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Timing and Outcomes of Intracranial Stenting in the Post-SAMMPRIS Era: A Systematic Review.

ABSTRACT: Objective: To investigate the impact of timing on the safety and efficacy of stenting for ICAS, we reviewed high-volume randomized controlled trials or prospective cohort studies of stenting for intracranial atherosclerotic artery stenosis (ICAS) after the SAMMPRIS trial. Methods: We included randomized controlled trials or prospective cohort studies since 2011 (the publication of the SAMMPRIS trial), evaluating the outcomes of intracranial stenting for ICAS patients. The primary outcomes were perioperative and 1-year stroke or death rate. The interaction of timing and outcomes were shown on trend plots. Overall meta-analysis and subgroup analysis by timing of intracranial stenting were conducted. Results: Fourteen studies with a total of 1,950 patients were included. The perioperative and post-operative stroke or death rates decreased with the time of stenting to the qualifying events. The perioperative stroke rate was significantly higher in patients treated within 21 days after the qualifying events, compared to those beyond 21 days (IRR = 1.60, 95%CI: 1.10-2.33; p = 0.014), similar relationships were obtained for both post-procedural (IRR = 1.61, 95%CI: 1.02-2.55; p = 0.042) and 1-year (IRR = 1.51, 95%CI: 1.10-2.08; p = 0.012) stroke or death rate. Conclusions: The timing of intracranial stenting may influence the safety and efficacy outcomes of stenting. Intracranial stenting within 21 days from the qualifying events may confer a higher risk of stroke or death. More studies are needed to confirm the impact of timing and the proper cut-off value.

SUBMITTER: Yu Y

PROVIDER: S-EPMC7890236 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Timing and Outcomes of Intracranial Stenting in the Post-SAMMPRIS Era: A Systematic Review.

Yu Yanying Y Wang Tao T Yang Kun K Zhang Xiao X Yu Simon Chun Ho SCH Luo Jichang J Yang Bin B Wang Yabing Y Ma Yan Y Gao Peng P Jiao Liqun L

Frontiers in neurology 20210204

<b>Objective:</b> To investigate the impact of timing on the safety and efficacy of stenting for ICAS, we reviewed high-volume randomized controlled trials or prospective cohort studies of stenting for intracranial atherosclerotic artery stenosis (ICAS) after the SAMMPRIS trial. <b>Methods:</b> We included randomized controlled trials or prospective cohort studies since 2011 (the publication of the SAMMPRIS trial), evaluating the outcomes of intracranial stenting for ICAS patients. The primary o ...[more]

PMID: 33613442

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Project description:Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial.Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm.Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P ? 0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P ? 0.05) with ischemic events.Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice. Clinical Trial Registration Information- URL: http://clinicaltrials.gov. Unique Identifier: NCT00576693.

Project description:ObjectiveTo investigate the potential beneficial and adverse effects of routine ureteric stent placement after ureteroscopy.DesignSystematic review and meta-analysis of randomised controlled trials.Data sourcesCochrane controlled trials register (2006 issue 2), Embase, and Medline (1966 to 31 March 2006), without language restrictions. Review methods We included all randomised controlled trials that reported various outcomes with or without stenting after ureteroscopy. Two reviewers independently extracted data and assessed quality. Meta-analyses used both fixed and random effects models with dichotomous data reported as relative risk and continuous data as a weighted mean difference with 95% confidence intervals.ResultsNine randomised controlled trials (reporting 831 participants) were identified. The incidence of lower urinary tract symptoms was significantly higher in participants who had a stent inserted (relative risk 2.25, 95% confidence interval 1.14 to 4.43, for dysuria; 2.00, 1.11 to 3.62, for frequency or urgency) after ureteroscopy. There was no significant difference in postoperative requirement for analgesia, urinary tract infections, stone free rate, and ureteric strictures in the two groups. Because of marked heterogeneity, formal pooling of data was not possible for some outcomes such as flank pain. A pooled analysis showed a reduced likelihood of unplanned medical visits or admission to hospital in the group with stents (0.53, 0.17 to 1.60), although this difference was not significant. None of the trials reported on health related quality of life. Cost reported in three randomised controlled trials favoured the group without stents. The overall quality of trials was poor and reporting of outcomes inconsistent.ConclusionsPatients with stents after ureteroscopy have significantly higher morbidity in the form of irritative lower urinary symptoms with no influence on stone free rate, rate of urinary tract infection, requirement for analgesia, or long term ureteric stricture formation. Because of the marked heterogeneity and poor quality of reporting of the included trials, the place of stenting in the management of patients after uncomplicated ureteroscopy remains unclear.

