大缺血核心患者应用替奈普酶或阿替普酶桥接治疗后的功能结局和出血率。
Functional Outcome and Hemorrhage Rates After Bridging Therapy With Tenecteplase or Alteplase in Patients With Large Ischemic Core.
机构信息
From the AP-HP (G.G., M.Y., T.C., S.A.), Urgences Cérébro-Vasculaires, Hôpital Pitié-Salpêtrière, Sorbonne Université; STARE Team (G.G., M.Y., T.C., S.A.), iCRIN, Institut du Cerveau et de la Moelle épinière, ICM; Institut de Psychiatrie et Neurosciences de Paris (G.G., G.T., N.C., P.S., M.Y., D.S., S.A.), U1266, INSERM, Paris; Neurologie (G.T.), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G.T.), FHU Neurovasc; Neurologie (O.M., P.S.), Fondation Rothschild, Paris; Neurologie (N.C., D.S.), Hôpital Sud-Francilien, Corbeil-Essonnes; Neuroradiologie (A.C.), Hôpital Foch, Université Versailles Saint-Quentin en Yvelines, Suresnes; Neurologie (S.O., I.S.), CHU de Bordeaux; AP-HP (J.C.), Neuroradiologie Interventionnelle, Hôpital Bicêtre, Université Paris-Saclay, Kremlin-Bicêtre; Neuroradiologie (G.M.), CHU de Bordeaux; Neuroradiologie (R. Blanc, M.P.), Fondation Rothschild; Neuroradiologie (W.B.H.), GHU Paris Psychiatrie et Neurosciences; Neurologie (B. Guillon), CHU de Nantes; Neurologie (E.W., F.P.), Centre Hospitalier de Versailles, Le Chesnay; Neuroradiologie (R. Bourcier), CHU de Nantes; Neurologie (T.-H.C.), Hospices Civils de Lyon; Neuroradiologie (B. Gory), and Neurologie (S.R.), CHRU de Nancy; Neuroradiologie (O.F.E.), Hospices Civils de Lyon; and Neurologie (B.L.), Hôpital Foch, Suresnes, France.
出版信息
Neurology. 2024 Jul 9;103(1):e209398. doi: 10.1212/WNL.0000000000209398. Epub 2024 Jun 11.
BACKGROUND AND OBJECTIVES
IV tenecteplase is an alternative to alteplase before mechanical thrombectomy (MT) in patients with large-vessel occlusion (LVO) ischemic stroke. Little data are available on its use in patients with large ischemic core. We aimed to compare the efficacy and safety of both thrombolytics in this population.
METHODS
We conducted a retrospective analysis of patients with anterior circulation LVO strokes and diffusion-weighed imaging Alberta Stroke Program Early CT Score (DWI-ASPECTS) ≤5 treated with tenecteplase or alteplase before MT from the TETRIS (tenecteplase) and ETIS (alteplase) French multicenter registries. Primary outcome was reduced disability at 3 months (ordinal analysis of the modified Rankin scale [mRS]). Safety outcomes were 3-month mortality, parenchymal hematoma (PH), and symptomatic intracranial hemorrhage (sICH). We used propensity score overlap weighting to reduce baseline differences between treatment groups.
RESULTS
We analyzed 647 patients (tenecteplase: n = 194; alteplase: n = 453; inclusion period 2015-2022). Median (interquartile range) age was 71 (57-81) years, with NIH Stroke Scale score 19 (16-22), DWI-ASPECTS 4 (3-5), and last seen well-to-IV thrombolysis and puncture times 165 minutes (130-226) and 260 minutes (203-349), respectively. After MT, the successful reperfusion rate was 83.1%. After propensity score overlap weighting, all baseline variables were well balanced between both treatment groups. Compared with patients treated with alteplase, patients treated with tenecteplase had better 3-month mRS (common odds ratio [OR] for reduced disability: 1.37, 1.01-1.87, = 0.046) and lower 3-month mortality (OR 0.52, 0.33-0.81, < 0.01). There were no significant differences between thrombolytics for PH (OR 0.84, 0.55-1.30, = 0.44) and sICH incidence (OR 0.70, 0.42-1.18, = 0.18).
DISCUSSION
Our data are encouraging regarding the efficacy and reassuring regarding the safety of tenecteplase compared with that of alteplase in bridging therapy for patients with LVO strokes and a large ischemic core in routine clinical care. These results support its consideration as an alternative to alteplase in bridging therapy for patients with large ischemic cores.
TRIALS REGISTRATION INFORMATION
NCT03776877 (ETIS registry) and NCT05534360 (TETRIS registry).
CLASSIFICATION OF EVIDENCE
This study provides Class III evidence that patients with anterior circulation LVO stroke and DWI-ASPECTS ≤5 treated with tenecteplase vs alteplase before MT experienced better functional outcomes and lower mortality at 3 months.
背景与目的
在接受机械取栓（MT）前，IV 型替奈普酶是大血管闭塞（LVO）缺血性脑卒中患者使用阿替普酶的替代药物。目前关于其在大缺血核心患者中的应用的数据较少。我们旨在比较这两种溶栓药物在该人群中的疗效和安全性。
方法
我们对来自法国多中心 TETRIS（替奈普酶）和 ETIS（阿替普酶）登记处的接受替奈普酶或阿替普酶溶栓治疗前 MT 的前循环 LVO 卒中和弥散加权成像 Alberta 卒中计划早期 CT 评分（DWI-ASPECTS）≤5 的患者进行了回顾性分析。主要结局为 3 个月时残疾程度降低（改良 Rankin 量表[mRS]的等级分析）。安全性结局为 3 个月死亡率、实质血肿（PH）和症状性颅内出血（sICH）。我们使用倾向评分重叠加权来减少治疗组之间的基线差异。
结果
我们分析了 647 例患者（替奈普酶：n=194；阿替普酶：n=453；纳入期 2015-2022 年）。中位（四分位距）年龄为 71（57-81）岁，NIH 卒中量表评分 19（16-22），DWI-ASPECTS 4（3-5），最后一次看到良好至 IV 级溶栓和穿刺时间分别为 165 分钟（130-226）和 260 分钟（203-349）。MT 后，再通率为 83.1%。在进行倾向评分重叠加权后，两组治疗的所有基线变量均得到很好的平衡。与接受阿替普酶治疗的患者相比，接受替奈普酶治疗的患者 3 个月时 mRS 更好（残疾程度降低的常见优势比[OR]：1.37，1.01-1.87， = 0.046），3 个月死亡率更低（OR 0.52，0.33-0.81， < 0.01）。两种溶栓药物在 PH（OR 0.84，0.55-1.30， = 0.44）和 sICH 发生率（OR 0.70，0.42-1.18， = 0.18）方面无显著差异。
讨论
与阿替普酶相比，我们的数据在替奈普酶用于 LVO 卒中和常规临床护理中大缺血核心患者桥接治疗的疗效方面令人鼓舞，在安全性方面令人安心。这些结果支持将替奈普酶作为大缺血核心患者桥接治疗的替代药物。
试验注册信息
NCT03776877（ETIS 登记处）和 NCT05534360（TETRIS 登记处）。
证据分类
本研究提供了 III 级证据，表明在前循环 LVO 卒中和 DWI-ASPECTS≤5 的患者中，与 MT 前接受阿替普酶相比，接受替奈普酶治疗的患者在 3 个月时的功能结局更好，死亡率更低。
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