BIC-8: Negative Troponin and Copeptin Tests Rule Out Acute Coronary Syndrome

September 03, 2013

AMSTERDAM — Suspected acute coronary syndrome (ACS) patients with a negative troponin test and a negative copeptin test (Brahms, Thermo Scientific) can be safely discharged from the hospital without further testing, according to the results of a new study presented here today at the European Society of Cardiology (ESC) 2013 Congress.

"The clinical need for instant rule-out of acute myocardial infarction and early discharge is based on the fact that we have an overcrowding of emergency facilities," said lead investigator Dr Martin Möckel (Charité–Universitätsmedizin Berlin, Germany) during a press conference announcing the results. "Ten percent of patients in the emergency department present with chest pain, but only 10% of those patients are having a real acute myocardial infarction. We do an extensive workup on patients who do not need specific cardiovascular care."

Copeptin, explained Möckel, is a marker of severe hemodynamic stress and is detectable immediately in patients with acute MI. In observational studies, a combination of cardiac troponin and copeptin was shown to be a significant predictor of acute events.

In the present study, known as the Biomarkers in Cardiology 8 (BIC-8) trial, researchers tested the emergency-department biomarker risk-stratification strategy in 902 patients at low to intermediate risk of ACS. After the initial negative troponin test, 451 patients were randomized to the experimental arm and underwent a copeptin assay. The other 451 patients were randomized to standard care, including serial cardiac troponin testing.

 
The marker doesn't substitute for a brain.
 

If the copeptin test was positive, defined as >10 pmol/L, they were treated with standard ACS care. If the copeptin assay showed copeptin levels <10 pmol/L, patients were discharged into ambulant care and scheduled for an outpatient visit within 72 hours.

At 30 days, the rate of major adverse cardiovascular events (MACE) was 5.46% in the experimental arm and 5.5% standard-care arm, a difference that was not statistically significant. The discharge rate from the emergency department among patients in the experimental arm was 66% compared with 12% among patients treated with standard care.

Presenting the results, Möckel said the results have the potential to change clinical practice, particularly since it was shown to safely rule out ACS and effectively discharged patients from the emergency department. He said a negative troponin and copeptin test would then be followed by a clinical assessment of the patient before sending them home.

"The marker doesn't substitute for a brain," said Möckel.

The copeptin assay has CE Mark approval in Europe. Currently, blood is drawn and sent to laboratory for assessment, a process that takes about one hour for copeptin results. He said the company that makes the tests envisions a point-of-care assay that would allow the troponin/copeptin tests to be conducted in parallel.

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