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Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China.

ABSTRACT: The SAMMPRIS trial suggested that aggressive treatment was superior to endovascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rates in patients in the stenting group. Given that 12.2% patients failed aggressive medical therapy in the SAMMPRIS study, it is imperative to perform a multicentre prospective registry study of stenting for patients with ICAS in China. This study aims to evaluate the safety and efficacy of endovascular stenting for patients with symptomatic intracranial artery stenosis and poor collaterals in China and to identify the characteristics of the population that would benefit the most from endovascular stenting in Chinese patients.This multicentre prospective registry study will involve 20 stroke centres in China, and plans to recruit 300 patients into the registry. Patients with ?70% stenosis and symptomatic intracranial atherosclerotic disease caused by hypoperfusion combined with poor collaterals who met the inclusion criteria and exclusion criteria would be enrolled for this study. The primary outcome is the target vessel stroke event (including haemorrhagic or ischaemic stroke) or death within 30?days after stenting. The secondary outcomes include the successful recanalisation rate, the incidence of recurrent ischaemic stroke in the territory of the stented artery between 30?days and 1?year postoperatively, the restenosis rate and health-related quality of life.The protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of cerebral catheterisation and intracranial artery stenting in China.http://www.clinicaltrials.gov (NCT01968122).

SUBMITTER: Wang Y

PROVIDER: S-EPMC4127916 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China.

Wang Yilong Y Miao Zhongrong Z Wang Yongjun Y Zhao Xingquan X Gao Peiyi P Liu Liping L Wang Feng F Liu Yajie Y Ma Ning N Xu Ziqi Z Mo Dapeng D Gao Feng F

BMJ open 20140808 8

<h4>Introduction</h4>The SAMMPRIS trial suggested that aggressive treatment was superior to endovascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rates in patients in the stenting group. Given that 12.2% patients failed aggressive medical therapy in the SAMMPRIS study, it is imperative to perform a multicentre prospective registry study of stenting for patients with ICAS in China. This study aims to evaluate the safety and ...[more]

PMID: 25107437

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Project description:Background and purpose:A multicentre prospective registry study of individually tailored stenting for a patient with symptomatic intracranial atherosclerotic stenosis (ICAS) combined with poor collaterals in China showed that the short-term safety and efficacy of stenting was acceptable. However, it remained uncertain whether the low event rate could be of a long term. We reported the 1-year outcome of this registry study to evaluate the long-term efficacy of individually tailored stenting for patients with severe symptomatic ICAS combined with poor collaterals. Methods:Patients with symptomatic ICAS caused by 70%-99%?stenosis located at the intracranial internal carotid, middle cerebral, intracranial vertebral or basilar arteries combined with poor collaterals were enrolled. Balloon-mounted stent or balloon plus self-expanding stent were selected based on the ease of vascular access and lesion morphology determined by the operators. The primary outcome was the rate of 30-day stroke, transient ischaemic attack and death, and 12-month ischaemic stroke within the same vascular territory, haemorrhagic stroke and vascular death after stenting. Results:From September 2013 to January 2015, 300 patients (ages 58.3±9.78 years) were recruited. Among them, 159 patients were treated with balloon-mounted stent and 141 with balloon plus self-expanding stent. During the 1-year follow-up, 25 patients had a primary end point event. The probability of primary outcome at 1?year was 8.1% (95% CI 5.3% to 11.7%). In 76 patients with digital subtraction angiography follow-up, 27.6% (21/76) had re-stenosis ?50%?and 18.4% (14/76) had re-stenosis ?70%. No baseline characteristic was associated with the primary outcome. Conclusion:The event rate remains low over 1?year of individually tailored stenting for patients with severe symptomatic ICAS combined with poor collaterals. Further randomised trial of comparing individually tailored stenting with best medical therapy is needed. Trial registration number:NCT01968122; Results.

