Author + information
- Received October 10, 2017
- Revision received November 7, 2017
- Accepted November 7, 2017
- Published online November 14, 2017.
- Zuzana Motovska, MD, PhDa,∗@ZMotovska (, )
- Ota Hlinomaz, MD, CScb,
- Petr Kala, MD, PhDc,
- Milan Hromadka, MD, PhDd,
- Jiri Knot, MD, PhDa,
- Ivo Varvarovsky, MD, PhDe,
- Jaroslav Dusek, MD, PhDf,
- Jiri Jarkovsky, MSc, PhDg,
- Roman Miklik, MD, PhDc,
- Richard Rokyta, MD, PhDd,
- Frantisek Tousek, MDh,
- Petra Kramarikova, Mgrb,
- Michal Svoboda, MScg,
- Bohumil Majtan, MDi,j,
- Stanislav Simek, MD, CSck,
- Marian Branny, MD, PhDl,
- Jan Mrozek, MDm,
- Pavel Cervinka, MD, PhDn,
- Jiri Ostransky, MDo,
- Petr Widimsky, MD, DrSca,
- PRAGUE-18 Study Group
- aCardiocentre, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic
- bFirst Department of Internal Medicine – Cardioangiology, ICRC, Faculty of Medicine of Masaryk University and St. Anne’s University Hospital, Brno, Czech Republic
- cDepartment of Internal Medicine and Cardiology, Faculty of Medicine of Masaryk University and University Hospital, Brno, Czech Republic
- dDepartment of Cardiology, University Hospital and Faculty of Medicine of Charles University, Pilsen, Czech Republic
- eCardiology Centre AGEL, Pardubice, Czech Republic
- fFirst Department of Internal Medicine, University Hospital Hradec Kralove, Charles University in Prague, Faculty of Medicine in Hradec Kralove, Czech Republic
- gInstitute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of Masaryk University, Brno, Czech Republic
- hCardiocentre – Department of Cardiology, Regional Hospital, Ceske Budejovice, Czech Republic
- iCardiocentre, Regional Hospital, Karlovy Vary, Czech Republic
- jCardiocentre, Hospital Na Homolce, Prague, Czech Republic
- kSecond Department of Medicine – Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic
- lAGEL Research and Training Institute – Trinec Branch, Cardiovascular Center, Podlesi Hospital, Trinec, Czech Republic
- mCardiovascular Department, University Hospital, Ostrava, Czech Republic
- nDepartment of Cardiology, Masaryk Hospital and UJEP, Usti nad Labem, Krajska zdravotni a.s., Czech Republic
- oFirst Internal Cardiology Clinic, University Hospital Olomouc, Olomouc, Czech Republic
- ↵∗Corresponding Author: Zuzana Motovska MD, PhD Cardiocenter, Third Faculty of Medicine Charles University and University Hospital Kralovske Vinohrady Srobarova 50, 100 34 Prague, Czech Republic Telephone: +420 267163760 Fax: +420 267163763.
Background Early outcomes of patients in the PRAGUE-18 study did not find any significant differences between two potent P2Y12 inhibitors.
Objective The one-year follow-up of the PRAGUE-18 study focused on (1) a comparison of efficacy and safety between prasugrel and ticagrelor, and (2) on 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 PCI were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. The combined endpoint was cardiovascular death, MI, or stroke at one year. Since 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 ticagrelor patients; HR, 1.167; 95% CI, 0.742–1.835; 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 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 switched to clopidogrel had (compared to patients who continued the study medications) a lower risk of major cardiovascular events, however they also had lower ischemic risk.
Conclusion 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.
Funding: The study was supported by the Charles University Cardiovascular Research Program P-35 and PROGRES Q38, Charles University, Czech Republic.
Disclosures: Dr Motovska reports receiving modest honoraria from AstraZeneca. Dr Rokyta reports receiving modest honoraria from AstraZeneca. The other authors report no conflicts.
- Received October 10, 2017.
- Revision received November 7, 2017.
- Accepted November 7, 2017.