scholarly journals Submaximal angioplasty for symptomatic intracranial atherosclerosis: a prospective Phase I study

2016 ◽  
Vol 125 (4) ◽  
pp. 964-971 ◽  
Author(s):  
Travis M. Dumont ◽  
Ashish Sonig ◽  
Maxim Mokin ◽  
Jorge L. Eller ◽  
Grant C. Sorkin ◽  
...  

OBJECTIVE Intracranial atherosclerotic disease (ICAD) accounts for approximately 10% of ischemic strokes. The recent Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study demonstrated a high incidence of perioperative complications (15%) for treatment of ICAD with stenting. Although the incidence of stroke was lower in the medical arm, recurrent stroke was found in 12% of patients despite aggressive medical management, suggesting that intervention may remain a viable option for ICAD if perioperative risk is minimized. Angioplasty without stenting represents an alternative and understudied revascularization treatment for ICAD. Submaximal angioplasty limits the risks of thromboembolism, vessel perforation, and reperfusion hemorrhage that were frequently reported with stenting in the SAMMPRIS trial. The authors conducted a prospective Phase I trial designed to assess the safety of submaximal angioplasty in patients with symptomatic ICAD. METHODS This study was approved by the local institutional review board. Demographic and clinical data were prospectively collected. Angioplasty was performed with a balloon undersized to approximately 50%–70% of the nondiseased vessel diameter in patients with symptomatic ICAD who had angiographically significant stenosis of ≥ 70%. The primary outcome measure was the incidence of periprocedural complications (combined rate of death, stroke, and hemorrhage occurring within 30 days and at 1 year). RESULTS Among the 65 patients with symptomatic ICAD who were screened, 24 had significant angiographic stenosis that met the inclusion criteria of this study. The mean age was 64.08 years (median 65 years; SD ± 11.24 years), most were men (62.5%), and most were white (66.67%). Many patients had concomitants of vascular disease, including hypertension (95.8%), hyperlipidemia (70.83%), smoking history (54.1%), and diabetes mellitus (50.0%). Coronary artery disease (41.66%) and previous stroke or transient ischemic attack (45.83%) were frequently present. Most patients (75%) had anterior circulation stenosis. The mean preprocedure stenosis was 80.16% (median 80%, range 70%–95%). Submaximal angioplasty was performed in patients who met the inclusion criteria, with a mean postangioplasty stenosis rate of 54.62% (median 55.5%, range 31%–78%). Rates of ischemic stroke in the territory of the treated artery were 0% within 30 days and 5.55% (in the only patient who presented with recurrent stroke) at 1 year. The mortality and hemorrhage rates in this series were 0%. CONCLUSIONS This study demonstrates the safety of the submaximal angioplasty technique, with no permanent periprocedural complications in 24 treated patients.

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Rajbeer S Sangha ◽  
Carlos Corado ◽  
Richard A Bernstein ◽  
Ilana Ruff ◽  
Yvonne Curran ◽  
...  

