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 Möckel 1 , Julia Searle 1 , Christian Hamm 2 , Anna Slagman 1 , Stefan Blankenberg 3 , Kurt Huber 4 , Christian Müller 5 , Jörn O Vollert 6 , Evangelos Giannitsis 7 Berlin 1 , Bad Nauheim/Gießen 2 , Hamburg 3 , Henningsdorf 6 , Heidelberg 7 , Germany; Vienna 4 , Austria; Basel 5 , 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
Biomarkers in Cardiology-8 Study design Patients Follow-up 30 and 90 days: MACE Standard process with Randomization Standard CPU: Serial cTn, ECG, further care suspected according to current guidelines ACS Copeptin positive (• 10 pmol/l) Experimental Standard care Initially process Troponin Copeptin negative with Copeptin (< 10 pmol/l) negative (from initial blood sample) Discharge Hot Line Session IV, ESC 03.09.2013 3
Biomarkers in Cardiology-8 Primary Endpoint: MACE within 30 days Standard group Copeptin group Absolute difference (n=451) (n=451) 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) 5·46 (3·49-8·08) 0·04 (-3·3) (23/418) (23/421) Per protocol analysis 5·68 (3·60-8·48) 3·18 (1·60-5·62) 2·51 (-0·78) (22/387) (11/346) Sensitivity analysis Assuming poor outcome 12·42 (9·52-15·82) 11·75 (8·93-15·09) 0·67 (-3·77) (56/451) (53/451) Assuming good outcome 5·1 (3·26-7·55) 5·1 (3·26-7·55) 0·00 (-3·12) (23/451) (23/451) Hot Line Session IV, ESC 03.09.2013 4
Biomarkers in Cardiology-8 Efficacy: Discharge from the ED in the two process groups Discharge from ED p<0.001 80 70 Discharge from ED (%) 60 50 40 30 20 10 0 Standard group Copeptin group Hot Line Session IV, ESC 03.09.2013 5
Biomarkers in Cardiology-8 Safety: “Miss-rate” in the experimental arm Overrulers 3.5% (n=12) (per protocol) Final clinical assessment Copeptin negative 4.1% (n=14) Discharged 0.6% (n=2)* * 1 patient: Rehospitalization day 23, acute unplanned PCI day 24 1 patient: Rehospitalization day 4, CABG day 12 Hot Line Session IV, ESC 03.09.2013 6
Biomarkers in Cardiology-8 Suggested new process based on BIC-8 results Troponin positive Combined copeptin + and/or + clinical evaluation Copeptin positive troponin testing Low to (• 10 pmol/l) Standard intermediate care risk patients Final clinical with assessment suspected excludes discharge Follow-up Cardiology appointment within 72h recommended ACS Troponin negative and Discharge Copeptin negative (< 10 pmol/l) Hot Line Session IV, ESC 03.09.2013 7
Biomarkers in Cardiology-8 Thank you! Berlin, 20. and 21. September 2013 http://notfallmedizin.charite.de Hot Line Session IV, ESC 03.09.2013 8
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