TY - JOUR
T1 - Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction
T2 - Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial
AU - Jolicoeur, E Marc
AU - Dendukuri, Nandini
AU - Belisle, Patrick
AU - Range, Grégoire
AU - Souteyrand, Geraud
AU - Bouisset, Frédéric
AU - Zemour, Gilles
AU - Delarche, Nicolas
AU - Schampaert, Erick
AU - Kouz, Simon
AU - Cayla, Guillaume
AU - Roubille, François
AU - Boueri, Ziad
AU - Mansour, Samer
AU - Marcaggi, Xavier
AU - Tardif, Jean-Claude
AU - McGillion, Michael
AU - Tanguay, Jean-François
AU - Brophy, James
AU - Yu, Cheol Woong
AU - Berry, Colin
AU - Carrick, David
AU - Høfsten, Dan Eik
AU - Engstrøm, Thomas
AU - Kober, Lars
AU - Kelbæk, Henning
AU - Belle, Loic
N1 - Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
PY - 2020/11
Y1 - 2020/11
N2 - 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.
AB - 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.
U2 - 10.1016/j.cjca.2020.01.019
DO - 10.1016/j.cjca.2020.01.019
M3 - Article
C2 - 32798463
SN - 0828-282X
VL - 36
SP - 1805
EP - 1814
JO - Canadian Journal of Cardiology
JF - Canadian Journal of Cardiology
IS - 11
ER -