Safety and Efficacy of Tenecteplase Compared With Alteplase in Patients With Large Vessel Occlusion Stroke

Author:

Bala Fouzi12,Singh Nishita13,Buck Brian4,Ademola Ayoola15,Coutts Shelagh B.1567,Deschaintre Yan89,Khosravani Houman10,Appireddy Ramana11,Moreau Francois12,Phillips Stephen13,Gubitz Gord13,Tkach Aleksander14,Catanese Luciana15,Dowlatshahi Dar16,Medvedev George17,Mandzia Jennifer18,Pikula Aleksandra19,Shankar Jai Jai20,Williams Heather21,Field Thalia S.22,Manosalva Alzate Alejandro23,Siddiqui Muzaffar24,Zafar Atif25,Imoukhoude Oje26,Hunter Gary27,Alhabli Ibrahim1,Benali Faysal128,Horn MacKenzie1,Hill Michael D.1567,Shamy Michel16,Sajobi Tolulope T.15,Swartz Richard H.10,Menon Bijoy K.1567,Almekhlafi Mohammed1567

Affiliation:

1. Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada

2. Diagnostic and Interventional Neuroradiology Department, University Hospital of Tours, Tours, France

3. Department of Internal Medicine, Neurology Division, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada

4. Division of Neurology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada

5. Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada

6. Department of Radiology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada

7. Hotchkiss Brain Institute, Calgary, Alberta, Canada

8. Department of Neurosciences, Université de Montréal, Montréal, Québec, Canada

9. Centre Hospitalier de l’Université de Montréal (CHUM), Montréal, Québec, Canada

10. Sunnybrook Health Sciences Centre and the University of Toronto, Toronto, Ontario, Canada

11. Division of Neurology, Department of Medicine, Queen’s University, Kingston, Ontario, Canada

12. Université de Sherbrooke, Sherbrooke, Québec, Canada

13. Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada

14. Kelowna General Hospital, Kelowna, British Columbia, Canada

15. Hamilton Health Sciences Centre and McMaster University, Hamilton, Ontario, Canada

16. Department of Medicine, University of Ottawa, and the Ottawa Heart Research Institute, Ottawa, Ontario, Canada

17. University of British Columbia and the Fraser Health Authority, New Westminster, British Columbia, Canada

18. London Health Sciences Centre and Western University, London, Ontario, Canada

19. Toronto Western Hospital and the University of Toronto, Toronto, Ontario, Canada

20. Department of Radiology, University of Manitoba, Winnipeg, Manitoba, Canada

21. Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, Canada

22. Vancouver Stroke Program and the Division of Neurology, University of British Columbia, Vancouver, British Columbia, Canada

23. Medicine Hat Regional Hospital, Medicine Hat, Alberta, Canada

24. Grey Nuns Community Hospital, Edmonton, Alberta, Canada

25. St Michael’s Hospital, Toronto, Ontario, Canada

26. Red Deer Regional Hospital, Red Deer, Alberta, Canada

27. Division of Neurology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada

28. Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre+, Maastricht, the Netherlands.

Abstract

ImportanceIt is unknown whether intravenous thrombolysis using tenecteplase is noninferior or preferable compared with alteplase for patients with acute ischemic stroke.ObjectiveTo examine the safety and efficacy of tenecteplase compared to alteplase among patients with large vessel occlusion (LVO) stroke.Design, Setting, and ParticipantsThis 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.ExposuresIntravenous tenecteplase (0.25 mg/kg) vs intravenous alteplase (0.9 mg/kg).Main Outcomes and MeasuresThe 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.ResultsAmong 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 RelevanceThe findings in this study indicate that intravenous tenecteplase conferred similar reperfusion, safety, and functional outcomes compared to alteplase among patients with LVO.

Publisher

American Medical Association (AMA)

Subject

Neurology (clinical)

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