Encephaloduroarteriosynangiosis (EDAS) revascularization for symptomatic intracranial atherosclerotic steno-occlusive (ERSIAS) Phase-II objective performance criterion trial

2020 ◽  
pp. 174749302096725
Author(s):  
Nestor R Gonzalez ◽  
Hao Jiang ◽  
Patrick Lyden ◽  
Shlee Song ◽  
Konrad Schlick ◽  
...  
Keyword(s):  
Phase Ii ◽  
Primary Endpoint ◽  
Medical Management ◽  
Performance Criterion ◽  
Atherosclerotic Disease ◽  
Intracranial Atherosclerotic Disease ◽  
Objective Performance ◽  
Endpoint Event ◽  
One Year ◽  
Event Rates

Background Intracranial atherosclerotic disease (ICAD) is one of the most challenging stroke etiologies, with frequent recurrences despite optimized medical management. Encephaloduroarteriosynangiosis (EDAS) is an indirect revascularization method that produces extra-cranial collaterals to intracranial vessels. We present the results of a phase-II trial of EDAS in intracranial atherosclerotic disease patients. Aims To evaluate the feasibility, safety, and preliminary efficacy of EDAS in intracranial atherosclerotic disease patients. Methods ERSIAS was a prospective objective-performance-criterion trial of EDAS plus intensive medical management (IMM) in intracranial atherosclerotic disease (ICAD) patients failing medical treatment. Primary endpoint was any stroke/death within 30-days post-surgery or stroke in the territory of the qualifying artery beyond 30 days. The primary analysis compared event rates through one year with an objective-performance-criterion based on a 10% reduction from the 20% rate in the intensive medical management arm of the stenting versus aggressive medical management for preventing recurrent stroke in intracranial stenosis trial (SAMMPRIS) in patients with poor collaterals. Event rates through two years were compared with propensity-score-matched (PSM) medically treated patients from SAMMPRIS and the carotid occlusion surgery study (COSS). Results During a median follow-up of 24.5 months, 5 (9.6%) of 52 patients had a primary endpoint event. The primary endpoint rate at one year met the threshold for nonfutility and advancement to phase III (<10%). In the sensitivity analysis, primary endpoint event rate at two years was lower than in PSM controls, 9.6% versus 21.2% (p < 0.07). Overall, 86% of EDAS-plus-intensive medical management patients were functionally independent at last follow-up and 89% demonstrated neovascularization. There were two (3.8%) surgical complications and no intracranial hemorrhages. Conclusion ERSIAS phase II provides evidence of safety and strong signals of efficacy of EDAS-plus-intensive medical management, supporting advancement to a seamless phase-IIb/III trial. Clinical Trial Registration URL: https://www.clinicaltrials.gov.NCT01819597 .

Abstract P476: Safety and Efficacy of Balloon Mounted Drug-Eluting Stent in the Treatment of Symptomatic Intracranial Atherosclerotic Disease Multicenter International Experience

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Mahmoud Mohammaden ◽  
Raul G Nogueira ◽  
WONDWOSSEN TEKLE ◽  
farhan siddiq ◽  
Diogo C Haussen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Endovascular Treatment ◽  
Medical Management ◽  
Randomized Clinical Trials ◽  
Atherosclerotic Disease ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Intracranial Atherosclerotic Disease ◽  
Drug Eluting

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.

Abstract 83: Encephaloduroarteriosynangiosis Surgery Averts Stroke in Atherosclerotic Patients With Border-Zone Stroke

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Miguel D Quintero-Consuegra ◽  
Juan F Toscano ◽  
Robin Babadjouni ◽  
Daniel Chang ◽  
Peyton Nisson ◽  
...  
Keyword(s):  
Medical Management ◽  
Recurrent Stroke ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
External Carotid Artery ◽  
Border Zone ◽  
External Carotid ◽  
Recurrence Rates ◽  
Intracranial Atherosclerotic Disease ◽  
One Year

