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Circulation. 2016 Nov 22;134(21):1603-1612. Epub 2016 Aug 30.

Prasugrel Versus Ticagrelor in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: Multicenter Randomized PRAGUE-18 Study.

Author information

1
From Cardiocenter, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic (Z.M., J.K., P.W.); First Department of Internal Medicine-Cardioangiology, ICRC, Faculty of Medicine of Masaryk University and St. Anne's University Hospital, Brno, Czech Republic (O.H., P. Kramarikova); Department of Internal Medicine and Cardiology, Faculty of Medicine of Masaryk University and University Hospital Brno, Brno, Czech Republic (R.M., P. Kala); Department of Cardiology, University Hospital and Faculty of Medicine in Pilsen, Charles University, Prague, Czech Republic (M.H., R.R.); Cardiology Centre AGEL, Pardubice, Czech Republic (I.V.); First Department of Internal Medicine, University Hospital Hradec Kralove, Charles University in Prague, Faculty of Medicine in Hradec Kralove, Czech Republic (J.D.); Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk University, Brno, Czech Republic (J..J.); Cardiocenter, Department of Cardiology, Regional Hospital, Ceske Budejovice, Czech Republic (F.T.); Cardiocenter, Regional Hospital, Karlovy Vary, Czech Republic (B.M.); Cardiocenter, Hospital Na Homolce, Prague, Czech Republic (B.M.); Second Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic (S.S.); AGEL Research and Training Institute, Trinec Branch, Cardiovascular Center, Podlesi Hospital, Trinec, Czech Republic (M.B.); Cardiovascular Department, University Hospital Ostrava, Ostrava, Czech Republic (J.M.); Department of Cardiology, Krajska zdravotni a.s., Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic (P.C.); and First Internal Cardiology Clinic, University Hospital Olomouc, Olomouc, Czech Republic (J.O.). motovska.zuzana@gmail.com.
2
From Cardiocenter, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic (Z.M., J.K., P.W.); First Department of Internal Medicine-Cardioangiology, ICRC, Faculty of Medicine of Masaryk University and St. Anne's University Hospital, Brno, Czech Republic (O.H., P. Kramarikova); Department of Internal Medicine and Cardiology, Faculty of Medicine of Masaryk University and University Hospital Brno, Brno, Czech Republic (R.M., P. Kala); Department of Cardiology, University Hospital and Faculty of Medicine in Pilsen, Charles University, Prague, Czech Republic (M.H., R.R.); Cardiology Centre AGEL, Pardubice, Czech Republic (I.V.); First Department of Internal Medicine, University Hospital Hradec Kralove, Charles University in Prague, Faculty of Medicine in Hradec Kralove, Czech Republic (J.D.); Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk University, Brno, Czech Republic (J..J.); Cardiocenter, Department of Cardiology, Regional Hospital, Ceske Budejovice, Czech Republic (F.T.); Cardiocenter, Regional Hospital, Karlovy Vary, Czech Republic (B.M.); Cardiocenter, Hospital Na Homolce, Prague, Czech Republic (B.M.); Second Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic (S.S.); AGEL Research and Training Institute, Trinec Branch, Cardiovascular Center, Podlesi Hospital, Trinec, Czech Republic (M.B.); Cardiovascular Department, University Hospital Ostrava, Ostrava, Czech Republic (J.M.); Department of Cardiology, Krajska zdravotni a.s., Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic (P.C.); and First Internal Cardiology Clinic, University Hospital Olomouc, Olomouc, Czech Republic (J.O.).

Abstract

BACKGROUND:

No randomized head-to-head comparison of the efficacy and safety of ticagrelor and prasugrel has been published in the 7 years since the higher efficacy of these newer P2Y12 inhibitors were first demonstrated relative to clopidogrel.

METHODS:

This academic study was designed to compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction treated with primary or immediate percutaneous coronary intervention. A total of 1230 patients were randomly assigned across 14 sites to either prasugrel or ticagrelor, which was initiated before percutaneous coronary intervention. Nearly 4% were in cardiogenic shock, and 5.2% were on mechanical ventilation. The primary end point was defined as death, reinfarction, urgent target vessel revascularization, stroke, or serious bleeding requiring transfusion or prolonging hospitalization at 7 days (to reflect primarily the in-hospital phase). This analysis presents data from the first 30 days (key secondary end point). The total follow-up will be 1 year for all patients and will be completed in 2017.

RESULTS:

The study was prematurely terminated for futility. The occurrence of the primary end point did not differ between groups receiving prasugrel and ticagrelor (4.0% and 4.1%, respectively; odds ratio, 0.98; 95% confidence interval, 0.55-1.73; P=0.939). No significant difference was found in any of the components of the primary end point. The occurrence of key secondary end point within 30 days, composed of cardiovascular death, nonfatal myocardial infarction, or stroke, did not show any significant difference between prasugrel and ticagrelor (2.7% and 2.5%, respectively; odds ratio, 1.06; 95% confidence interval, 0.53-2.15; P=0.864).

CONCLUSIONS:

This head-to-head comparison of prasugrel and ticagrelor does not support the hypothesis that one is more effective or safer than the other in preventing ischemic and bleeding events in the acute phase of myocardial infarction treated with a primary percutaneous coronary intervention strategy. The observed rates of major outcomes were similar but with broad confidence intervals around the estimates. These interesting observations need to be confirmed in a larger trial.

CLINICAL TRIAL REGISTRATION:

URL: http://www.ClinicalTrials.gov. Unique identifier: NCT02808767.

KEYWORDS:

myocardial infarction; percutaneous coronary intervention; prasugrel hydrochloride; safety; ticagrelor; treatment outcome

[Indexed for MEDLINE]

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