美国亚特兰大格雷迪纪念医院Raul G. Nogueira团队探讨了在巴西公共卫生保健系统中进行脑卒中血栓切除术的效果。相关论文发表在2020年6月11日出版的《新英格兰医学杂志》上。

关于中风患者的随机试验已证明，通过使用大血管阻塞性血栓切除术可以改善预后。这些试验在资源丰富的国家/地区进行，但在中低收入国家/地区医疗实践有限。

研究组探讨了巴西公共卫生系统中血栓切除术的安全性和有效性。在12所公立医院中，研究组招募卒中发作后8小时内接受治疗的前循环近端颅内阻塞的患者，按1：1随机分组，分别接受标准治疗+机械血栓切除术（血栓切除术组）或标准单独治疗（对照组）。主要结果为90天时的改良Rankin量表评分，0-6分，分数越高病情越严重。

共有300例患者入组，其中79例在开放标签滚动期间进行了血栓切除术。两组中约70%的患者接受了静脉阿替普酶治疗。原计划招募690例患者，但当221例患者接受随机分组（血栓切除术组111例，对照组110例）时，该试验因疗效而提前中止。治疗90天后，血栓切除术组的改良Rankin量表评分与对照组的优势比为2.28，差异显著。血栓切除术组中改良Rankin量表评分为0-2分的患者占35.1%，对照组为20.0%。血栓切除术组中无症状颅内出血的发生率为51.4％，对照组为24.5％。每组中有4.5％的患者出现症状性颅内出血。

总之，在巴西进行的这项随机试验中，卒中症状发作后8小时内进行血管内治疗联合标准治疗，在90天时的功能结局优于单纯标准治疗。

附：英文原文

Title: Thrombectomy for Stroke in the Public Health Care System of Brazil

Author: Sheila O. Martins, M.D., Ph.D.,, Francisco Mont’Alverne, M.D., Ph.D.,, Letícia C. Rebello, M.D.,, Daniel G. Abud, M.D., Ph.D.,, Gisele S. Silva, M.D., Ph.D.,, Fabrício O. Lima, M.D., Ph.D.,, Bruno S.M. Parente, M.D.,, Guilherme S. Nakiri, M.D., Ph.D.,, Mário B. Faria, M.D.,, Michel E. Frudit, M.D., Ph.D.,, Joo J.F. de Carvalho, M.D.,, Eduardo Waihrich, M.D., Ph.D.,, José A. Fiorot, Jr., M.D.,, Fabrício B. Cardoso, M.D.,, Raquel C.T. Hidalgo, M.D.,, Viviane F. Zétola, M.D., Ph.D.,, Fernanda M. Carvalho, M.D., Ph.D.,, Ana C. de Souza, M.D.,, Francisco A. Dias, M.D.,, Diego Bandeira, M.D.,, Maramélia Miranda Alves, M.D.,, Mário B. Wagner, M.D., Ph.D.,, Leonardo A. Carbonera, M.D.,, Jamary Oliveira-Filho, M.D., Ph.D.,, Daniel C. Bezerra, M.D., Ph.D.,, David S. Liebeskind, M.D.,, Joseph Broderick, M.D.,, Carlos A. Molina, M.D., Ph.D.,, José E. Fogolin Passos, M.D.,, Jeffrey L. Saver, M.D.,, Octávio M. Pontes-Neto, M.D., Ph.D.,, and Raul G. Nogueira, M.D.

Issue&Volume: 2020-06-10

Abstract: Abstract

Background

Randomized trials involving patients with stroke have established that outcomes are improved with the use of thrombectomy for large-vessel occlusion. These trials were performed in high-resource countries and have had limited effects on medical practice in low- and middle-income countries.

Methods

We studied the safety and efficacy of thrombectomy in the public health system of Brazil. In 12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms were randomly assigned in a 1:1 ratio to receive standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group). The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days.

Results

A total of 300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period. Approximately 70% in the two groups received intravenous alteplase. The trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69; P=0.001), favoring thrombectomy. The percentage of patients with a score on the modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit, was 35.1% in the thrombectomy group and 20.0% in the control group (difference, 15.1 percentage points; 95% CI, 2.6 to 27.6). Asymptomatic intracranial hemorrhage occurred in 51.4% of the patients in the thrombectomy group and 24.5% of those in the control group; symptomatic intracranial hemorrhage occurred in 4.5% of the patients in each group.

Conclusions

In this randomized trial conducted in the public health care system of Brazil, endovascular treatment within 8 hours after the onset of stroke symptoms in conjunction with standard care resulted in better functional outcomes at 90 days than standard care alone.

DOI: NJ202006113822410

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2000120