Thrombectomy for Stroke in the Public Health Care System of Brazil

被引:171
作者
Martins, Sheila O. [1 ,4 ]
Mont'Alverne, Francisco [5 ]
Rebello, Leticia C. [8 ]
Abud, Daniel G. [10 ]
Silva, Gisele S. [12 ,14 ]
Lima, Fabricio O. [6 ]
Parente, Bruno S. M. [9 ]
Nakiri, Guilherme S. [10 ]
Faria, Mario B. [2 ]
Frudit, Michel E. [13 ]
de Carvalho, Joao J. F. [6 ]
Waihrich, Eduardo [9 ]
Fiorot, Jose A., Jr. [17 ]
Cardoso, Fabricio B. [15 ]
Hidalgo, Raquel C. T. [16 ]
Zetola, Viviane F. [18 ]
Carvalho, Fernanda M. [6 ,7 ]
de Souza, Ana C. [1 ,4 ]
Dias, Francisco A. [11 ]
Bandeira, Diego [5 ,6 ]
Miranda Alves, Maramelia [12 ]
Wagner, Mario B. [3 ,4 ]
Carbonera, Leonardo A. [1 ,4 ]
Oliveira-Filho, Jamary [19 ]
Bezerra, Daniel C. [20 ]
Liebeskind, David S. [22 ,23 ]
Broderick, Joseph [24 ]
Molina, Carlos A. [25 ]
Fogolin Passos, Jose E. [21 ]
Saver, Jeffrey L. [22 ,23 ]
Pontes-Neto, Octavio M. [11 ]
Nogueira, Raul G. [26 ]
机构
[1] Univ Fed Rio Grande do Sul, Dept Neurol, Porto Alegre, RS, Brazil
[2] Univ Fed Rio Grande do Sul, Dept Intervent Neuroradiol, Porto Alegre, RS, Brazil
[3] Univ Fed Rio Grande do Sul, Dept Social Med, Porto Alegre, RS, Brazil
[4] Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil
[5] Univ Fortaleza, Hosp Geral Fortaleza, Dept Intervent Neuroradiol, Fortaleza, Ceara, Brazil
[6] Univ Fortaleza, Hosp Geral Fortaleza, Dept Neurol, Fortaleza, Ceara, Brazil
[7] Univ Fortaleza, Dept Postgrad Med Sci, Fortaleza, Ceara, Brazil
[8] Inst Hosp Base Dist Fed, Dept Neurol, Brasilia, DF, Brazil
[9] Inst Hosp Base Dist Fed, Dept Neurosurg, Brasilia, DF, Brazil
[10] Univ Sao Paulo, Ribeirao Preto Med Sch, Stroke Neurol Div, Dept Intervent Neuroradiol, Ribeirao Preto, Brazil
[11] Univ Sao Paulo, Ribeirao Preto Med Sch, Stroke Neurol Div, Dept Neurosci & Behav Sci, Ribeirao Preto, Brazil
[12] Univ Fed Sao Paulo, Dept Neurol, Sao Paulo, Brazil
[13] Univ Fed Sao Paulo, Dept Intervent Neuroradiol, Sao Paulo, Brazil
[14] Univ Estadual Campinas, Acad Res Org, Hosp Israelita Albert Einstein, Sao Paulo, Brazil
[15] Univ Estadual Campinas, Dept Neurol, Sao Paulo, Brazil
[16] Hosp Base Sao Jose Rio Preto, Dept Neurol & Intervent Neuroradiol, Sao Paulo, Brazil
[17] Hosp Estadual Cent Vitoria, Dept Neurol, Vitoria, ES, Brazil
[18] Univ Fed Parana, Dept Neurol, Curitiba, Parana, Brazil
[19] Univ Fed Bahia, Postgrad Program Hlth Sci, Sch Med, Salvador, BA, Brazil
[20] Hosp Procardiaco, Dept Neurol, Rio De Janeiro, Brazil
[21] Natl Council Municipal Hlth Secretariats, Bauru, SP, Brazil
[22] Univ Calif Los Angeles, David Geffen Sch Med, Dept Neurol, Los Angeles, CA 90095 USA
[23] Univ Calif Los Angeles, David Geffen Sch Med, Comprehens Stroke Ctr, Los Angeles, CA 90095 USA
[24] Univ Cincinnati, Coll Med, Dept Neurol & Rehabil Med, Cincinnati, OH USA
[25] Autonomous Univ Barcelona, Vall Hebron Res Inst, Vall Hebron Univ Hosp, Dept Neurol,Stroke Unit, Barcelona, Spain
[26] Emory Univ, Sch Med, Dept Neurol, Grady Mem Hosp,Marcus Stroke & Neurosci Ctr, Atlanta, GA 30322 USA
关键词
ACUTE ISCHEMIC-STROKE; MECHANICAL THROMBECTOMY; ENDOVASCULAR TREATMENT; VALIDATION; GUIDELINES; ALTEPLASE;
D O I
10.1056/NEJMoa2000120
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Endovascular thrombectomy has been effective in reducing stroke-related disability in high-income countries. This trial in the public health care system of Brazil, a developing country, showed similar effectiveness in patients treated within 8 hours after the onset of symptoms. 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. (Funded by the Brazilian Ministry of Health; RESILIENT ClinicalTrials.gov number, NCT02216643.)
引用
收藏
页码:2316 / 2326
页数:11
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