E Marc Jolicoeur1, Nandini Dendukuri2, Patrick Belisle3, Grégoire Range4, Geraud Souteyrand5, Frédéric Bouisset6, Gilles Zemour7, Nicolas Delarche8, Brahim Harbaoui9, Erick Schampaert10, Simon Kouz11, Guillaume Cayla12, François Roubille13, Ziad Boueri14, Samer Mansour15, Xavier Marcaggi16, Jean-Claude Tardif17, Michael McGillion18, Jean-François Tanguay17, James Brophy19, Cheol Woong Yu20, Colin Berry21, David Carrick22, Dan Eik Høfsten23, Thomas Engstrøm23, Lars Kober23, Henning Kelbæk24, Loic Belle25. 1. Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada. Electronic address: marc.jolicoeur@icm-mhi.org. 2. Centre for Outcomes Research, McGill University Health Centre-Research Institute, Montreal, Quebec, Canada. 3. Montreal Health Innovation Coordination Center, Montreal, Quebec, Canada. 4. Department of Cardiology, Les Hôpitaux de Chartres, Euret-Loir, France. 5. CHU-Clermont Ferrand, Clermont-Ferrand, France. 6. Toulouse Rangueil University Hospital (CHU), Toulouse, France. 7. Centre Hospitalier Pierre Nouveau Cannes, Cannes, France. 8. Centre Hospitalier de Pau, Pau, France. 9. Hôpital Croix-Rousse and Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France. 10. Hopital Sacre-Coeur, Interventional Cardiology, Université de Montréal, Montreal, Quebec, Canada. 11. Centre Hospitalier Régional de Lanaudiere, Joliette, Quebec, Canada. 12. Centre Hospitalier Universitaire Nimes, Université de Montpellier, Nimes, France. 13. PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, Montpellier, France. 14. Centre Hospitalier de Bastia, Bastia, France. 15. Centre Hospitalier Universitaire de l'Université de Montréal, Université de Montréal, Montreal, Quebec, Canada. 16. Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France. 17. Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada. 18. Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. 19. McGill University Health Centre, Division of Cardiology, Montreal, Quebec, Canada. 20. Korea University Anam Hospital, Cardiovascular Center (Interventional Cardiology), Seoul, Republic of Korea. 21. BHF Glasgow Cardiovascular Research Center, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow; and West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Dunbartonshire, United Kingdom. 22. University Hospital Hairmyres, East Kilbride, Glasgow, United Kingdom. 23. Rigshospitalet-Copenhagen University Hospital, Department of Cardiology, Copenhagen, Denmark. 24. Dept of Cardiology, Zealand University Hospital, Roskilde, Denmark. 25. Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France.
Abstract
BACKGROUND: Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain. METHODS: The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy. RESULTS: A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials. CONCLUSIONS: We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.
RCT Entities:
BACKGROUND: Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain. METHODS: The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy. RESULTS: A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials. CONCLUSIONS: We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.
Authors: Xenofon M Sakellariou; Georgios I Katsanos; Andreas P Efstathopoulos; Dimitrios G Sfairopoulos; Konstantinos V Stamatis; Spyridon D Pappas; Theofilos M Kolettis; Dimitrios N Nikas Journal: J Cardiovasc Dev Dis Date: 2021-05-21