Yang Pengfei, Treurniet Kilian M, Zhang Lei, Zhang Yongwei, Li Zifu, Xing Pengfei, Zhang Yongxin, Zhang Ping, Wang Hao, Hong Bo, Dippel Diederik Wj, Roos Yvo Bwem, Majoie Charles Blm, Deng Benqiang, Liu Jianmin
Neurosurgery, Changhai Hospital - Naval Medical University, Shanghai, China.
Radiology & Nuclear Medicine, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.
Int J Stroke. 2020 Aug;15(6):689-698. doi: 10.1177/1747493019882837. Epub 2019 Oct 30.
Intravenous thrombolysis combined with mechanical thrombectomy (MT) has been proven safe and clinical effective in patients with acute ischemic stroke of anterior circulation large vessel occlusion. However, despite reperfusion, a considerable proportion of patients do not recover. Incidence of symptomatic intracerebral hemorrhage was similar between patients treated with the combination of intravenous thrombolysis and MT, as compared to intravenous thrombolysis alone, suggesting that this complication should be attributed to pre-treatment with intravenous thrombolysis. Conversely, intravenous thrombolysis may be beneficial in patients with small clots occluding intracranial arteries with underlying intracranial atherosclerotic disease, not accessible for MT.
To assess whether direct MT is non-inferior compared to combined intravenous thrombolysis plus MT in patients with AIS due to an anterior circulation large vessel occlusion, and to assess treatment effect modification by presence of intracranial atherosclerotic disease.
Aim to randomize 636 patients 1:1 to receive direct MT (intervention) or combined intravenous thrombolysis plus MT (control).
This is a multicenter, prospective, open label parallel group trial with blinded outcome assessment (PROBE design) assessing non-inferiority of direct MT compared to combined intravenous thrombolysis plus MT.
The primary outcome is the score on the modified Rankin Scale assessed blindly at 90 (±14) days. An common odds ratio, adjusted for the prognostic factors (age, NIHSS, collateral score), representing the shift on the 6-category mRS scale measured at three months, estimated with ordinal logistic regression, will be the primary effect parameter. Non-inferiority is established if the lower boundary of the 95% confidence interval does not cross 0.8.
DIRECT-MT could result in improved therapeutic efficiency and cost reduction in treatment of anterior circulation large vessel occlusion stroke.
静脉溶栓联合机械取栓（MT）已被证明对急性前循环大血管闭塞性缺血性卒中患者是安全且临床有效的。然而，尽管实现了再灌注，但仍有相当一部分患者未能恢复。与单纯静脉溶栓相比，接受静脉溶栓联合MT治疗的患者出现症状性脑出血的发生率相似，这表明该并发症应归因于静脉溶栓的预处理。相反，对于颅内动脉被小血栓阻塞且存在颅内动脉粥样硬化疾病而无法进行MT的患者，静脉溶栓可能有益。
评估在因前循环大血管闭塞导致急性缺血性卒中（AIS）的患者中，直接MT与静脉溶栓联合MT相比是否不劣，并评估颅内动脉粥样硬化疾病的存在对治疗效果的影响。
旨在将636例患者按1:1随机分组，分别接受直接MT（干预组）或静脉溶栓联合MT（对照组）治疗。
这是一项多中心、前瞻性、开放标签平行组试验，采用盲法结局评估（PROBE设计），评估直接MT与静脉溶栓联合MT相比的非劣效性。
主要结局指标是在90（±14）天时采用盲法评估的改良Rankin量表评分。将通过序贯逻辑回归估计的、针对预后因素（年龄、美国国立卫生研究院卒中量表[NIHSS]评分、侧支循环评分）进行调整的共同比值比，作为三个月时在6级改良Rankin量表上测量的变化的主要效应参数。如果95%置信区间的下限不超过0.8，则确定为非劣效。
DIRECT-MT可能会提高前循环大血管闭塞性卒中治疗的疗效并降低成本。
