Rationale and design of the STOP-IMH randomised trial: Safety of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction and the effect on intramyocardial haemorrhage.

Autor:	Woelders ECI; Radboud University Medical Centre, Department of Cardiology, Nijmegen, The Netherlands., Yosofi B; Radboud University Medical Centre, Department of Cardiology, Nijmegen, The Netherlands., Peeters DAM; Radboud University Medical Centre, Department of Cardiology, Nijmegen, The Netherlands., Konijnenberg LSF; Radboud University Medical Centre, Department of Cardiology, Nijmegen, The Netherlands., von Birgelen C; Medisch Spectrum Twente, Department of Cardiology, University of Twente, Health Technology and Services Research, Faculty BMS, Enschede, The Netherlands., van Rees JB; Rijnstate Ziekenhuis, Department of Cardiology, Arnhem, The Netherlands., van den Oord SCH; Rijnstate Ziekenhuis, Department of Cardiology, Arnhem, The Netherlands., Heestermans AACM; Noordwest Ziekenhuisgroep, Department of Cardiology, Alkmaar, The Netherlands., Claessen BEPM; Amsterdam UMC, locatie AMC, Department of Cardiology, Amsterdam, The Netherlands., van Royen N; Radboud University Medical Centre, Department of Cardiology, Nijmegen, The Netherlands., van Geuns RJM; Radboud University Medical Centre, Department of Cardiology, Nijmegen, The Netherlands., Nijveldt R; Radboud University Medical Centre, Department of Cardiology, Nijmegen, The Netherlands., Damman P; Radboud University Medical Centre, Department of Cardiology, Nijmegen, The Netherlands.
Jazyk:	angličtina
Zdroj:	International journal of cardiology. Heart & vasculature [Int J Cardiol Heart Vasc] 2024 Nov 22; Vol. 56, pp. 101564. Date of Electronic Publication: 2024 Nov 22 (Print Publication: 2025).
DOI:	10.1016/j.ijcha.2024.101564
Abstrakt:	Background: Ticagrelor monotherapy after 1-3 months of dual antiplatelet therapy (DAPT) has shown to be effective and safe after percutaneous coronary intervention (PCI), including in patients with an ST elevation myocardial infarction (STEMI). Direct omission of aspirin could further reduce bleeding complications and may reduce the incidence and expansion of intramyocardial haemorrhage (IMH), a frequent complication after revascularisation for a STEMI. Methods: This multicentre open label pilot study randomises 200 STEMI patients within 24 hours after primary PCI and before the first subsequent dose of aspirin to ticagrelor monotherapy or ticagrelor plus aspirin for twelve months. As IMH is more frequently observed after an anterior STEMI, IMH and infarct size will be determined with cardiac magnetic resonance (CMR) imaging in 60 anterior STEMI patients. In this subgroup, blood samples will be analysed for biochemical outcomes. Results: The primary safety endpoint consists of major adverse cardiac and cerebral events, and the primary efficacy endpoint is infarct size on CMR. Secondary efficacy endpoints consist of the incidence and extent of IMH determined by CMR, and of clinical bleeding events. Other endpoints include all-cause mortality and biochemical outcomes. Conclusion: The STOP-IMH pilot study compares ticagrelor monotherapy with ticagrelor plus aspirin directly after primary PCI in 200 STEMI patients. We aim to provide a signal of safety regarding ischemic events for the direct omission of aspirin after primary PCI, and to compare the infarct size by CMR between the two treatment strategies in the first week after primary PCI. Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Peter Damman has received research grants from Abbott, Philips, and AstraZeneca. Robin Nijveldt has received research grants from Philips Volcano and Biotronik. Robert Jan M. van Geuns has received grants and personal fees from Boston Scientific, Abbott Vascular, AstraZeneca and Amgen, and grants from InfraRedx. Bimmer Claessen has received speaker and/or consultancy fees from Abbott Vascular, Abiomed, Amgen, Boston Scientific, BBraun, and Sanofi, educational grants from Boston Scientific and Abiomed, and research grants from Philips, Novo Nordisk, BBraun and Nipro/Infraredx. Niels van Royen has received research grants from Philips, Biotronik, Abbott and Medtronic and speaker fees from Abbott, RainMed, Microport and Bayer. Clemens von Birgelen reported institutional research grants from Abbott Vascular, Biotronik, and Medtronic, outside the present study. The other authors report no relationships that could be construed as a conflict of interest. (© 2024 The Authors.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu