High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial
Year: 2021
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Objectives High-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the efficacy and safety of this approach is uncertain. We investigated whether an early-rule out pathway is safe and effective for the management of patients with suspected acute coronary syndrome. Design A stepped-wedge cluster randomised controlled trial. Setting Seven acute care hospitals in Scotland. Participants 31,492 consecutive patients with suspected acute coronary syndrome between December 2014 to December 2016. Intervention Sites were randomised to implement an early rule-out pathway where myocardial infarction was ruled out if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a prior validation phase, myocardial infarction was ruled out where troponin concentrations were < 99 th centile at 6-12 hours after symptom onset. Main outcome measures The co-primary outcome was length of stay (efficacy), and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate the safety outcome and other secondary outcomes. Results We enrolled 31,492 patients (59±17 years, 45% women) with troponin concentrations < 99 th centile at presentation. The length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio 0.78, 95% confidence interval [CI] 0.73 to 0.83, P< 0.001) following implementation, and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio [aOR] 1.59, 95% CI 1.45 to 1.75). Non-inferiority was not demonstrated for the 30-day safety outcome (upper limit of one-sided 95% CI for adjusted risk difference 0.70%, non-inferiority margin 0.50%, P = 0.068), but the observed differences favoured the early rule-out pathway (0.4% [57/14,700] versus 0.3% [56/16,792]). At 1 year, the safety outcome occurred in 2.7% (396/14,700) and 1.8% (307/16,792) of patients before and after implementation (aOR 1.02, 95% CI 0.74 to 1.40, P = 0.894), and there were no differences in hospital reattendance or all-cause mortality. Conclusions Implementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Whilst non-inferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway will have major benefits for patients and healthcare providers. Trial registration http://ClinicalTrials.gov number, NCT03005158
Source: Circulation
Authors: Atul Anand, Kuan Ken Lee, Andrew R. Chapman, Amy V. Ferry, Phil D. Adamson, Fiona E. Strachan, Colin Berry, Iain Findlay, Anne Cruikshank, Alan Reid, Paul O. Collinson, Fred S. Apple, David A. McAllister, Donogh Maguire, Keith A.A. Fox, David E. Newby, Chris Tuck, Ronald Harkess, Catriona Keerie, Christopher J. Weir, Richard A. Parker, Alasdair Gray, Anoop S.V. Shah, Nicholas L. Mills, Bill Alexander, Shannon Amoils, Roma Armstrong, Anda Bularga, Bernard L. Croal, Dimitrios Doudesis, Colin M. Fischbacher, Ian Ford, Takeshi Fujisawa, Ronnie Harkess, Dorien M. Kimenai, Stephen J. Leslie, Pamela Linksted, Matthew T.H. Lowry, Claire MacDonald, Lucy Marshall, Filip Mendusic, John Norrie, Imran Sadat, Catherine L. Stables, Jennifer Stevens, Stacey D. Stewart, Laura Stirling, Caelan Taggart, Ryan Wereski, Stephen Young
Institutions: University of Edinburgh, University of Otago, University of Glasgow, Royal Alexandra Hospital, Queen Elizabeth University Hospital, St George's, University of London, St George’s University Hospitals NHS Foundation Trust, University of Minnesota, Glasgow Royal Infirmary, Edinburgh Royal Infirmary
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Awards: G1157659655, G1484820322, G1493233644, High-sensitivity cardiac troponin beyond the acute coronary syndrome, G2001474594, G2574353342, G3009210321, Personalised care for older patients with myocardial infarction (MiRisk), High-sensitivity cardiac troponin I and risk stratification of patients with suspected acute coronary syndrome, G4058705228, G5131124023, G5460676972, G7311655536, HIgh-Sensitivity cardiac Troponin On presentation to Rule out myocardial InfarCtion (HiSTORIC), Redefining Unstable Angina with High-sensitivity Cardiac Troponin, High-Sensitive Troponin in the Evaluation of patients with Acute Coronary Syndrome (High-STEACS): a randomised controlled trial, Research Excellence (round 3), The BHF Butler Senior Clinical Research Fellowship: High-sensitivity cardiac troponin and coronary heart disease
OpenAlex ID: W3138958193