Department for Diagnostic and Interventional Neuroradiology, Inselspital University Hospital Bern, Bern, Switzerland
Department for Diagnostic and Interventional Neuroradiology, Inselspital University Hospital Bern, Bern, Switzerland.
J Neurointerv Surg. 2023 Mar;15(3):227-232. doi: 10.1136/neurintsurg-2022-018665. Epub 2022 Mar 1.
Most trials comparing endovascular treatment (EVT) alone versus intravenous thrombolysis with alteplase (IVT) + EVT in directly admitted patients with a stroke are non-inferiority trials. However, the margin based on the level of uncertainty regarding non-inferiority of the experimental treatment that clinicians are willing to accept to incorporate EVT alone into clinical practice remains unknown.
To characterize what experienced stroke clinicians would consider an acceptable level of uncertainty for hypothetical decisions on whether to administer IVT or not before EVT in patients admitted directly to EVT-capable centers.
A web-based, structured survey was distributed to a cross-section of 600 academic neurologists/neurointerventionalists. For this purpose, a response framework for a hypothetical trial comparing IVT+EVT (standard of care) with EVT alone (experimental arm) was designed. In this trial, a similar proportion of patients in each arm achieved functional independence at 90 days. Invited physicians were asked at what level of certainty they would feel comfortable skipping IVT in clinical practice, considering these hypothetical trial results.
There were 180 respondents (response rate: 30%) and 165 with complete answers. The median chosen acceptable uncertainty suggesting reasonable comparability between both treatments was an absolute difference in the rate of day 90 functional independence of 3% (mode 5%, IQR 1-5%), with higher chosen margins observed in interventionalists (aOR 2.20, 95% CI 1.06 to 4.67).
Physicians would generally feel comfortable skipping IVT before EVT at different certainty thresholds. Most physicians would treat with EVT alone if randomized trial data suggested that the number of patients achieving functional independence at 90 days was similar between the two groups, and one could be sufficiently sure that no more than 3 out of 100 patients would not achieve functional independence at 90 days due to skipping IVT.
大多数比较直接收治的卒中患者中血管内治疗（EVT）与阿替普酶静脉溶栓（IVT）+EVT 的临床试验都是非劣效性试验。然而，对于临床医生愿意接受的实验性治疗非劣效性的不确定性程度，从而将 EVT 单独纳入临床实践的边缘仍未知。
在直接收入 EVT 能力中心的患者中，确定经验丰富的卒中临床医生在考虑是否在 EVT 前给予 IVT 时对假设性决策可接受的不确定性水平。
通过网络向 600 名学术神经科医生/神经介入医生进行了一项基于网络的结构化调查。为此，设计了一个用于比较 IVT+EVT（标准治疗）与 EVT 单独（实验臂）的假设性试验的应答框架。在该试验中，各臂中相似比例的患者在 90 天时实现了功能独立性。邀请医生在考虑这些假设性试验结果的情况下，对他们在临床实践中感到舒适的跳过 IVT 的置信度水平进行回答。
共有 180 名应答者（应答率：30%）和 165 名回答完整。选择的可接受不确定性中位数提示两种治疗方法具有合理可比性的是，第 90 天功能独立性的绝对差异为 3%（模式为 5%，IQR 1-5%），干预医生选择的范围更大（OR 2.20，95%CI 1.06 至 4.67）。
在不同的置信度阈值下，医生通常会感到舒适地跳过 EVT 前的 IVT。如果随机试验数据表明，两组患者在 90 天达到功能独立性的患者数量相似，并且可以非常确定由于跳过 IVT，每 100 名患者中不会有超过 3 名患者在 90 天内无法实现功能独立性，那么大多数医生将单独接受 EVT 治疗。
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