Safety and Efficacy of Tenecteplase Compared With Alteplase in Patients With Large Vessel Occlusion Stroke A Prespecified Secondary Analysis of the ACT Randomized Clinical Trial

被引：35

作者：

Bala, Fouzi ^{[1
,2
]}

Singh, Nishita ^{[1
,34
]}

Buck, Brian ^{[6
]}

Ademola, Ayoola ^{[1
,3
]}

Coutts, Shelagh B. B. ^{[1
,3
,4
,5
]}

Deschaintre, Yan ^{[7
,8
]}

Khosravani, Houman ^{[9
,10
]}

Appireddy, Ramana ^{[11
]}

Moreau, Francois ^{[12
]}

Phillips, Stephen ^{[13
]}

Gubitz, Gord ^{[13
]}

Tkach, Aleksander ^{[14
]}

Catanese, Luciana ^{[15
,16
]}

Dowlatshahi, Dar ^{[17
,18
]}

Medvedev, George ^{[19
,20
]}

Mandzia, Jennifer ^{[21
,22
]}

Pikula, Aleksandra ^{[10
,23
]}

Shankar, Jai Jai ^{[24
]}

Williams, Heather ^{[25
]}

Field, Thalia S. S. ^{[26
,27
]}

Alzate, Alejandro Manosalva ^{[28
]}

Siddiqui, Muzaffar ^{[29
]}

Zafar, Atif ^{[30
]}

Imoukhoude, Oje ^{[31
]}

Hunter, Gary ^{[32
]}

Alhabli, Ibrahim ^{[1
]}

Benali, Faysal ^{[1
,33
]}

Horn, MacKenzie ^{[1
]}

Hill, Michael D. D. ^{[1
,3
,4
,5
]}

Shamy, Michel ^{[17
,18
]}

Sajobi, Tolulope T. T. ^{[1
,3
]}

Swartz, Richard H. H. ^{[9
,10
]}

Menon, Bijoy K. K. ^{[1
,3
,4
,5
]}

Almekhlafi, Mohammed ^{[1
,3
,4
,5
]}

机构：

[1] Univ Calgary, Cumming Sch Med, Dept Clin Neurosci, 1403 29th St NW, Calgary, AB T2N 2T9, Canada

