Abstract | 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: 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:
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Authors | Kenneth 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, PLATO Investigators |
Journal | Journal 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 |
PMID | 24561148
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Purinergic P2Y Receptor Antagonists
- Ticagrelor
- Adenosine
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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)
- Ticagrelor
- Treatment Outcome
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