Universidad Peruana Cayetano Heredia

Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial

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dc.contributor.author Berwanger, Otavio
dc.contributor.author Nicolau, Jose C.
dc.contributor.author Carvalho, Antonio C.
dc.contributor.author Jiang, Lixin
dc.contributor.author Goodman, Shaun G.
dc.contributor.author Nicholls, Stephen J.
dc.contributor.author Parkhomenko, Alexander
dc.contributor.author Averkov, Oleg
dc.contributor.author Tajer, Carlos
dc.contributor.author Málaga Rodríguez, Germán Javier
dc.contributor.author Saraiva, Jose F. K.
dc.contributor.author Fonseca, Francisco A.
dc.contributor.author De Luca, Fábio A.
dc.contributor.author Guimaraes, Helio P.
dc.contributor.author de Barros E Silva, Pedro G. M.
dc.contributor.author Damiani, Lucas P.
dc.contributor.author Paisani, Denise M.
dc.contributor.author Lasagno, Camila M. R.
dc.contributor.author Candido, Carolina T.
dc.contributor.author Valeis, Nanci
dc.contributor.author Moia, Diogo D. F.
dc.contributor.author Piegas, Leopoldo S.
dc.contributor.author Granger, Christopher B.
dc.contributor.author White, Harvey D.
dc.contributor.author Lopes, Renato D.
dc.contributor.author TREAT Study Group
dc.date.accessioned 2018-11-30T23:41:30Z
dc.date.available 2018-11-30T23:41:30Z
dc.date.issued 2018
dc.identifier.uri https://hdl.handle.net/20.500.12866/4198
dc.description.abstract Importance: The bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy remains uncertain. Objective: To evaluate the short-term safety of ticagrelor when compared with clopidogrel in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy. Design, Setting and Participants: We conducted a multicenter, randomized, open-label with blinded end point adjudication trial that enrolled 3799 patients (younger than 75 years) with ST-segment elevation myocardial infarction receiving fibrinolytic therapy in 152 sites from 10 countries from November 2015 through November 2017. The prespecified upper boundary for noninferiority for bleeding was an absolute margin of 1.0%. Interventions: Patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter). Patients were randomized with a median of 11.4 hours after fibrinolysis, and 90% were pretreated with clopidogrel. Main Outcomes and Measures: The primary outcome was thrombolysis in myocardial infarction (TIMI) major bleeding through 30 days. Results: The mean (SD) age was 58.0 (9.5) years, 2928 of 3799 patients (77.1%) were men, and 2177 of 3799 patients (57.3%) were white. At 30 days, TIMI major bleeding had occurred in 14 of 1913 patients (0.73%) receiving ticagrelor and in 13 of 1886 patients (0.69%) receiving clopidogrel (absolute difference, 0.04%; 95% CI, -0.49% to 0.58%; P < .001 for noninferiority). Major bleeding defined by the Platelet Inhibition and Patient Outcomes criteria and by the Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 23 patients (1.20%) in the ticagrelor group and in 26 patients (1.38%) in the clopidogrel group (absolute difference, -0.18%; 95% CI, -0.89% to 0.54; P = .001 for noninferiority). The rates of fatal (0.16% vs 0.11%; P = .67) and intracranial bleeding (0.42% vs 0.37%; P = .82) were similar between the ticagrelor and clopidogrel groups, respectively. Minor and minimal bleeding were more common with ticagrelor than with clopidogrel. The composite of death from vascular causes, myocardial infarction, or stroke occurred in 76 patients (4.0%) treated with ticagrelor and in 82 patients (4.3%) receiving clopidogrel (hazard ratio, 0.91; 95% CI, 0.67-1.25; P = .57). Conclusions and Relevance: In patients younger than 75 years with ST-segment elevation myocardial infarction, delayed administration of ticagrelor after fibrinolytic therapy was noninferior to clopidogrel for TIMI major bleeding at 30 days. en_US
dc.language.iso eng
dc.publisher American Medical Association
dc.relation.ispartofseries JAMA Cardiology
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Acute Coronary Syndromes en_US
dc.subject Cardiology en_US
dc.subject Clinical Pharmacy and Pharmacology en_US
dc.subject Emergency Medicine en_US
dc.subject Bleeding and Transfusion en_US
dc.subject Ischemic Heart Disease Anticoagulation en_US
dc.title Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1001/jamacardio.2018.0612
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.04
dc.relation.issn 2380-6591


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