Sex Differences in Outcomes After Tenecteplase for Minor Stroke: A Subanalysis of the TEMPO‐2 Trial
Background In this subanalysis of the TEMPO‐2 (Tenecteplase Versus Standard of Care for Minor Ischaemic Stroke With Proven Occlusion) trial, a randomized clinical trial comparing tenecteplase and nonthrombolytic control in patients with minor stroke and symptomatic intracranial occlusion, we investi...
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Wiley
2025-05-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
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| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.124.039154 |
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| author | Amy Y. X. Yu Shabnam Vatanpour Aravind Ganesh Thalia S. Field Philip A. Barber Philip M. C. Choi Brian Buck Timothy Kleinig Carlos A. Molina Bruce C. V. Campbell Ramana Appireddy Keith W. Muir Michael D. Hill Shelagh B. Coutts |
| author_facet | Amy Y. X. Yu Shabnam Vatanpour Aravind Ganesh Thalia S. Field Philip A. Barber Philip M. C. Choi Brian Buck Timothy Kleinig Carlos A. Molina Bruce C. V. Campbell Ramana Appireddy Keith W. Muir Michael D. Hill Shelagh B. Coutts |
| author_sort | Amy Y. X. Yu |
| collection | DOAJ |
| description | Background In this subanalysis of the TEMPO‐2 (Tenecteplase Versus Standard of Care for Minor Ischaemic Stroke With Proven Occlusion) trial, a randomized clinical trial comparing tenecteplase and nonthrombolytic control in patients with minor stroke and symptomatic intracranial occlusion, we investigated sex differences in the efficacy and safety of tenecteplase. Methods We compared outcomes after tenecteplase versus control, stratified by sex. We also compared outcomes in female versus male patients treated with tenecteplase. The primary outcome was a “responder” outcome, defined as return to baseline modified Rankin Scale score at 90 days. Secondary outcomes included the Lawton Instrumental Activities of Daily Living Scale, the EuroQol‐5 Dimension, vessel recanalization, and adverse events. We used generalized linear modeling with a Poisson distribution adjusted for baseline differences to calculate adjusted risk ratios (aRR) and 95% CIs. Results There were 884 patients in the intention‐to‐treat analysis (48.9% tenecteplase, 41.5% female). Among female participants, the tenecteplase group was less likely to be a responder compared with control (63.8% tenecteplase, 73.9% control, aRR, 0.87 [95% CI, 0.76–1.00]). Among male participants, the responder outcome was similar between groups (77.5% tenecteplase, 75.4% control, 1.03 [95% CI, 0.94–1.13]). Female participants randomized to tenecteplase were less likely to be responders than male counterparts (63.8% female, 77.5% male, 0.85 [95% CI, 0.75–0.96]). Early recanalization was more frequent after tenecteplase than control in both sexes. Conclusions Tenecteplase was not associated with better clinical outcomes over nonthrombolytic control in female or male patients with minor ischemic stroke, despite more frequent recanalization. Fewer women treated with tenecteplase returned to baseline function compared with men. |
| format | Article |
| id | doaj-art-824deca8196d407b905b23cacf4a29a8 |
| institution | Kabale University |
| issn | 2047-9980 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Wiley |
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| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-824deca8196d407b905b23cacf4a29a82025-08-20T03:47:36ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802025-05-0114910.1161/JAHA.124.039154Sex Differences in Outcomes After Tenecteplase for Minor Stroke: A Subanalysis of the TEMPO‐2 TrialAmy Y. X. Yu0Shabnam Vatanpour1Aravind Ganesh2Thalia S. Field3Philip A. Barber4Philip M. C. Choi5Brian Buck6Timothy Kleinig7Carlos A. Molina8Bruce C. V. Campbell9Ramana Appireddy10Keith W. Muir11Michael D. Hill12Shelagh B. Coutts13Department of Medicine (Neurology), University of Toronto Sunnybrook Health Sciences Centre Toronto ON CanadaDepartment of Clinical Neurosciences, Cumming School of Medicine University of Calgary AB CanadaDepartment of Clinical Neurosciences, Cumming School of Medicine University of Calgary AB CanadaVancouver Stroke Program, Division