Stroke, Death Rate Higher With Carotid Stenting Than Surgery

2011 ◽  
Vol 4 (1) ◽  
pp. 14
Author(s):  
MARY ANN MOON
VASA ◽  
2013 ◽  
Vol 42 (4) ◽  
pp. 264-274
Author(s):  
Dagmar Krajíčková ◽  
Antonín Krajina ◽  
Miroslav Lojík ◽  
Martina Mulačová ◽  
Martin Vališ

Background: Intracranial atherosclerotic stenosis is a major cause of stroke and yet there are currently no proven effective treatments for it. The SAMMPRIS trial, comparing aggressive medical management alone with aggressive medical management combined with intracranial angioplasty and stenting, was prematurely halted when an unexpectedly high rate of periprocedural events was found in the endovascular arm. The goal of our study is to report the immediate and long-term outcomes of patients with ≥ 70 % symptomatic intracranial atherosclerotic stenosis treated with balloon angioplasty and stent placement in a single centre. Patients and methods: This is a retrospective review of 37 consecutive patients with 42 procedures of ballon angioplasty and stenting for intracranial atherosclerotic stenosis (≥ 70 % stenosis) treated between 1999 and 2012. Technical success (residual stenosis ≤ 50 %), periprocedural success (no vascular complications within 72 hours), and long-term outcomes are reported. Results: Technical and periprocedural success was achieved in 90.5 % of patients. The within 72 hours periprocedural stroke/death rate was 7.1 % (4.8 % intracranial haemorrhage), and the 30-day stroke/death rate was 9.5 %. Thirty patients (81 %) had clinical follow-up at ≥ 6 months. During follow-up, 5 patients developed 6 ischemic events; 5 of them (17 %) were ipsilateral. The restenosis rate was 27 %, and the retreatment rate was 12 %. Conclusions: Our outcomes of the balloon angioplasty/stent placement for intracranial atherosclerotic stenosis are better than those in the SAMMPRIS study and compare favourably with those in large registries and observational studies.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Paola De Rango ◽  
Fabio Verzini ◽  
Piergiorgio Cao ◽  
Enrico Cieri ◽  
Giuseppe Giordano ◽  
...  

Absolute stroke risk and perioperative stroke risk during carotid revascularization are higher in patients with symptomatic than in those with asymptomatic carotid stenosis. Age is one of the main risk factors for stroke and trials have shown a significant age interaction after carotid stenting (CAS). This study aims to analyze the effect of age on outcomes of carotid revascularization using the 70-year threshold as suggested by CREST. Methods: From 2001 to 2010 patients receiving carotid revascularization, either by CAS or by endarterectomy (CEA) were reviewed. Perioperative stroke-death rates and 72-month survival and late stroke incidence were compared in symptomatic and asymptomatic patients with less and more than 70years. Results: 2196 procedures, 1080 by CAS 1116 by CEA, were reviewed;684 were performed for carotid referable symptoms. Symptomatic patients showed higher perioperative stroke/death risks (3.5% vs 1.9%, p=0.034) and lower 72-months survival (74% vs 82%, p=0.0001) or freedom from late stroke (93% vs 97%, p=0.002) than asymptomatic patients with similar differences detected within CEA or CAS procedure. When only the group of 949 youngsters (≤70y) was analyzed, symptomatic and asymptomatic patients shared similar low perioperative stroke/death risks: 2.1% vs 1.3%, p=0.39. For young symptomatic patients, perioperative stroke/death risk was comparably low in CAS and CEA: 1.8% vs 1.2%. At 72 months, survival (98% vs 97%, p=0.49) and freedom from stroke (89% vs 89%, p=0.33) rates were similarly high in symptomatic and asymptomatic young patients. Comparable risks between the symptomatic and asymptomatic youngsters were found after each CAS (perioperative stroke/death: p=0.64; survival: p=0.10; late stroke: p=0.50) and CEA (perioperative stroke/death: p=0.49; survival: p=0.91; late stroke: p=0.64) procedure. Higher perioperative and late risks were confirmed for symptomatic patients in the elderly (>70y) subgroup (n=1247) regardless of the procedure. Conclusions: Outcomes following carotid revascularization are related to patient age. For younger ages (≤70years) symptomatic and asymptomatic patients may share similarly low perioperative and late risks of stroke and death after carotid revascularization whichever the procedure applied.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Paola De Rango ◽  
Massimo Lenti ◽  
Enrico Cieri ◽  
Piergiorgio Cao ◽  
Giuseppe Giordano ◽  
...  

