Effects of alteplase for acute stroke according to criteria defining the European Union and United States marketing authorizations : Individual-patient-data meta-analysis of randomized trials
Background The recommended maximum age and time window for intravenous alteplase treatment of acute ischemic stroke differs between the Europe Union and United States. Aims We compared the effects of alteplase in cohorts defined by the current Europe Union or United States marketing approval labels, and by hypothetical revisions of the labels that would remove the Europe Union upper age limit or extend the United States treatment time window to 4.5 h. Methods We assessed outcomes in an individual-patient-data meta-analysis of eight randomized trials of intravenous alteplase (0.9 mg/kg) versus control for acute ischemic stroke. Outcomes included: excellent outcome (modified Rankin score 0-1) at 3-6 months, the distribution of modified Rankin score, symptomatic intracerebral hemorrhage, and 90-day mortality. Results Alteplase increased the odds of modified Rankin score 0-1 among 2449/6136 (40%) patients who met the current European Union label and 3491 (57%) patients who met the age-revised label (odds ratio 1.42, 95% CI 1.21-1.68 and 1.43, 1.23-1.65, respectively), but not in those outside the age-revised label (1.06, 0.90-1.26). By 90 days, there was no increased mortality in the current and age-revised cohorts (hazard ratios 0.98, 95% CI 0.76-1.25 and 1.01, 0.86-1.19, respectively) but mortality remained higher outside the age-revised label (1.19, 0.99-1.42). Similarly, alteplase increased the odds of modified Rankin score 0-1 among 1174/6136 (19%) patients who met the current US approval and 3326 (54%) who met a 4.5-h revised approval (odds ratio 1.55, 1.19-2.01 and 1.37, 1.17-1.59, respectively), but not for those outside the 4.5-h revised approval (1.14, 0.97-1.34). By 90 days, no increased mortality remained for the current and 4.5-h revised label cohorts (hazard ratios 0.99, 0.77-1.26 and 1.02, 0.87-1.20, respectively) but mortality remained higher outside the 4.5-h revised approval (1.17, 0.98-1.41). Conclusions An age-revised European Union label or 4.5-h-revised United States label would each increase the number of patients deriving net benefit from alteplase by 90 days after acute ischemic stroke, without excess mortality.
| Errataetall: |
ErratumIn: Int J Stroke. 2018 Feb;13(2):NP3. - PMID 29243573 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2018 |
|---|---|
| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
|---|---|
| Enthalten in: |
International journal of stroke : official journal of the International Stroke Society - 13(2018), 2 vom: 01. Feb., Seite 175-189 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Hacke, Werner [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 18.02.2019 Date Revised 08.04.2022 published: Print-Electronic ErratumIn: Int J Stroke. 2018 Feb;13(2):NP3. - PMID 29243573 Citation Status MEDLINE |
|---|
| doi: |
10.1177/1747493017744464 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM27837316X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM27837316X | ||
| 003 | DE-627 | ||
| 005 | 20231225020425.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2018 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1177/1747493017744464 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0927.xml |
| 035 | |a (DE-627)NLM27837316X | ||
| 035 | |a (NLM)29171359 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Hacke, Werner |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effects of alteplase for acute stroke according to criteria defining the European Union and United States marketing authorizations |b Individual-patient-data meta-analysis of randomized trials |
| 264 | 1 | |c 2018 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 18.02.2019 | ||
