Abstract
BackgroundAdditional diagnostic means could be of added value when evaluating possible acute coronary syndrome (ACS) in primary care.AimTo determine whether heart-type fatty acid-binding protein (H-FABP)-based point-of-care (POC) biomarker testing, embedded in a clinical decision rule (CDR), is helpful to the GP when evaluating possible ACS.Design & settingA prospective, non-randomised, double-blinded, diagnostic derivation study was undertaken, with a delayed-type cross-sectional diagnostic model among GPs in the Netherlands and Belgium.MethodSigns and symptoms predicting acute myocardial infarction (AMI) or ACS were identified using both logistic regression analysis, and classification and regression trees (CART). Diagnostic values of the POC H-FABP test (cut-off value 4 ng/ml) alone and as part of a CDR were determined.ResultsA total of 303 participants (48.8% male) with chest pain or discomfort who had consulted a GP were enrolled. ACS was found in 32 (10.6%) of these 303 patients. For ACS, sensitivity and negative predictive value (NPV) of the POC H-FABP test was 25.8% (95% confidence interval [CI] = 12.5 to 44.9) and 91.6% (95% CI = 87.6% to 94.5%), respectively. The area under the receiver operating curve of the optimal CDR was 0.78 for ACS.ConclusionSensitivity of the current H-FABP POC test (cut-off value 4 ng/ml) as a stand-alone test is poor, either owing to limitations of the marker or of the test device. Usability of a CDR derived from these results is doubtful: the number of ACS cases missed by the GP is reduced but, as a consequence, disproportionally more ACS-negative patients are referred.
Highlights
BackgroundIn primary care, 1.26% of all consultations are about chest pain.[1]
For acute coronary syndrome (ACS), sensitivity and negative predictive value (NPV) of the POC heart-type fatty acid-binding protein (H-FABP) test was 25.8% (95% confidence interval [CI] = 12.5 to 44.9) and 91.6%, respectively
Usability of a clinical decision rule (CDR) derived from these results is doubtful: the number of ACS cases missed by the GP is reduced but, as a consequence, disproportionally more ACS-negative patients are referred
Summary
BackgroundIn primary care, 1.26% of all consultations are about chest pain.[1]. Among these patients, cases of ACS are largely outnumbered by less severe causes of chest pain.[1,2,3,4,5] Yet, to avoid missing ACS, the GP's threshold to refer patients with chest pain is low.[1,5,6,7] To reduce ACS-negative referrals in primary care and thereby diminish costs and patient discomfort — without a rise in missed cases of ACS — a CDR based on a clinical score of signs, symptoms, and POC biomarker testing detecting myocardial cell damage (such as high-sensitive cardiac troponin [hs-cTn] or H-FABP) is desirable.[3,8,9,10,11,12,13,14,15,16,17] A potential role for H-FABP POC testing was earlier found using a cut-off value of 4 ng/ml, in an emergency department setting.[18]. Additional diagnostic means could be of added value when evaluating possible acute coronary syndrome (ACS) in primary care
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