Kite, Thomas A., Ladwiniec, Andrew, Greenwood, John P., Gale, Chris P., Anantharam, Brijesh, More, Ranjit, Hetherington, Simon Lee, Khan, Sohail Q., O'Kane, Peter, Rakhit, Roby, Chase, Alexander, Barber, Shaun, Waheed, Ghazala, Berry, Colin, Flather, Marcus, McCann, Gerry P., Curzen, Nick, Banning, Adrian P. and Gershlick, Anthony H. , (2024) Very early invasive strategy in higher risk non-ST-elevation acute coronary syndrome: the RAPID NSTEMI trial. Heart, 110 (7), 500-507. (doi:10.1136/heartjnl-2023-323513).
Abstract
Objective: to investigate whether a very early invasive strategy (IS)±revascularisation improves clinical outcomes compared with standard care IS in higher risk patients with non-ST-elevation acute coronary syndrome (NSTE-ACS).
Methods: multicentre, randomised, controlled, pragmatic strategy trial of higher risk patients with NSTE-ACS, defined by Global Registry of Acute Coronary Events 2.0 score of ≥118, or ≥90 with at least one additional high-risk feature. Participants were randomly assigned to very early IS±revascularisation (<90 min from randomisation) or standard care IS±revascularisation (<72 hours). The primary outcome was a composite of all-cause mortality, new myocardial infarction or hospitalisation for heart failure at 12 months.
Results: the trial was discontinued early by the funder due to slow recruitment during the COVID-19 pandemic. 425 patients were randomised, of whom 413 underwent an IS: 204 to very early IS (median time from randomisation: 1.5 hours (IQR: 0.9–2.0)) and 209 to standard care IS (median: 44.0 hours (IQR: 22.9–72.6)). At 12 months, there was no significant difference in the primary outcome between the early IS (5.9%) and standard IS (6.7%) groups (OR 0.93, 95% CI 0.42 to 2.09; p=0.86). The incidence of stroke and major bleeding was similar. The length of hospital stay was reduced with a very early IS (3.9 days (SD 6.5) vs 6.3 days (SD 7.6), p<0.01).
Conclusions: a strategy of very early IS did not improve clinical outcomes compared with a standard care IS in higher risk patients with NSTE-ACS. However, the primary outcome rate was low and the trial was underpowered to detect such a difference.
Trial registration number NCT03707314.
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