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

Overview

Journal BMJ Open

Specialty General Medicine

Date 2022 May 3

PMID 35504645

Authors

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

Affiliations

Soon will be listed here.

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.

Citing Articles

Very early invasive strategy in higher risk non-ST-elevation acute coronary syndrome: the RAPID NSTEMI trial.

Kite T, Ladwiniec A, Greenwood J, Gale C, Anantharam B, More R Heart. 2023; 110(7):500-507.

PMID: 38103913 PMC: 10958296. DOI: 10.1136/heartjnl-2023-323513.

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