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Ischemic stroke
Original research
Stenting versus medical treatment alone for symptomatic intracranial artery stenosis: a preplanned pooled individual patient data analysis
  1. Tao Wang1,
  2. Jichang Luo1,
  3. Tianhua Li1,
  4. Eyad Almallouhi2,
  5. Peng Gao1,3,
  6. Haozhi Gong1,
  7. Xiao Zhang1,
  8. Jie Wang1,
  9. Taoyuan Lu1,
  10. Yifan Yang1,
  11. Renjie Yang1,
  12. Zixuan Xing4,
  13. Haibo Wang5,
  14. Colin P Derdeyn6,
  15. Liqun Jiao1,3
    1. 1Department of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China
    2. 2Neuro Interventional Surgery, Sarasota Memorial Hospital, Sarasota, Florida, USA
    3. 3Department of Interventional Neuroradiology, Xuanwu Hospital Capital Medical University, Beijing, China
    4. 4Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, China
    5. 5Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China
    6. 6Department of Radiology and Medical Imaging, University of Virginia, Charlottesville, Virginia, USA
    1. Correspondence to Dr Liqun Jiao; liqunjiao{at}sina.cn; Dr Colin P Derdeyn; cpd3yt{at}uvahealth.org; Dr Haibo Wang; hbwang2005{at}163.com

    Abstract

    Background Whether the safety and efficacy of percutaneous transluminal angioplasty and stenting (PTAS) is significantly different from that of medical treatment alone for symptomatic intracranial arterial stenosis (ICAS) is debatable. A study was undertaken to determine the safety and efficacy of both treatments for symptomatic ICAS.

    Methods This preplanned pooled individual patient data analysis included 400 participants treated with PTAS and 409 treated with medical treatment alone in two large multicenter randomized clinical trials (SAMMPRIS and CASSISS). Patients were treated with PTAS using a self-expanding stent or medical treatment alone. The primary outcome was stroke or death within 30 days, or ischemic stroke in the territory of the qualifying artery more than 30 days after enrollment.

    Results Individual data were obtained for 809 patients, 451 from SAMMPRIS and 358 from CASSISS. 400 participants were randomly assigned to the PTAS group and 409 to the medical group. The risk of the primary outcome was not significant between the PTAS and medical groups (17.5% vs 13.2%; HR 1.37 (95% CI 0.96 to 1.95), P=0.08). However, the risk of stroke or death within 30 days was higher in the PTAS group (10.5% vs 4.2%; HR 2.62 (95% CI 1.49 to 4.61), P<0.001). Patients of white ethnicity (HR 1.97, 95% CI 1.17 to 3.31) and those with hyperlipidemia (HR 2.04, 95% CI 1.27 to 3.26) or a transient ischemic attack (TIA) (HR 2.19, 95% CI 1.08 to 4.45) were at higher risk for PTAS.

    Conclusions PTAS poses an increased risk of short-term stroke/death and therefore is not advised as primary treatment for symptomatic ICAS. A balance exists between stroke risks and revascularization benefits. For patients with asymptomatic ICAS of white ethnicity and those with hyperlipidemia or a history of TIA, a thorough assessment is warranted before considering PTAS.

    Trial registration ClinicalTrials.gov Identifier: NCT00576693, NCT01763320.

    • Atherosclerosis
    • Stent
    • Stenosis
    • Intervention

    Data availability statement

    Data are available upon reasonable request. The data are available from the corresponding author on reasonable request.

    https://doi.org/10.1136/jnis-2024-022189

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      Data availability statement

      Data are available upon reasonable request. The data are available from the corresponding author on reasonable request.

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      Footnotes

      • TW, JL, TL and EA contributed equally.

      • Contributors LJ led the study design. TW, JL and TL drafted the manuscript. HW did the statistical analyses. PG, HG, XZ, JW, TL, YY, RY, GL, and ZX accessed and verified the data underlying this article. EA and CPD critically revised the manuscript. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.All authors have agreed to conditions of authorship.LJ is responsible for the overall content.

      • Funding This work was supported by Beijing Hospitals Authority’s Ascent Plan (DFL20220702).

      • Competing interests None declared.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.