Objective. Due to the different stroke risk exposure, advisability of carotid revascularization by carotid stenting (CAS) or endarterectomy (CEA) strictly depends on patients’ symptomatic status. Periprocedural and 5-year data of 2196 consecutive procedures (1080 CAS, 1116 CEA) based on physician-guided indication for CEA vs CAS and performed after training outside randomized trials, were reviewed for safety. Methods. 684 symptomatic and 1512 asymptomatic patients were analyzed for periprocedural stroke/death and 5-year death or stroke incidence. Kaplan-Meier survival curves with type-of-procedure interaction were employed. Results. Symptomatic patients were older (71.9y vs 71.04y), less frequently females (25.3% vs 30.8%) and treated more by CEA (60.8%) than by CAS (p<0.001). Asymptomatic patients were more likely affected by cardiac disease, peripheral disease and hyperlipidemia. Periprocedural stroke/death was higher in symptomatic than in asymptomatic patients (3.5% vs 1.9%;OR 1.8, 95%CI1.07-3.2) without significant differences between CAS and CEA in both symptomatic (4.5%CAS vs 2.9%CEA) and asymptomatic (2.2% CAS vs 1.6% CEA) groups. Symptomatic patients showed higher 5-year mortality and stroke incidence: survival rate was 78.4% in symptomatic and 85.5% in asymptomatic (p<0.0001). Late stroke freedom was 93.5% in symptomatic and 97.7% in asymptomatic (p=0.001). There were no differences, according to the procedure (CAS vs CEA) for treatment, in survival (Symptomatic: 85% vs 75%; Asymptomatic: 83% vs 83%) or late stroke incidence (Symptomatic: 93% vs 93%; Asymptomatic: 97% vs 97%). Conclusions. Symptomatic patients show higher risks after carotid revascularization and 5-year outcomes are inferior to those of asymptomatic patients regardless of the surgical procedure. Periprocedural stroke/death rates, either by CAS or CEA, are within the complication threshold rates suggested in current guidelines for both symptomatic and asymptomatic patients.


2017 ◽  
Vol 10 (12) ◽  
pp. 1257-1265 ◽  
Author(s):  
Christoph Knappich ◽  
Andreas Kuehnl ◽  
Pavlos Tsantilas ◽  
Sofie Schmid ◽  
Thorben Breitkreuz ◽  
...  

Stroke ◽  
2020 ◽  
Vol 51 (9) ◽  
pp. 2620-2629 ◽  
Author(s):  
Vikram S. Kashyap ◽  
Peter A. Schneider ◽  
Mazin Foteh ◽  
Raghu Motaganahalli ◽  
Rasesh Shah ◽  
...  

Background and Purpose: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience. Methods: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events. Results: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%. Conclusions: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02536378.


2002 ◽  
Vol 9 (6) ◽  
pp. 777-785 ◽  
Author(s):  
Sumaira Macdonald ◽  
Fiona McKevitt ◽  
Graham S. Venables ◽  
Trevor J. Cleveland ◽  
Peter A. Gaines

Purpose: To compare outcomes for two nonrandomized cohorts of patients with high-grade carotid disease who underwent either unprotected carotid stenting or stent implantation protected by the NeuroShield filter. Methods: Under this protocol, symptomatic patients with carotid stenoses >70% or asymptomatic patients with bilateral carotid stenoses who were being evaluated for coronary artery bypass grafting were eligible for carotid stenting. Between December 1998 and November 2001, 75 consecutive patients (57 men; median age 67 years range 45–85) underwent carotid stenting without cerebral protection; concurrently, 75 carotid stent procedures protected with the NeuroShield filter were performed in 73 patients (51 men; median age 66 years, range 47–83). A neurologist reviewed all patients before and after treatment. The groups were comparable for age, sex, and symptoms, but the protected group had a higher proportion of postsurgical restenoses (14.7% versus 1.3%; p=0.003). Outcome measures included death and neurological events at 24 hours and 30 days. Results: There were minor technical difficulties in 12 of the protected group, but none were clinically relevant. The procedural all-stroke/death rates in the unprotected versus protected groups, respectively, were 5.3% (4/75) and 2.7% (2/75; p=0.681), while the disabling stroke/death rates were 4% (3/75) and 1.3% (1/75; p=0.620). At 30 days, the all-stroke/death rates were 10.7% (8/75) in the unprotected group and 4.0% (3/75) in the protected group (p=0.117); the death/major-disability-from-stroke rates were 6.7% (5/75) and 2.7% (2/75), respectively (p=0.442). Conclusions: Filter-related complications are well tolerated. Neuroprotection devices have the potential to reduce the procedural neurological event rate. Larger series and/or randomized trials are required for further evaluation.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Nancy T Kung ◽  
Dushyant Damania ◽  
Minal Jain ◽  
Anunaya Jain ◽  
George E Koch ◽  
...  

