Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial

Autor: Lars Køber, Thomas Engstrøm, Grégoire Rangé, Patrick Bélisle, E. Marc Jolicoeur, Nicolas Delarche, Brahim Harbaoui, Colin Berry, David Carrick, Michael McGillion, Jean-François Tanguay, Géraud Souteyrand, Frédéric Bouisset, François Roubille, Simon Kouz, Samer Mansour, Jean-Claude Tardif, Dan Eik Høfsten, Guillaume Cayla, James M. Brophy, Erick Schampaert, Cheol Woong Yu, Gilles Zemour, Loic Belle, Nandini Dendukuri, Henning Kelbæk, X. Marcaggi, Ziad Boueri
Přispěvatelé: MORNET, Dominique, Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada., Centre for Outcomes Research, McGill University Health Centre-Research Institute, Montreal, Quebec, Canada, HOPITAL CHARTRES - DEPT CARDIOL, Montreal Health Innovation Coordination Center, Montreal, Quebec, CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Service Cardiologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier de Cannes (Centre Hospitalier de Cannes), Centre Hospitalier de Cannes, Centre hospitalier de Pau, Imagerie Ultrasonore, Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hopital Sacre-Coeur, Interventional Cardiology, Université de Montréal, Montreal, Quebec, Centre Hospitalier Régional de Lanaudiere [Joliette, QC, Canada] (CHRDL), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital de Bastia, Ctr Hosp Vichy, Montreal Heart Institute Coordinating Centre (MHICC), Université de Montréal (UdeM), Montreal Heart Institute - Institut de Cardiologie de Montréal, Department of Cardiology, Gentofte University Hospital, Rigshospitalet [Copenhagen], Copenhagen University Hospital, Service de Cardiologie, Centre hospitalier de la région d'Annecy, Service de cardiologie [Toulouse], Hôpital de Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional de Lanaudiere, Joliette, Quebec, Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
medicine.medical_specialty
medicine.medical_treatment
[SDV]Life Sciences [q-bio]
030204 cardiovascular system & hematology
Prosthesis Design
law.invention
Time-to-Treatment
03 medical and health sciences
0302 clinical medicine
Percutaneous Coronary Intervention
Randomized controlled trial
law
St elevation myocardial infarction
Internal medicine
medicine
Humans
cardiovascular diseases
030212 general & internal medicine
Myocardial infarction
ComputingMilieux_MISCELLANEOUS
Randomized Controlled Trials as Topic
business.industry
Antithrombin
Stent
Percutaneous coronary intervention
Bayes Theorem
medicine.disease
3. Good health
[SDV] Life Sciences [q-bio]
surgical procedures
operative
medicine.anatomical_structure
Heart failure
Cardiology
ST Elevation Myocardial Infarction
Stents
Cardiology and Cardiovascular Medicine
business
medicine.drug
Artery
Zdroj: Canadian Journal of Cardiology
Canadian Journal of Cardiology, 2020, ⟨10.1016/j.cjca.2020.01.019⟩
Canadian Journal of Cardiology, Elsevier, 2020, ⟨10.1016/j.cjca.2020.01.019⟩
ISSN: 0828-282X
1916-7075
Popis: 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.
Databáze: OpenAIRE
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