SAN DIEGO--(BUSINESS WIRE)--Critical Diagnostics announced today that encouraging results from numerous studies continue to flood in from international investigators in support of the clinical use of the cardiac biomarker ST2.
As more than 125,000 top decision-makers in the medical industry descend on Düsseldorf Germany from November 20-23, 2013 for MEDICA, the world‘s largest medical marketplace, much of the attention will be focused on solutions to global health issues, such as cardiovascular disease (CVD).
CVD is the single largest cause of death in developed countries and on the rise in developing nations due to socio-economic changes, increase in life span and lifestyle related risk factors. While many other forms of CVD have become less common in recent years, heart failure has been increasing steadily. Over 26 million people worldwide suffer from heart failure.1
Heart failure biomarkers can give the physician information about a patient’s status and the likelihood of disease progression that goes beyond clinical observations, helping them treat what they can’t see. One cardiac biomarker, ST2, is receiving particular attention from across the globe for its prognostic accuracy and reliability, helping improve outcomes and save lives, as these recent studies illustrate.
Polish Study Shows ST2 is Not Affected by Typical Confounding Factors
A study out of the Department of Cardiology, Medical University of Lodz, Poland (“Soluble ST2 Protein in Chronic Heart Failure Is Independent of Traditional Factors,” Woitczak-Soska et al) looked at 66 heart failure patients in stable NYHA class I-III with left ventricular ejection fraction below 45%. Their conclusions were that ST2 is independent of traditional confounding factors which usually affect levels of NT-proBNP. There was no relationship between sST2 levels and age, body mass index, and hsTnT.
Taiwan Study Offers Diagnostic Aid In Hypertensive Patients
A study conducted at the National Taiwan University Hospital, Taipei, Taiwan (“Soluble ST2 As A Biomarker For Detecting Stable Heart Failure With A Normal Ejection Fraction in Hypertensive Patients [HFNEF],” Wang YC et al,) found that sST2 measurements provided diagnostic aid. sST2 concentrations were evaluated in 107 hypertensive patients with ejection fraction above 50 percent. Investigators found that the area under the receiver operating characteristic curve for sST2 was 0.80 (95% CI 0.70-0.89; P < .001), relatively better than that for NT-proBNP. Moreover, multivariate analysis showed that elevated sST2 levels were strongly independently associated with HFNEF in hypertensive patients (odds ratio 11.7, 95% CI = 2.9-47.4; P = .001).
Chinese Study of Heart Attack Patients Reveals ST2 Predicts Outcomes
In a 59-patient study conducted at hospitals in Beijing China who presented with chest pain or shortness of breath, and found to have an acute myocardial infarction (heart attack), ST2 offered independent predictive value of future risk stratification and prognosis of patients, over and above the cardiac biomarker NT-proBNP, as well as the GRACE risk score (The Global Registry of Acute Coronary Events is an international database designed to track outcomes of patients presenting with acute coronary syndromes, including myocardial infarction or unstable angina).
Global Study Proves ST2 Predictive of Death in Acute Heart Failure Patients
In a global study of just over 200 acute heart failure patients admitted to Sant’Andrea Hospital in Rome, Italy and Massachusetts General Hospital in Boston, (“Mortality Prognostic Value of ST2 in Patients With Acute Heart Failure At Admission in Emergency Room,” Benedetta De Berardinis et al), concluded that ST2 evaluation at ER admission was highly predictive of 18-month mortality, and that ST2 was not affected by kidney dysfunction or age.
Italian Study Demonstrates ST2 Useful In Patients With Chronic Degenerative Mitral Regurgitation
In a study out of the Division of Cardiac Surgery, Department of Emergency and Organ Transplant, University "Aldo Moro" of Bari, Italy (“Interleukin-1 Receptor-Related Protein ST2 and Mitral Valve Repair Outcome in Patients with Chronic Degenerative Mitral Regurgitation,” Galeone et al) sought to assess for the first time the activation of the ST2 pathway in patients with severe chronic degenerative mitral regurgitation. Serum sST2 levels were measured in 20 patients scheduled for mitral valve (MV) repair at baseline, at the end of the intervention, on postoperative day one, at hospital discharge, and after six months. The investigators concluded that preoperative ST2 activation, evidenced by the presence of serum sST2 levels, is present in half of the patients with chronic degenerative mitral regurgitation and is associated with higher levels of ejection fraction and lower levels of lower left ventricular end-diastolic diameter after MV repair.
South African Study Links ST2 And Left Ventricular Hypertrophy
A study conducted at the University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria and the Hatter Institute for Cardiovascular Research in Africa, University of Cape Town, Cape Town, South Africa (“Relationship Between Left Ventricular Geometry and Soluble ST2 in a Cohort of Hypertensive Patients,” Ojji DB et al,) concluded that ST2 levels are not only affected by hypertensive left ventricular hypertrophy, but may be a future biomarker in differentiating concentric hypertrophy from normal geometry in hypertension.
About ST2
ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis associated with heart failure. ST2 is not adversely affected by confounding factors such as age, body mass index and impaired renal function. Unlike many other cardiac biomarkers, ST2 levels change quickly in response to changes in the patient’s condition—thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust treatment. All this makes ST2 an ideal serial biomarker for monitoring and treating heart failure patients.
The Presage® ST2 Assay from Critical Diagnostics is the only commercially available ST2 biomarker in the world. The Presage ST2 Assay has been CE Marked and cleared by the U.S. FDA for use in the risk stratification of chronic heart failure patients.
The 2013 ACC/AHA Guideline For The Management of Heart Failure, recognizes ST2 as “not only predictive of hospitalization and death in patients with HF but also additive to natriuretic peptide levels in [its] prognostic value.”
About Critical Diagnostics
Founded in 2004, Critical Diagnostics (www.criticaldiagnostics.com) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. Critical Diagnostics has distribution partners for its Presage ST2 Assay in 45 countries, covering two-thirds of the world’s population.
| 1 | Medicographia. 2011;33:363-369 |
