Clinical governance of patients with acute coronary syndromes

Abstract

Aims: Using the principles of clinical governance, a patient-centred approach intended to promote holistic quality improvement, we designed a prospective, multicentre study in patients with acute coronary syndrome (ACS). We aimed to verify and quantify consecutive inclusion and describe relative and absolute effects of indicators of quality for diagnosis and therapy.

Methods and results: Administrative codes for invasive coronary angiography and acute myocardial infarction were used to estimate the ACS universe. The ratio between the number of patients included and the estimated ACS universe was the consecutive index. Co-primary quality indicators were timely reperfusion in patients admitted with ST-elevation ACS and optimal medical therapy at discharge. Cox-proportional hazard models for 1-year death with admission and discharge-specific covariates quantified relative risk reductions and adjusted number needed to treat (NNT) absolute risk reductions. Hospital codes tested had a 99.5% sensitivity to identify ACS universe. We estimated that 7344 (95% CI: 6852-7867) ACS patients were admitted and 5107 were enrolled-i.e. a consecutive index of 69.6% (95% CI 64.9-74.5%), which varied from 30.7 to 79.2% across sites. Timely reperfusion was achieved in 22.4% (95% CI: 20.7-24.1%) of patients, was associated with an adjusted hazard ratio (HR) for 1-year death of 0.60 (95% CI: 0.40-0.89) and an adjusted NNT of 65 (95% CI: 44-250). Corresponding values for optimal medical therapy were 70.1% (95% CI: 68.7-71.4%), HR of 0.50 (95% CI: 0.38-0.66), and NNT of 98 (95% CI: 79-145).

Conclusion: A comprehensive approach to quality for patients with ACS may promote equitable access of care and inform implementation of health care delivery.

Registration: ClinicalTrials.Gov ID NCT04255537.

Keywords: acute coronary syndromes; clinical governance; quality improvement.

Conflict of interest statement

Conflicts of interest: S.L. reports grants and personal fees from Astra Zeneca, personal fees from Daiichi Sankyo, personal fees from Bayer, personal fees from Pfizer/BMS, personal fees from ICON, personal fees from Chiesi, personal fees from Novonordisk, all outside the submitted work. C.M. has nothing to disclose. G.Carrara reports personal fee from Advice Pharma during the conduct of the study. G.Casella has nothing to disclose. D.G. reports he has participated in advisory boards for Amgen and for Sanofi, outside the submitted work. M.G., A.R., L.T., M.P., F.O., M.G., L.G., L.S.C., Dr. S.D.S., and A.A. have nothing to disclose. G.M.D.F. serves as member of the steering committee for Amgen and consultant for UCB. L.O.V. reports personal fees from Eli Lilly; personal fees from Daiichi Sankyo, personal fees from AstraZeneca; personal fees from Menarini; personal fees from Bayer; personal fees from Pfizer; personal fees from BMS; personal fees from Boehringer Ingelheim, all outside the submitted work. Prof. Campo reports grants from SMT; grants from Siemens; Grants from MEDIS; grants from Boston Scientific, grants from GE Healthcare, all outside the submitted work.

© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Graphical Abstract

Figure 1

Timing of principal diagnostic tests in acute coronary syndrome patients managed invasively (S1 and S3) and median delays in patients with ST-elevation acute coronary syndrome intended for urgent reperfusion (S1). Distribution of the timing of qualifying electrocardiogram and the timing of invasive coronary angiography in patients with and without ST elevation were measured and are represented as dots, while the timing of cardiac biomarkers (diamond) was not collected and is hypothetical. The lower part of the figure focuses on median time intervals in patients with ST elevation acute coronary syndrome intended for urgent reperfusion (S1). Door-to-balloon, door-to-artery, and door-in-door-out times are shown according to the type of patients: transfer (from spoke hospitals) or non-transfer. IQR, interquartile range.

Figure 2

Implementation of primary quality indicators in eligible patients. The figure illustrates the proportion of co-primary quality indicators per corresponding eligible population from hospital admission (outer circles, patients with acute coronary syndrome) to hospital discharge (inner circles, acute myocardial infarction, unstable angina, or an alternative diagnosis) among the totality (universe) of patients with acute coronary syndrome, i.e. both those included and those estimated not to be included. Implementation to timely reperfusion is measured at admission in S1 (ST-elevation acute coronary syndrome patients managed invasively). Adherence to optimal medical therapy is measured in patients who survived hospital discharge with a diagnosis of acute myocardial infarction or unstable angina. Light coloured sectors for co-primary quality indicator (i.e. indicator not reached) quantify opportunities for quality improvements. Abbreviations are listed on the right side.

Figure 3

Implementation of key secondary quality indicators in eligible patients. (A). Implementation of radial access and measurement of left ventricular ejection fraction. Adherence to radial access is measured at admission in acute coronary syndrome patients managed invasively (i.e. S1 and S3). Assessment of left ventricular ejection fraction is measured in patients who survived hospital discharge with a diagnosis of acute myocardial infarction or unstable angina. Light coloured sectors for quality indicator (i.e. indicator not reached) quantify opportunities for quality improvements. Abbreviations are listed on the right side. (B). Implementation of optimal medical therapy stratified by presence of heart failure or left ventricular systolic dysfunction. Optimal medical therapy considered three classes of drugs in patients without heart failure (HF) or left ventricular systolic dysfunction (LVSD), aspirin, adequate P2Y12 inhibition, and high-intensity statin and five classes of drugs (these 3, plus betablockers and angiotensin inhibitors) in patients with HF or LVSD. All therapies were assessed only in patients without reported contraindications. Light coloured sectors for quality indicator (i.e. indicator not reached) quantify opportunities for quality improvements. Abbreviations are listed on the right side.

Figure 4

Adjusted survival curves of primary and key secondary quality indicators at 1-year and corresponding hazard ratios. Adjusted Kaplan–Meier curves for timely reperfusion (A), optimal medical therapy (B), radial access (C), and assessment of left ventricular ejection fraction (D) with corresponding adjusted hazard ratio and 95% confidence intervals.