of Neurology University of British Columbia Vancouver BC CanadaDepartment of Clinical Neurosciences, Cumming School of Medicine University of Calgary AB CanadaDepartment of Neuroscience, Box Hill Hospital Eastern Health Melbourne AustraliaDepartment of Medicine, Division of Neurology University of Alberta Edmonton AB CanadaDepartment of Neurology Royal Adelaide Hospital Adelaide SA AustraliaVall d’Hebron Stroke Center Hospital Vall d’Hebron Barcelona SpainDepartment of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital University of Melbourne Parkville VIC AustraliaDivision of Neurology, Department of Medicine Queen’s University Kingston ON CanadaSchool of Neuroscience & Psychology University of Glasgow UKDepartment of Clinical Neurosciences, Cumming School of Medicine University of Calgary AB CanadaDepartment of Clinical Neurosciences, Cumming School of Medicine University of Calgary AB CanadaBackground In this subanalysis of the TEMPO‐2 (Tenecteplase Versus Standard of Care for Minor Ischaemic Stroke With Proven Occlusion) trial, a randomized clinical trial comparing tenecteplase and nonthrombolytic control in patients with minor stroke and symptomatic intracranial occlusion, we investigated sex differences in the efficacy and safety of tenecteplase. Methods We compared outcomes after tenecteplase versus control, stratified by sex. We also compared outcomes in female versus male patients treated with tenecteplase. The primary outcome was a “responder” outcome, defined as return to baseline modified Rankin Scale score at 90 days. Secondary outcomes included the Lawton Instrumental Activities of Daily Living Scale, the EuroQol‐5 Dimension, vessel recanalization, and adverse events. We used generalized linear modeling with a Poisson distribution adjusted for baseline differences to calculate adjusted risk ratios (aRR) and 95% CIs. Results There were 884 patients in the intention‐to‐treat analysis (48.9% tenecteplase, 41.5% female). Among female participants, the tenecteplase group was less likely to be a responder compared with control (63.8% tenecteplase, 73.9% control, aRR, 0.87 [95% CI, 0.76–1.00]). Among male participants, the responder outcome was similar between groups (77.5% tenecteplase, 75.4% control, 1.03 [95% CI, 0.94–1.13]). Female participants randomized to tenecteplase were less likely to be responders than male counterparts (63.8% female, 77.5% male, 0.85 [95% CI, 0.75–0.96]). Early recanalization was more frequent after tenecteplase than control in both sexes. Conclusions Tenecteplase was not associated with better clinical outcomes over nonthrombolytic control in female or male patients with minor ischemic stroke, despite more frequent recanalization. Fewer women treated with tenecteplase returned to baseline function compared with men.https://www.ahajournals.org/doi/10.1161/JAHA.124.039154sexstrokeminor ischemic strokethrombolysis |
| spellingShingle | Amy Y. X. Yu Shabnam Vatanpour Aravind Ganesh Thalia S. Field Philip A. Barber Philip M. C. Choi Brian Buck Timothy Kleinig Carlos A. Molina Bruce C. V. Campbell Ramana Appireddy Keith W. Muir Michael D. Hill Shelagh B. Coutts Sex Differences in Outcomes After Tenecteplase for Minor Stroke: A Subanalysis of the TEMPO‐2 Trial Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease sex stroke minor ischemic stroke thrombolysis |
| title | Sex Differences in Outcomes After Tenecteplase for Minor Stroke: A Subanalysis of the TEMPO‐2 Trial |
| title_full | Sex Differences in Outcomes After Tenecteplase for Minor Stroke: A Subanalysis of the TEMPO‐2 Trial |
| title_fullStr | Sex Differences in Outcomes After Tenecteplase for Minor Stroke: A Subanalysis of the TEMPO‐2 Trial |
| title_full_unstemmed | Sex Differences in Outcomes After Tenecteplase for Minor Stroke: A Subanalysis of the TEMPO‐2 Trial |
| title_short | Sex Differences in Outcomes After Tenecteplase for Minor Stroke: A Subanalysis of the TEMPO‐2 Trial |
| title_sort | sex differences in outcomes after tenecteplase for minor stroke a subanalysis of the tempo 2 trial |
| topic | sex stroke minor ischemic stroke thrombolysis |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.124.039154 |
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