From the Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, P.Y., Y. Zhang, L.Z., Z.L., G.D., B.H., J.L.); Neurosurgery Intensive Care Unit, ZhouKou Center Hospital, He'nan, China (Y.J., X. Yue, Y.R., Y.S., B.L., W.Y., S. Li); Department of Radiology, University Hospital Basel, Basel, Switzerland (J.O.); Department of Clinical Neurosciences and Diagnostic Imaging, University of Calgary Cumming School of Medicine, Calgary, Canada (M.G., R.M.); Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany (R.M.); Health Statistics Department, Naval Medical University, Shanghai, China (X. Ye); Department of Neurosurgery, First Hospital Affiliate to Harbin Medical University, Harbin, China (H.S.); Department of Neurology, Linyi People's Hospital, Shandong, China (H.H.); Department of Radiology, Jiangsu People's Hospital, Jiangsu, China (S. Liu).
Radiology. 2022 Nov;305(2):410-418. doi: 10.1148/radiol.212358. Epub 2022 Jul 12.
Background Recent evidence suggests that presence of an intracranial arterial thrombus with a hyperdense artery sign (HAS) at noncontrast CT (NCCT) is associated with better response to intravenous alteplase. Patients with HAS may benefit more from combined intravenous alteplase and endovascular treatment (EVT). Purpose To investigate whether HAS at NCCT modifies the treatment effect of adding intravenous alteplase on clinical outcome in patients with acute large-vessel occlusion undergoing EVT. Materials and Methods This study is a secondary analysis of a prospective randomized trial (Direct Intra-arterial thrombectomy in order to Revascularize AIS patients with large-vessel occlusion Efficiently in Chinese Tertiary hospitals: A Multicenter randomized clinical Trial [DIRECT-MT]), which compared adding alteplase to EVT versus EVT alone in participants with acute large-vessel occlusion between February 2018 and July 2019. Participants with catheter angiograms and adequate NCCT for HAS evaluation were included. HAS was determined visually by two independent investigators at baseline NCCT. Treatment effect of intravenous alteplase administration according to presence of HAS on the primary clinical outcome (modified Rankin Scale [mRS] score at 90 days) and secondary and safety outcomes were assessed using adjusted multivariable regression models. Results Among 633 included participants (356 men [56%]; median age, 69 years), HAS was observed in 283 participants (45%): 142 of 313 participants (45%) in the EVT-only group and 141 of 320 participants (44%) in the group with added intravenous alteplase. Treatment-by-HAS interaction was observed for the primary outcome ( < .001), whereby a shift in favor of better outcomes with added intravenous alteplase occurred in participants with HAS (adjusted odds ratio [OR]: 1.82; 95% CI: 1.18, 2.79), while an adverse effect was seen in participants without HAS (adjusted OR: 0.62; 95% CI: 0.42, 0.91). This also held true for three secondary outcomes (excellent outcome [mRS score of 0-1 at 90 days], = .005; good outcome [mRS score of 0-2 at 90 days], = .008; final successful reperfusion, = .04) in the adjusted models. Conclusion After acute ischemic stroke, presence of hyperdense artery sign (HAS) at baseline noncontrast CT indicated better outcomes when alteplase was added to endovascular treatment, but adding alteplase to endovascular treatment resulted in worse outcomes in participants without HAS. Clinical trial registration no. NCT03469206 © RSNA, 2022
背景 最近的证据表明,非对比 CT(NCCT)上存在颅内动脉血栓伴高密度动脉征(HAS)与静脉内使用阿替普酶更好的反应相关。有 HAS 的患者可能从静脉内使用阿替普酶和血管内治疗(EVT)的联合治疗中获益更多。
目的 探讨 NCCT 上的 HAS 是否改变了接受 EVT 的急性大血管闭塞患者中添加静脉内阿替普酶对临床结局的治疗效果。
材料与方法 本研究是一项前瞻性随机试验(直接动脉内血栓切除术以提高中国三级医院急性大血管闭塞患者的再通效率:多中心随机临床试验[DIRECT-MT])的二次分析,该试验比较了急性大血管闭塞患者在接受 EVT 治疗时添加阿替普酶与单独接受 EVT 的治疗效果。纳入了具有导管血管造影和足够 HAS 评估 NCCT 的参与者。在基线 NCCT 上由两名独立的研究者通过视觉判断 HAS。根据 HAS 的存在,使用调整后的多变量回归模型评估静脉内阿替普酶给药的治疗效果(90 天时改良 Rankin 量表[mRS]评分)以及次要和安全性结局。
结果 在纳入的 633 名参与者(356 名男性[56%];中位年龄,69 岁)中,283 名参与者(45%)观察到 HAS:EVT 组 313 名参与者中有 142 名(45%),EVT 加静脉内阿替普酶组 320 名参与者中有 141 名(44%)。主要结局的治疗- HAS 交互作用有统计学意义(<.001),HAS 阳性的患者静脉内添加阿替普酶后预后更好(调整后比值比[OR]:1.82;95%CI:1.18,2.79),而 HAS 阴性的患者预后更差(调整后 OR:0.62;95%CI:0.42,0.91)。在调整后的模型中,三个次要结局(90 天时 mRS 评分 0-1 的优秀结局[OR:1.82;95%CI:1.18,2.79]、90 天时 mRS 评分 0-2 的良好结局[OR:0.62;95%CI:0.42,0.91]和最终成功再灌注[OR:0.62;95%CI:0.42,0.91])也观察到治疗- HAS 交互作用。
结论 在急性缺血性脑卒中后,基线 NCCT 上出现高密度动脉征(HAS)表明在血管内治疗中添加阿替普酶可获得更好的结局,但在 HAS 阴性的患者中,添加阿替普酶进行血管内治疗会导致结局更差。
临床试验注册号 NCT03469206