting have been attempted, with controversial results, mainly attributed to perioperative complications and a high incidence of restenosis or in-stent restenosis. Drug-coated balloons (DCBs) have shown encouraging results for coronary and peripheral artery disease, without convincing data for intracranial vasculature.

          Objectives

          To assess the feasibility, clinical and angiographic outcomes of DCBs for patients with intracranial de novo atherosclerotic disease.

          Methods

          Between September 2016 and September 2017, details of 30 patients with 31 arteries treated with DCBs for symptomatic severe intracranial atherosclerotic disease (≥70% stenosis or chronic total occlusion) were retrospectively collected in our centre. All lesions were predilated with conventional balloons. Periprocedural complications and clinical and vascular imaging follow-up outcomes were analysed.

          Results

          All arteries were successfully dilated with DCBs and 29 (93.5%) arteries achieved good antegrade perfusion, with remedial stenting for two arteries. Two patients presented with new ischemic stroke after the procedure. Over a mean follow-up of 9.8±2.6 months, no patient had recurrent ischemic symptoms. Repeat vascular imaging was performed at 7.0±1.1 months, with cerebral angiography in 24 patients (25 arteries) and MR angiography in six patients (six arteries). Only one (3.2%) artery presented with angiographic asymptomatic restenosis.

          Conclusions

          This study suggests that DCB dilatation may be a safe and effective alternative for intracranial de novo atherosclerotic disease.

          Related collections

          Most cited references19

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          Stenting versus aggressive medical therapy for intracranial arterial stenosis.

          Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of follow-up, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.).
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            Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis.

            Atherosclerotic intracranial arterial stenosis is an important cause of stroke. Warfarin is commonly used in preference to aspirin for this disorder, but these therapies have not been compared in a randomized trial. We randomly assigned patients with transient ischemic attack or stroke caused by angiographically verified 50 to 99 percent stenosis of a major intracranial artery to receive warfarin (target international normalized ratio, 2.0 to 3.0) or aspirin (1300 mg per day) in a double-blind, multicenter clinical trial. The primary end point was ischemic stroke, brain hemorrhage, or death from vascular causes other than stroke. After 569 patients had undergone randomization, enrollment was stopped because of concerns about the safety of the patients who had been assigned to receive warfarin. During a mean follow-up period of 1.8 years, adverse events in the two groups included death (4.3 percent in the aspirin group vs. 9.7 percent in the warfarin group; hazard ratio for aspirin relative to warfarin, 0.46; 95 percent confidence interval, 0.23 to 0.90; P=0.02), major hemorrhage (3.2 percent vs. 8.3 percent, respectively; hazard ratio, 0.39; 95 percent confidence interval, 0.18 to 0.84; P=0.01), and myocardial infarction or sudden death (2.9 percent vs. 7.3 percent, respectively; hazard ratio, 0.40; 95 percent confidence interval, 0.18 to 0.91; P=0.02). The rate of death from vascular causes was 3.2 percent in the aspirin group and 5.9 percent in the warfarin group (P=0.16); the rate of death from nonvascular causes was 1.1 percent and 3.8 percent, respectively (P=0.05). The primary end point occurred in 22.1 percent of the patients in the aspirin group and 21.8 percent of those in the warfarin group (hazard ratio, 1.04; 95 percent confidence interval, 0.73 to 1.48; P=0.83). Warfarin was associated with significantly higher rates of adverse events and provided no benefit over aspirin in this trial. Aspirin should be used in preference to warfarin for patients with intracranial arterial stenosis. Copyright 2005 Massachusetts Medical Society.
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              Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial.

              Intracranial stenosis is one of the most common etiologies of stroke. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis.
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                Author and article information

                Journal
                Journal of NeuroInterventional Surgery
                J NeuroIntervent Surg
                BMJ
                1759-8478
                1759-8486
                May 31 2019
                June 2019
                June 2019
                October 18 2018
                : 11
                : 6
                : 569-573
                Article
                10.1136/neurintsurg-2018-014237
                30337378
                1675c413-c2e7-4f51-bc90-cc612ad81526
                © 2018
                History

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