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. Issue 5 (3rd May 2022)

• Record Type: Journal Article
• Authors: Kite, Thomas A; Banning, Amerjeet S; Ladwiniec, Andrew; Gale, Chris P; Greenwood, John P; Dalby, Miles; Hobson, Rachel; Barber, Shaun; Parker, Emma; Berry, Colin; Flather, Marcus D; Curzen, Nick; Banning, Adrian P; McCann, Gerry P; Gershlick, Anthony H
• Is Part Of: BMJ open. Volume 12:Issue 5(2022)
• Publication Date: 2022-05-03
• Subjects: ischaemic heart disease -- myocardial infarction -- coronary intervention -- coronary heart disease; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-055878
• Languages: English
• ISSNs: 2044-6055

Abstract

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.