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

Publication ,  Journal Article
Berwanger, O; Nicolau, JC; Carvalho, AC; Jiang, L; Goodman, SG; Nicholls, SJ; Parkhomenko, A; Averkov, O; Tajer, C; Malaga, G; Saraiva, JFK ...
Published in: JAMA Cardiol
May 1, 2018

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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02298088.

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Published In

JAMA Cardiol

DOI

EISSN

2380-6591

Publication Date

May 1, 2018

Volume

3

Issue

5

Start / End Page

391 / 399

Location

United States

Related Subject Headings

  • Ticagrelor
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Humans
  • Hemorrhage
  • Fibrinolytic Agents
  • Female
  • Clopidogrel
  • Aged
 

Citation

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Berwanger, O., Nicolau, J. C., Carvalho, A. C., Jiang, L., Goodman, S. G., Nicholls, S. J., … TREAT Study Group. (2018). Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol, 3(5), 391–399. https://doi.org/10.1001/jamacardio.2018.0612
Berwanger, Otavio, Jose C. Nicolau, Antonio C. Carvalho, Lixin Jiang, Shaun G. Goodman, Stephen J. Nicholls, Alexander Parkhomenko, et al. “Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial.JAMA Cardiol 3, no. 5 (May 1, 2018): 391–99. https://doi.org/10.1001/jamacardio.2018.0612.
Berwanger O, Nicolau JC, Carvalho AC, Jiang L, Goodman SG, Nicholls SJ, et al. Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2018 May 1;3(5):391–9.
Berwanger, Otavio, et al. “Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial.JAMA Cardiol, vol. 3, no. 5, May 2018, pp. 391–99. Pubmed, doi:10.1001/jamacardio.2018.0612.
Berwanger O, Nicolau JC, Carvalho AC, Jiang L, Goodman SG, Nicholls SJ, Parkhomenko A, Averkov O, Tajer C, Malaga G, Saraiva JFK, Fonseca FA, De Luca FA, Guimaraes HP, de Barros E Silva PGM, Damiani LP, Paisani DM, Lasagno CMR, Candido CT, Valeis N, Moia DDF, Piegas LS, Granger CB, White HD, Lopes RD, TREAT Study Group. Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2018 May 1;3(5):391–399.

Published In

JAMA Cardiol

DOI

EISSN

2380-6591

Publication Date

May 1, 2018

Volume

3

Issue

5

Start / End Page

391 / 399

Location

United States

Related Subject Headings

  • Ticagrelor
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Humans
  • Hemorrhage
  • Fibrinolytic Agents
  • Female
  • Clopidogrel
  • Aged