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

2018 ◽  
Vol 11 (6) ◽  
pp. 569-573 ◽  
Author(s):  
Ju Han ◽  
Jun Zhang ◽  
Xiao Zhang ◽  
Jinping Zhang ◽  
Yun Song ◽  
...  

BackgroundThe 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.ObjectivesTo assess the feasibility, clinical and angiographic outcomes of DCBs for patients with intracranial de novo atherosclerotic disease.MethodsBetween 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.ResultsAll 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.ConclusionsThis study suggests that DCB dilatation may be a safe and effective alternative for intracranial de novo atherosclerotic disease.

2018 ◽  
Vol 10 (9) ◽  
pp. e24-e24 ◽  
Author(s):  
Jun Zhang ◽  
Xiao Zhang ◽  
Jin-Ping Zhang ◽  
Ju Han

The optimal treatment for patients with chronic symptomatic middle cerebral artery (MCA) total occlusion is not well established. In addition to medical therapy, vessel recanalisation with stenting has shown much promise, especially for patients with recurrent ischemic symptoms. Nevertheless, the incidence of symptomatic in-stent restenosis (ISR) is high, and is associated with an unfavorable prognosis. Drug coated balloons (DCBs) have been proven to be effective in treating and preventing ISR. However, the feasibility of DCBs for de novo intracranial atherothrombotic stenosis has not been previously described, especially for total occlusion lesions. Here we reported a patient with chronic left MCA total occlusion successfully treated with DCBs, with a good outcome at the 1 year follow-up. More studies are warranted to further compare the efficacy of DCBs and stentings for intracranial revascularisation.


2021 ◽  
pp. neurintsurg-2020-017114
Author(s):  
Marlon Carl Monayao ◽  
Ahmed A Malik ◽  
Laurie Preston ◽  
Marlon Carl Monayao Sr ◽  
Wondwossen Tekle ◽  
...  

BackgroundThe incidence of intracranial atherosclerotic disease (ICAD) in acute ischemic stroke treated with mechanical thrombectomy (MT) is not well defined, and its description may lead to improved stroke devices and rates of first pass success.MethodsA retrospective study was performed on MT patients from 2012 to 2019 at a comprehensive stroke center using chart review and angiogram analysis. Angiograms at the time of MT were reviewed for ICAD, and location and severity were recorded. Patients with ICAD were divided according to ICAD location relative to the large vessel occlusion (LVO) site. Statistical analyses were performed on baseline demographics, comorbidities, MT procedure variables, outcome variables, and their association with ICAD.ResultsOf the 533 patients (mean age 70.4 (SD 13.20) years, 43.5% women), 131 (24.6%) had ICAD. There was no significant difference in favorable discharge outcomes (modified Rankin Scale score of 0–2; 23.8% ICAD vs 27.0% non-ICAD; p=0.82) or groin puncture to recanalization times (average 43.5 (range 8–181) min for ICAD vs 40.2 (4–204) min for non-ICAD; p=0.42). Patients with ICAD experienced a significantly higher number of passes (average 1.8 (range 1–7) passes for ICAD vs 1.6 (1–5) passes for non-ICAD; p=0.0059). Adjusting for age, ≥3 device passes, baseline National Institutes of Health Stroke Scale, rates of angioplasty only, rates of concurrent angioplasty and stenting, coronary artery disease and atrial fibrillation incidences, and time from emergency department arrival to recanalization, yielded no significant difference in rates of favorable outcomes between the two groups.ConclusionPatients who underwent MT with underlying ICAD had similar rates of favorable outcomes as those without, but required a higher number of device passes.


Neurosurgery ◽  
2020 ◽  
Vol 87 (5) ◽  
pp. 992-998
Author(s):  
Jun Zhang ◽  
Xiao Zhang ◽  
Jinping Zhang ◽  
Yun Song ◽  
Meimei Zheng ◽  
...  

Abstract BACKGROUND Conventional stent-based angioplasty was challenged for the high incidence of perioperative complications and follow-up in-stent restenosis (ISR) in treating intracranial atherosclerotic disease (ICAD). Currently, the drug-coated balloon (DCB) has shown promise in preventing and treating ISR. OBJECTIVE To compare the efficacy and safety of DCB dilation (with or without stenting) with conventionally only stenting angioplasty for symptomatic ICAD in routine clinical practice. METHODS From January 2016 to January 2019, consecutive patients treated with endovascular therapy for symptomatic ICAD were identified and dichotomized by whether DCB was used. The efficacy and safety endpoints, including periprocedural complications, clinical, and imaging follow-up outcomes between the 2 groups, were compared by propensity score matching. RESULTS A total of 42 patients in the DCB group and 73 patients in the non-DCB group were enrolled. Propensity score matching analysis selected 76 matched patients. Angiographic follow-up was completed at 185 ± 33 d. The median stenosis degree (0 [0%-20.0%] vs 15.0 [0%-62.5%], P = .005) and total restenosis incidence (5.3% [2/38] vs 34.2% [13/38], P = .003) in the DCB group were significantly lower than those in the non-DCB group. The periprocedural complications (2.6% vs 10.5%, P = .375), recurrent ischemic events (2.6% vs 13.2%, P = .219), and symptomatic restenosis (2.6% vs 10.5%, P = .375) were not statistically different between the 2 groups. CONCLUSION Compared with conventionally only stenting angioplasty, DCB dilation can effectively lower restenosis degree and total restenosis risk, with no superiority in symptomatic restenosis at 6-mo follow-up.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.M.Z Mohd Saad Jalaluddin

