A retrospective analysis was conducted on clinical data from patients who had experienced transient ischemic attacks or non-disabling ischemic strokes (mRS ≤ 2分) within 60 days at the Department of Neurology, Jiangxi Provincial People's Hospital, from January 2020 to December 2021. All patients underwent cerebral angiography, confirming severe stenosis (stenosis rate: 70%-99%). Based on whether they underwent balloon angioplasty, the eligible patients were divided into the medication treatment group and the balloon angioplasty group. Preoperative ischemic symptoms in the balloon angioplasty group remained stable for at least 7 days. Prior to obtaining informed consent, patients or their families were informed about the surgical risks.
Inclusion criteria were as follows: (1) Age 18–85 years; (2) Ischemic stroke or transient ischemic attack within 60 days of onset; (3) Cerebral angiography confirmed major intracranial vessel involvement (intracranial segments of the internal carotid artery, middle cerebral artery, intracranial segments of the vertebral artery, and basilar artery), measured using the WASID method 8, with stenosis severity ranging from 70–99% and vessel diameter ≥ 1.5 mm; (4) Preoperative modified Rankin Scale (mRS) score ≤ 2 points. Exclusion criteria were: (1) History of intracranial bleeding; (2) Uncontrolled hypertension before treatment, blood pressure > 185/110 mmHg; (3) Active bleeding or bleeding tendency; (4) Severe heart, liver, or kidney dysfunction; (5) Non-atherosclerotic causes of stenosis; (6) Hemoglobin < 100 g/L, platelet count < 100×109/L, coagulation dysfunction, or uncontrollable bleeding factors; (7) Intolerance to antiplatelet drugs; (8) Incomplete clinical data or inability to cooperate with follow-up.
Patients in the medical treatment group received dual antiplatelet therapy consisting of aspirin (100 mg/day), clopidogrel (75 mg/day), or ticagrelor (90 mg/day twice daily). Upon admission, all patients underwent CYP2C19 gene detection using polymerase chain reaction (PCR) with a fluorescence probe. If the patient does not carry the CYP2C19 loss-of-function allele, the treatment of choice is a combination of aspirin and clopidogrel. If a patient carries the CYP2C19 loss-of-function allele, the treatment of choice is a combination of aspirin and ticagrelor 9.
In the balloon angioplasty group, patients received a minimum of 7 days of dual antiplatelet therapy prior to the procedure. Anesthetic administration (local or general) was determined by the operator. The Seldinger technique was utilized for femoral artery puncture, and a 6F guiding catheter was employed, with the option of a 6F long sheath or an 8F guiding catheter plus an intermediate catheter. The microcatheter, guided by a 0.014-inch 2 m micro-guidewire, traversed the lesion to reach the distal end. After exchanging for a 3 m micro-guidewire, the microcatheter was carefully withdrawn. The chosen balloon (SacSpeed, Acandis, China; Gateway, Stryker, USA; Neuro RX, SinoMed, China) was advanced along the micro-guidewire to the lesion site. The balloon size was selected slightly smaller than the target vessel diameter (< 90% of the target vessel diameter), with a length covering the entire lesion and extending ≥ 2 mm beyond both ends. The balloon was slowly inflated once (30–60 s/atmospheric pressure), reaching nominal pressure, followed by a 1-minute dwell time and slow deflation (10 s/atmospheric pressure). If the remaining stenosis was more than 50%, a second or third dilation was considered, or a larger balloon was chosen. A follow-up angiogram was performed 15–20 minutes later, and the procedure was considered successful if the residual stenosis was less than 50%, the procedure is deemed successful. As a rescue strategy, stenting (APOLLP, MicroPort, China; Neuroform EZ, Stryker, USA; Enterprise, Johnson & Johnson, USA) may be used at the operator's discretion under the following conditions,: (1) residual stenosis rate ≥ 50%; (2) the occurrence of dissection at the lesion site with extended thrombolysis in cerebral infarction (eTICI) score < 3 10.
Clinical data collected from both groups included sex, age, medical history (hypertension, diabetes, hyperlipidemia, smoking and drinking, and history of stroke), NIH Stroke Scale (NIHSS) score at onset (total score ranging from 0 to 42) 11, responsible vessels, degree of vascular stenosis, and treatment modalities (medical treatment, balloon angioplasty, and stent rescue treatment). Additionally, information on anesthesia methods, balloon size and length, post-treatment outcomes (including immediate residual stenosis rate), and postoperative follow-up status were also obtained. Patients underwent a 30-day follow-up involving a combination of outpatient visits, telephone communication, and hospital readmission.
The observation period involves vigilant monitoring for any stroke-related events occurring within 30 days post-procedure. This includes ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, and progressive stroke (defined as an increase of ≥ 2 points in the NIHSS score during the follow-up period) 12,13. Additionally, mortality outcomes were documented and tracked.
This study was approved by the local Research Ethics Committee (No: 2022-042) and adhered to the principles of the Declaration of Helsinki. Informed consent for data publication was obtained from the patients or their family members.
Statistical Analysis
Data analysis was conducted using SPSS 22.0 statistical software. The normal distribution of continuous data was visually assessed using graphs and histograms. Normally distributed continuous data are reported as mean ± standard deviation (x ± s), while non-normally distributed continuous data are presented as median and quartiles [༭(P25, P75)]. Group comparisons were performed using independent sample t-tests for normally distributed data or Mann-Whitney U tests for non-normally distributed data. Categorical data are expressed as frequencies and percentages (%). Group comparisons for categorical data were carried out using the χ2 test, continuous correction χ2 test, or Fisher's exact test, with statistical significance set at P < 0.05.