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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 purposeA 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.MethodsPatients 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.ResultsFrom 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.ConclusionThe 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 numberNCT01968122; 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:Background: Stroke is currently the second-leading cause of death just behind ischaemic heart disease. Drug therapy is currently the standard of care for patients with symptomatic intracranial artery stenosis (sICAS). Stenting is an important treatment for the prevention and treatment of ischemic stroke. It has been suggested that vertebral artery stenting might reduce this risk, but operation-related complications limit the application of stenting in the treatment of ischemic stroke. The differences in the safety and efficacy of stenting combined with drugs and drugs alone in the treatment of sICAS are unclear. The aim of this study was to assess the impact of both treatment modalities on the prognosis of patients with sICAS through a systematic review and meta-analysis. Methods: The Chinese databases (CNKI, Wanfang, VIP, CBM, DUXIU) and English databases (Pubmed, Embase, Ovid_medline, Cochrane library, Web of science)were searched to identify all studies describing sICAS. The “Risk of Bias Assessment” tool and the “Jadad Scale” provided by the Cochrane Collaboration were used to evaluate the risk of bias and quality of the collected literature. The risk ratio (RR) and its 95% confidence interval (CI) were determined using Stata statistical software version 14.0. Results: A total of 11 studies were included, comprising a total of 1,915 patients. The combined results of the study showed no significant difference between the incidence of transient cerebral ischemia (TIA)and stroke in patients with sICAS treated with drugs in combination with stents versus drugs alone. The incidence of death or stroke, cerebral haemorrhage, disabling stroke or death was significantly higher in patients receiving stent-combined drug therapy versus drug therapy alone for sICAS. Conclusion: Studies suggest that stenting combined with medication for patients with sICAS may increase the incidence of death or stroke, cerebral haemorrhage, stroke or death, but has no significant effect on the incidence of TIA and stroke. The studies report inadequate and conflicting data and therefore the safety and efficacy of stenting for sICAS should be interpreted with caution. Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022377090, identifier CRD42022377090

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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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