Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial
Background The benefit of intravenous alteplase in acute ischaemic stroke (AIS) is time-dependent. Tenecteplase is non-inferior to alteplase among patients with AIS. We aimed to delineate the association of the stroke onset to treatment time (OTT) with tenecteplase compared with alteplase on therape...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-12-01
|
| Series: | Stroke and Vascular Neurology |
| Online Access: | https://svn.bmj.com/content/9/6/613.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846099843162832896 |
|---|---|
| author | Bruce C V Campbell Yongjun Wang Yilong Wang Zixiao Li Xingquan Zhao David Wang Yunyun Xiong Hao Li Xia Meng Yuesong Pan Lee H Schwamm Aoming Jin Mark W Parsons Huaguang Zheng Shuya Li Runhui Li Marc Fisher Runqi Wangqin Ziran Wang Deyang Li Hongguo Dai Junhai Wang |
| author_facet | Bruce C V Campbell Yongjun Wang Yilong Wang Zixiao Li Xingquan Zhao David Wang Yunyun Xiong Hao Li Xia Meng Yuesong Pan Lee H Schwamm Aoming Jin Mark W Parsons Huaguang Zheng Shuya Li Runhui Li Marc Fisher Runqi Wangqin Ziran Wang Deyang Li Hongguo Dai Junhai Wang |
| author_sort | Bruce C V Campbell |
| collection | DOAJ |
| description | Background The benefit of intravenous alteplase in acute ischaemic stroke (AIS) is time-dependent. Tenecteplase is non-inferior to alteplase among patients with AIS. We aimed to delineate the association of the stroke onset to treatment time (OTT) with tenecteplase compared with alteplase on therapeutic benefit and clinical risks.Methods This is a post hoc analysis of the Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-2 an open-label, randomised, controlled, non-inferior trial. A total of 1430 AIS within 4.5 hours onset at 53 sites in China from 12 June 2021 to 29 May 2022 were randomly assigned (1:1) to receive either tenecteplase 0.25 mg/kg or alteplase 0.9 mg/kg. The primary efficacy outcome was the proportion of participants with a modified Rankin Scale score of 0–1 at 90 days. A post hoc subgroup analysis was conducted with the OTT divided into three intervals (0–90 min, 91–180 min and 181–270 min). The primary safety outcome was symptomatic intracranial haemorrhage within 36 hours post-thrombolytic treatment.Results Treatment was initiated within 270 min of stroke onset in 1412 patients who were randomly allocated to either tenecteplase (n=707) or alteplase (n=705). The OR of primary efficacy outcome was similar as OTT increased (p=0.84). Adjusted odds of an excellent functional outcome were 0.99 (95% CI 0.37 to 2.67) for 0–90 min, 1.23 (95% CI 0.88 to 1.71) for 91–180 min and 1.21 (95% CI 0.88 to 1.65) for 181–270 min. All were in favour of the tenecteplase group. Meta-analysis of 2949 patients yielded a pooled risk difference of 5.54 (95% CI −0.18 to 11.26; p=0.82) in favour of tenecteplase for more than 180 min and 1.77 (95% CI −2.66 to 6.20; p=0.58) for 0–180 min.Conclusions In AIS patients who were treated with either tenecteplase or alteplase within 4.5 hours onset, there was no difference observed in the efficacy and safety between the two groups at the three different OTT time intervals. |
| format | Article |
| id | doaj-art-ec522871c46d43d38a8b6179e1b8b4d1 |
| institution | Kabale University |
| issn | 2059-8696 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Stroke and Vascular Neurology |
| spelling | doaj-art-ec522871c46d43d38a8b6179e1b8b4d12024-12-31T06:20:08ZengBMJ Publishing GroupStroke and Vascular Neurology2059-86962024-12-019610.1136/svn-2023-002694Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trialBruce C V Campbell0Yongjun Wang1Yilong Wang2Zixiao Li3Xingquan Zhao4David Wang5Yunyun Xiong6Hao Li7Xia Meng8Yuesong Pan9Lee H Schwamm10Aoming Jin11Mark W Parsons12Huaguang Zheng13Shuya Li14Runhui Li15Marc Fisher16Runqi Wangqin17Ziran Wang18Deyang Li19Hongguo Dai20Junhai Wang21professor of neurologyChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China1 Department of Neurology, Beijing Tiantan Hospital, Beijing, China1 Department of Neurology, Beijing Tiantan Hospital, Beijing, ChinaDepartment of Neurology, University of Illinois College of Medicine at Peoria, Peoria, IL, USANeurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China2 China National Clinical Research Center for Neurological Diseases, Beijing, China1 Department of Neurology, Beijing Tiantan Hospital, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaYale New Haven Health System, Yale School of Medicine, New Haven, Connecticut, USADepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaMelbourne Brain Centre, Parkville, Victoria, AustraliaprofessorChina National Clinical Research Center for Neurological Diseases, Beijing, China3 Neurology, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China5 Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USADuke Clinical Research Institute, Duke