Project description:Early results of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial showed that, by 30 days, 33 (14·7%) of 224 patients in the stenting group and 13 (5·8%) of 227 patients in the medical group had died or had a stroke (percentages are product limit estimates), but provided insufficient data to establish whether stenting offered any longer-term benefit. Here we report the long-term outcome of patients in this trial.We randomly assigned (1:1, stratified by centre with randomly permuted block sizes) 451 patients with recent transient ischaemic attack or stroke related to 70-99% stenosis of a major intracranial artery to aggressive medical management (antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle-modification programme) or aggressive medical management plus stenting with the Wingspan stent. The primary endpoint was any of the following: stroke or death within 30 days after enrolment, ischaemic stroke in the territory of the qualifying artery beyond 30 days of enrolment, or stroke or death within 30 days after a revascularisation procedure of the qualifying lesion during follow-up. Primary endpoint analysis of between-group differences with log-rank test was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT 00576693.During a median follow-up of 32·4 months, 34 (15%) of 227 patients in the medical group and 52 (23%) of 224 patients in the stenting group had a primary endpoint event. The cumulative probability of the primary endpoints was smaller in the medical group versus the percutaneous transluminal angioplasty and stenting (PTAS) group (p=0·0252). Beyond 30 days, 21 (10%) of 210 patients in the medical group and 19 (10%) of 191 patients in the stenting group had a primary endpoint. The absolute differences in the primary endpoint rates between the two groups were 7·1% at year 1 (95% CI 0·2 to 13·8%; p=0·0428), 6·5% at year 2 (-0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 [26%] of 224 patients vs 42 [19%] of 227 patients; p=0·0468) and major haemorrhage (29 [13%]of 224 patients vs 10 [4%] of 227 patients; p=0·0009).The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up. Our findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis.National Institute of Neurological Disorders and Stroke (NINDS) and others.

Project description:Intracranial arterial stenosis (ICAS) and small vessel disease (SVD) may coexist. There are limited data on the frequency and risk factors for coexistent SVD and the effect of SVD on stroke recurrence in patients receiving medical treatment for ICAS.To investigate the frequency and risk factors for SVD and the effect of SVD on stroke recurrence in patients with ICAS.A post hoc analysis of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study, a prospective, multicenter clinical trial. Among 451 participants, 313 (69.4%) had baseline brain magnetic resonance imaging scans read centrally for SVD that was defined by any of the following: old lacunar infarction, grade 2 to 3 on the Fazekas scale (for high-grade white matter hyperintensities), or microbleeds. Patient enrollment in SAMMPRIS began November 25, 2008, and follow-up ended on April 30, 2013. Data analysis for the present study was performed from May 13, 2014, to July 29, 2015.Risk factors in patients with vs without SVD and the association between SVD and other baseline risk factors with any ischemic stroke and ischemic stroke in the territory of the stenotic artery determined using proportional hazards regression.Of 313 patients, 155 individuals (49.5%) had SVD noted on baseline magnetic resonance imaging. Variables that were significantly higher in patients with SVD, reported as mean (SD), included age, 63.5 (10.5) years (P?<?.001), systolic blood pressure, 149 (22) mm Hg (P?<?.001), glucose level, 130 (50) mg/dL (P?=?.03), and lower Montreal Cognitive Assessment scores (median, ?24 [interquartile range, 20-26]; P?=?.02).Other significant variables were the number of patients with diabetes mellitus (88 of 155 [56.8%]; P?=?.003), coronary artery disease (46 [29.7%]; P?=?.004), stroke before the qualifying event (59 [38.1%]; P?<?.001), old infarct in the territory of the stenotic intracranial artery (88 [56.8%]; P?<?.001), and receiving antithrombotic therapy at the time of the qualifying event (109 [70.3%]; P?=?.005). The association between SVD and any ischemic stroke was nearly significant in the direction of a higher risk (18 [23.7%]); P?=?.07) for patients with SVD. On bivariate analysis, SVD was not associated with an increased risk on multivariable analyses (hazard ratio, 1.7 [95% CI, 0.8-3.8]; P?=?.20). In addition, SVD was not associated with an increased risk of stroke in the territory on either bivariate or multivariable analyses.Although SVD is common in patients with ICAS, the presence of SVD on baseline magnetic resonance imaging is not independently associated with an increased risk of stroke in patients with ICAS.clinicaltrials.gov Identifier: NCT00576693.

Dataset Information

Timing and Outcomes of Intracranial Stenting in the Post-SAMMPRIS Era: A Systematic Review.

Publications

Timing and Outcomes of Intracranial Stenting in the Post-SAMMPRIS Era: A Systematic Review.

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