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

E. Marc Jolicoeur; Nandini Dendukuri; Patrick Belisle; Grégoire Range; Geraud Souteyrand; Frédéric Bouisset; Gilles Zemour; Nicolas Delarche; Brahim Harbaoui; Erick Schampaert; Simon Kouz; Guillaume Cayla; François Roubille; Ziad Boueri; Samer Mansour; Xavier Marcaggi; Jean Claude Tardif; Michael McGillion; Jean François Tanguay; James Brophy; Cheol Woong Yu; Colin Berry; David Carrick; Dan Eik Høfsten; Thomas Engstrøm; Lars Kober; Henning Kelbæk; Loic Belle

doi:10.1016/j.cjca.2020.01.019

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

E. Marc Jolicoeur^*
, Nandini Dendukuri
, Patrick Belisle
, Grégoire Range
, Geraud Souteyrand
, Frédéric Bouisset
, Gilles Zemour
, Nicolas Delarche
, Brahim Harbaoui
, Erick Schampaert
, Simon Kouz
, Guillaume Cayla
, François Roubille
, Ziad Boueri
, Samer Mansour
, Xavier Marcaggi
, Jean Claude Tardif
, Michael McGillion
, Jean François Tanguay
, James Brophy

Cheol Woong Yu, Colin Berry, David Carrick, Dan Eik Høfsten, Thomas Engstrøm, Lars Kober, Henning Kelbæk, Loic Belle

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Review › peer review

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.

Originalsprog	Engelsk
Tidsskrift	Canadian Journal of Cardiology
Vol/bind	36
Udgave nummer	11
Sider (fra-til)	1805-1814
Antal sider	10
ISSN	0828-282X
DOI	https://doi.org/10.1016/j.cjca.2020.01.019
Status	Udgivet - 2020

Finansiering

The trial was supported by an operating grant from the Canadian Institute of Health Research Industry-Partnered Collaborative Research program (grant 298937 ), in collaboration with Boston Scientific and AstraZeneca (unrestricted grant support). Dr E. Marc Jolicoeur holds a midcareer award from les Fonds la Recherche du Québec en santé (Junior 2), and is supported by la Fondation de l’Institut de Cardiologie de Montréal . The trial was supported by an operating grant from the Canadian Institute of Health Research Industry-Partnered Collaborative Research program (grant 298937), in collaboration with Boston Scientific and AstraZeneca (unrestricted grant support). Dr E. Marc Jolicoeur holds a midcareer award from les Fonds la Recherche du Qu?bec en sant? (Junior 2), and is supported by la Fondation de l'Institut de Cardiologie de Montr?al.

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10.1016/j.cjca.2020.01.019

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Citationsformater

Jolicoeur, E. M., Dendukuri, N., Belisle, P., Range, G., Souteyrand, G., Bouisset, F., Zemour, G., Delarche, N., Harbaoui, B., Schampaert, E., Kouz, S., Cayla, G., Roubille, F., Boueri, Z., Mansour, S., Marcaggi, X., Tardif, J. C., McGillion, M., Tanguay, J. F., ... Belle, L. (2020). Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial. Canadian Journal of Cardiology, 36(11), 1805-1814. https://doi.org/10.1016/j.cjca.2020.01.019

Jolicoeur, EM, Dendukuri, N, Belisle, P, Range, G, Souteyrand, G, Bouisset, F, Zemour, G, Delarche, N, Harbaoui, B, Schampaert, E, Kouz, S, Cayla, G, Roubille, F, Boueri, Z, Mansour, S, Marcaggi, X, Tardif, JC, McGillion, M, Tanguay, JF, Brophy, J, Yu, CW, Berry, C, Carrick, D, Høfsten, DE , Engstrøm, T , Kober, L, Kelbæk, H & Belle, L 2020, 'Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial', Canadian Journal of Cardiology, bind 36, nr. 11, s. 1805-1814. https://doi.org/10.1016/j.cjca.2020.01.019

@article{b93c88926bbd4b13bd2b8018ce2acb89,

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

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{\textendash}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.",

author = "Jolicoeur, \{E. Marc\} and Nandini Dendukuri and Patrick Belisle and Gr{\'e}goire Range and Geraud Souteyrand and Fr{\'e}d{\'e}ric Bouisset and Gilles Zemour and Nicolas Delarche and Brahim Harbaoui and Erick Schampaert and Simon Kouz and Guillaume Cayla and Fran{\c c}ois Roubille and Ziad Boueri and Samer Mansour and Xavier Marcaggi and Tardif, \{Jean Claude\} and Michael McGillion and Tanguay, \{Jean Fran{\c c}ois\} and James Brophy and Yu, \{Cheol Woong\} and Colin Berry and David Carrick and H{\o}fsten, \{Dan Eik\} and Thomas Engstr{\o}m and Lars Kober and Henning Kelb{\ae}k and Loic Belle",

year = "2020",

doi = "10.1016/j.cjca.2020.01.019",

language = "English",

volume = "36",

pages = "1805--1814",

journal = "Canadian Journal of Cardiology",

issn = "0828-282X",

publisher = "Elsevier",

number = "11",

}

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 - Harbaoui, Brahim

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

PY - 2020

Y1 - 2020

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 - Review

C2 - 32798463

AN - SCOPUS:85089989176

SN - 0828-282X

VL - 36

SP - 1805

EP - 1814

JO - Canadian Journal of Cardiology

JF - Canadian Journal of Cardiology

IS - 11

ER -