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, 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 YuColin Berry, David Carrick, Dan Eik Høfsten, Thomas Engstrøm, Lars Kober, Henning Kelbæk, Loic Belle

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstrakt

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.

OriginalsprogEngelsk
Sider (fra-til)1805-1814
Antal sider10
TidsskriftCanadian Journal of Cardiology
Vol/bind36
Udgave nummer11
Tidlig onlinedato25 jan. 2020
DOI
StatusUdgivet - nov. 2020

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Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

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