Univeristy Medical Center, Durham, North Carolina, USADepartment of Neurology, Linyi People`s Hospital, Linyi, ChinaBiomedical and Molecular Sciences, Queen`s University, Kingston, Ontario, CanadaDepartment of Emergency, Linfen Central Hospital, Shanxi Province, China13 Department of Neurology, General Hospital of DaTong Coal Mine Group, Datong, Shanxi, ChinaBackground The benefit of intravenous alteplase in acute ischaemic stroke (AIS) is time-dependent. Tenecteplase is non-inferior to alteplase among patients with AIS. We aimed to delineate the association of the stroke onset to treatment time (OTT) with tenecteplase compared with alteplase on therapeutic benefit and clinical risks.Methods This is a post hoc analysis of the Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-2 an open-label, randomised, controlled, non-inferior trial. A total of 1430 AIS within 4.5 hours onset at 53 sites in China from 12 June 2021 to 29 May 2022 were randomly assigned (1:1) to receive either tenecteplase 0.25 mg/kg or alteplase 0.9 mg/kg. The primary efficacy outcome was the proportion of participants with a modified Rankin Scale score of 0–1 at 90 days. A post hoc subgroup analysis was conducted with the OTT divided into three intervals (0–90 min, 91–180 min and 181–270 min). The primary safety outcome was symptomatic intracranial haemorrhage within 36 hours post-thrombolytic treatment.Results Treatment was initiated within 270 min of stroke onset in 1412 patients who were randomly allocated to either tenecteplase (n=707) or alteplase (n=705). The OR of primary efficacy outcome was similar as OTT increased (p=0.84). Adjusted odds of an excellent functional outcome were 0.99 (95% CI 0.37 to 2.67) for 0–90 min, 1.23 (95% CI 0.88 to 1.71) for 91–180 min and 1.21 (95% CI 0.88 to 1.65) for 181–270 min. All were in favour of the tenecteplase group. Meta-analysis of 2949 patients yielded a pooled risk difference of 5.54 (95% CI −0.18 to 11.26; p=0.82) in favour of tenecteplase for more than 180 min and 1.77 (95% CI −2.66 to 6.20; p=0.58) for 0–180 min.Conclusions In AIS patients who were treated with either tenecteplase or alteplase within 4.5 hours onset, there was no difference observed in the efficacy and safety between the two groups at the three different OTT time intervals.https://svn.bmj.com/content/9/6/613.full |
| spellingShingle | Bruce C V Campbell Yongjun Wang Yilong Wang Zixiao Li Xingquan Zhao David Wang Yunyun Xiong Hao Li Xia Meng Yuesong Pan Lee H Schwamm Aoming Jin Mark W Parsons Huaguang Zheng Shuya Li Runhui Li Marc Fisher Runqi Wangqin Ziran Wang Deyang Li Hongguo Dai Junhai Wang Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial Stroke and Vascular Neurology |
| title | Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial |
| title_full | Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial |
| title_fullStr | Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial |
| title_full_unstemmed | Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial |
| title_short | Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial |
| title_sort | outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke subgroup analysis of the trace 2 randomised controlled clinical trial |
| url | https://svn.bmj.com/content/9/6/613.full |
| work_keys_str_mv | AT brucecvcampbell outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT yongjunwang outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT yilongwang outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT zixiaoli outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT xingquanzhao outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT davidwang outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT yunyunxiong outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT haoli outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT xiameng outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT yuesongpan outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT leehschwamm outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT aomingjin outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT markwparsons outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT huaguangzheng outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT shuyali outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT runhuili outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT marcfisher outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT runqiwangqin outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT ziranwang outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT deyangli outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT hongguodai outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial AT junhaiwang outcomesassociatedtothetimetotreatmentwithintravenoustenecteplaseforacuteischaemicstrokesubgroupanalysisofthetrace2randomisedcontrolledclinicaltrial |