A study conducted by clinicians in leading German, Swiss and Austrian hospitals demonstrates that low-to-intermediate risk patients with suspected Acute Coronary Syndrome (ACS) can safely be discharged earlier from the Emergency Department (ED) using cardiac Troponin together with Copeptin. The study suggests that, by implementing the new process, clinics can better manage overcrowded EDs and increase patient well-being.
The study, entitled "Biomarkers in Cardiology (BIC)-8" was published in the April issue of the European Heart Journal, published by Oxford University Press for the European Society of Cardiology (ESC).(1) The purpose of BIC-8 study was to ascertain the effect of integrating the biomarker Copeptin into the process of managing patients with suspected Acute Cardiac Syndrome (ACS).
The interventional clinical trial demonstrated that it is safe to discharge suspected ACS patients who have normal levels of Troponin and Copeptin at admission. The academic recognition by a leading cardiology journal paves the way for implementing new processes and algorithms in everyday clinical work that lead to improved cost-efficient diagnosis. The study was conducted under the leadership of Principle Investigator Prof. Dr. med. Martin Möckel, Dept. of Cardiology; Chief, Division of Emergency Medicine, Charité Virchow-Klinikum and Mitte - Universitätsmedizin Berlin, Germany, and was presented at the ESC Congress 2013 in Amsterdam for the first time.
"We are delighted to see that the scientific community has endorsed the BIC-8 study by publication in its prestigious European Heart Journal. The positive results reflect our long-term commitment to biomarker development in order to help clinicians in their daily work and improve patient care", said Dr. med. Jörn Ole Vollert, Medical Director for Thermo Scientific Biomarkers at Thermo Fisher Scientific.
Benefits for clinics, patients and health care providers
Faster, yet safe, diagnosis accelerates the rule-out of Acute Myocardial Infarction (AMI) in patients with chest pain who present in hospitals, thereby reducing congestion in emergency departments (ED) and financial burden on health systems. EDs worldwide are increasingly challenged with overcrowding. Patients with suspected ACS are common, even though only few of these patients are ultimately diagnosed with AMI. As a result, rapid rule-out of AMI is a major benefit for hospitals and the public health system in general. Additionally, faster diagnosis can improve patient well-being by avoiding unnecessary patient stress, anxiety and other risks associated with hospitalization.
"Thanks to the Copeptin biomarker, clinics can better manage overcrowded emergency departments if the clinical assessment is consistent with the discharge decision and as long as a timely diagnostic work-up is done in the outpatient setting. The clinical judgment of the treating physician remains utmost in importance," said Prof. Martin Möckel. "We have implemented a new algorithm using Troponin and Copeptin at the ED at the Charité now that our study has been published."
The BIC-8 Study Design
The primary outcome of the BIC-8 study - a prospective, randomized, open, controlled, multicenter interventional study with data from 902 patients - was an assessment of the proportion of Major Adverse Cardiac Events (MACE) reported within 30 days in the group of patients with Copeptin results available for the treating physicians versus the standard care group where Copeptin levels were not disclosed (non-inferiority).
The 902 study patients with negative results in the Troponin test were initially sampled. In the experimental arm (n=451) patients with a negative Copeptin test result (less than 10 pmol/L) were eligible for discharge to ambulant care after a final clinical assessment, with an outpatient visit scheduled within 72 hours, while those with a positive Copeptin test received standard treatment. Patients in the standard arm (n=451) were treated according to current guidelines; their Copeptin results were not made available to treating staff.
The study revealed that at 30 days of follow-up the incident of MACE was similar in the two patient groups (5.17% in the experimental arm versus 5.19% in the standard arm). However, the ED early discharge rates were significantly higher in the experimental arm (66% vs 12%; P < 0.001), supporting a call for a new treatment algorithm in low-to-intermediate risk patients with suspected ACS.