Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke

Importance: Prior trials of dual antiplatelet therapy excluded patients with moderate ischemic stroke. These patients were included in the Acute Stroke or Transient Ischaemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death (THALES) trial, but results have not been reported...

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Autores: Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R., Himmelmann, Anders, James, Stefan, Birve, Filip, Ladenvall, Per, Molina, Carlos A.|||0000-0001-6058-6259, Johnston, S. Claiborne
Formato: artículo
Fecha de publicación:2021
País:España
Recursos:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:270309
Acesso em linha:https://ddd.uab.cat/record/270309
https://dx.doi.org/urn:doi:10.1001/jamaneurol.2021.2440
Access Level:acceso abierto
Palavra-chave:Aged
Aspirin
Dual Anti-Platelet Therapy
Female
Humans
Ischemic Stroke
Male
Middle Aged
Patient Acuity
Platelet Aggregation Inhibitors
Ticagrelor
Treatment Outcome
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dc.title.none.fl_str_mv Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke
An Exploratory Analysis of the THALES Randomized Clinical Trial
title Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke
spellingShingle Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke
Wang, Yongjun
Aged
Aspirin
Dual Anti-Platelet Therapy
Female
Humans
Ischemic Stroke
Male
Middle Aged
Patient Acuity
Platelet Aggregation Inhibitors
Ticagrelor
Treatment Outcome
title_short Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke
title_full Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke
title_fullStr Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke
title_full_unstemmed Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke
title_sort Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic Stroke
dc.creator.none.fl_str_mv Wang, Yongjun
Pan, Yuesong
Li, Hao
Amarenco, Pierre
Denison, Hans
Evans, Scott R.
Himmelmann, Anders
James, Stefan
Birve, Filip
Ladenvall, Per
Molina, Carlos A.|||0000-0001-6058-6259
Johnston, S. Claiborne
author Wang, Yongjun
author_facet Wang, Yongjun
Pan, Yuesong
Li, Hao
Amarenco, Pierre
Denison, Hans
Evans, Scott R.
Himmelmann, Anders
James, Stefan
Birve, Filip
Ladenvall, Per
Molina, Carlos A.|||0000-0001-6058-6259
Johnston, S. Claiborne
author_role author
author2 Pan, Yuesong
Li, Hao
Amarenco, Pierre
Denison, Hans
Evans, Scott R.
Himmelmann, Anders
James, Stefan
Birve, Filip
Ladenvall, Per
Molina, Carlos A.|||0000-0001-6058-6259
Johnston, S. Claiborne
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Aged
Aspirin
Dual Anti-Platelet Therapy
Female
Humans
Ischemic Stroke
Male
Middle Aged
Patient Acuity
Platelet Aggregation Inhibitors
Ticagrelor
Treatment Outcome
topic Aged
Aspirin
Dual Anti-Platelet Therapy
Female
Humans
Ischemic Stroke
Male
Middle Aged
Patient Acuity
Platelet Aggregation Inhibitors
Ticagrelor
Treatment Outcome
description Importance: Prior trials of dual antiplatelet therapy excluded patients with moderate ischemic stroke. These patients were included in the Acute Stroke or Transient Ischaemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death (THALES) trial, but results have not been reported separately, raising concerns about safety and efficacy in this subgroup. Objective: To evaluate the efficacy and safety of ticagrelor plus aspirin in patients with moderate ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 4 to 5). Design, Setting, and Participants: The THALES trial was a randomized trial conducted at 414 hospitals in 28 countries in January 2018 and December 2019. This exploratory analysis compared patients with moderate stroke (baseline NIHSS score of 4 to 5) with patients with less severe stroke (NIHSS score of 0 to 3). A total of 9983 patients with stroke were included in the present analysis, after excluding 2 patients with NIHSS scores greater than 5 and 1031 patients with transient ischemic attack. Data were analyzed from March to April 2021. Interventions: Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily on days 2 to 30) or placebo within 24 hours after symptom onset. All patients received aspirin, 300 to 325 mg, on day 1 followed by aspirin, 75 to 100 mg, daily on days 2 to 30. Patients were observed for 30 additional days. Main Outcomes and Measures: The primary outcome was time to stroke or death within 30 days. The primary safety outcome was time to severe bleeding. Results: In total, 3312 patients presented with moderate stroke and 6671 presented with less severe stroke. Of those in the moderate stroke group, 1293 (39.0%) were female, and the mean (SD) age was 64.5 (10.8) years; of those in the less severe stroke group, 2518 (37.7%) were female, and the mean (SD) age was 64.8 (11.2) years. The observed primary outcome event rate in patients with moderate stroke was 7.6% (129 of 1671) for those in the ticagrelor group and 9.1% (150 of 1641) for those in the placebo group (hazard ratio, 0.84; 95% CI, 0.66-1.06); the primary outcome event rate in patients with less severe stroke was 4.7% (158 of 3359) for those in the ticagrelor group and 5.7% (190 of 3312) for those in the placebo group (hazard ratio, 0.82; 95% CI, 0.66-1.01) (P for interaction =.88). Severe bleeding occurred in 8 patients (0.5%) in the ticagrelor group and in 4 patients (0.2%) in the placebo group in those with moderate stroke compared with 16 patients (0.5%) and 3 patients (0.1%), respectively, with less severe stroke (P for interaction =.26). Conclusions and Relevance: In this study, patients with a moderate ischemic stroke had consistent benefit from ticagrelor plus aspirin vs aspirin alone compared with patients with less severe ischemic stroke, with no further increase in the risk of intracranial bleeding or other severe bleeding events. Trial Registration: ClinicalTrials.gov Identifier: NCT03354429
