急性基底动脉闭塞血管内治疗试验。
Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion.
机构信息
From the Stroke Center and Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (USTC), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei (C.T., Y.Z., J. Sun, Li Wang, C.Z., T.L., J. Song, R. Li, P.X., Y.Y., G.W., X.L., W.H.), the Department of Neurology, Linyi People's Hospital, Linyi (H.H.), the Emergency Department, Xiangtan Central Hospital, Xiangtan (G.Y.), the Department of Neurology, Nanyang Central Hospital, Nanyang (C.W.), the Department of Neurology, Xiangyang No. 1 People's Hospital, Hubei University of Medicine, Xiangyang (P.Z.), the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurology, Ganzhou People's Hospital, Ganzhou (G.Z.), the Department of Neurology, Heze Municipal Hospital, Heze (Y. Li), the Department of Neurology, Suzhou Hospital of Anhui Medical University (Z.M.), and the Department of Neurology and Clinical Research Center of Neurologic Disease, Second Affiliated Hospital of Soochow University (G.X.), Suzhou, the Department of Neurology, First Affiliated Hospital of Anhui University of Science and Technology, First People's Hospital of Huainan, Huainan (C.Y.), the Department of Neurology, Jingzhou Hospital Affiliated to Yangtze University, Jingzhou (J. Su), the Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu (Z.Z.), the Department of Neurointervention, Dalian Municipal Central Hospital Affiliated with Dalian Medical University, Dalian (Z.C.), the Department of Neurology, Maoming People's Hospital, Maoming (G.L.), the Department of Neurology, Shanxi Provincial People's Hospital, Taiyuan (Y.S.), the Department of Neurology, Linquan Country People's Hospital, Linquan (Y.R.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical College, Bengbu (H.Z.), the Department of Neurosurgery, Tongling People's Hospital, Tongling (J.C.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Zigong Third People's Hospital, Zigong (Li Wang), the Department of Neurology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing (R. Liu, X.L.), the Department of Neurology, Wuhan No. 1 Hospital, Wuhan (W.L.), and the Department of Neurology, Lu'an Hospital of Anhui Medical University, Lu'an (Y. Liu) - all in China; the UPMC Stroke Institute, Department of Neurology and Neurosurgery, University of Pittsburgh School of Medicine, Pittsburgh (R.G.N.), and Lehigh Valley Health Network, Allentown (B.B.) - both in Pennsylvania; and the Zeenat Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia (A.I.Q.).
出版信息
N Engl J Med. 2022 Oct 13;387(15):1361-1372. doi: 10.1056/NEJMoa2206317.
BACKGROUND
Data from trials investigating the effects and risks of endovascular thrombectomy for the treatment of stroke due to basilar-artery occlusion are limited.
METHODS
We conducted a multicenter, prospective, randomized, controlled trial of endovascular thrombectomy for basilar-artery occlusion at 36 centers in China. Patients were assigned, in a 2:1 ratio, within 12 hours after the estimated time of basilar-artery occlusion to receive endovascular thrombectomy or best medical care (control). The primary outcome was good functional status, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]), at 90 days. Secondary outcomes included a modified Rankin scale score of 0 to 2, distribution across the modified Rankin scale score categories, and quality of life. Safety outcomes included symptomatic intracranial hemorrhage at 24 to 72 hours, 90-day mortality, and procedural complications.
RESULTS
Of the 507 patients who underwent screening, 340 were in the intention-to-treat population, with 226 assigned to the thrombectomy group and 114 to the control group. Intravenous thrombolysis was used in 31% of the patients in the thrombectomy group and in 34% of those in the control group. Good functional status at 90 days occurred in 104 patients (46%) in the thrombectomy group and in 26 (23%) in the control group (adjusted rate ratio, 2.06; 95% confidence interval [CI], 1.46 to 2.91, P<0.001). Symptomatic intracranial hemorrhage occurred in 12 patients (5%) in the thrombectomy group and in none in the control group. Results for the secondary clinical and imaging outcomes were generally in the same direction as those for the primary outcome. Mortality at 90 days was 37% in the thrombectomy group and 55% in the control group (adjusted risk ratio, 0.66; 95% CI, 0.52 to 0.82). Procedural complications occurred in 14% of the patients in the thrombectomy group, including one death due to arterial perforation.
CONCLUSIONS
In a trial involving Chinese patients with basilar-artery occlusion, approximately one third of whom received intravenous thrombolysis, endovascular thrombectomy within 12 hours after stroke onset led to better functional outcomes at 90 days than best medical care but was associated with procedural complications and intracerebral hemorrhage. (Funded by the Program for Innovative Research Team of the First Affiliated Hospital of USTC and others; ATTENTION ClinicalTrials.gov number, NCT04751708.).
背景
关于血管内血栓切除术治疗基底动脉闭塞性卒中的效果和风险的数据有限。
方法
我们在中国 36 家中心进行了一项多中心、前瞻性、随机、对照试验，对基底动脉闭塞进行血管内血栓切除术。在发病后 12 小时内，将患者按照 2:1 的比例随机分配，接受血管内血栓切除术或最佳药物治疗（对照组）。主要结局是 90 天时改良 Rankin 量表（范围 0 [无症状]至 6 [死亡]）评分 0 至 3 的良好功能状态。次要结局包括改良 Rankin 量表评分 0 至 2 分、改良 Rankin 量表评分分布类别以及生活质量。安全性结局包括 24 至 72 小时时症状性颅内出血、90 天死亡率和手术并发症。
结果
在接受筛选的 507 名患者中，340 名患者符合意向治疗人群标准，其中 226 名患者被分配到血栓切除术组，114 名患者被分配到对照组。在血栓切除术组中，31%的患者接受了静脉溶栓治疗，对照组中这一比例为 34%。在血栓切除术组中，104 名患者（46%）在 90 天时功能状态良好，对照组中 26 名患者（23%）功能状态良好（调整后的率比，2.06；95%置信区间[CI]，1.46 至 2.91，P<0.001）。血栓切除术组中有 12 名患者（5%）发生症状性颅内出血，对照组中无此情况。次要临床和影像学结局的结果通常与主要结局一致。90 天死亡率在血栓切除术组为 37%，对照组为 55%（调整后的风险比，0.66；95%CI，0.52 至 0.82）。血栓切除术组中有 14%的患者发生手术并发症，包括 1 例因动脉穿孔导致的死亡。
结论
在一项涉及中国基底动脉闭塞患者的试验中，约三分之一的患者接受了静脉溶栓治疗，与最佳药物治疗相比，发病后 12 小时内进行血管内血栓切除术可在 90 天时改善功能结局，但与手术并发症和颅内出血有关。（由中国科学技术大学附属第一医院创新团队计划等资助；ATTENTION 临床试验.gov 编号，NCT04751708。）
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