| 500 | |a Date Revised 08.04.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ErratumIn: Int J Stroke. 2018 Feb;13(2):NP3. - PMID 29243573 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Background The recommended maximum age and time window for intravenous alteplase treatment of acute ischemic stroke differs between the Europe Union and United States. Aims We compared the effects of alteplase in cohorts defined by the current Europe Union or United States marketing approval labels, and by hypothetical revisions of the labels that would remove the Europe Union upper age limit or extend the United States treatment time window to 4.5 h. Methods We assessed outcomes in an individual-patient-data meta-analysis of eight randomized trials of intravenous alteplase (0.9 mg/kg) versus control for acute ischemic stroke. Outcomes included: excellent outcome (modified Rankin score 0-1) at 3-6 months, the distribution of modified Rankin score, symptomatic intracerebral hemorrhage, and 90-day mortality. Results Alteplase increased the odds of modified Rankin score 0-1 among 2449/6136 (40%) patients who met the current European Union label and 3491 (57%) patients who met the age-revised label (odds ratio 1.42, 95% CI 1.21-1.68 and 1.43, 1.23-1.65, respectively), but not in those outside the age-revised label (1.06, 0.90-1.26). By 90 days, there was no increased mortality in the current and age-revised cohorts (hazard ratios 0.98, 95% CI 0.76-1.25 and 1.01, 0.86-1.19, respectively) but mortality remained higher outside the age-revised label (1.19, 0.99-1.42). Similarly, alteplase increased the odds of modified Rankin score 0-1 among 1174/6136 (19%) patients who met the current US approval and 3326 (54%) who met a 4.5-h revised approval (odds ratio 1.55, 1.19-2.01 and 1.37, 1.17-1.59, respectively), but not for those outside the 4.5-h revised approval (1.14, 0.97-1.34). By 90 days, no increased mortality remained for the current and 4.5-h revised label cohorts (hazard ratios 0.99, 0.77-1.26 and 1.02, 0.87-1.20, respectively) but mortality remained higher outside the 4.5-h revised approval (1.17, 0.98-1.41). Conclusions An age-revised European Union label or 4.5-h-revised United States label would each increase the number of patients deriving net benefit from alteplase by 90 days after acute ischemic stroke, without excess mortality | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Meta-Analysis | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Alteplase | |
| 650 | 4 | |a European Union | |
| 650 | 4 | |a United States | |
| 650 | 4 | |a acute ischemic stroke | |
| 650 | 4 | |a acute stroke therapy | |
| 650 | 4 | |a meta-analysis | |
| 650 | 4 | |a rt-PA | |
| 650 | 4 | |a thrombolysis | |
| 650 | 7 | |a Fibrinolytic Agents |2 NLM | |
| 650 | 7 | |a Tissue Plasminogen Activator |2 NLM | |
| 650 | 7 | |a EC 3.4.21.68 |2 NLM | |
| 700 | 1 | |a Lyden, Patrick |e verfasserin |4 aut | |
| 700 | 1 | |a Emberson, Jonathan |e verfasserin |4 aut | |
| 700 | 1 | |a Baigent, Colin |e verfasserin |4 aut | |
| 700 | 1 | |a Blackwell, Lisa |e verfasserin |4 aut | |
| 700 | 1 | |a Albers, Gregory |e verfasserin |4 aut | |
| 700 | 1 | |a Bluhmki, Erich |e verfasserin |4 aut | |
| 700 | 1 | |a Brott, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Cohen, Geoffrey |e verfasserin |4 aut | |
| 700 | 1 | |a Davis, Stephen M |e verfasserin |4 aut | |
| 700 | 1 | |a Donnan, Geoffrey A |e verfasserin |4 aut | |
| 700 | 1 | |a Grotta, James C |e verfasserin |4 aut | |
| 700 | 1 | |a Howard, George |e verfasserin |4 aut | |
| 700 | 1 | |a Kaste, Markku |e verfasserin |4 aut | |
| 700 | 1 | |a Koga, Masatoshi |e verfasserin |4 aut | |
| 700 | 1 | |a von Kummer, Rüdiger |e verfasserin |4 aut | |
| 700 | 1 | |a Lansberg, Maarten G |e verfasserin |4 aut | |
| 700 | 1 | |a Lindley, Richard I |e verfasserin |4 aut | |
| 700 | 1 | |a Olivot, Jean-Marc |e verfasserin |4 aut | |
| 700 | 1 | |a Parsons, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Sandercock, Peter Ag |e verfasserin |4 aut | |
| 700 | 1 | |a Toni, Danilo |e verfasserin |4 aut | |
| 700 | 1 | |a Toyoda, Kazunori |e verfasserin |4 aut | |
| 700 | 1 | |a Wahlgren, Nils |e verfasserin |4 aut | |
| 700 | 1 | |a Wardlaw, Joanna M |e verfasserin |4 aut | |
| 700 | 1 | |a Whiteley, William N |e verfasserin |4 aut | |
| 700 | 1 | |a Del Zoppo, Gregory |e verfasserin |4 aut | |
| 700 | 1 | |a Lees, Kennedy R |e verfasserin |4 aut | |
| 700 | 0 | |a Stroke Thrombolysis Trialists’ Collaborators Group |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t International journal of stroke : official journal of the International Stroke Society |d 2006 |g 13(2018), 2 vom: 01. Feb., Seite 175-189 |w (DE-627)NLM181612585 |x 1747-4949 |7 nnns |
| 773 | 1 | 8 | |g volume:13 |g year:2018 |g number:2 |g day:01 |g month:02 |g pages:175-189 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1177/1747493017744464 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 13 |j 2018 |e 2 |b 01 |c 02 |h 175-189 | ||