Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysis
Background: Outcome data regarding the administration of tenecteplase (TNK) to acute ischemic stroke (AIS) patients presenting in the extended time window are limited. Objectives: We aimed to assess the current evidence regarding the efficacy and safety of TNK at a dose of 0.25 mg/kg for AIS treatme...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2024-01-01
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| Series: | Therapeutic Advances in Neurological Disorders |
| Online Access: | https://doi.org/10.1177/17562864231221324 |
| _version_ | 1797363876606509056 |
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| author | Lina Palaiodimou Aristeidis H. Katsanos Guillaume Turc Michele Romoli Aikaterini Theodorou Robin Lemmens Simona Sacco Georgios Velonakis Charalambos Vlachopoulos Georgios Tsivgoulis |
| author_facet | Lina Palaiodimou Aristeidis H. Katsanos Guillaume Turc Michele Romoli Aikaterini Theodorou Robin Lemmens Simona Sacco Georgios Velonakis Charalambos Vlachopoulos Georgios Tsivgoulis |
| author_sort | Lina Palaiodimou |
| collection | DOAJ |
| description | Background: Outcome data regarding the administration of tenecteplase (TNK) to acute ischemic stroke (AIS) patients presenting in the extended time window are limited. Objectives: We aimed to assess the current evidence regarding the efficacy and safety of TNK at a dose of 0.25 mg/kg for AIS treatment in the extended time window. Design: A systematic review and meta-analysis was conducted including all available randomized-controlled clinical trials (RCTs) that compared TNK 0.25 mg/kg versus no thrombolysis in AIS patients presenting in the extended time window (>4.5 h after last-seen-well or witnessed onset). Data sources and methods: Eligible studies were identified by searching Medline, Scopus, and international conference abstracts. The predefined efficacy outcomes of interest were 3-month excellent functional outcome [defined as the modified Rankin Scale (mRS) score ⩽1; primary outcome], 3-month good functional outcome (mRS ⩽ 2), 3-month reduced disability (⩾1-point reduction across all mRS scores). We determined symptomatic intracranial hemorrhage (sICH), any ICH and 3-month mortality as safety endpoints. A random-effects model was used to calculate risk ratios (RRs) and common odds ratios (cORs) with corresponding 95% confidence intervals (CIs). Results: Three RCTs were included comprising 556 patients treated with TNK versus 560 controls. TNK 0.25 mg/kg was associated with a higher likelihood of 3-month excellent functional outcome compared to controls (RR = 1.17; 95% CI = 1.01–1.36; I 2 = 0%), whereas there was no difference regarding good functional outcome (RR = 1.05; 95% CI = 0.94–1.17; I 2 = 0%) and reduced disability (adjusted cOR = 1.14; 95% CI = 0.92–1.40; I 2 = 0%) at 3 months. The risks of sICH (RR = 1.67; 95% CI = 0.70–4.00; I 2 = 0%), any ICH (RR = 1.08; 95% CI = 0.90–1.29; I 2 = 0%) and 3-month mortality (RR = 1.10; 95% CI = 0.81–1.49; I 2 = 0%) were similar between the groups. Conclusion: Based on data from three RCTs showing increased efficacy and a favorable safety profile of TNK in the treatment of AIS in the extended time window, continuing efforts of ongoing RCTs in the field are clearly supported. Trial registration: PROSPERO registration ID: CRD42023448707. |
| first_indexed | 2024-03-08T16:27:16Z |
| format | Article |
| id | doaj.art-61e3c028df2049588b6a2ddde6fefa1b |
| institution | Directory Open Access Journal |
| issn | 1756-2864 |
| language | English |
| last_indexed | 2024-03-08T16:27:16Z |
| publishDate | 2024-01-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Neurological Disorders |
| spelling | doaj.art-61e3c028df2049588b6a2ddde6fefa1b2024-01-06T18:04:10ZengSAGE PublishingTherapeutic Advances in Neurological Disorders1756-28642024-01-011710.1177/17562864231221324Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysisLina PalaiodimouAristeidis H. KatsanosGuillaume TurcMichele RomoliAikaterini TheodorouRobin LemmensSimona SaccoGeorgios VelonakisCharalambos VlachopoulosGeorgios TsivgoulisBackground: Outcome data regarding the administration of tenecteplase (TNK) to acute ischemic stroke (AIS) patients presenting in the extended time window are limited. Objectives: We aimed to assess the current evidence regarding the efficacy and safety of TNK at a dose of 0.25 mg/kg for AIS treatment in the extended time window. Design: A systematic review and meta-analysis was conducted including all available randomized-controlled clinical trials (RCTs) that compared TNK 0.25 mg/kg versus no thrombolysis in AIS patients presenting in the extended time window (>4.5 h after last-seen-well or witnessed onset). Data sources and methods: Eligible studies were identified by searching Medline, Scopus, and international conference abstracts. The predefined efficacy outcomes of interest were 3-month excellent functional outcome [defined as the modified Rankin Scale (mRS) score ⩽1; primary outcome], 3-month good functional outcome (mRS ⩽ 2), 3-month reduced disability (⩾1-point reduction across all mRS scores). We determined symptomatic intracranial hemorrhage (sICH), any ICH and 3-month mortality as safety endpoints. A random-effects model was used to calculate risk ratios (RRs) and common odds ratios (cORs) with corresponding 95% confidence intervals (CIs). Results: Three RCTs were included comprising 556 patients treated with TNK versus 560 controls. TNK 0.25 mg/kg was associated with a higher likelihood of 3-month excellent functional outcome compared to controls (RR = 1.17; 95% CI = 1.01–1.36; I 2 = 0%), whereas there was no difference regarding good functional outcome (RR = 1.05; 95% CI = 0.94–1.17; I 2 = 0%) and reduced disability (adjusted cOR = 1.14; 95% CI = 0.92–1.40; I 2 = 0%) at 3 months. The risks of sICH (RR = 1.67; 95% CI = 0.70–4.00; I 2 = 0%), any ICH (RR = 1.08; 95% CI = 0.90–1.29; I 2 = 0%) and 3-month mortality (RR = 1.10; 95% CI = 0.81–1.49; I 2 = 0%) were similar between the groups. Conclusion: Based on data from three RCTs showing increased efficacy and a favorable safety profile of TNK in the treatment of AIS in the extended time window, continuing efforts of ongoing RCTs in the field are clearly supported. Trial registration: PROSPERO registration ID: CRD42023448707.https://doi.org/10.1177/17562864231221324 |
| spellingShingle | Lina Palaiodimou Aristeidis H. Katsanos Guillaume Turc Michele Romoli Aikaterini Theodorou Robin Lemmens Simona Sacco Georgios Velonakis Charalambos Vlachopoulos Georgios Tsivgoulis Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysis Therapeutic Advances in Neurological Disorders |
| title | Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysis |
| title_full | Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysis |
| title_fullStr | Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysis |
| title_full_unstemmed | Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysis |
| title_short | Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysis |
| title_sort | tenecteplase for the treatment of acute ischemic stroke in the extended time window a systematic review and meta analysis |
| url | https://doi.org/10.1177/17562864231221324 |
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