Background: SAMMPRIS concluded that aggressive medical management (AMM) was superior to early percutaneous transluminal angioplasty and stenting (PTAS) plus AMM for patients with symptomatic severe intracranial stenosis. WASID and SAMMPRIS have shown that the risk of recurrent stroke after the initial event is early, non-linear, and markedly diminishes over one year irrespective of treatment. We therefore investigated the feasibility of demonstrating benefit for a new endovascular intervention (nEI) for these patients within this narrow time window. Methods: We compared 1-year stroke/death rates in patients treated with AMM versus a hypothesized nEI. The 1-year stroke/death rate for AMM was derived from the SAMMPRIS trial. A minimal 30-day stroke/death rate for a nEI was set to 3% using data from endovascular treatment of unruptured intracranial aneurysms. The subsequent stroke/death rate over the ensuing 11 months was varied above and below the rates achieved in SAMMPRIS, and the sample size for a future 1-sided superiority trial was calculated at 0.05 alpha and 80% power. Results: For a nEI with the same 31-365 days stroke/death rate as SAMMPRIS AMM (5.3%) but an improved 30-day stroke/death rate of 3%, a total of 1,484 subjects would be required to show significant benefit over AMM. At the SAMMPRIS recruitment rate of 187 patients/year, it would take 7.9 years to recruit 1,484 patients. Varying the 31-365 days stroke/death rate for nEI from 3% to 8%, and keeping 0-30 days stroke/death rate constant at 3%, (1 year total nEI stroke/death rate ranging from 6% to 11%), the total sample size required to show significant benefit at 1 year over AMM (1 year stroke/death rate of 12.2%) would be 518 and 17,600 respectively. This trial would take approximately 2.8 years and 94.1 years to recruit the eligible subjects at the SAMMPRIS rate, respectively. Conclusion: Identification of higher-risk subgroups, demonstration of decreased 30-day endovascular complication rates, and enhanced recruitment strategies will be necessary before institution of trials of new endovascular interventions for symptomatic intracranial stenosis.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Mahmoud Rayes ◽  
Pratik Bhattacharya ◽  
Rahul Damani ◽  
Seemant Chaturvedi

Background: Nonspecific symptoms such as dizziness and syncope may prompt evaluation of the carotid circulation and detection of carotid stenosis. The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) demonstrated equivalent outcomes from Endarterectomy (CEA) and Stenting (CAS) in asymptomatic stenosis. We reviewed the trends in selection and outcomes from revascularization procedures for nonspecific symptoms in the light of CREST results. Methods: We performed a retrospective review of carotid revascularization procedures at a large volume urban medical center, between June 2009 (8 months pre-CREST) and April 2012. Demographics, surgical risk features and in-hospital outcomes of stroke/death/MI were reviewed. Patients were labeled as having nonspecific symptoms when they presented with posterior circulation symptoms or with non-focal symptoms i.e. Dizziness, syncope, etc. To evaluate the effect of CREST, we compared pre CREST (up to Jan 2010) and post CREST cases (Feb 2010 to Apr 2012). Results: 701 procedures (36.1% CEA, 63.9% CAS) were performed and mean age was 70 ±10 years. Non-specific indications accounted for 13% of CEA and 15.9% of CAS. Procedures for nonspecific symptoms did not increase post CREST in the CEA group (12.1% VS 13.3%). They increased significantly in the CAS group (6.3% pre and 18.5% post CREST). Among CAS, the rise was insignificant in the first 8 months (Feb 2010-Sep 2010) post CREST: 7.5%. This rose to 21.2% from Oct 2010 to May 2011: p=0.0017; and 23.8% from June 2011 to April 2012: p=0.0004. The rise in CAS was noted among elderly patients (>70 years), a group in which CREST demonstrated higher complication rates. The rise was noted among both men and women and they did not have surgical high-risk criteria. In-hospital complication rates of stroke/death/MI were 5.6% in this group. Most complications occurred in patients >70 years. Conclusion: CAS for nonspecific symptoms has increased following CREST, and the complication rates associated with these procedures is significant. This raises concern about the value of this procedure. Primary care physicians evaluating non-specific symptoms should obtain neurological expertise prior to revascularization procedures, to allow appropriate patient selection.


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