Background: Since the SAMMPRIS trial, aggressive medical management (AMM) with the use of dual antiplatelets (aspirin, clopidogrel) and high dose statin therapy has been standard of care for patients with symptomatic intracranial atherosclerotic disease (ICAD). However, there is limited data on the “real-world” application of this regimen. We hypothesized that 30-day recurrent stroke risk among patients treated with AMM would be similar to that in SAMMPRIS medically-treated patients. Methods: Using the prospective Northwestern University Brain Attack Registry, we identified all patients admitted between 8/1/12 and 1/31/14 with 1) confirmed ischemic stroke or transient ischemic attack (TIA); 2) independently adjudicated symptomatic ICAD; and 3) discharged on AMM. At 30 days (28-35 day window) post-stroke, patients or proxies were contacted by telephone to review events and outcomes. We also utilized an electronic surveillance system of hospital records at any of 3 health system hospitals with confirmation by manual review of the medical record in all instances of reported recurrent stroke or TIA. Ischemic stroke in the territory of the symptomatic stenotic artery was the primary outcome. We calculated 30-day rate of stroke in the territory of the stenotic artery and 95% confidence intervals using the Wald method and compared it with that reported in the SAMMPRIS trial. Results: Among 36 patients who met study criteria, 13 (36.1%) were female and mean age was 65.4 (± 9.7) years. Median initial NIHSS score was 4 (interquartile range 0-17). Symptomatic ICAD was localized to the anterior circulation in 21 (58%) patients and posterior circulation in 15 (41.7%). At 30 days, 3 of the 36 patients (8.3%, 95% CI 2.1-22.6%) had recurrent stroke compared to 5.8% in the medical arm of SAMMPRIS (p=0.47). An additional 3 patients (8.3%) experienced TIA within 30 days. Conclusions: In a single-center observational cohort study, we found that AMM in patients with symptomatic ICAD yielded similar rates of recurrent stroke at 30-days as observed in the SAMMPRIS trial. Our study provides “real-world” confirmation of the potential benefits of AMM in this high-risk stroke subtype.


2016 ◽  
Vol 5 (3-4) ◽  
pp. 157-164 ◽  
Author(s):  
Tareq Kass-Hout ◽  
Melanie Winningham ◽  
Omar Kass-Hout ◽  
Laura Henriquez ◽  
Frank Tong ◽  
...  

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.


2019 ◽  
Vol 47 (1-2) ◽  
pp. 24-31 ◽  
Author(s):  
Tanya N. Turan ◽  
Sami Al Kasab ◽  
Alison Smock ◽  
George Cotsonis ◽  
David Bachman ◽  
...  

Background: Cerebrovascular disease is an important cause of cognitive impairment. The aim of this study is to report the relationship between cognitive function and risk factors at baseline and during follow-up in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial. Methods: Subjects in the SAMMPRIS trial were included in this study. In order to have an assessment of cognitive function independent of stroke, patients with a stroke as a qualifying event whose deficits included aphasia or neglect were excluded from these analyses as were those with a cerebrovascular event during follow-up. The Montreal Cognitive Assessment (MoCA) score was used to assess cognitive impairment at baseline, 4 months, 12 months and closeout. Cognitive impairment was defined as MoCA < 26. A multivariate analysis was performed to determine what risk factors were independent predictors of cognitive function at baseline, 12 months and closeout. Among patients randomized to aggressive medical management only, the percentage of patients with cognitive impairment was compared between patients in versus out of target for each risk factor at 12 months and closeout. Results: Of the 451 patients in SAMMPRIS, 371 patients met the inclusion criteria. MoCA < 26 was present in 55% at baseline. Older age and physical inactivity were associated with cognitive impairment at baseline. Older age, non-white race, lower baseline body mass index, and baseline cognitive impairment were associated with cognitive impairment at 12 months. In the aggressive medical management group, at 12 months, physical inactivity during follow-up was the strongest risk factor associated with cognitive impairment. Conclusion: Cognitive impairment is common in patients with severe symptomatic intracranial atherosclerosis. Physical inactivity at baseline and during follow-up is a strong predictor of cognitive impairment.


Stroke ◽  
2012 ◽  
Vol 43 (10) ◽  
pp. 2806-2809 ◽  
Author(s):  
Marc I. Chimowitz ◽  
David Fiorella ◽  
Colin P. Derdeyn ◽  
Tanya N. Turan ◽  
Bethany F. Lane ◽  
...  

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Miguel D Quintero-Consuegra ◽  
Juan F Toscano ◽  
Robin Babadjouni ◽  
Daniel Chang ◽  
Peyton Nisson ◽  
...  

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.


2021 ◽  
Author(s):  
Rimal H Dossani ◽  
Muhammad Waqas ◽  
Justin M Cappuzzo ◽  
Ashish Sonig ◽  
Adnan H Siddiqui ◽  
...  

