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.

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 T P102: Recurrent Stroke Risk in Patients With ICAD Treated With Aggressive Medical Management: A Comparison With The Sammpris Trial

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Rajbeer S Sangha ◽  
Carlos Corado ◽  
Richard A Bernstein ◽  
Ilana Ruff ◽  
Yvonne Curran ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Real World ◽  
Medical Management ◽  
Stroke Risk ◽  
Recurrent Stroke ◽  
High Dose ◽  
Stroke Subtype ◽  
Anterior Circulation ◽  
Intracranial Atherosclerotic Disease ◽  
Aggressive Medical Management

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.

scholarly journals Stapled hemorrhoidectomy: present status

2005 ◽  
Vol 42 (3) ◽  
pp. 191-194 ◽  
Author(s):  
Antônio Lacerda-Filho ◽  
Rodrigo Gomes da Silva
Keyword(s):  
Clinical Trials ◽  
Return To Work ◽  
Randomized Clinical Trials ◽  
Recovery Period ◽  
Conventional Technique ◽  
Stapled Hemorrhoidectomy ◽  
Large Size ◽  
Conventional Hemorrhoidectomy ◽  
Long Term Follow Up

AIM: To evaluate cost-effectiveness of stapled hemorrhoidectomy comparing its results with conventional technique. SOURCE OF DATA: We retrospectively analyzed the MEDLINE data basis from 2000 to 2004 studying randomized clinical trials which compared pain intensity, recovery period, return to work and occurrence of anal incontinence, in addition to postoperative complications and costs evaluation between stapled and conventional hemorrhoidectomy during different periods of follow-up. CONCLUSIONS: Stapled hemorrhoidectomy provides lesser postoperative pain and earlier return to work than conventional hemorrhoidectomy. However, its efficacy could not be determined, since rigorous prospective and randomized clinical trials with long-term follow-up periods and large size samples are not available at this time.

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.

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