OBJECTIVES : Coronary artery disease (CAD) is still the most common cause of death globally. Chest pain is the most common sign of CAD. Around 90% patients showing up in German GP offices with chest pain suffer not from CAD. Ultra-sensitive phonocardiography (CADScore®, Acarix A/S) is a new technology to aid early rule-out of CAD to avoid more invasive or expensive diagnostic. To support cost-effectiveness modelling, Real world data had been collected, to prove the representativity of clinical trials results.

METHODS : Patient demographics and test results with ultra-sensitive phonocardiography (USP) had been collected retrospectively in four German/Austrian cardiologic outpatient offices between 2017 and 2020. Comparative dataset was a major trial for test quality DanNICAD-1, performed in two Danish hospitals between 2014 and 2016.

RESULTS

1,030 examinations with USP were collected from real world (RW) versus 1,501 in DanNICAD-1 trial (TR). Average age: RW 59.1y (±12.4), TR 57.2y (±8.7); gender: RW 53.7% male, TR 51.7% male; BMI: RW 26.4 (±4.6), TR 26.7 (±4.1), systolic blood pressure: RW 136.0 mmHg (±21.8), TR 138.5 mmHg (±18.7), diastolic: RW 81.6 mmHg (±11.6), TR 82.9 mmHg (±10.9); current smokers: RW:11.9%, TR 15.5%; dyslipidemia: RW 49.5%, TR 37.3%; diabetes: RW 17.1%, TR 5.3%. Symptoms typical angina: RW 13.5%, TR 27.4%; atypical angina: RW 43.4%, TR 34.9%; non-angina pain: RW 33.1%, TR 38.6%. Diamond-Forrester low: RW 12,6%, TR 14.3%, intermediate-low: RW 71.4%, TR 57.4%, intermediate-high: RW 14.0%, TR 25.8%.

In RW 46.5% of USP-test resulted in rule-out, TR 39.4%. Test-statistics sensitivity: RW 93.9%, TR 85.0%, specificity: RW 44.4%, TR: 42.1%; negative predictive value: RW 99.2%, TR 96.1%.

CONCLUSIONS : Ultra-sensitive phonocardiography has proven to be a clinically relevant diagnostic measurement in clinical trials. The use in real world demonstrated that neither patient demographics nor test results differ relevantly from the trial setting. Real world data could be used for further economic modelling.