[2] Univ Hosp Tours, Diagnost & Intervent Neuroradiol Dept, Tours, France

[3] Univ Calgary, Dept Community Hlth Sci, Calgary, AB, Canada

[4] Univ Calgary, Cumming Sch Med, Dept Radiol, Calgary, AB, Canada

[5] Hotchkiss Brain Inst, Calgary, AB, Canada

[6] Univ Alberta, Dept Med, Div Neurol, Edmonton, AB, Canada

[7] Univ Montreal, Dept Neurosci, Montreal, PQ, Canada

[8] Ctr Hosp Univ Montreal CHUM, Montreal, PQ, Canada

[9] Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada

[10] Univ Toronto, Toronto, ON, Canada

[11] Queens Univ, Dept Med, Div Neurol, Kingston, ON, Canada

[12] Univ Sherbrooke, Sherbrooke, PQ, Canada

[13] Queen Elizabeth 2 Hlth Sci Ctr, Halifax, NS, Canada

[14] Kelowna Gen Hosp, Kelowna, BC, Canada

[15] Hamilton Hlth Sci Ctr, Hamilton, ON, Canada

[16] McMaster Univ, Hamilton, ON, Canada

[17] Univ Ottawa, Dept Med, Ottawa, ON, Canada

[18] Ottawa Heart Res Inst, Ottawa, ON, Canada

[19] Univ British Columbia, New Westminster, BC, Canada

[20] Fraser Hlth Author, New Westminster, BC, Canada

[21] London Hlth Sci Ctr, London, ON, Canada

[22] Western Univ, London, ON, Canada

[23] Toronto Western Hosp, Toronto, ON, Canada

[24] Univ Manitoba, Dept Radiol, Winnipeg, MB, Canada

[25] Queen Elizabeth Hosp, Charlottetown, PE, Canada

[26] Univ British Columbia, Vancouver Stroke Program, Vancouver, BC, Canada

[27] Univ British Columbia, Div Neurol, Vancouver, BC, Canada

[28] Med Hat Reg Hosp, Medicine Hat, AB, Canada

[29] Grey Nuns Community Hosp, Edmonton, AB, Canada

[30] St Michaels Hosp, Toronto, ON, Canada

[31] Red Deer Reg Hosp, Red Deer, AB, Canada

[32] Univ Saskatchewan, Div Neurol, Saskatoon, SK, Canada

[33] Maastricht Univ Med Ctr, Dept Radiol & Nucl Med, Maastricht, Netherlands

[34] Univ Manitoba, Rady Fac Hlth Sci, Dept Internal Med, Neurol Div, Winnipeg, MB, Canada

来源：

JAMA NEUROLOGY | 2023年 / 80卷 / 08期

基金：

加拿大健康研究院;

关键词：

ACUTE ISCHEMIC-STROKE; THROMBUS CHARACTERISTICS; INTRAVENOUS ALTEPLASE; MANAGEMENT;

D O I：

10.1001/jamaneurol.2023.2094

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

IMPORTANCE It is unknown whether intravenous thrombolysis using tenecteplase is noninferior or preferable compared with alteplase for patients with acute ischemic stroke. OBJECTIVE To examine the safety and efficacy of tenecteplase compared to alteplase among patients with large vessel occlusion (LVO) stroke.DESIGN, SETTING, AND PARTICIPANTS This was a prespecified analysis of the Intravenous Tenecteplase Compared With Alteplase for Acute Ischaemic Stroke in Canada (ACT) randomized clinical trial that enrolled patients from 22 primary and comprehensive stroke centers across Canada between December 10, 2019, and January 25, 2022. Patients 18 years and older with a disabling ischemic stroke within 4.5 hours of symptom onset were randomly assigned (1:1) to either intravenous tenecteplase or alteplase and were monitored for up to 120 days. Patients with baseline intracranial internal carotid artery (ICA), M1-middle cerebral artery (MCA), M2-MCA, and basilar occlusions were included in this analysis. A total of 1600 patients were enrolled, and 23 withdrew consent.EXPOSURES Intravenous tenecteplase (0.25 mg/kg) vs intravenous alteplase (0.9 mg/kg). MAIN OUTCOMES AND MEASURES The primary outcome was the proportion of modified Rankin scale (mRS) score 0-1 at 90 days. Secondary outcomes were an mRS score from 0 to 2, mortality, and symptomatic intracerebral hemorrhage. Angiographic outcomes were successful reperfusion (extended Thrombolysis in Cerebral Infarction scale score 2b-3) on first and final angiographic acquisitions. Multivariable analyses (adjusting for age, sex, National Institute of Health Stroke Scale score, onset-to-needle time, and occlusion location) were carried out.RESULTS Among 1577 patients, 520 (33.0%) had LVO (median [IQR] age, 74 [64-83] years; 283 [54.4%] women): 135 (26.0%) with ICA occlusion, 237 (45.6%) with M1-MCA, 117 (22.5%) with M2-MCA, and 31(6.0%) with basilar occlusions. The primary outcome (mRS score 0-1) was achieved in 86 participants (32.7%) in the tenecteplase group vs 76 (29.6%) in the alteplase group. Rates of mRS 0-2 (129 [49.0%] vs 131 [51.0%]), symptomatic intracerebral hemorrhage (16 [6.1%] vs 11 [4.3%]), and mortality (19.9% vs 18.1%) were similar in the tenecteplase and alteplase groups, respectively. No difference was noted in successful reperfusion rates in the first (19 [9.2%] vs 21 [10.5%]) and final angiogram (174 [84.5%] vs 177 [88.9%]) among 405 patients who underwent thrombectomy.CONCLUSIONS AND RELEVANCE The findings in this study indicate that intravenous tenecteplase conferred similar reperfusion, safety, and functional outcomes compared to alteplase among patients with LVO.

引用

页码：824 / 832

页数：9

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