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Coronary artery disease
Original article
Safety and efficacy of ticagrelor and clopidogrel in primary percutaneous coronary intervention
  1. Matthijs A Velders1,2,
  2. Jérémie Abtan3,
  3. Dominick J Angiolillo4,
  4. Diego Ardissino5,
  5. Robert A Harrington6,
  6. Anne Hellkamp7,
  7. Anders Himmelmann8,
  8. Steen Husted9,
  9. Hugo A Katus10,
  10. Bernhard Meier11,
  11. Phillip J Schulte7,12,
  12. Robert F Storey13,
  13. Lars Wallentin1,2,
  14. Philippe Gabriel Steg3,14,15,16,
  15. Stefan K James1,2
  16. on behalf of the PLATO Investigators
  1. 1Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden
  2. 2Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden
  3. 3Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France
  4. 4Department of Medicine, University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, USA
  5. 5Azienda Ospedaliero, Universitaria di Parma, Parma, Italy
  6. 6Department of Medicine, Stanford University, Stanford, California, USA
  7. 7Duke Clinical Research Institute, Duke University, Medical Center, Durham, North Carolina, USA
  8. 8AstraZeneca Research and Development, Gothenburg, Sweden
  9. 9Medical Department, Hospital Unit West, Holstebro – Herning/Holstebro, Denmark
  10. 10Medizinishe Klinik, Universitätsklinikum Heidelberg, Heidelberg, Germany
  11. 11Bern University Hospital, Bern, Switzerland
  12. 12Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA
  13. 13Department of Cardiovascular Science, University of Sheffield, Sheffield, UK
  14. 14INSERM-Unité 1148, Paris, France
  15. 15Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France
  16. 16NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK
  1. Correspondence to Professor Stefan K James, Department of Medical Sciences, Cardiology, Uppsala University, Uppsala Clinical Research Center, Dag Hammarskjölds väg 14B 752 37 Uppsala stefan.james{at}ucr.uu.se

Abstract

Objective The effects of ticagrelor in the subpopulation of patients with ST-elevation myocardial infarction (STEMI) were consistent with those observed in the overall Platelet Inhibition and Patient Outcomes (PLATO) study. However, this subgroup included patients initially or ultimately treated conservatively. The aim of this study is to compare treatment using ticagrelor with treatment using clopidogrel in patients with STEMI undergoing primary percutaneous coronary intervention (PCI).

Methods This post-hoc subgroup analysis compared ticagrelor with clopidogrel in 4949 PLATO patients with STEMI that were treated with primary PCI within 12 h of admission. The primary endpoint was cardiovascular death, myocardial infarction or stroke. The safety endpoint consisted of any major bleeding. Secondary endpoints included stent thrombosis. The analysis was not adequately powered to establish significance of any treatment effects.

Results During a median of 286 days, the primary endpoint occurred in 7.9% of ticagrelor-treated patients versus 8.6% of clopidogrel-treated patients (HR 0.91, 95% CI 0.75 to 1.12, p=0.38). Major bleeding occurred in 6.7% in ticagrelor-treated patients versus 6.8% of clopidogrel-treated patients (HR 0.97, 95% CI 0.77 to 1.22, p=0.79). No interactions were observed for the treatment effect of ticagrelor versus clopidogrel on the primary efficacy (p=0.40) and primary safety endpoints (p=0.15) as compared with the full PLATO population. Treatment with ticagrelor versus clopidogrel reduced the occurrence of definite stent thrombosis (HR 0.58, 95% CI 0.37 to 0.89, p=0.013).

Conclusions In the subset of patients with STEMI treated with primary PCI, ticagrelor compared with clopidogrel was safe, and efficacy outcomes were consistent with the overall PLATO trial.

Trial registration number NCT00391872; Results.

https://doi.org/10.1136/heartjnl-2015-308963

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