The Use of Biomarkers in Clinical Management Guidelines: A Critical Appraisal

Abstract

In cardiovascular disease (CVD), biomarkers (i.e., “biological markers”) could have multiple roles in understanding the complexity of cardiovascular (CV) pathophysiology and to offer an integrated approach to management. Biomarkers could help in daily practice as a diagnostic tool, to monitor therapy response, to assess prognosis and as early marker of CV damage, or to stratify risk. In recent years, the role of biomarkers in CVD is even more relevant and some have recently been included in clinical management guideline recommendations. The aim of this review is to discuss the recommendations in clinical guidelines of various biomarkers and to review their usefulness in daily clinical practice. Ultimately, a balance is needed between simplicity and practicality for clinical decision-making. Most biomarkers (whether blood, urine, or imaging-based) will improve on clinical risk stratification, but awaiting biomarker results may lead to delays in the initiation of therapy, for example, anticoagulation for stroke prevention in atrial fibrillation. Many biomarkers are nonspecific, being predictive of many CV and non-CV outcomes, so would be better as “rule-out” rather than “rule-in” assessments. Derivation of some biomarkers have also been made in highly selected clinical trial cohorts, where measurement is made at baseline but outcomes determined many years later; given the dynamic nature of risk in the “real world” where patients get older and develop incident risk factors, this may give a false impression of the risk profile. Finally, some laboratory biomarkers have a diurnal variation and inter-/intravariability (and lower limits of detection) in assays, which may be expensive, are added considerations.

Accuracy of HAS‐BLED and other bleeding risk assessment tools in predicting major bleeding events in atrial fibrillation: A network meta‐analysis

“…The ABC‐bleeding tool is a recently proposed assessment tool, which adds GDF‐15, Troponin T, and hemoglobin biological indicators to predict the risk of major bleeding events within 1 or 3 years . The ABC‐bleeding tool was derived in a highly selected anticoagulated clinical trial cohort, while the performance of the ABC‐bleeding tool confers limited advantage in a real‐world cohort due to older patients and the progression of risk factors . Therefore, patients at high risk should be assessed by the above high sensitivity tools owing to the prevalence of major bleeding was high.…”

A Novel ABC Score Predicts Mortality in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Who underwent Percutaneous Coronary Intervention

“…Thrombosis and Haemostasis predict mortality. Nevertheless, Esteve-Pastor et al 26 suggested that most biomarkers will improve on clinical risk stratification, but awaiting biomarker results may lead to delays in the initiation of therapy. Therefore, the application of biomarker-based predictive models has some limitations in clinical practice.…”

Pilot Study on the Role of Circulating miRNAs for the Improvement of the Predictive Ability of the 2MACE Score in Patients with Atrial Fibrillation

“…Nevertheless, the clinical usefulness of biomarkers when they are evaluated alone may be only limited. In fact, a common criticism of biomarkers is their high variability and lack of specificity in different clinical settings [38][39][40]. However, an advantage of miRNAs compared to other biomarkers is their plasma stability, which makes them less likely to be altered due to acute conditions [9,41], even though results from miRNAs levels should be interpreted with caution and contextualized according to clinical risk factors.…”