Project description:BackgroundPatients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment; however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience regarding natural history nor treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective, randomized, multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria.MethodsThe China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial is an ongoing, government-funded, prospective, multicenter, randomized trial. It recruits patients with recent TIA or stroke caused by 70%-99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume centers with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days. The CASSISS trial will be conducted in eight sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 participants (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by December 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019.ConclusionIn the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The present manuscript outlines the rationale and design of the study. We estimate that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high-volume centers.

Project description:AimsWe performed a meta-analysis to indirectly compare the treatment effectiveness of balloon angioplasty and stenting for patients with intracranial arterial stenosis.MethodsLiterature searches were performed in well-known databases to identify eligible studies published before January 04, 2021. The incidence of restenosis, transient ischemic attack (TIA), stroke, death, and dissection after balloon angioplasty or stenting were pooled. An indirect comparison of balloon angioplasty vs. stenting was performed, and the ratios of incidence (RIs) with 95% confidence intervals (CIs) were calculated using the random-effects model.Results120 studies that recruited 10,107 patients with intracranial arterial stenosis were included. The pooled incidence of restenosis after balloon angioplasty and stenting were 13% (95%CI: 8-17%) and 11% (95%CI: 9-13%), respectively, with no significant difference between them (RI: 1.18; 95%CI: 0.78-1.80; P = 0.435). Moreover, the pooled incidence of TIA after balloon angioplasty and stenting was 3% (95%CI: 0-6%) and 4% (95%CI: 3%-5%), and no significant difference was observed (RI: 0.75; 95%CI: 0.01-58.53; P = 0.897). The pooled incidence of stroke after balloon angioplasty and stenting was 7% (95%CI: 5-9%) and 8% (95%CI: 7-9%), respectively, and the difference between groups was found to be statistically insignificant (RI: 0.88; 95%CI: 0.64-1.20; P = 0.413). Additionally, the pooled incidence of death after balloon angioplasty and stenting was 2% (95%CI: 1-4%) and 2% (95%CI: 1-2%), with no significant difference between groups (RI: 1.00; 95%CI: 0.44-2.27; P = 1.000). Finally, the pooled incidence of dissection after balloon angioplasty and stenting was 13% (95%CI: 5-22%) and 3% (95%CI: 2-5%), respectively, and balloon angioplasty was associated with a higher risk of dissection than that with stenting for patients with intracranial arterial stenosis (RI: 4.33; 95%CI: 1.81-10.35; P = 0.001).ConclusionThis study found that the treatment effectiveness of balloon angioplasty and stenting were similar for patients with symptomatic intracranial arterial stenosis.

Project description:IntroductionAtherosclerotic intracranial artery stenosis (ICAS) is one of most common causes of stroke, which is the second-leading cause of death worldwide. Medical, surgical and endovascular therapy are three major treatments for ICAS. Currently, medical therapy is considered as the standard of care for most patients with ICAS, while extracranial to intracranial bypass is only used in rare situations. Balloon angioplasty alone, balloon-mounted stent and self-expanding stent, collectively called endovascular treatment, have shown promising potentials in treating specific subgroups of patients with symptomatic ICAS; however, their comparative safety and efficacy is still unclear. Therefore, a systematic review with network meta-analysis is needed to establish a hierarchy of these endovascular treatments.Methods and analysisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols was followed to establish this protocol. The search will be limited to studies published from 1 January 2000 to the formal search date. Major databases including Cochrane Library, MEDLINE, EMBASE, Chinese Biomedical Literature Database, conference proceedings and grey literature database will be searched for clinical studies comparing at least two interventions for patients with symptomatic ICAS. Primary outcomes include short-term and long-term mortality or stroke rate. Random effects pairwise and network meta-analyses of included studies will be performed on STATA (V.14, StataCorp, 2015). The surface under the cumulative ranking curve and mean rank will be calculated in order to establish a hierarchy of the endovascular treatments. Evaluation of the risk of bias, heterogeneity, consistency, transitivity and quality of evidence will follow the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions.Ethics and disseminationEthics approval is not needed as systematic review is based on published studies. Study findings will be presented at international conferences and published on a peer-reviewed journal.Prospero registration numberCRD42018084055; Pre-results.

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Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China.

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Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China.

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