Matthijs A Velders1, Jérémie Abtan2, Dominick J Angiolillo3, Diego Ardissino4, Robert A Harrington5, Anne Hellkamp6, Anders Himmelmann7, Steen Husted8, Hugo A Katus9, Bernhard Meier10, Phillip J Schulte11, Robert F Storey12, Lars Wallentin1, Philippe Gabriel Steg13, Stefan K James1. 1. Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 2. Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France. 3. Department of Medicine, University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, USA. 4. Azienda Ospedaliero, Universitaria di Parma, Parma, Italy. 5. Department of Medicine, Stanford University, Stanford, California, USA. 6. Duke Clinical Research Institute, Duke University, Medical Center, Durham, North Carolina, USA. 7. AstraZeneca Research and Development, Gothenburg, Sweden. 8. Medical Department, Hospital Unit West, Holstebro - Herning/Holstebro, Denmark. 9. Medizinishe Klinik, Universitätsklinikum Heidelberg, Heidelberg, Germany. 10. Bern University Hospital, Bern, Switzerland. 11. Duke Clinical Research Institute, Duke University, Medical Center, Durham, North Carolina, USA Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA. 12. Department of Cardiovascular Science, University of Sheffield, Sheffield, UK. 13. Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France INSERM-Unité 1148, Paris, France Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Authors: Lukasz Koltowski; Mariusz Tomaniak; Lisa Gross; Bartosz Rymuza; Michal Kowara; Radoslaw Parma; Anna Komosa; Mariusz Klopotowski; Claudius Jacobshagen; Tommaso Gori; Daniel Aradi; Kurt Huber; Martin Hadamitzky; Steffen Massberg; Maciej Lesiak; Krzysztof J Filipiak; Adam Witkowski; Grzegorz Opolski; Zenon Huczek; Dirk Sibbing Journal: J Thromb Thrombolysis Date: 2019-04 Impact factor: 2.300