Introduction: Intracranial atherosclerotic disease (ICAD) is one of the most common causes of stroke around the world. Among patients with ICAD being treated with Intensive Medical Management (IMM), those who initially present with ischemia in border-zone areas have the highest recurrence rates (37% at one year) due to association with poor collaterals. Methods: We recently concluded a phase II clinical trial of EDAS revascularization for patients with symptomatic ICAD failing medical management (ERSIAS). EDAS creates new collaterals from the donor branches of the external carotid artery. We performed an analysis of ERSIAS patients who had stroke as qualifying event and ischemia of a border-zone area on their initial MRI. We compared their outcomes to the subgroup of patients with border-zone ischemia from SAMMPRIS. Results: Of 52 patients included in the ERSIAS trial, 35 patients presented with strokes at baseline and 28 had border-zone pattern, including 15 (54%) with exclusive border-zone ischemia and 13 (46%) with mixed patterns including the border-zone. Of these 28 patients with border zone strokes as qualifying event, three (11%) presented recurrent strokes up to one year after EDAS surgery. When compared with the matched population from the medical arm of SAMMPRIS, EDAS patients had significantly lower than expected rate of recurrence (11% vs. 37% p=0.02, OR:0.21, 95%CI= 0.05-0.84), representing an absolute risk reduction of 26%. Conclusion: When compared with matched controls on IMM, EDAS reduced the expected rate of recurrent stroke in patients at the highest risk of recurrence. This supports the concept that EDAS might avert strokes due to hypoperfusion by generating new collaterals to ischemic cerebral territories and could supplement IMM in patients with border-zone infarctions due to ICAD.

scholarly journals Clopidogrel plus Aspirin for Symptomatic Intracranial Atherosclerotic Stenosis: A Pilot Study

2016 ◽  
Vol 5 (3-4) ◽  
pp. 157-164 ◽  
Author(s):  
Tareq Kass-Hout ◽  
Melanie Winningham ◽  
Omar Kass-Hout ◽  
Laura Henriquez ◽  
Frank Tong ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Medical Management ◽  
Dual Antiplatelet Therapy ◽  
Recurrent Stroke ◽  
Intracranial Stenosis ◽  
Atherosclerotic Disease ◽  
Vascular Events ◽  
Intracranial Atherosclerotic Disease ◽  
Atherosclerotic Stenosis ◽  
Aggressive Medical Management

Background and Purpose: There are limited data on the optimal duration of dual antiplatelet therapy for secondary stroke prevention in patients with symptomatic intracranial atherosclerotic disease. Methods: Consecutive patients presenting with high-grade (70-99%) symptomatic intracranial stenosis from January 1, 2011, to December 31, 2013, and evaluated within 30 days of the index event were eligible for this analysis. All patients underwent treatment with aspirin plus clopidogrel for a target duration of 12 months along with aggressive medical management based on the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) protocol; all patients were given gastrointestinal prophylaxis for the duration of their aspirin and clopidogrel treatment. Clinical and safety outcomes of our cohort were compared with the medical arm of the SAMMPRIS trial cohort (n = 227). Results: Our cohort included 25 patients that met the inclusion criteria. Achievement of blood pressure and LDL cholesterol targets were similar between our cohort and the SAMMPRIS cohort. At 1 year, the rates of stroke, myocardial infarction or vascular death were 0% in our cohort and 16% in the SAMMPRIS cohort (p = 0.03). At 1 year, major bleeding rates were similar between our cohort and the SAMMPRIS cohort (4 vs. 2.2%, p = 1.0). Conclusion: A prolonged course of dual antiplatelet therapy for symptomatic intracranial atherosclerotic disease may be associated with less vascular events with no increase in hemorrhagic complications.

scholarly journals Submaximal Angioplasty for Symptomatic Intracranial Atherosclerotic Disease: A Meta-Analysis of Peri-Procedural and Long-Term Risk

Neurosurgery ◽  
2019 ◽  
Vol 86 (6) ◽  
pp. 755-762
Author(s):  
Christopher J Stapleton ◽  
Yi-Fan Chen ◽  
Hussain Shallwani ◽  
Kunal Vakharia ◽  
Tanya N Turan ◽  
...  
Keyword(s):  
English Language ◽  
Meta Analysis ◽  
Rank Correlation ◽  
Posterior Circulation ◽  
Atherosclerotic Disease ◽  
Inclusion Criteria ◽  
Intracranial Atherosclerotic Disease ◽  
Language Studies ◽  
Event Rates

