Peng Gao1, Tao Wang1, Daming Wang2, David S Liebeskind3, Huaizhang Shi4, Tianxiao Li5, Zhenwei Zhao6, Yiling Cai7, Wei Wu8, Weiwen He9, Jia Yu6, Bingjie Zheng4, Haibo Wang10, Yangfeng Wu10, Adam A Dmytriw11, Timo Krings12, Colin P Derdeyn13, Liqun Jiao1. 1. Departments of Neurosurgery and Interventional Neuroradiology, Xuanwu Hospital, Capital Medical University, Beijing, China. 2. Department of Neurosurgery, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China. 3. David Geffen School of Medicine, Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles. 4. Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin, China. 5. Department of Cerebrovascular and Neurosurgery, Henan Provincial People's Hospital, Zhengzhou University, Zhengzhou, China. 6. Department of Neurosurgery, Tangdu Hospital of Air Force Medical University, Xi'an, China. 7. Department of Neurology, Strategic Support Force Medical Center, Beijing, China. 8. Department of Neurology, Qilu Hospital of Shandong University, Ji'nan, China. 9. Department of Neurosurgery, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. 10. Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China. 11. Neuroendovascular Program, Massachusetts General Hospital, Harvard Medical School, Boston. 12. Department of Medical Imaging, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada. 13. Departments of Radiology and Neurology, University of Iowa Hospitals and Clinics, Iowa City.
Abstract
Importance: Prior randomized trials have generally shown harm or no benefit of stenting added to medical therapy for patients with symptomatic severe intracranial atherosclerotic stenosis, but it remains uncertain as to whether refined patient selection and more experienced surgeons might result in improved outcomes. Objective: To compare stenting plus medical therapy vs medical therapy alone in patients with symptomatic severe intracranial atherosclerotic stenosis. Design, Setting, and Participants: Multicenter, open-label, randomized, outcome assessor-blinded trial conducted at 8 centers in China. A total of 380 patients with transient ischemic attack or nondisabling, nonperforator (defined as nonbrainstem or non-basal ganglia end artery) territory ischemic stroke attributed to severe intracranial stenosis (70%-99%) and beyond a duration of 3 weeks from the latest ischemic symptom onset were recruited between March 5, 2014, and November 10, 2016, and followed up for 3 years (final follow-up: November 10, 2019). Interventions: Medical therapy plus stenting (n = 176) or medical therapy alone (n = 182). Medical therapy included dual-antiplatelet therapy for 90 days (single antiplatelet therapy thereafter) and stroke risk factor control. Main Outcomes and Measures: The primary outcome was a composite of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. There were 5 secondary outcomes, including stroke in the qualifying artery territory at 2 years and 3 years as well as mortality at 3 years. Results: Among 380 patients who were randomized, 358 were confirmed eligible (mean age, 56.3 years; 263 male [73.5%]) and 343 (95.8%) completed the trial. For the stenting plus medical therapy group vs medical therapy alone, no significant difference was found for the primary outcome of risk of stroke or death (8.0% [14/176] vs 7.2% [13/181]; difference, 0.4% [95% CI, -5.0% to 5.9%]; hazard ratio, 1.10 [95% CI, 0.52-2.35]; P = .82). Of the 5 prespecified secondary end points, none showed a significant difference including stroke in the qualifying artery territory at 2 years (9.9% [17/171] vs 9.0% [16/178]; difference, 0.7% [95% CI, -5.4% to 6.7%]; hazard ratio, 1.10 [95% CI, 0.56-2.16]; P = .80) and 3 years (11.3% [19/168] vs 11.2% [19/170]; difference, -0.2% [95% CI, -7.0% to 6.5%]; hazard ratio, 1.00 [95% CI, 0.53-1.90]; P > .99). Mortality at 3 years was 4.4% (7/160) in the stenting plus medical therapy group vs 1.3% (2/159) in the medical therapy alone group (difference, 3.2% [95% CI, -0.5% to 6.9%]; hazard ratio, 3.75 [95% CI, 0.77-18.13]; P = .08). Conclusions and Relevance: Among patients with transient ischemic attack or ischemic stroke due to symptomatic severe intracranial atherosclerotic stenosis, the addition of percutaneous transluminal angioplasty and stenting to medical therapy, compared with medical therapy alone, resulted in no significant difference in the risk of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. The findings do not support the addition of percutaneous transluminal angioplasty and stenting to medical therapy for the treatment of patients with symptomatic severe intracranial atherosclerotic stenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT01763320.
