评估直接血管内血栓切除术(dEVT)与桥接治疗(BT;IV组织型纤溶酶原激活剂+EVT)相比的安全性和有效性,并评估BT潜在益处是否与卒中严重程度相关。尺寸,以及EVT与非EVT中心的初始报告。
在一项血管内血栓切除术影像学选择的前瞻性多中心队列研究(优化急性缺血性卒中血管内治疗的患者选择[SELECT]),前循环大血管闭塞(LVO)患者在最近一次已知的4.5小时内出现在有EVT能力的中心,被分层为BT和dEVT.主要结果是90天功能独立性(改良Rankin量表[mRS]评分0-2)。次要结果包括90天mRS等级的转变,死亡率,有症状的颅内出血.我们还根据对具有EVT能力的中心的初始呈现进行了亚组分析(直接与转移),中风严重程度,和基线梗死核心体积。
我们确定了226个LVOs(54%的男性,平均年龄65.6±14.6岁,中位NIH卒中量表[NIHSS]评分17分,28%接受dEVT)。BT患者从到达腹股沟穿刺的中位时间没有差异(dEVT1.43[四分位距(IQR)1.13-1.90]小时vsBT1.58[IQR1.27-2.02]小时,p=0.40)或转移到具有EVT功能的中心(dEVT1.17[IQR0.90-1.48]小时vsBT1.27[IQR0.97-1.87]小时,p=0.24)。BT与90天功能独立的几率更高(57%vs44%,调整后的比值比[aOR]2.02,95%置信区间[CI]1.01-4.03,p=0.046)和功能改善(调整后的普通OR2.06,95%CI1.18-3.60,p=0.011)以及90天死亡率的可能性较低(11%vs23%,OR0.20,95%CI0.07-0.58,p=0.003)。没有检测到任何其他结果的差异。在亚组分析中,与有dEVT的患者相比,基线NIHSS评分<15的BT患者具有更高的功能独立性可能性(aOR4.87,95%CI1.56~15.18,p=0.006);对于NIHSS评分≥15的患者,这种关联并不明显(aOR1.05,95%CI0.40~2.74,p=0.92).同样,在核心体积层(缺血核心<50cm3:aOR2.10,95%CI1.02-4.33,p=0.044vs缺血核心≥50cm3:aOR0.41,95%CI0.01-16.02,p=0.64)和转移状态(转移:aOR2.21,95%CI0.93-9.65,p=0.29vs直接到EVT中心:aOR1.84,0.15%)的功能结局得到改善.
BT似乎与更好的临床结果相关,尤其是NIHSS分数比较温和,较小的演示核心卷,和那些“滴水和运送”的人。“我们没有观察到BT在更严重的中风患者中的任何潜在益处。
ClinicalTrials.gov标识符:NCT02446587。
这项研究提供了III类证据表明,对于前循环LVO患者,与dEVT相比,BT导致更好的90天功能结果。
To evaluate the comparative safety and efficacy of direct endovascular thrombectomy (dEVT) compared to bridging therapy (BT; IV tissue plasminogen activator + EVT) and to assess whether BT potential benefit relates to stroke severity, size, and initial presentation to EVT vs non-EVT center.
In a prospective multicenter cohort
study of imaging selection for endovascular thrombectomy (Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke [SELECT]), patients with anterior circulation large vessel occlusion (LVO) presenting to EVT-capable centers within 4.5 hours from last known well were stratified into BT vs dEVT. The primary outcome was 90-day functional independence (modified Rankin Scale [mRS] score 0-2). Secondary outcomes included a shift across 90-day mRS grades, mortality, and symptomatic intracranial hemorrhage. We also performed subgroup analyses according to initial presentation to EVT-capable center (direct vs transfer), stroke severity, and baseline infarct core volume.
We identified 226 LVOs (54% men, mean age 65.6 ± 14.6 years, median NIH Stroke Scale [NIHSS] score 17, 28% received dEVT). Median time from arrival to groin puncture did not differ in patients with BT when presenting directly (dEVT 1.43 [interquartile range (IQR) 1.13-1.90] hours vs BT 1.58 [IQR 1.27-2.02] hours, p = 0.40) or transferred to EVT-capable centers (dEVT 1.17 [IQR 0.90-1.48] hours vs BT 1.27 [IQR 0.97-1.87] hours, p = 0.24). BT was associated with higher odds of 90-day functional independence (57% vs 44%, adjusted odds ratio [aOR] 2.02, 95% confidence interval [CI] 1.01-4.03, p = 0.046) and functional improvement (adjusted common OR 2.06, 95% CI 1.18-3.60, p = 0.011) and lower likelihood of 90-day mortality (11% vs 23%, aOR 0.20, 95% CI 0.07-0.58, p = 0.003). No differences in any other outcomes were detected. In subgroup analyses, patients with BT with baseline NIHSS scores <15 had higher functional independence likelihood compared to those with dEVT (aOR 4.87, 95% CI 1.56-15.18, p = 0.006); this association was not evident for patients with NIHSS scores ≥15 (aOR 1.05, 95% CI 0.40-2.74, p = 0.92). Similarly, functional outcomes improvements with BT were detected in patients with core volume strata (ischemic core <50 cm3: aOR 2.10, 95% CI 1.02-4.33, p = 0.044 vs ischemic core ≥50 cm3: aOR 0.41, 95% CI 0.01-16.02, p = 0.64) and transfer status (transferred: aOR 2.21, 95% CI 0.93-9.65, p = 0.29 vs direct to EVT center: aOR 1.84, 95% CI 0.80-4.23, p = 0.15).
BT appears to be associated with better clinical outcomes, especially with milder NIHSS scores, smaller presentation core volumes, and those who were \"dripped and shipped.\" We did not observe any potential benefit of BT in patients with more severe strokes.
ClinicalTrials.gov Identifier: NCT02446587.
This
study provides Class III evidence that for patients with ischemic stroke from anterior circulation LVO within 4.5 hours from last known well, BT compared to dEVT leads to better 90-day functional outcomes.