Abstract BACKGROUND Symptomatic intracranial atherosclerotic disease (ICAD) is an important cause of stroke. Although the high periprocedural risk of intracranial stenting from recent randomized studies has dampened enthusiasm for such interventions, submaximal angioplasty without stenting may represent a safer endovascular treatment option. OBJECTIVE To examine the periprocedural and long-term risks associated with submaximal angioplasty for ICAD based on the available literature. METHODS All English language studies of intracranial angioplasty for ICAD were screened. Inclusion criteria were as follows: ≥ 5 patients, intervention with submaximal angioplasty alone, and identifiable periprocedural (30-d) outcomes. Analysis was co-nducted to identify the following: 1) periprocedural risk of any stroke (ischemic or hemorrh-agic) or death, and 2) stroke in the territory of the target vessel and fatal stroke beyond 30 d. Mixed effects logistic regression was used to summarize event rates. Funnel plot and rank correlation tests were employed to detect publication bias. The relative risk of periprocedural events from anterior vs posterior circulation disease intervention was also examined. RESULTS A total of 9 studies with 408 interventions in 395 patients met inclusion criteria. Six of these studies included 113 posterior circulation interventions. The estimated pooled rate for 30-d stroke or death following submaximal angioplasty was 4.9% (95% CI: 3.2%-7.5%), whereas the estimated pooled rate beyond 30 d was 3.7% (95% CI: 2.2%-6.0%). There was no statistical difference in estimated pooled rate for 30-d stroke or death between patients with anterior (4.8%, 95% CI: 2.8%-7.9%) vs posterior (5.3%, 95% CI: 2.4%-11.3%) circulation disease (P &gt; .99). CONCLUSION Submaximal angioplasty represents a potentially promising intervention for symptomatic ICAD.

scholarly journals Update in the treatment of intracranial atherosclerotic disease

2019 ◽  
Vol 5 (1) ◽  
pp. 59-64 ◽  
Author(s):  
Zachary R Barnard ◽  
Michael J Alexander
Keyword(s):  
Patient Outcomes ◽  
Medical Management ◽  
Atherosclerotic Disease ◽  
Intracranial Atherosclerotic Disease ◽  
Technological Developments ◽  
Surgical Bypass ◽  
Surgical Options ◽  
Intracranial Arteries ◽  
Improve Patient ◽  
Treatment Window

This review highlights the recent evolution of the imaging, medical management, surgical options and endovascular therapies for symptomatic intracranial atherosclerotic disease (ICAD). Recent imaging developments including optical coherence tomography and other modalities to assess the intracranial arteries for symptomatic ICAD are reviewed, not only to diagnose ICAD but to determine if ICAD plaques have any high-risk features for treatment. Potential future developments in the treatment of ICAD are discussed, including the development of trackable drug-coated balloons for the cerebral circulation to treat primary or restenotic arteries, new iterations of self-expanding intracranial stents with easier delivery systems, and the re-examination of indirect surgical bypass techniques for revascularisation. In addition to these important technological developments, however, is the evolving evidence regarding the best treatment window for these techniques and additional factors in medical management which can improve patient outcomes in this devastating pathology.

Safety and efficacy of balloon-mounted stent in the treatment of symptomatic intracranial atherosclerotic disease: a multicenter experience

2021 ◽  
pp. neurintsurg-2021-017818
Author(s):  
Mahmoud H Mohammaden ◽  
Raul G Nogueira ◽  
Wondwossen Tekle ◽  
Santiago Ortega-Gutierrez ◽  
Mudassir Farooqui ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Management ◽  
Randomized Clinical Trials ◽  
Recurrent Stroke ◽  
Atherosclerotic Disease ◽  
Anterior Circulation ◽  
Safety And Efficacy ◽  
Intracranial Atherosclerotic Disease ◽  
Long Term Follow Up

