Biomarkers in Cardiology-8 Instant early rule-out using cardiac - - PowerPoint PPT Presentation

Biomarkers in Cardiology-8

Instant early rule-out using cardiac troponin and copeptin in low- to intermediate-risk patients with suspected ACS: A prospective, randomized multicenter study for early discharge

Acronym: Biomarkers in Cardiology-8 Study (BIC-8) Martin Möckel1, Julia Searle1, Christian Hamm2, Anna Slagman1, Stefan Blankenberg3, Kurt Huber4, Christian Müller5, Jörn O Vollert6, Evangelos Giannitsis7 Berlin1, Bad Nauheim/Gießen2, Hamburg3, Henningsdorf6, Heidelberg7, Germany; Vienna4, Austria; Basel5, Switzerland

Hot Line Session IV, ESC 03.09.2013 1

Biomarkers in Cardiology-8

Disclosures

This investigator initiated trial was funded by a research grant of B.R.A.H.M.S GmbH a ThermoFisher company and the following institutions

Hot Line Session IV, ESC 03.09.2013 2

Study design

Follow-up 30 and 90 days: MACE

Patients with suspected ACS

Standard process

Standard CPU: Serial cTn, ECG, further care according to current guidelines

Randomization

Experimental process with Copeptin

(from initial blood sample)

Initially Troponin negative

Copeptin positive (• 10 pmol/l) Standard care Copeptin negative (< 10 pmol/l) Discharge

Biomarkers in Cardiology-8

3 Hot Line Session IV, ESC 03.09.2013

Primary Endpoint: MACE within 30 days

Biomarkers in Cardiology-8

4 Hot Line Session IV, ESC 03.09.2013

Standard group (n=451) Copeptin group (n=451) Absolute difference in MACE proportion (97.5% one-sided CI) MACE at 30 days Yes 23 23

• No

395 398

• Unknown

33 30

• MACE % (95%-CI)

(absolute numbers) Intention to treat analysis 5·50 (3·52-8·14) (23/418) 5·46 (3·49-8·08) (23/421) 0·04 (-3·3) Per protocol analysis 5·68 (3·60-8·48) (22/387) 3·18 (1·60-5·62) (11/346) 2·51 (-0·78) Sensitivity analysis Assuming poor outcome 12·42 (9·52-15·82) (56/451) 11·75 (8·93-15·09) (53/451) 0·67 (-3·77) Assuming good outcome 5·1 (3·26-7·55) (23/451) 5·1 (3·26-7·55) (23/451) 0·00 (-3·12)

Biomarkers in Cardiology-8

Efficacy: Discharge from the ED in the two process groups

5 Hot Line Session IV, ESC 03.09.2013

Discharge from ED

10 20 30 40 50 60 70 80 Standard group Copeptin group Discharge from ED (%)

p<0.001

Safety: “Miss-rate” in the experimental arm

Copeptin negative 4.1% (n=14)

Biomarkers in Cardiology-8

6 Hot Line Session IV, ESC 03.09.2013

Discharged 0.6% (n=2)* Overrulers 3.5% (n=12) * 1 patient: Rehospitalization day 23, acute unplanned PCI day 24 1 patient: Rehospitalization day 4, CABG day 12 Final clinical assessment (per protocol)

Suggested new process based on BIC-8 results

Biomarkers in Cardiology-8

7 Hot Line Session IV, ESC 03.09.2013

Follow-up Cardiology appointment within 72h recommended

Low to intermediate risk patients with suspected ACS

Combined copeptin + troponin testing + clinical evaluation

Final clinical assessment excludes discharge Troponin positive and/or Copeptin positive

(• 10 pmol/l)

Troponin negative and Copeptin negative

(< 10 pmol/l)

Standard care

Discharge

Biomarkers in Cardiology-8

Thank you!

8

Berlin, 20. and 21. September 2013 http://notfallmedizin.charite.de

Hot Line Session IV, ESC 03.09.2013