publishDate 2021
dc.date.none.fl_str_mv 2
2021-01-01
2021
2021-01-01
dc.type.none.fl_str_mv Article
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VoR
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dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/270309
https://dx.doi.org/urn:doi:10.1001/jamaneurol.2021.2440
url https://ddd.uab.cat/record/270309
https://dx.doi.org/urn:doi:10.1001/jamaneurol.2021.2440
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
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rights_invalid_str_mv open access
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https://creativecommons.org/licenses/by-nc-nd/4.0/
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dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
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spelling Efficacy and Safety of Ticagrelor and Aspirin in Patients with Moderate Ischemic StrokeAn Exploratory Analysis of the THALES Randomized Clinical TrialWang, YongjunPan, YuesongLi, HaoAmarenco, PierreDenison, HansEvans, Scott R.Himmelmann, AndersJames, StefanBirve, FilipLadenvall, PerMolina, Carlos A.|||0000-0001-6058-6259Johnston, S. ClaiborneAgedAspirinDual Anti-Platelet TherapyFemaleHumansIschemic StrokeMaleMiddle AgedPatient AcuityPlatelet Aggregation InhibitorsTicagrelorTreatment OutcomeImportance: Prior trials of dual antiplatelet therapy excluded patients with moderate ischemic stroke. These patients were included in the Acute Stroke or Transient Ischaemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death (THALES) trial, but results have not been reported separately, raising concerns about safety and efficacy in this subgroup. Objective: To evaluate the efficacy and safety of ticagrelor plus aspirin in patients with moderate ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 4 to 5). Design, Setting, and Participants: The THALES trial was a randomized trial conducted at 414 hospitals in 28 countries in January 2018 and December 2019. This exploratory analysis compared patients with moderate stroke (baseline NIHSS score of 4 to 5) with patients with less severe stroke (NIHSS score of 0 to 3). A total of 9983 patients with stroke were included in the present analysis, after excluding 2 patients with NIHSS scores greater than 5 and 1031 patients with transient ischemic attack. Data were analyzed from March to April 2021. Interventions: Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily on days 2 to 30) or placebo within 24 hours after symptom onset. All patients received aspirin, 300 to 325 mg, on day 1 followed by aspirin, 75 to 100 mg, daily on days 2 to 30. Patients were observed for 30 additional days. Main Outcomes and Measures: The primary outcome was time to stroke or death within 30 days. The primary safety outcome was time to severe bleeding. Results: In total, 3312 patients presented with moderate stroke and 6671 presented with less severe stroke. Of those in the moderate stroke group, 1293 (39.0%) were female, and the mean (SD) age was 64.5 (10.8) years; of those in the less severe stroke group, 2518 (37.7%) were female, and the mean (SD) age was 64.8 (11.2) years. The observed primary outcome event rate in patients with moderate stroke was 7.6% (129 of 1671) for those in the ticagrelor group and 9.1% (150 of 1641) for those in the placebo group (hazard ratio, 0.84; 95% CI, 0.66-1.06); the primary outcome event rate in patients with less severe stroke was 4.7% (158 of 3359) for those in the ticagrelor group and 5.7% (190 of 3312) for those in the placebo group (hazard ratio, 0.82; 95% CI, 0.66-1.01) (P for interaction =.88). Severe bleeding occurred in 8 patients (0.5%) in the ticagrelor group and in 4 patients (0.2%) in the placebo group in those with moderate stroke compared with 16 patients (0.5%) and 3 patients (0.1%), respectively, with less severe stroke (P for interaction =.26). Conclusions and Relevance: In this study, patients with a moderate ischemic stroke had consistent benefit from ticagrelor plus aspirin vs aspirin alone compared with patients with less severe ischemic stroke, with no further increase in the risk of intracranial bleeding or other severe bleeding events. Trial Registration: ClinicalTrials.gov Identifier: NCT03354429Universitat Autònoma de Barcelona 22021-01-0120212021-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/270309https://dx.doi.org/urn:doi:10.1001/jamaneurol.2021.2440reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2703092026-06-06T12:50:31Z
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