BackgroundRandomized clinical trials have failed to prove that the safety and efficacy of endovascular treatment for symptomatic intracranial atherosclerotic disease (ICAD) is better than that of medical management. A recent study using a self-expandable stent showed acceptable lower rates of periprocedural complications.ObjectiveTo study the safety and efficacy of a balloon-mounted stent (BMS) in the treatment of symptomatic ICAD.MethodsProspectively maintained databases from 15 neuroendovascular centers between 2010 and 2020 were reviewed. Patients were included if they had severe symptomatic intracranial stenosis in the target artery, medical management had failed, and they underwent intracranial stenting with BMS after 24 hours of the qualifying event. The primary outcome was the occurrence of stroke and mortality within 72 hours after the procedure. Secondary outcomes were the occurrence of stroke, transient ischemic attacks (TIAs), and mortality on long-term follow-up.ResultsA total of 232 patients were eligible for the analysis (mean age 62.8 years, 34.1% female). The intracranial stenotic lesions were located in the anterior circulation in 135 (58.2%) cases. Recurrent stroke was the qualifying event in 165 (71.1%) while recurrent TIA was identified in 67 (28.9%) cases. The median (IQR) time from the qualifying event to stenting was 5 (2–20.75) days. Strokes were reported in 13 (5.6%) patients within 72 hours of the procedure; 9 (3.9%) ischemic and 4 (1.7%) hemorrhagic, and mortality in 2 (0.9%) cases. Among 189 patients with median follow-up time 6 (3–14.5) months, 12 (6.3%) had TIA and 7 (3.7%) had strokes. Three patients (1.6%) died from causes not related to stroke.ConclusionOur study has shown that BMS may be a safe and effective treatment for medically refractory symptomatic ICAD. Additional prospective randomized clinical trials are warranted.

Medical Management Versus Surgical Bypass for Symptomatic Intracranial Atherosclerotic Disease: A Systematic Review

2019 ◽  
Vol 129 ◽  
pp. 62-71 ◽  
Author(s):  
Adeel Ilyas ◽  
Ching-Jen Chen ◽  
Natasha Ironside ◽  
Thomas J. Buell ◽  
Gustavo Chagoya ◽  
...  
Keyword(s):  
Systematic Review ◽  
Medical Management ◽  
Atherosclerotic Disease ◽  
Intracranial Atherosclerotic Disease ◽  
Surgical Bypass

scholarly journals 318. Deferring Amputation in Diabetic Foot Osteomyelitis: Doing more Harm than Good?

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S231-S232
Author(s):  
Shiwei Zhou ◽  
Brian M Schmidt ◽  
Oryan Henig ◽  
Keith S Kaye
Keyword(s):  
Diabetic Foot ◽  
Medical Management ◽  
Wound Care ◽  
Cohort Analysis ◽  
Severity Of Illness ◽  
Complete Healing ◽  
Knee Amputation ◽  
Management Group ◽  
One Year ◽  
Diabetic Foot Osteomyelitis

Abstract Background Diabetic foot osteomyelitis (DFO) is a leading cause of below knee amputation (BKA). Even when medical treatment is deemed unlikely to succeed, patients with DFO are often resistant to amputation. Methods An observational cohort analysis was done on patients with DFO at Michigan Medicine who were evaluated by podiatry and recommended BKA from Oct 2015 - Jun 2019. Primary outcome was mortality after BKA recommendation. Secondary outcomes were healing of affected limb, rate of BKA or above knee amputation (AKA) and total antibiotic days in the 6 months following. All intravenous antibiotics and oral courses of linezolid and fluoroquinolones were captured. Results Of 44 patients with DFO, 18 chose BKA, 26 chose medical management with wound care. Mean age of the cohort was 61, 68% male, 80% white with a median Charlson Comorbidity Index of 6 (IQR 4,7). The two groups were similar with regards to demographics and comorbid conditions. Those who chose medical management did so because their infection was non-life-threatening and they desired to avoid amputation. One-year mortality was greater in patients who were medically managed compared to those who had BKA (23.1% vs 0%, OR 11.7, 95% CI 0.6–222.9). Considering only the 33 patients who were followed for at least 2 years, 2-year mortality was also greater in the medically managed group compared to the BKA group (38.5% vs 5.6%, OR 10.6, 95% CI 1.2–92.7, Figure 1). Fewer patients in the medical management group had complete healing of their wound/stump compared to the BKA group (46.2% vs 88.9%, OR 9.3, 95% CI 1.8–49.1). In the medically managed group, 18 (69%) patients went on to require BKA or AKA at a median of 76.5 days compared to 2 (11%) in the BKA group who required AKA at 1 and 11 days following recommendation. Median antibiotic days were significantly greater in the medically managed group compared to the BKA group (55 IQR 42,78 vs 17 IQR 10,37, p=0.0017). Conclusion In this cohort of DFO patients where BKA was recommended, medical management was associated with increased mortality, poor healing of the affected limb, and excess antibiotic exposure compared to BKA. These findings are particularly notable as case mix and severity of illness were similar between the two groups. This study can be used to inform providers and patients in cases where BKA is recommended. Disclosures All Authors: No reported disclosures

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