Very early invasive strategy in higher risk non-ST-elevation acute coronary syndrome: the RAPID NSTEMI trial
Thomas A Kite1, Andrew Ladwiniec2, John P Greenwood3
1Department of Cardiovascular Sciences and the NIHR Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, UK tom.kite@nhs.net.
Insights
A very early invasive strategy did not improve clinical outcomes for high-risk non-ST-elevation acute coronary syndrome patients. However, this approach did reduce hospital stays, though the trial was underpowered.
Area of Science:
- Cardiology
- Clinical Trials
- Acute Coronary Syndromes
Background:
- Investigating early invasive strategies for non-ST-elevation acute coronary syndrome (NSTE-ACS).
- Assessing clinical outcomes in higher-risk NSTE-ACS patients.
- Trial NCT03707314 was a pragmatic, randomized controlled trial.
Purpose of the Study:
- To determine if a very early invasive strategy (IS) with revascularization improves outcomes compared to standard care IS in high-risk NSTE-ACS patients.
- Evaluating the efficacy of rapid intervention in acute cardiac events.
Main Methods:
- Multicenter, randomized trial comparing very early IS (<90 minutes) versus standard care IS (<72 hours) in high-risk NSTE-ACS patients.
- Primary outcome: composite of all-cause mortality, myocardial infarction, or heart failure hospitalization at 12 months.
- Patient risk stratification based on Global Registry of Acute Coronary Events 2.0 score.
Main Results:
- Trial discontinued early due to slow recruitment; 425 patients randomized.
- No significant difference in the primary outcome between very early IS (5.9%) and standard IS (6.7%) groups (p=0.86).
- Very early IS significantly reduced length of hospital stay (3.9 vs 6.3 days, p<0.01); similar rates of stroke and major bleeding.
Conclusions:
- A very early invasive strategy did not improve clinical outcomes for high-risk NSTE-ACS patients compared to standard care.
- The trial was underpowered to detect potential differences in the primary outcome.
- Early IS was associated with a shorter hospital stay.
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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