Tenecteplase vs Alteplase in Acute Ischemic Stroke Within 4.5 Hours: A Systematic Review and Meta-Analysis of Randomized Trials.

Autor:	Palaiodimou L; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Katsanos AH; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Turc G; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Asimakopoulos AG; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Mavridis D; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Schellinger PD; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Theodorou A; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Lemmens R; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Sacco S; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Safouris A; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Katan M; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Sarraj A; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Fischer U; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland., Tsivgoulis G; From the Second Department of Neurology (L.P., A.T., A. Safouris, G. Tsivgoulis), 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Medicine (Neurology) (A.H.K.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada; Department of Neurology (Guillaume Turc), GHU Paris Psychiatrie et Neurosciences; Université Paris Cité (G. Turc); INSERM U1266 (G. Turc); FHU NeuroVasc (G. Turc), Paris, France; Department of Primary Education (A.-G.A., D.M.), University of Ioannina, Greece; Department of Neurology and Neurogeriatrics (P.D.S.), Johannes Wesling Klinikum Minden, Ruhr-University Bochum, Germany; Department of Neurology (R.L.), University Hospitals Leuven; Division of Experimental Neurology (R.L.), Department of Neurosciences, KU Leuven-University of Leuven, Belgium; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Stroke Unit (A. Safouris), Metropolitan Hospital, Piraeus, Greece; Department of Neurology (M.K., U.F.), University Hospital Basel, University of Basel, Switzerland; Department of Neurology (A. Sarraj), Case Western Reserve University, University Hospitals Cleveland Medical Center, OH; and Department of Neurology (U.F.), University Hospital Bern, University of Bern, Switzerland.
Jazyk:	angličtina
Zdroj:	Neurology [Neurology] 2024 Nov 12; Vol. 103 (9), pp. e209903. Date of Electronic Publication: 2024 Oct 16.
DOI:	10.1212/WNL.0000000000209903
Abstrakt:	Background and Objectives: The current European Stroke Organisation expedited recommendation on tenecteplase (TNK) for acute ischemic stroke (AIS) advocates that TNK 0.25 mg/kg can be used alternatively to alteplase (tissue plasminogen activator [TPA]) for AIS of <4.5 hours duration, based on a meta-analytical approach establishing noninferiority. Since the publication of these guidelines, 4 additional randomized controlled clinical trials (RCTs) have provided further insight. Methods: We conducted an updated systematic review and meta-analysis including all available RCTs that investigated efficacy and safety of TNK 0.25 mg/kg compared with TPA for the treatment of AIS within 4.5 hours of onset. The primary outcome was defined as the excellent functional outcome at 3 months (modified Rankin Scale [mRS] score 0-1), whereas good functional outcome (mRS score 0-2), reduced disability at 3 months (≥1-point reduction across all mRS scores), symptomatic intracranial hemorrhage (sICH), and 3-month mortality were evaluated as secondary outcomes. Pooled estimates were calculated with random-effects model. A prespecified subgroup analysis was performed stratifying for TNK formulation, that is, original TNK vs biocopy: recombinant human TNK tissue-type plasminogen activator that is available in China and has a different production process. Results: Eleven RCTs were included comprising a total of 3,788 patients treated with TNK vs 3,757 patients treated with TPA. TNK was associated with higher likelihood of excellent functional outcome (risk ratio [RR] 1.05, 95% CI 1.01-1.10; p = 0.012; I 2 = 0%; risk difference 2.95%; 95% CI 0.76%-5.14%; p = 0.008; I 2 = 0%) and reduced disability at 3 months (common odds ratio 1.10, 95% CI 1.01-1.19; p = 0.034; I 2 = 0%) compared with TPA while good functional outcome (RR 1.03, 95% CI 0.99-1.07; p = 0.142; I 2 = 28%) was similar between the groups. Regarding safety outcomes, similar rates of sICH (RR 1.12, 95% CI 0.83-1.53; p = 0.456; I 2 = 0%) and 3-month mortality (RR 0.97, 95% CI 0.82-1.15; p = 0.727; I 2 = 12%) were observed. When stratified for TNK regimen (original vs biocopy), statistical significance in achieving an excellent functional outcome at 3 months was retained for the original TNK (RR 1.05, 95% CI 1.00-1.10; p = 0.044; I 2 = 0%). Discussion: The updated meta-analysis confirms similar safety between TNK 0.25 mg/kg and TPA, while showing that TNK is superior to TPA regarding excellent functional outcome and reduced disability at 3 months. These findings support transitioning to TNK in clinical practice.
Databáze:	MEDLINE
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