Ontology highlight
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.
SUBMITTER: Kite TA
PROVIDER: S-EPMC10958296 | biostudies-literature | 2024 Mar
REPOSITORIES: biostudies-literature
Kite Thomas A TA Ladwiniec Andrew A Greenwood John P JP Gale Chris P CP Anantharam Brijesh B More Ranjit R Hetherington Simon Lee SL Khan Sohail Q SQ O'Kane Peter P Rakhit Roby R Chase Alexander A Barber Shaun S Waheed Ghazala G Berry Colin C Flather Marcus M McCann Gerry P GP Curzen Nick N Banning Adrian P AP Gershlick Anthony H AH
Heart (British Cardiac Society) 20240312 7
<h4>Objective</h4>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).<h4>Methods</h4>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 rando ...[more]