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Rationale and design of switch Swedeheart: A registry-based, stepped-wedge, cluster-randomized, open-label multicenter trial to compare prasugrel and ticagrelor for treatment of patients with acute coronary syndrome - 30/06/22

Doi : 10.1016/j.ahj.2022.05.017 
Elmir Omerovic, MDPhD a, b, David Erlinge, MDPhD c, Sasha Koul, MDPhD c, Ole Frobert, MDPhD d, e, Jonas Andersson, MDPhD f, Johan Ponten, MDPhD g, Fredrik Björklund, MDPhD h, Robert Kastberg, MDPhD h, Max Petzold, PhD i, Charlotta Ljungman, MDPhD a, b, Kristian Bolin, PhD j, Björn Redfors, MDPhD a, b,
a Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden 
b Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden 
c Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden 
d Department of Cardiology, Faculty of Health, Örebro University Hospital, Örebro, Sweden 
e Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark 
f Department of Cardiology, Umeå University Hospital, Umeå, Sweden 
g Department of Cardiology, Hallands hospital Halmstad, Halmstad, Sweden 
h Department of Cardiology, Östersund Hospital, Östersund, Sweden 
i School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg, Sweden 
j Department of Economics, Centre for Health Economics, University of Gothenburg, Gothenburg, Sweden 

Reprint requests: Bjorn Redfors, MD, PhD, Department of Cardiology, Sahlgrenska University Hospital, Gothenburg 413 45, SwedenDepartment of CardiologySahlgrenska University HospitalGothenburg413 45Sweden

Riassunto

Background

European treatment guidelines recommend prasugrel over ticagrelor for treating patients with non–ST-elevation acute coronary syndrome (ACS), prompting several Swedish administrative regions to transition from ticagrelor to prasugrel as the preferred treatment for patients with ACS. We aim to systematically evaluate this transition to determine the relative efficacy of prasugrel versus ticagrelor in a real-world cohort of patients with ACS.

Study design and objectives

The SWITCH SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial, in which administrative regions in Sweden will constitute the clusters. At the start of the study, all clusters will use ticagrelor as the P2Y12 inhibitor drug of choice for ACS. The order in which the clusters will implement the transition from ticagrelor to prasugrel will be randomly assigned. Every 9 months, 1 cluster will switch from ticagrelor to prasugrel as the P2Y12 inhibitor of choice for patients with ACS. The primary endpoint is the composite 1-year rate of the death, stroke, or myocardial infarction.

Conclusions

The SWITCH SWEDEHEART study will provide an extensive randomized comparison between ticagrelor and prasugrel. Novel therapies are frequently costly and supported by evidence from few or small studies, and systematic evaluation after the introduction is rare. This study will establish an important standard for introducing and evaluating the effects of health care changes within our societies.

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P. 70-77 - settembre 2022 Ritorno al numero
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