Zuzana Motovska1, Ota Hlinomaz2, Petr Kala3, Milan Hromadka4, Jiri Knot5, Ivo Varvarovsky6, Jaroslav Dusek7, Jiri Jarkovsky8, Roman Miklik3, Richard Rokyta4, Frantisek Tousek9, Petra Kramarikova2, Michal Svoboda8, Bohumil Majtan10, Stanislav Simek11, Marian Branny12, Jan Mrozek13, Pavel Cervinka14, Jiri Ostransky15, Petr Widimsky5. 1. Cardiocentre, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: motovska.zuzana@gmail.com. 2. First Department of Internal Medicine-Cardioangiology, The International Clinical Research Center, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic. 3. Department of Internal Medicine and Cardiology, Faculty of Medicine, Masaryk University and University Hospital, Brno, Czech Republic. 4. Department of Cardiology, University Hospital and Faculty of Medicine of Charles University, Pilsen, Czech Republic. 5. Cardiocentre, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic. 6. Cardiology Centre AGEL, Pardubice, Czech Republic. 7. First Department of Internal Medicine, University Hospital Hradec Kralove and Charles University, Faculty of Medicine in Hradec Kralove, Hradec Kralove, Czech Republic. 8. Institute of Biostatistics and Analyses, Faculty of Medicine and the Faculty of Science, Masaryk University, Brno, Czech Republic. 9. Cardiocentre-Department of Cardiology, Regional Hospital, Ceske Budejovice, Czech Republic. 10. Cardiocentre, Regional Hospital, Karlovy Vary, Czech Republic; Cardiocentre, Hospital Na Homolce, Prague, Czech Republic. 11. Second Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic. 12. AGEL Research and Training Institute-Trinec Branch, Cardiovascular Center, Podlesi Hospital, Trinec, Czech Republic. 13. Cardiovascular Department, University Hospital, Ostrava, Czech Republic. 14. Department of Cardiology, Krajska Zdravotni a.s., Masaryk Hospital and Jan Evangelista Purkyně University, Usti nad Labem, Czech Republic. 15. First Internal Cardiology Clinic, University Hospital Olomouc, Olomouc, Czech Republic.
Abstract
BACKGROUND: Early outcomes of patients in the PRAGUE-18 (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction) study did not find any significant differences between 2 potent P2Y12 inhibitors. OBJECTIVES: The 1-year follow-up of the PRAGUE-18 study focused on: 1) a comparison of efficacy and safety between prasugrel and ticagrelor; and 2) the risk of major ischemic events related to an economically motivated post-discharge switch to clopidogrel. METHODS: A total of 1,230 patients with acute myocardial infarction (MI) treated with primary percutaneous coronary intervention were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. The combined endpoint was cardiovascular death, MI, or stroke at 1 year. Because patients had to cover the costs of study medication after hospital discharge, some patients decided to switch to clopidogrel. RESULTS: The endpoint occurred in 6.6% of prasugrel patients and in 5.7% of ticagrelorpatients (hazard ratio: 1.167; 95% confidence interval: 0.742 to 1.835; p = 0.503). No significant differences were found in: cardiovascular death (3.3% vs. 3.0%; p = 0.769), MI (3.0% vs. 2.5%; p = 0.611), stroke (1.1% vs. 0.7%; p = 0.423), all-cause death (4.7% vs. 4.2%; p = 0.654), definite stent thrombosis (1.1% vs. 1.5%; p = 0.535), all bleeding (10.9% vs. 11.1%; p = 0.999), and TIMI (Thrombolysis In Myocardial Infarction) major bleeding (0.9% vs. 0.7%; p = 0.754). The percentage of patients who switched to clopidogrel for economic reasons was 34.1% (n = 216) for prasugrel and 44.4% (n = 265) for ticagrelor (p = 0.003). Patients who were economically motivated to switch to clopidogrel had (compared with patients who continued the study medications) a lower risk of major cardiovascular events; however, they also had lower ischemic risk. CONCLUSIONS:Prasugrel and ticagrelor are similarly effective during the first year after MI. Economically motivated early post-discharge switches to clopidogrel were not associated with an increased risk of ischemic events. (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction [PRAGUE-18]; NCT02808767).
RCT Entities:
BACKGROUND: Early outcomes of patients in the PRAGUE-18 (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction) study did not find any significant differences between 2 potent P2Y12 inhibitors. OBJECTIVES: The 1-year follow-up of the PRAGUE-18 study focused on: 1) a comparison of efficacy and safety between prasugrel and ticagrelor; and 2) the risk of major ischemic events related to an economically motivated post-discharge switch to clopidogrel. METHODS: A total of 1,230 patients with acute myocardial infarction (MI) treated with primary percutaneous coronary intervention were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. The combined endpoint was cardiovascular death, MI, or stroke at 1 year. Because patients had to cover the costs of study medication after hospital discharge, some patients decided to switch to clopidogrel. RESULTS: The endpoint occurred in 6.6% of prasugrelpatients and in 5.7% of ticagrelorpatients (hazard ratio: 1.167; 95% confidence interval: 0.742 to 1.835; p = 0.503). No significant differences were found in: cardiovascular death (3.3% vs. 3.0%; p = 0.769), MI (3.0% vs. 2.5%; p = 0.611), stroke (1.1% vs. 0.7%; p = 0.423), all-cause death (4.7% vs. 4.2%; p = 0.654), definite stent thrombosis (1.1% vs. 1.5%; p = 0.535), all bleeding (10.9% vs. 11.1%; p = 0.999), and TIMI (Thrombolysis In Myocardial Infarction) major bleeding (0.9% vs. 0.7%; p = 0.754). The percentage of patients who switched to clopidogrel for economic reasons was 34.1% (n = 216) for prasugrel and 44.4% (n = 265) for ticagrelor (p = 0.003). Patients who were economically motivated to switch to clopidogrel had (compared with patients who continued the study medications) a lower risk of major cardiovascular events; however, they also had lower ischemic risk. CONCLUSIONS:Prasugrel and ticagrelor are similarly effective during the first year after MI. Economically motivated early post-discharge switches to clopidogrel were not associated with an increased risk of ischemic events. (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction [PRAGUE-18]; NCT02808767).
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