Importance: Prior randomized trials have generally shown harm or no benefit of stenting added to medical therapy for patients with symptomatic severe intracranial atherosclerotic stenosis, but it remains uncertain as to whether refined patient selection and more experienced surgeons might result in improved outcomes. Objective: To compare stenting plus medical therapy vs medical therapy alone in patients with symptomatic severe intracranial atherosclerotic stenosis. Design, Setting, and Participants: Multicenter, open-label, randomized, outcome assessor-blinded trial conducted at 8 centers in China. A total of 380 patients with transient ischemic attack or nondisabling, nonperforator (defined as nonbrainstem or non-basal ganglia end artery) territory ischemic stroke attributed to severe intracranial stenosis (70%-99%) and beyond a duration of 3 weeks from the latest ischemic symptom onset were recruited between March 5, 2014, and November 10, 2016, and followed up for 3 years (final follow-up: November 10, 2019). Interventions: Medical therapy plus stenting (n = 176) or medical therapy alone (n = 182). Medical therapy included dual-antiplatelet therapy for 90 days (single antiplatelet therapy thereafter) and stroke risk factor control. Main Outcomes and Measures: The primary outcome was a composite of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. There were 5 secondary outcomes, including stroke in the qualifying artery territory at 2 years and 3 years as well as mortality at 3 years. Results: Among 380 patients who were randomized, 358 were confirmed eligible (mean age, 56.3 years; 263 male [73.5%]) and 343 (95.8%) completed the trial. For the stenting plus medical therapy group vs medical therapy alone, no significant difference was found for the primary outcome of risk of stroke or death (8.0% [14/176] vs 7.2% [13/181]; difference, 0.4% [95% CI, -5.0% to 5.9%]; hazard ratio, 1.10 [95% CI, 0.52-2.35]; P = .82). Of the 5 prespecified secondary end points, none showed a significant difference including stroke in the qualifying artery territory at 2 years (9.9% [17/171] vs 9.0% [16/178]; difference, 0.7% [95% CI, -5.4% to 6.7%]; hazard ratio, 1.10 [95% CI, 0.56-2.16]; P = .80) and 3 years (11.3% [19/168] vs 11.2% [19/170]; difference, -0.2% [95% CI, -7.0% to 6.5%]; hazard ratio, 1.00 [95% CI, 0.53-1.90]; P > .99). Mortality at 3 years was 4.4% (7/160) in the stenting plus medical therapy group vs 1.3% (2/159) in the medical therapy alone group (difference, 3.2% [95% CI, -0.5% to 6.9%]; hazard ratio, 3.75 [95% CI, 0.77-18.13]; P = .08). Conclusions and Relevance: Among patients with transient ischemic attack or ischemic stroke due to symptomatic severe intracranial atherosclerotic stenosis, the addition of percutaneous transluminal angioplasty and stenting to medical therapy, compared with medical therapy alone, resulted in no significant difference in the risk of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. The findings do not support the addition of percutaneous transluminal angioplasty and stenting to medical therapy for the treatment of patients with symptomatic severe intracranial atherosclerotic stenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT01763320.
Authors: Colin P Derdeyn; David Fiorella; Michael J Lynn; Zoran Rumboldt; Harry J Cloft; Daniel Gibson; Tanya N Turan; Bethany F Lane; L Scott Janis; Marc I Chimowitz Journal: Neurosurgery Date: 2013-05 Impact factor: 4.654
Authors: Michael J Alexander; Alois Zauner; John C Chaloupka; Blaise Baxter; Richard C Callison; Rishi Gupta; Shlee S Song; Wengui Yu Journal: Stroke Date: 2019-04 Impact factor: 7.914
Authors: Wiebke Kurre; Joachim Berkefeld; Friedhelm Brassel; Roland Brüning; Bernd Eckert; Seniye Kamek; Guenther E Klein; Michael Knauth; Thomas Liebig; Jana Maskova; Dirk Mucha; Tobias Neumann-Haefelin; Sara Pilgram-Pastor; Matthias Sitzer; Michael Sonnberger; Mark Tietke; Johannes Trenkler; Bernd Turowski Journal: Stroke Date: 2010-01-14 Impact factor: 7.914
Authors: Jose G Romano; Shyam Prabhakaran; Azhar Nizam; Edward Feldmann; Rajbeer Sangha; George Cotsonis; Iszet Campo-Bustillo; Sebastian Koch; Tatjana Rundek; Marc I Chimowitz; David S Liebeskind Journal: J Stroke Cerebrovasc Dis Date: 2020-12-01 Impact factor: 2.136
Authors: Simon Chun Ho Yu; Thomas Wai Hong Leung; Kwok Tung Lee; Lawrence Ka Sing Wong Journal: J Neurointerv Surg Date: 2013-03-20 Impact factor: 5.836