荷兰阿姆斯特丹UMC的Yvo B.W.E.M. Roos团队比较了脑卒中血管内治疗前静脉注射与不注射阿替普酶的临床预后。相关论文于2021年11月10日发表在《新英格兰医学杂志》上。

急性缺血性脑卒中在血管内治疗（EVT）前静脉注射阿替普酶的价值尚未得到广泛研究，特别是在非亚洲人群中。

研究人员在欧洲进行了一项开放标签、多中心、随机试验，招募直接就诊于有能力提供EVT的医院并符合静脉注射阿替普酶和EVT条件的脑卒中患者。将患者按1:1的比例随机分配，分别接受单独EVT或静脉注射阿替普酶后进行EVT（标准护理）。

主要终点为90天时改良Rankin量表的功能结局（范围为0[无残疾]至6[死亡]）。研究组评估了两个试验组的优势比，以及单独EVT与阿替普酶+EVT的非劣效性。全因死亡和症状性脑出血是主要的安全终点。

该分析共包括539名患者。单独EVT组改良Rankin量表在90天时的中位评分为3分，阿替普酶加EVT组为2分。校正后的共同优势比为0.84，这表明单独EVT既没有优势也没有劣势。单独EVT组的死亡率为20.5%，阿替普酶加EVT组的死亡率为15.8%（校正后的优势比为1.39）。症状性脑出血发生率分别为5.9%和5.3%（校正后的优势比为1.30）。

这项涉及欧洲患者的随机试验表明，就脑卒中后90天的残疾结局而言，单用EVT既不优于也不劣于静脉注射阿替普酶+EVT。两组症状性脑出血的发生率相似。

附：英文原文

Title: A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke

Author: Natalie E. LeCouffe, M.D.,, Manon Kappelhof, M.D.,, Kilian M. Treurniet, M.D., Ph.D.,, Leon A. Rinkel, M.D.,, Agnetha E. Bruggeman, M.D.,, Olvert A. Berkhemer, M.D., Ph.D.,, Lennard Wolff, M.D.,, Henk van Voorst, M.D.,, Manon L. Tolhuisen, M.Sc.,, Diederik W.J. Dippel, M.D., Ph.D.,, Aad van der Lugt, M.D., Ph.D.,, Adriaan C.G.M. van Es, M.D., Ph.D.,, Jelis Boiten, M.D., Ph.D.,, Geert J. Lycklama à Nijeholt, M.D., Ph.D.,, Koos Keizer, M.D., Ph.D.,, Rob A.R. Gons, M.D., Ph.D.,, Lonneke S.F. Yo, M.D.,, Robert J. van Oostenbrugge, M.D., Ph.D.,, Wim H. van Zwam, M.D., Ph.D.,, Bob Roozenbeek, M.D., Ph.D.,, H. Bart van der Worp, M.D., Ph.D.,, Rob T.H. Lo, M.D., Ph.D.,, Ido R. van den Wijngaard, M.D., Ph.D.,, Inger R. de Ridder, M.D., Ph.D.,, Vincent Costalat, M.D., Ph.D.,, Caroline Arquizan, M.D.,, Robin Lemmens, M.D., Ph.D.,, Jelle Demeestere, M.D.,, Jeannette Hofmeijer, M.D., Ph.D.,, Jasper M. Martens, M.D.,, Wouter J. Schonewille, M.D., Ph.D.,, Jan-Albert Vos, M.D., Ph.D.,, Maarten Uyttenboogaart, M.D., Ph.D.,, Reinoud P.H. Bokkers, M.D., Ph.D.,, Julia H. van Tuijl, M.D., Ph.D.,, Hans Kortman, M.D.,, Floris H.B.M. Schreuder, M.D., Ph.D.,, Hieronymus D. Boogaarts, M.D., Ph.D.,, Karlijn F. de Laat, M.D., Ph.D.,, Lukas C. van Dijk, M.D., Ph.D.,, Heleen M. den Hertog, M.D., Ph.D.,, Boudewijn A.A.M. van Hasselt, M.D.,, Paul J.A.M. Brouwers, M.D., Ph.D.,, Tomas Bulut, M.D.,, Michel J.M. Remmers, M.D.,, Anouk van Norden, M.D.,, Farshad Imani, M.D.,, Anouk D. Rozeman, M.D., Ph.D.,, Otto E.H. Elgersma, M.D., Ph.D.,, Philippe Desfontaines, M.D.,, Denis Brisbois, M.D.,, Yves Samson, M.D.,, Frédéric Clarenon, M.D., Ph.D.,, G. Menno Krietemeijer, M.D.,, Alida A. Postma, M.D., Ph.D.,, Pieter-Jan van Doormaal, M.D.,, René van den Berg, M.D., Ph.D.,, Anouk van der Hoorn, M.D., Ph.D.,, Ludo F.M. Beenen, M.D., Ph.D.,, Daan Nieboer, M.Sc.,, Hester F. Lingsma, Ph.D.,, Bart J. Emmer, M.D., Ph.D.,, Jonathan M. Coutinho, M.D., Ph.D.,, Charles B.L.M. Majoie, M.D., Ph.D.,, and Yvo B.W.E.M. Roos, M.D., Ph.D.

Issue&Volume: 2021-11-10

Abstract:

Background

The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations.

Methods

We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points.

Results

The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P=0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81).

Conclusions

In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups.

DOI: 10.1056/NEJMoa2107727

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2107727