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Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial.

Publication ,  Journal Article
Mahaffey, KW; Held, C; Wojdyla, DM; James, SK; Katus, HA; Husted, S; Steg, PG; Cannon, CP; Becker, RC; Storey, RF; Khurmi, NS; Nicolau, JC ...
Published in: J Am Coll Cardiol
April 22, 2014

OBJECTIVES: This study sought to report the treatment effect of ticagrelor on myocardial infarction (MI) and the strategy for and impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. BACKGROUND: In PLATO, ticagrelor reduced cardiovascular death, MI, or stroke in patients with acute coronary syndromes (ACS). METHODS: A clinical events committee (CEC) prospectively defined and adjudicated all suspected MI events, on the basis of events reported by investigators and by triggers on biomarkers. Treatment comparisons used CEC-adjudicated data, and per protocol, excluded silent MI. RESULTS: Overall, 1,299 (610 ticagrelor, 689 clopidogrel) MIs reported by the CEC occurred during the trial. Of these, 1,097 (504 ticagrelor, 593 clopidogrel) contributed to the primary composite endpoint. Site investigators reported 1,198 (580 ticagrelor, 618 clopidogrel) MIs. Ticagrelor significantly reduced overall MI rates (12-month CEC-adjudicated Kaplan-Meier rates: 5.8% ticagrelor, 6.9% clopidogrel; hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.75 to 0.95). Nonprocedural MI (HR: 0.86; 95% CI: 0.74 to 1.01) and MI related to percutaneous coronary intervention or stent thrombosis tended to be lower with ticagrelor. MIs related to coronary artery bypass graft surgery were few, but numerical excess was observed in patients assigned ticagrelor. Analyses of overall MIs using investigator-reported data showed similar results but did not reach statistical significance (HR: 0.88; 95% CI: 0.78 to 1.00). CONCLUSIONS: In patients with ACS, ticagrelor significantly reduced the incidence of MI compared with clopidogrel, with consistent results across most MI subtypes. CEC procedures identified more MI endpoints compared with site investigators. (A Comparison of Ticagrelor [AZD6140] and Clopidogrel in Patients With Acute Coronary Syndrome [PLATO]; NCT00391872).

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

April 22, 2014

Volume

63

Issue

15

Start / End Page

1493 / 1499

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Ticagrelor
  • Survival Rate
  • Purinergic P2Y Receptor Antagonists
  • Prospective Studies
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Incidence
  • Humans
 

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Mahaffey, K. W., Held, C., Wojdyla, D. M., James, S. K., Katus, H. A., Husted, S., … PLATO Investigators. (2014). Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. J Am Coll Cardiol, 63(15), 1493–1499. https://doi.org/10.1016/j.jacc.2014.01.038
Mahaffey, Kenneth W., Claes Held, Daniel M. Wojdyla, Stefan K. James, Hugo A. Katus, Steen Husted, Philippe Gabriel Steg, et al. “Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial.J Am Coll Cardiol 63, no. 15 (April 22, 2014): 1493–99. https://doi.org/10.1016/j.jacc.2014.01.038.
Mahaffey KW, Held C, Wojdyla DM, James SK, Katus HA, Husted S, et al. Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. J Am Coll Cardiol. 2014 Apr 22;63(15):1493–9.
Mahaffey, Kenneth W., et al. “Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial.J Am Coll Cardiol, vol. 63, no. 15, Apr. 2014, pp. 1493–99. Pubmed, doi:10.1016/j.jacc.2014.01.038.
Mahaffey KW, Held C, Wojdyla DM, James SK, Katus HA, Husted S, Steg PG, Cannon CP, Becker RC, Storey RF, Khurmi NS, Nicolau JC, Yu C-M, Ardissino D, Budaj A, Morais J, Montgomery D, Himmelmann A, Harrington RA, Wallentin L, PLATO Investigators. Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. J Am Coll Cardiol. 2014 Apr 22;63(15):1493–1499.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

April 22, 2014

Volume

63

Issue

15

Start / End Page

1493 / 1499

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Ticagrelor
  • Survival Rate
  • Purinergic P2Y Receptor Antagonists
  • Prospective Studies
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Incidence
  • Humans