Department of Neurology, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.
University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.
J Neurointerv Surg. 2023 Sep;15(e1):e102-e110. doi: 10.1136/jnis-2022-019207. Epub 2022 Jul 28.
We hypothesized that treatment delays might be an effect modifier regarding risks and benefits of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT).
We used the dataset of the SWIFT-DIRECT trial, which randomized 408 patients to IVT+MT or MT alone. Potential interactions between assignment to IVT+MT and expected time from onset-to-needle (OTN) as well as expected time from door-to-needle (DTN) were included in regression models. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes included mRS shift, mortality, recanalization rates, and (symptomatic) intracranial hemorrhage at 24 hours.
We included 408 patients (IVT+MT 207, MT 201, median age 72 years (IQR 64-81), 209 (51.2%) female). The expected median OTN and DTN were 142 min and 54 min in the IVT+MT group and 129 min and 51 min in the MT alone group. Overall, there was no significant interaction between OTN and bridging IVT assignment regarding either the functional (adjusted OR (aOR) 0.76, 95% CI 0.45 to 1.30) and safety outcomes or the recanalization rates. Analysis of in-hospital delays showed no significant interaction between DTN and bridging IVT assignment regarding the dichotomized functional outcome (aOR 0.48, 95% CI 0.14 to 1.62), but the shift and mortality analyses suggested a greater benefit of IVT when in-hospital delays were short.
We found no evidence that the effect of bridging IVT on functional independence is modified by overall or in-hospital treatment delays. Considering its low power, this subgroup analysis could have missed a clinically important effect, and exploratory analysis of secondary clinical outcomes indicated a potentially favorable effect of IVT with shorter in-hospital delays. Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials.
URL: https://www.
gov ; Unique identifier: NCT03192332.
我们假设，在机械血栓切除术（MT）之前，静脉溶栓（IVT）的治疗延迟可能是风险和获益的一个影响因素。
我们使用了 SWIFT-DIRECT 试验的数据，该试验将 408 名患者随机分配到 IVT+MT 或 MT 单独治疗组。在回归模型中纳入了从发病到溶栓（OTN）时间和从入急诊到溶栓（DTN）时间的预期值与 IVT+MT 分组的预期交互作用。主要结局是 3 个月时的功能独立性（改良 Rankin 量表（mRS）0-2 分）。次要结局包括 mRS 评分变化、死亡率、再通率和 24 小时内（症状性）颅内出血。
我们纳入了 408 名患者（IVT+MT 组 207 名，MT 组 201 名，中位年龄 72 岁（IQR 64-81 岁），209 名（51.2%）女性）。IVT+MT 组的预期中位 OTN 和 DTN 分别为 142 分钟和 54 分钟，MT 单独治疗组分别为 129 分钟和 51 分钟。总体而言，在功能和安全性结局以及再通率方面，OTN 与桥接 IVT 治疗分配之间没有显著的交互作用。对院内延迟的分析显示，在功能的二分类结局（调整后 OR（aOR）0.76，95%CI 0.45 至 1.30）和死亡率分析中，DTN 与桥接 IVT 治疗分配之间也没有显著的交互作用，但移位和死亡率分析表明，当院内延迟较短时，IVT 的获益更大。
我们没有发现桥接 IVT 对功能独立性的影响受整体或院内治疗延迟的影响。考虑到其低效能，本次亚组分析可能遗漏了一个具有临床意义的影响，而对次要临床结局的探索性分析表明，与较短的院内延迟相关，IVT 可能具有潜在的有利作用。应进一步在比较试验的个体患者荟萃分析中分析 MT 前 IVT 效果大小的异质性。
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