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Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial.
- Source :
-
Journal of the American College of Cardiology [J Am Coll Cardiol] 2014 Apr 22; Vol. 63 (15), pp. 1493-9. Date of Electronic Publication: 2014 Feb 19. - Publication Year :
- 2014
-
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.<br />Background: In PLATO, ticagrelor reduced cardiovascular death, MI, or stroke in patients with acute coronary syndromes (ACS).<br />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.<br />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).<br />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).<br /> (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Acute Coronary Syndrome blood
Acute Coronary Syndrome complications
Adenosine administration & dosage
Aged
Double-Blind Method
Female
Follow-Up Studies
Global Health
Humans
Incidence
Male
Middle Aged
Myocardial Infarction etiology
Myocardial Infarction prevention & control
Prospective Studies
Purinergic P2Y Receptor Antagonists administration & dosage
Survival Rate trends
Ticagrelor
Treatment Outcome
Acute Coronary Syndrome drug therapy
Adenosine analogs & derivatives
Blood Platelets drug effects
Myocardial Infarction epidemiology
Subjects
Details
- Language :
- English
- ISSN :
- 1558-3597
- Volume :
- 63
- Issue :
- 15
- Database :
- MEDLINE
- Journal :
- Journal of the American College of Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 24561148
- Full Text :
- https://doi.org/10.1016/j.jacc.2014.01.038