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Colin Derdeyn ◽  
David Fiorella ◽  
Tanya Turan ◽  
Jean Montgomery ◽  
Bethany Lane ◽  
...  

Purpose: To investigate the incidence and clinical characteristics of recurrent stroke beyond 30 days after uncomplicated angioplasty and stenting for symptomatic intracranial stenosis. Methods: Primary endpoints in SAMMPRIS (Stenting and Aggressive Medical Management for the Prevention of Recurrent Ischemic Stroke) after 30 days past enrollment were defined as ischemic stroke in the territory or any stroke or death within 30 days of a subsequent revascularization procedure. Endpoints were independently and blindly adjudicated. Study records and imaging studies of subjects randomized to the stent arm with post-30 day primary endpoints were reviewed. Instent restenosis (ISR) was categorized as severe (>70%), moderate (50-69%) or mild (< 50%) based on consensus of two reviewers. Findings were categorized as definite, probable, or indeterminate based on imaging modality and study quality. Results: 224 subjects were randomized to the stent arm and 33 suffered a primary endpoint within 30 days of enrollment. Nineteen of the remaining 191 subjects (9.9%) suffered a primary endpoint during follow up (median follow up of 32.4 months). Eighteen had an ischemic stroke in the territory and one had a symptomatic intracranial hemorrhage after repeat angioplasty for in stent restenosis (ISR). In the 18 patients with ischemic stroke, the vascular imaging findings were: complete stent occlusion in 2 (1 of these was acutely revascularized and severe underlying ISR was identified), severe ISR by catheter angiography in 5, severe ISR or occlusion by computed tomographic angiography (CTA) in 1, probable ISR by CTA or magnetic resonance angiography (MRA) in 3, moderate stenosis on angiography in 2 (1 with ISR and 1 with a residual stenosis), indeterminate in 2, normal in 2, and not done in 1. Lesion locations included: distal internal carotid (6), petrous carotid (1), basilar (5), middle cerebral (6), and vertebral (1) arteries. Median time to recurrent stroke was 7.7 months from enrollment (2.2 to 28.2 months). Conclusions: The incidence of recurrent stroke beyond 30 days after uncomplicated angioplasty and stenting in the SAMMPRIS trial was nearly 10% over a mean follow-up of almost 3 years. In stent restenosis was associated with the majority of recurrent strokes.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Mahmoud Mohammaden ◽  
Raul G Nogueira ◽  
WONDWOSSEN TEKLE ◽  
farhan siddiq ◽  
Diogo C Haussen ◽  
...  

Introduction: Intracranial atherosclerotic disease (ICAD) is a common cause of refractory stroke. Randomized clinical trials failed to prove the safety and efficacy of the endovascular treatment options of symptomatic ICAD (sICAD). However, there are many concerns regarding inclusion criteria in these trials which made them less effective than standard medical management. Herein, we aim to study the safety and efficacy of drug-eluting balloon mounted stents (DES) in the treatment of sICAD. Methods: A retrospective review of endovascular database from 10 comprehensive stroke centers inside and outside the USA from January 2017 to January 2020 was reviewed. Patients were included if they had symptomatic intracranial stenosis ≥70% in the target vessel, failed best medical management, and underwent intracranial stenting with DES. The primary outcome was the occurrence of ischemic stroke, hemorrhage, or mortality within 72 hours of the procedure. Secondary outcomes included rates of symptomatic and angiographic recurrence within 6 months of the procedure. Results: There was a total of 129 patients, the median age was 65 [58-72] years, 40 (31%) were females. The intracranial stenotic lesions were located in anterior circulation in 74 (57.4%) of cases [24 (18.6%) supraclinoid ICA, 5 (3.9%) cavernous ICA, 17 (13.2%) petrous ICA, 5 (19.4%) MCA-M1, and 3 (2.3%) M2] and in posterior circulation in 55 (42.6%) of cases [36 (27.9) vertebral artery V4 segment, 18 (14%) basilar and 1 (0.7%) PCA]. Recurrent stroke was the qualifying event in 101 (78.3%) while transient ischemic attacks (TIA) were identified in 28 (21.7%) of cases. The median time from the qualifying event to stenting was 6 [2-24] days. Strokes were reported within 72 hours of the procedure; 2 (1.6%) ischemic, 2 (1.6%) hemorrhagic strokes and 2 (1.6%) patients suffered inpatient mortality. The median follow-up time was 6 [3-6.75] months. Among 99 patients who had clinical follow up 2 (2%) had TIA and 6 (6.1%) had strokes. Fifty-one patients had follow-up imaging of whom symptomatic ISR was reported in 8 (15.7%). Conclusion: Our study has shown that in appropriately selected patients with sICAD, endovascular treatment using DES is safe and effective. Prospective randomized clinical trials are warranted.