Abstract Intracranial atherosclerotic disease (ICAD) is a common cause of stroke. Antiplatelet therapy is the mainstay for symptomatic ICAD treatment. Endovascular management with submaximal angioplasty and/or intracranial stenting is reserved for patients with repeated ischemic events despite optimal medical therapy. We demonstrate intracranial angioplasty and stenting technique, technique indications, and sizing of stent and target vessel diameter. Stenting and angioplasty have been described in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis and Wingspan Stent System Post Market Surveillance trials.1,2 Submaximal angioplasty has also been described.3 This patient, who had been on dual antiplatelet therapy for several months, initially presented with occlusion of the left middle cerebral artery M2 inferior division and underwent mechanical thrombectomy with successful reperfusion. Postoperatively, the patient's symptoms did not improve. Medical management was optimized with heparin infusion. However, repeat stroke study demonstrated M2 inferior division reocclusion. A decision was made to proceed with intracranial angioplasty and stenting. P2Y12 levels were therapeutic. Under moderate conscious sedation, submaximal angioplasty of up to 80% of the normal M2 caliber was attempted. However, we observed persistent high-grade stenosis of the M2 inferior division. The major risk of crossing the lesion for angioplasty is vessel perforation. To safely perform this maneuver, we used a J-configured Synchro-2 microwire (Stryker). Because of the patient's recent thrombectomy, we also had prior tactile feedback about how much resistance was encountered while crossing the occlusion. We then deployed a balloon-mounted intracranial stent for optimal radial force across the stenotic area to restore perfusion. Postoperative computed tomography perfusion showed resolution of the previously noticed perfusion deficit. The patient gave informed consent for the procedures and video recording. Institutional review board approval was deemed unnecessary. Video. ©University at Buffalo Neurosurgery, September 2020. With permission.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Shyam Prabhakaran ◽  
Rajbeer Sangha ◽  
Sameer Ansari ◽  
PN Sylaja ◽  
David S Liebeskind ◽  
...  

Introduction: Compared to recurrent stroke risk, data are scarce on cognitive outcomes in patients with symptomatic intracranial atherosclerotic disease (ICAD). We evaluated cognition in patients with symptomatic ICAD at 90 days and factors that predict cognitive function. Methods: Using a prospective registry at a single center, we identified consecutive patients admitted between 2012 and 2017 with confirmed ischemic stroke or transient ischemic attack (TIA) and independently adjudicated symptomatic ICAD with stenosis of >50%. A blinded rater assessed infarct pattern: single perforator, territorial, borderzone, or mixed. At 90 days post-stroke, patients or proxies were emailed Neuro-QOL surveys for cognitive and motor function. We also collected data on recurrent stroke in the territory of the stenosis within 3 months. We evaluated baseline and imaging predictors of 90-day cognition T-score using stepwise linear regression adjusting for age, sex, prior stroke, initial NIHSS score, location of stenosis, degree of stenosis, use of dual antiplatelet therapy at discharge, and recurrent stroke. Results: Among 212 patients who met study criteria, 125 (59.0%) completed cognition surveys; those who completed surveys were similar to those who did not across demographic, clinical, and imaging characteristics. In the analyzed cohort, the mean age was 68.3 (±12.6) years and median initial NIHSS score was 3 (interquartile range 1-6). Symptomatic ICAD was localized to the anterior circulation in 84 (67.2%) patients and 102 (81.6%) had stenosis >70%. At 90 days, the mean cognition T-score was 50.1 (±10.4) and 25 (20%) had scores <40. In adjusted analysis, increasing age (b=-0.15, p=0.031), higher initial NIHSS score (b=-0.69, p<0.001), and a mixed or territorial infarct pattern (b=-0.39, p=0.028) were associated with lower cognition T-scores. Conclusions: In a single-center observational cohort study, cognitive impairment was noted in 20% of patients with symptomatic ICAD at 3 months. Besides age and NIHSS score, baseline infarct pattern was a strong predictor of worse cognitive function. Our data suggest that cognitive impairment is common in patients with symptomatic ICAD and baseline clinical and imaging characteristics may identify those at risk.


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