Very early invasive angiography versus standard of care in higher-risk non-ST elevation myocardial infarction: study protocol for the prospective multicentre randomised controlled RAPID N-STEMI trial

Thomas A Kite, Amerjeet S Banning, Andrew Ladwiniec, Chris P Gale, John P Greenwood, Miles Dalby, Rachel Hobson, Shaun Barber, Emma Parker, Colin Berry, Marcus D Flather, Nick Curzen, Adrian P Banning, Gerry P McCann, Anthony H Gershlick, Thomas A Kite, Amerjeet S Banning, Andrew Ladwiniec, Chris P Gale, John P Greenwood, Miles Dalby, Rachel Hobson, Shaun Barber, Emma Parker, Colin Berry, Marcus D Flather, Nick Curzen, Adrian P Banning, Gerry P McCann, Anthony H Gershlick

Abstract

Background: There are a paucity of randomised data on the optimal timing of invasive coronary angiography (ICA) in higher-risk patients with non-ST elevation myocardial infarction (N-STEMI). International guideline recommendations for early ICA are primarily based on retrospective subgroup analyses of neutral trials.

Aims: The RAPID N-STEMI trial aims to determine whether very early percutaneous revascularisation improves clinical outcomes as compared with a standard of care strategy in higher-risk N-STEMI patients.

Methods and analysis: RAPID N-STEMI is a prospective, multicentre, open-label, randomised-controlled, pragmatic strategy trial. Higher-risk N-STEMI patients, as defined by Global Registry of Acute Coronary Events 2.0 score ≥118, or >90 with at least one additional high-risk feature, were randomised to either: very early ICA±revascularisation or standard of care timing of ICA±revascularisation. The primary outcome is the proportion of participants with at least one of the following events (all-cause mortality, non-fatal myocardial infarction and hospital admission for heart failure) at 12 months. Key secondary outcomes include major bleeding and stroke. A hypothesis generating cardiac magnetic resonance (CMR) substudy will provide mechanistic data on infarct size, myocardial salvage and residual ischaemia post percutaneous coronary intervention. On 7 April 2021, the sponsor discontinued enrolment due to the impact of the COVID-19 pandemic and lower than expected event rates. 425 patients were enrolled, and 61 patients underwent CMR.

Ethics and dissemination: The trial has been reviewed and approved by the East of England Cambridge East Research Ethics Committee (18/EE/0222). The study results will be submitted for publication within 6 months of completion.

Trial registration number: NCT03707314; Pre-results.

Keywords: coronary heart disease; coronary intervention; ischaemic heart disease; myocardial infarction.

Conflict of interest statement

Competing interests: CB is employed by the University of Glasgow which holds consultancy and research agreements for his work with Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Causeway Therapeutics, Coroventis, Genentech, GSK, HeartFlow, Menarini, Neovasc, Siemens Healthcare and Valo Health.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Rapid N-STEMI study flow diagram. CMR, cardiac MR; hs-Tn, high sensitivity troponin; N-STEMI, non-ST elevation myocardial infarction; OMT, optimal medical therapy; PCI, percutaneous coronary intervention; SAQ, Seattle Angina Questionnaire; STEMI, ST elevation myocardial infarction; ULN, upper limit of normal.

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