Copeptin is Ready for Implementation in Routine Emergency Department
Assessment of Chest Pain Patients
Rule-out of MI and patient management using Copeptin is safe
Clinics can now better manage overcrowded EDs
Study results signal potential to change clinical practice
HENNIGDORF, Germany – (September 11, 2013) – Thermo Fisher Scientific Inc., the world leader in serving science, in conjunction with its Clinical Diagnostic Division, today announced the presentation of the Biomarkers in Cardiology (BIC)-8 study results in a HOT LINE session at the ESC Congress 2013 in Amsterdam. The purpose of the prospective, randomized, open, controlled, multicenter study with 902 patients was to ascertain the effect of integrating the biomarker Copeptin into the process of managing patients with suspected Acute Cardiac Syndrome (ACS).
The BIC-8 is the first interventional clinical trial to study whether it is safe to discharge suspected ACS patients who test Troponin and Copeptin negative at admission. The primary outcome of the BIC-8 study was to assess the proportion of Major Adverse Cardiac Events (MACE) reported within 30 days in the Copeptin vs the standard care arm (non-inferiority). Faster and better diagnosis accelerates the rule-out of Acute Myocardial Infarction (AMI) in patients with chest pain who present in hospitals, thereby alleviating congestion in emergency departments (ED) and financial burden on health systems.
EDs worldwide are challenged with overcrowding, and increasingly so. Patients with suspected ACS are very common, even though only some 15% of these patients are ultimately diagnosed with AMI. As a result, rapid rule-out of AMI is a major clinical need for not only EDs and the health system, but to avoid unnecessary patient stress, anxiety and other risks associated with hospitalization.
Current ED guidelines recommend that patients receive serial Troponin testing to confirm whether hospital discharge is appropriate but this testing delays definitive action.
The 902 study patients were initially sampled with a negative Troponin test. In the experimental arm (n=451) patients with a negative Copeptin test (less than 10 pmol/L) were discharged 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 (5.46% in the experimental arm vs 5.5% in the standard arm). However, the ED 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.
“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. and Principle Investigator Martin Möckel, Dept. of Cardiology; Chief, Division of Emergency Medicine, Charité Mitte – Universitätsmedizin Berlin, Germany. “We will implement a new algorithm using Troponin and Copeptin at the ED at the Charité once our study has been published.”
“We are delighted to see the positive outcome of the BIC-8 study findings which reflects our long term commitment to biomarker development in order to help clinicians in their daily work and improve patient care, said Christophe Fraudeau, Managing Director of B.R.A.H.M.S GmbH, part of Thermo Fisher Scientific.
Notes for Editors:
Copeptin, part of the vasopressin prohormone, is a marker of the individual stress response. Arginine vasopressin (AVP) is a key hormone in the human body. Despite the clinical relevance of AVP in maintaining fluid balance and vascular tone, measurement of mature AVP is difficult and subject to preanalytical errors. Copeptin, a 39-amino acid glycopeptide that comprises the C-terminal part of the AVP precursor (CT-proAVP), has been found to be a stable and sensitive surrogate marker for AVP, analogous to C-peptide for insulin. Copeptin measurement has been shown to be useful in various clinical indications, e.g., in endocrinology (differential diagnosis of the polyuria-polydipsia syndrome) and cardiovascular diseases. After acute myocardial infarction (AMI), circulating Copeptin levels rise to peak values rapidly and then decline over the next hours. Thermo Scientific™ BRAHMS™ Copeptin is part of a series of biomarker assays which can be used in cardiology.
About Charité – Universitätsmedizin Berlin
The Charité is one of the oldest and long-standing hospitals in Germany as well as being one of the largest university clinics in Europe. It enjoys a global reputation as an outstanding training center. The campus is distributed over four locations, comprising over 100 clinics and institutes. In the course of its over three-hundred-year history and its eight Nobel Laureates, the Charité has established a unique reputation.
Every day, a staff of over 13,000 follow the slogan: “Research, teaching, healing, helping”. The Charité has achieved outstanding results not only in preclinical research but also in the clinical development of medicines, medical products and innovations in healthcare. It combines tactful care, scientificity, responsibility, respect and entrepreneurship in university medicine in the interest of a self-determined life.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $13 billion, we have 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.
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