From the Departments of Neurology (A.S., J.G., D.P., H.K., A.D.B.), Neurosurgery (S.B., A.D., M.D.), Radiology (C.S.), and Clinical and Translational Science (C.C.), University of Texas at Houston; Department of Neurology (G.W.A., M.L.), Stanford University, CA; Department of Neurology (A.E.H., W.G.T.), University of Texas Rio Grande Valley, Harlingen; Department of Neurology (M.A.), Kansas University Medical Center, Kansas City; Department of Neurology (W.H., R.B., N.V.), OhioHealth-Riverside Methodist Hospital, Columbus; Cone Health (A.A.), Greensboro, NC; Department of Neurology (B.A.), St. Vincent Mercy Health Medical Center, Toledo, OH; Department of Neurology (O.M.), New York University Langone Health, New York; Department of Neurology (R.G.), WellStar Health System, Atlanta, GA; Department of Neurology (S.M.-S.), Touro Infirmary and New Orleans East Hospital, LA; Department of Neurology (S.S.), Institute for Stroke and Cerebrovascular Diseases-UTHealth, Houston; University of Tennessee Health Science Center (G.T.), Memphis; and Second Department of Neurology (G.T.), National & Kapodistrian University of Athens, Greece.
Neurology. 2021 Jun 8;96(23):e2839-e2853. doi: 10.1212/WNL.0000000000012063. Epub 2021 Apr 19.
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, = 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, = 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, = 0.046) and functional improvement (adjusted common OR 2.06, 95% CI 1.18-3.60, = 0.011) and lower likelihood of 90-day mortality (11% vs 23%, aOR 0.20, 95% CI 0.07-0.58, = 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, = 0.006); this association was not evident for patients with NIHSS scores ≥15 (aOR 1.05, 95% CI 0.40-2.74, = 0.92). Similarly, functional outcomes improvements with BT were detected in patients with core volume strata (ischemic core <50 cm: aOR 2.10, 95% CI 1.02-4.33, = 0.044 vs ischemic core ≥50 cm: aOR 0.41, 95% CI 0.01-16.02, = 0.64) and transfer status (transferred: aOR 2.21, 95% CI 0.93-9.65, = 0.29 vs direct to EVT center: aOR 1.84, 95% CI 0.80-4.23, = 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.
评估直接血管内血栓切除术（dEVT）与桥接治疗（BT；静脉组织型纤溶酶原激活剂+EVT）相比的相对安全性和疗效，并评估 BT 的潜在益处是否与卒中严重程度、大小以及初始 EVT 与非-EVT 中心就诊相关。
在前循环大血管闭塞（LVO）的血管内取栓术的前瞻性多中心队列研究（优化血管内治疗急性缺血性卒中的患者选择[SELECT]）中，在发病后 4.5 小时内，将符合条件的前循环 LVO 患者分为 BT 与 dEVT 组。主要结局为 90 天功能独立性（改良 Rankin 量表[mRS]评分 0-2）。次要结局包括 90 天 mRS 评分的变化、死亡率和症状性颅内出血。我们还根据初始就诊于 EVT 中心（直接就诊 vs 转院）、卒中严重程度和基线梗死核心体积进行了亚组分析。
我们确定了 226 例 LVO（54%为男性，平均年龄 65.6±14.6 岁，中位数 NIH 卒中量表[NIHSS]评分 17，28%接受了 dEVT）。BT 患者直接就诊（dEVT 组 1.43 [IQR 1.13-1.90] 小时 vs BT 组 1.58 [IQR 1.27-2.02] 小时，=0.40）或转院至 EVT 中心（dEVT 组 1.17 [IQR 0.90-1.48] 小时 vs BT 组 1.27 [IQR 0.97-1.87] 小时，=0.24）时，到达股动脉穿刺的中位时间没有差异。BT 与 90 天功能独立性（57% vs 44%，调整后的优势比[aOR]2.02，95%置信区间[CI]1.01-4.03，=0.046）和功能改善（调整后的共同比值[aOR]2.06，95%CI 1.18-3.60，=0.011）的可能性更高，90 天死亡率（11% vs 23%，aOR 0.20，95%CI 0.07-0.58，=0.003）的可能性更低。其他结局均无差异。在亚组分析中，基线 NIHSS 评分＜15 的 BT 患者的功能独立性可能性高于 dEVT 患者（aOR 4.87，95%CI 1.56-15.18，=0.006）；基线 NIHSS 评分≥15 的患者（aOR 1.05，95%CI 0.40-2.74，=0.92）则没有观察到这种关联。同样，在核心体积分层的患者中（缺血核心＜50cm：aOR 2.10，95%CI 1.02-4.33，=0.044 vs 缺血核心≥50cm：aOR 0.41，95%CI 0.01-16.02，=0.64）和转院状态（转院：aOR 2.21，95%CI 0.93-9.65，=0.09 vs 直接到 EVT 中心：aOR 1.84，95%CI 0.80-4.23，=0.15）中，BT 与功能改善相关。
BT 似乎与更好的临床结局相关，尤其是在 NIHSS 评分较轻、初始梗死核心体积较小和“滴注转院”的患者中。我们没有观察到 BT 在卒中更严重的患者中存在任何潜在获益。
ClinicalTrials.gov 标识符：NCT02446587。
本研究提供了 III 级证据，对于发病后 4.5 小时内前循环 LVO 的缺血性卒中患者，与直接 EVT 相比，BT 可带来更好的 90 天功能结局。
