Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis

Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis · SciRah

^aChina National Clinical Research Center for Neurological Diseases, Beijing
^bInterventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
^cDepartment of Neurology, The Affiliated Hospital of Qingdao University, Shandong, China
^dDepartments of Neurology and Radiology, Boston Medical Center, Boston, Massachusetts
^eDepartment of Neurology, Beijing Luhe Hospital, Capital Medical University, Beijing, China
^fDepartment of Neurosurgery, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
^gDepartment of Neurology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China
^hDepartment of Neurointervention, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Anhui, China
ⁱAdvanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China
^jChinese Institute for Brain Research, Beijing, China
^kDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
^lDepartment of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
^mNational Center for Neurological Disorders, Beijing, China
ⁿDepartment of Cerebrovascular Disease and Neurosurgery, Zhengzhou University People’s Hospital, Zhengzhou, China
^oDepartment of Neurology, The First Affiliated Hospital, Sun Yat-sen University, Guangdong, China
^pDepartment of Neurology, Qilu Hospital of Shandong University, Shandong, China
^qDepartment of Neurosurgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangdong, China
^rDepartment of Neurosurgery, The Affiliated Hospital of Guizhou Medical University, Guizhou, China
^sDepartment of Neurology, The First Hospital of Jilin University, Jilin, China
^tDepartment of Neurology, Hunan Provincial People’s Hospital, Hunan, China
^uDepartment of Neurology, The First Affiliated Hospital of Anhui Medical University, Anhui, China
^vCerebrovascular Disease Department, Neurological Disease Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
✉Corresponding author

Abstract

Importance: Previous randomized clinical trials did not demonstrate the superiority of endovascular stenting over aggressive medical management for patients with symptomatic intracranial atherosclerotic stenosis (sICAS). However, balloon angioplasty has not been investigated in a randomized clinical trial. Objective: To determine whether balloon angioplasty plus aggressive medical management is superior to aggressive medical management alone for patients with sICAS. Design, Setting, and Participants: A randomized, open-label, blinded end point clinical trial at 31 centers across China. Eligible patients aged 35 to 80 years with sICAS defined as recent transient ischemic attack (<90 days) or ischemic stroke (14-90 days) before enrollment attributed to a 70% to 99% atherosclerotic stenosis of a major intracranial artery receiving treatment with at least 1 antithrombotic drug and/or standard risk factor management were recruited between November 8, 2018, and April 2, 2022 (final follow-up: April 3, 2023). Interventions: Submaximal balloon angioplasty plus aggressive medical management (n = 249) or aggressive medical management alone (n = 252). Aggressive medical management included dual antiplatelet therapy for the first 90 days and risk factor control. Main Outcomes and Measures: The primary outcome was a composite of any stroke or death within 30 days after enrollment or after balloon angioplasty of the qualifying lesion or any ischemic stroke in the qualifying artery territory or revascularization of the qualifying artery after 30 days through 12 months after enrollment. Results: Among 512 randomized patients, 501 were confirmed eligible (mean age, 58.0 years; 158 [31.5%] women) and completed the trial. The incidence of the primary outcome was lower in the balloon angioplasty group than the medical management group (4.4% vs 13.5%; hazard ratio, 0.32 [95% CI, 0.16-0.63]; P < .001). The respective rates of any stroke or all-cause death within 30 days were 3.2% and 1.6%. Beyond 30 days through 1 year after enrollment, the rates of any ischemic stroke in the qualifying artery territory were 0.4% and 7.5%, respectively, and revascularization of the qualifying artery occurred in 1.2% and 8.3%, respectively. The rate of symptomatic intracranial hemorrhage in the balloon angioplasty and medical management groups was 1.2% and 0.4%, respectively. In the balloon angioplasty group, procedural complications occurred in 17.4% of patients and arterial dissection occurred in 14.5% of patients. Conclusions and Relevance: In patients with sICAS, balloon angioplasty plus aggressive medical management, compared with aggressive medical management alone, statistically significantly lowered the risk of a composite outcome of any stroke or death within 30 days or an ischemic stroke or revascularization of the qualifying artery after 30 days through 12 months. The findings suggest that balloon angioplasty plus aggressive medical management may be an effective treatment for sICAS, although the risk of stroke or death within 30 days of balloon angioplasty should be considered in clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT03703635.

TL;DRIn patients with sICAS, balloon angioplasty plus aggressive medical management, compared with aggressive medical management alone, statistically significantly lowered the risk of a composite outcome of any stroke or death within 30 days or an ischemic stroke or revascularization of the qualifying artery after 30 days through 12 months. (Semantic Scholar)

Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis

Abstract

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Discussion