Zhang Xuening, Cao Le, Wu Simiao, Wang Duolao, Wang Hang, Zhang Dingwen, Wang Jian, Chen Lizhang, Lin Xue, Qian Decai, Zhang Qinjun, Xiong Lan, Wang Weiping, Tang Yufeng, Lei Bo, Liu Tianzhu, He Jie, Wang Li, Guo Fuqiang, Li Guangzong, Wang Kuiyun, Li Jinglun, Luo Jun, Shen Jian, Xu Mangmang, Zheng Hongbo, Zhou Dong, Liu Ming, Hu Fayun, Wu Bo
Department of Neurology, West China Hospital, Sichuan University, Chengdu, China.
Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, United Kingdom.
Lancet Reg Health West Pac. 2025 Jun 6;59:101589. doi: 10.1016/j.lanwpc.2025.101589. eCollection 2025 Jun.
The optimal blood pressure (BP) management following successful endovascular treatment (EVT) in acute ischaemic stroke (AIS) patients remains unclear. This study investigated the safety and efficacy of intensive BP control in AIS patients who had received EVT within 6 h.
This randomised, multicentre, open-label, blinded-endpoint clinical trial (ChiCTR2200057770) was conducted at 63 stroke centres in China. Eligible participants had AIS due to large vessel occlusion in anterior circulation, underwent EVT within 6 h, and achieved successful recanalisation. Patients were randomised to intensive (systolic BP target <130 mm Hg) or standard (systolic BP target <180 mm Hg) management, maintained until 24 h post-EVT. The primary outcome was unfavourable functional outcome (modified Rankin Scale score of 3-6) at 90 days. The trial was terminated following a neutral interim analysis results and publication of counterpart randomised trials.
Between October 14, 2022 and March 18, 2024, 383 patients were randomised. Unfavourable functional outcome occurred in 71.0% (130/183) of the intensive-management group and 67.5% (135/200) of the standard-management group (risk ratio, 1.05; 95% CI, 0.92-1.20; p = 0.45). There was no significant difference in symptomatic intracerebral haemorrhage, malignant brain oedema, or all-cause death at 90 days.
Intensive BP management to <130 mm Hg did not improve outcomes in AIS patients undergoing EVT within 6 h and achieved successful recanalisation. The optimal BP management strategies require further investigation.
Sichuan University West China Hospital, National Natural Science Foundation of China, National Key R&D Programme of China, and Science and Technology Department of Sichuan Province.
急性缺血性卒中(AIS)患者成功接受血管内治疗(EVT)后的最佳血压管理仍不明确。本研究调查了在6小时内接受EVT的AIS患者强化血压控制的安全性和有效性。
这项随机、多中心、开放标签、盲终点临床试验(ChiCTR2200057770)在中国的63个卒中中心进行。符合条件的参与者因前循环大血管闭塞导致AIS,在6小时内接受了EVT,并实现了成功再通。患者被随机分为强化管理组(收缩压目标<130mmHg)或标准管理组(收缩压目标<180mmHg),持续至EVT后24小时。主要结局是90天时不良功能结局(改良Rankin量表评分为3 - 6分)。在一项中性中期分析结果和同类随机试验发表后,该试验提前终止。
在2022年10月14日至2024年3月18日期间,383例患者被随机分组。强化管理组71.0%(130/183)和标准管理组67.5%(135/200)出现不良功能结局(风险比,1.05;95%CI,0.92 - 1.20;p = 0.45)。90天时,症状性脑出血、恶性脑水肿或全因死亡方面无显著差异。
将血压强化管理至<130mmHg并未改善6小时内接受EVT且实现成功再通的AIS患者的结局。最佳血压管理策略需要进一步研究。
四川大学华西医院、中国国家自然科学基金委员会、国家重点研发计划、四川省科学技术厅。