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

AbstractOBJECTIVES:
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).
AuthorsKenneth W Mahaffey, Claes Held, Daniel M Wojdyla, Stefan K James, Hugo A Katus, Steen Husted, Philippe Gabriel Steg, Christopher P Cannon, Richard C Becker, Robert F Storey, Nardev S Khurmi, José C Nicolau, Cheuk-Man Yu, Diego Ardissino, Andrzej Budaj, Joao Morais, Debra Montgomery, Anders Himmelmann, Robert A Harrington, Lars Wallentin,
JournalJournal of the American College of Cardiology (J Am Coll Cardiol) Vol. 63 Issue 15 Pg. 1493-9 (Apr 22 2014) ISSN: 1558-3597 [Electronic] United States
PMID24561148 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Chemical References
  • Purinergic P2Y Receptor Antagonists
  • Ticagrelor
  • Adenosine
Topics
  • Acute Coronary Syndrome (blood, complications, drug therapy)
  • Adenosine (administration & dosage, analogs & derivatives)
  • Aged
  • Blood Platelets (drug effects)
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Global Health
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Myocardial Infarction (epidemiology, etiology, prevention & control)
  • Prospective Studies
  • Purinergic P2Y Receptor Antagonists (administration & dosage)
  • Survival Rate (trends)
  • Treatment Outcome

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