Article Text
Abstract
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.
- atherosclerosis
- intracranial stenosis
- angioplasty and stenting
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Footnotes
Contributors ZM had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: YLW, YJW, NM and ZRM. Acquisition of clinical data: NM, YZ, JS, CCJ, QYZ, KNC, LL, BML, XQS, LBG, YJL, FW, YLL, TYL, HBZ, DPM, FG and The Study Group of Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China. Analysis and interpretation of data: NM, FL and ZRM. Drafting of the manuscript: NM, FL and ZRM. Critical revision of the manuscript for important intellectual content: YJW and ZRM. Statistical analysis: NM.
Funding This work is supported by National Natural Science Foundation of China (81371290), Beijing High-level Personnel Funds (2013-2-019). This study is also funded by the National Science and Technology Support Program of ‘The 12th Five-Year Plan’ of the Ministry of Science and Technology (2011BAI08B02).
Competing interests None declared.
Patient consent Next of kin consent obtained.
Ethics approval Each site’s institutional review board or ethics committee.
Provenance and peer review Not commissioned; internally peer reviewed.
Collaborators A complete list of study participants is given in the online supplementary appendix.