2016 ◽  
Vol 9 (10) ◽  
pp. 948-951 ◽  
Author(s):  
Sami Al Kasab ◽  
Zayed Almadidy ◽  
Alejandro M Spiotta ◽  
Aquilla S Turk ◽  
M Imran Chaudry ◽  
...  

BackgroundAcute large vessel occlusion (LVO) can result from thromboemboli or underlying intracranial atherosclerotic disease (ICAD). Although the technique for revascularization differs significantly for these two lesions (simple thrombectomy for thromboemboli and balloon angioplasty and stenting for ICAD), the underlying etiology is often unknown in acute ischemic stroke (AIS).ObjectiveTo evaluate whether procedural complications, revascularization rates, and functional outcomes differ among patients with LVO from ICAD or thromboembolism.MethodsA retrospective review of thrombectomy cases from 2008 to 2015 was carried out for cases of AIS due to underlying ICAD. Thirty-six patients were identified. A chart and imaging review was performed to determine revascularization rates, periprocedural complications, and functional outcomes. Patients with ICAD and acute LVO were compared with those with underlying thromboemboli.ResultsAmong patients with ICAD and LVO, mean National Institutes of Health Stroke Scale (NIHSS) score on admission was 12.9±8.5, revascularization (Thrombolysis In Cerebral Infarction, TICI ≥2b) was achieved in 22/34 (64.7%) patients, 11% had postprocedural intracerebral hemorrhage (PH2), and 14/33 (42.4%) had achieved a modified Rankin Scale (mRS) score of 0–2 at the 3-month follow-up. Compared with patients without underlying ICAD, there was no difference in NIHSS on presentation, or in the postprocedural complication rate. However, procedure times for ICAD were longer (98.5±59.8 vs 37.1±34.2 min), there was significant difference in successful revascularization rate between the groups (p=0.001), and a trend towards difference in functional outcome at 3 months (p=0.07).ConclusionsDespite AIS with underlying ICAD requiring a more complex, technically demanding recanalization strategy than traditional thromboembolic AIS, it appears safe, and good outcomes are obtainable.


2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Yohsuke Honda ◽  
Keisuke Hirano ◽  
Masahiro Yamawaki ◽  
Motoharu Araki ◽  
Norihiro Kobayashi ◽  
...  

Introduction. The proportion of patients with comorbid atrial fibrillation (AF) and peripheral artery disease (PAD) has increased in this era. This study aimed to assess the relationship between AF and totally occlusive in-stent restenosis (ISR) in femoropopliteal (FP) lesions. Methods. In this study, 363 patients (461 stents) who underwent endovascular therapy with de novo stent implantation in our hospital between April 2007 and December 2016 were retrospectively evaluated. The patients were divided into two groups according to the AF status (AF group, 61 patients; sinus group, 302 patients). The primary endpoint was the incidence of totally occlusive ISR within 3 years. The secondary endpoint was the incidence of acute limb ischemia (ALI) due to FP stent occlusion. Results. Baseline characteristics were similar, except for higher age and a lower prevalence of dyslipidemia in the AF group. The incidence of a totally occlusive ISR was higher in the AF group than in the sinus group (29.5% vs. 14.6%, p = 0.004 ). A multiple Cox regression model suggested that presence of AF (hazard ratio, 2.10) and CTO lesion (hazard ratio, 1.97) which were the independent predictors of a totally occlusive ISR within 3 years. The incidence of ALI was significantly higher in the AF group than in the sinus group (3.9% vs. 0%, p = 0.0001 ). In the AF group, the introduction of an anticoagulant did not prevent the occurrence of totally occlusive ISR ( p = 0.71 ) for ALI ( p = 0.79 ). Conclusions. AF is independently associated with totally occlusive ISR of FP stents; however, anticoagulant use does not prevent stent occlusion.


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