One-year clinical outcomes in older patients with non-ST elevation acute coronary syndrome undergoing coronary angiography: An analysis of the ICON1 study

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Highlights

  • Invasive strategy was feasible and was tolerated among older patients presenting with NSTEACS, regardless of frailty status.

  • There was no increase in procedure related complications and 30-day clinical outcomes between the frailty groups.

  • At 1-year, frailty was associated with adverse clinical outcomes driven by excess mortality, myocardial infarction and re-hospitalisation.

  • The point-based FRAIL-HEART risk score may enable improved risk stratification in practice in older NSTEACS patients.

Abstract

Aims

The aim of this prospective, observational study was to identify predictors of adverse outcome at one year, following invasive care of older patients with non-ST-elevation acute coronary syndrome (NSTEACS) according to frailty status.

Methods

Older patients (aged ≥ 75 years), presenting with NSTEACS, undergoing invasive coronary angiography with a view to revascularisation, underwent assessment of frailty, cognition, functional status and quality of life. Participants were categorised as robust, pre-frail or frail using the Fried criteria. The primary outcome comprised a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularisation and major bleeding, at one year. Cox proportional hazards regression was used to derive a multivariate risk score.

Results

Overall, the composite endpoint was observed in 81 participants (29%). There was a significant difference in the occurrence of the primary outcome in the 3 frailty groups (robust 18.0%, pre-frail 27.5% and frail 39%; p = 0.03; hazard ratio (HR) for frail vs. robust: 2.79, 95% Confidence Interval [CI] 1.28–6.08). Fried frailty classification, age (categorised as ≥85 years), raised Killip class, systolic blood pressure on admission, history of peripheral vascular disease (PVD), problems dressing self and implantation of a bare metal stent were identified as predictors of adverse events at one year, with a C-statistic of 0.77 (95% CI 0.71–0.83). A point-based clinical risk score (FRAIL-HEART) was defined, which had a C-statistic of 0.70 (95% CI 0.63–0.77) and significantly outperformed the GRACE 2 score.

Conclusion

Frailty is associated with adverse clinical outcomes, following invasive management of older patients with NSTEACS. The derived risk models may enable improved risk stratification in practice.

Introduction

Despite the development of contemporary treatment strategies, including early invasive revascularisation, dual antiplatelet therapy and intensive risk factor reduction, acute coronary syndrome (ACS) remains a leading cause of mortality among patients aged over 75 years [1,2]. Evidence-based British, European and North American guidelines advocate that all older patients with non-ST-elevation ACS (NSTEACS) should undergo assessment for discretionary invasive revascularisation [[3], [4], [5]]. The importance of a patient-centred approach is emphasised with evaluation of comorbidity, cognition, functional status and life expectancy, although no specific, evidence-based risk model is recommended.

The performance of conventional ACS risk scores in older patients is suboptimal [6]. Such models are predictive of mortality, but do not take account of other morbidity outcomes which are of importance in this age group, such as myocardial infarction (MI), stroke, major bleeding and quality of life. Although age constitutes the single greatest risk factor for adverse outcome, many age-related factors are heterogeneous; leading to poor discrimination within an older population. Frailty is a complex, clinical phenotype; defined as a vulnerability to physiological stressors as a consequence of age-associated decline in resilience and reserve [7]. The frailty phenotype commonly manifests as slowness, weakness, reduced activity, low energy levels and unintended weight loss. Frail, older patients with ACS may be at greater long-term risk of adverse events, compared with their robust counterparts [8]. Given the paucity of data regarding risk stratification in older patients, the aim of this prospective cohort study was to determine the prevalence of the frailty phenotype and identify predictors of adverse outcome at one year, in patients aged 75 and older undergoing invasive management for NSTEACS.

Section snippets

Study design

The study to Improve Clinical Outcomes in high-risk patieNts with acute coronary syndrome (ICON-1) is a multi-centre, observational, prospective cohort study. The full protocol has previously been published [9]. The ICON-1 study was approved by Local Ethics Committees and the National Research Ethics Service (12/NE/0160) and was conducted in accordance with the Declaration of Helsinki. The written, informed consent of all participants was required. ICON-1 was prospectively registered with the

Results

The study flow chart is shown in Fig. 1. Study participants had a mean ± standard deviation age of 81 ± 4 years, were predominantly male (60%) and had a range of cardiovascular risk factors (Table 1). Of the 280 patients, 50 were classified as robust (17.9%), 153 as pre-frail (54.6) and 77 as frail (27.5%) using the Fried Frailty Index (Table 1). Full details of medical and invasive management are presented in (Supplemental Table 3).

Discussion

This study demonstrates that invasive revascularisation was feasible and well tolerated among older patients presenting with NSTEACS, regardless of frailty status. With the exception of vascular complications, which were more common among frail patients, there was no increase in procedure related complications and 30-day clinical outcomes (myocardial infarction, stroke, unplanned repeat revascularization, major bleeding and all-cause mortality) between the frailty groups. However, at 1-year,

Conclusions

Invasive revascularisation was well tolerated among older patients with non-ST-elevation ACS, regardless of frailty status. However, frailty was associated with adverse, long-term clinical outcomes, driven by excess mortality, myocardial infarction and all cause re-hospitalisation. The addition of determinants of frailty to conventional risk-stratification models, or application of the FRAIL-HEART risk model, may facilitate improved, patient-centred and evidence-based decision-making, in those

Funding

The research was supported/funded by the National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre based at Newcastle Hospitals NHS Foundation Trust and Newcastle University. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Acknowledgements

The research is supported by the National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre based at Newcastle-upon-Tyne Hospitals NHS Foundation Trust and Newcastle University. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. VK has received research funding from the British Heart Foundation (CS/15/7/31679).

The authors would like to thank:

Dr. J Ahmed, Dr. A Bagnall, Dr. R Das, Dr. R Edwards, Dr. M

Disclosures

All authors have reported that they have no relationships with industry relevant to the contents of this paper to disclose.

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