Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Stroke Vasc Neurol. 2024 Feb 27;9(1):66-74. doi: 10.1136/svn-2022-002288.
The superiority of balloon angioplasty plus aggressive medical management (AMM) to AMM alone for symptomatic intracranial artery stenosis (sICAS) on efficacy and safety profiles still lacks evidence from randomised controlled trials (RCTs).
To demonstrate the design of an RCT on balloon angioplasty plus AMM for sICAS.
Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS) trial is a multicentre, prospective, randomised, open-label, blinded end-point trial to investigate whether balloon angioplasty plus AMM could improve clinical outcome compared with AMM alone in patients with sICAS. Patients eligible in BASIS were 35-80 years old, with a recent transient ischaemic attack within the past 90 days or ischaemic stroke between 14 days and 90 days prior to enrolment due to severe atherosclerotic stenosis (70%-99%) of a major intracranial artery. The eligible patients were randomly assigned to receive balloon angioplasty plus AMM or AMM alone at a 1:1 ratio. Both groups will receive identical AMM, including standard dual antiplatelet therapy for 90 days followed by long-term single antiplatelet therapy, intensive risk factor management and life-style modification. All participants will be followed up for 3 years.
Stroke or death in the next 30 days after enrolment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischaemic stroke or revascularisation from the qualifying artery after 30 days but before 12 months of enrolment, is the primary outcome.
BASIS trail is the first RCT to compare the efficacy and safety of balloon angioplasty plus AMM to AMM alone in sICAS patients, which may provide an alternative perspective for treating sICAS.
NCT03703635; https://www.
gov.
对于症状性颅内动脉狭窄（sICAS），球囊血管成形术联合强化药物治疗（AMM）在疗效和安全性方面优于 AMM 单独治疗，但仍缺乏来自随机对照试验（RCT）的证据。
展示一项关于球囊血管成形术联合 AMM 治疗 sICAS 的 RCT 设计。
球囊血管成形术治疗症状性颅内动脉狭窄（BASIS）试验是一项多中心、前瞻性、随机、开放标签、盲终点试验，旨在研究球囊血管成形术联合 AMM 是否能改善 sICAS 患者的临床结局，与 AMM 单独治疗相比。BASIS 试验纳入的患者年龄在 35-80 岁之间，在入组前 90 天内有近期短暂性脑缺血发作或 14-90 天内有缺血性卒中，由于颅内主要动脉严重粥样硬化性狭窄（70%-99%）而导致。符合条件的患者被随机分配接受球囊血管成形术联合 AMM 或 AMM 单独治疗，比例为 1:1。两组均接受相同的 AMM，包括标准双联抗血小板治疗 90 天，随后长期单联抗血小板治疗、强化危险因素管理和生活方式改变。所有参与者将接受 3 年的随访。
入组后 30 天内或 qualifying 病变球囊血管成形术后 30 天内发生卒中或死亡，或入组后 30 天至 12 个月内 qualifying 动脉发生任何缺血性卒中或血运重建，是主要结局。
BASIS 试验是第一项比较球囊血管成形术联合 AMM 与 AMM 单独治疗 sICAS 患者疗效和安全性的 RCT，可能为治疗 sICAS 提供另一种视角。
NCT03703635；https://www.clinicaltrials.gov。
NCT03703635。
