Critical Diagnostics announced today that results of the HF-ACTION study just published in the American Heart Association’s Circulation: Heart Failure demonstrate that levels of the biomarker ST2 are predictive of long-term outcomes for people suffering with heart failure, and identify those patients who may benefit from exercise.
Duke Clinical Research Institute investigators evaluated 912 subjects, part of a large, multicenter, randomized study of exercise training in well-treated ambulatory heart failure patients. The subjects were followed for 32 months. In multivariable models, ST2 remained a significant predictor of outcomes after adjustment for clinical variables and the natriuretic peptide biomarker NT-proBNP. This association was particularly strong for cardiovascular death and heart failure hospitalization, consistent with ST2's role as a cardiovascular risk marker.
Almost all the patients in this study (95 percent) were receiving beta blockers and three-quarters were also on ACE inhibitors. Besides medication, exercise is another treatment option often recommended for heart failure patients to help improve symptoms and lower risk of adverse outcomes or death, but it has never been clear which patients would benefit most from exercise.
“Of the endpoints tested,” note the authors, “there was a statistical interaction between exercise training and the outcome of all-cause mortality, such that patients with lower ST2 levels were more likely to have a benefit of exercise training than were patients with higher levels.”
Researchers also found that increased levels of ST2 were strong predictors of cardiovascular events. They note: “Elevation of ST2 was significantly associated with long-term outcomes . . . These associations were relatively robust for disease specific endpoints (cardiovascular death and heart failure hospitalization) in traditional multivariable modeling, persisting even after comprehensive covariate adjustment, including demographics, clinical variables, and NT-proBNP.”
ST2 was recently included in the 2013 ACC/AHA Guideline For The Management of Heart Failure, recognizing ST2 as “not only predictive of hospitalization and death in patients with HF but also additive to natriuretic peptide levels in [its] prognostic value.”
This study supports that recommendation. When considered along with NT-proBNP, as four groups based on NT-proBNP levels above or below the median level for NT-proBNP, and ST2 levels above or below the standard FDA-cleared 35 ng/mL cutpoint, patients with both markers elevated had nearly a six-fold increased risk of death during the course of long-term follow up, compared to those with neither marker elevated.
The ST2 findings in this study are in sharp contrast to that of Galectin-3 by BG Medicine (NASDAQ:BGMD). In a separate paper (“Galectin-3 in Ambulatory Patients with Heart Failure: Results from the HF-ACTION Study”) published in Circulation: Heart Failure in January, 2012, using the same HF-ACTION study cohort, the authors stated: “In a final model adjusting for all predictors of the primary endpoint in the HF-ACTION dataset as a whole . . . as well as NT-proBNP, there was no evidence for an independent association between galectin-3 and outcomes." The authors went on to add, “Given the unique nature of the randomized intervention in the HF-ACTION study (exercise training), we examined the interaction between baseline galectin-3 levels and treatment assignment. There was no significant interaction between galectin-3 levels and exercise training for any of the 3 study endpoints [all-cause death or hospitalization, cardiovascular death or cardiovascular hospitalization, and for cardiovascular death or heart failure hospitalization.]”
“The ability of a biomarker to identify low risk as well as high risk patients with heart failure is very important,” says Critical Diagnostics’ President James Snider. “As noted in this study, patients identified as low risk by ST2 showed a significant benefit from exercise as part of their care plan, and is thus another example of how ST2 can provide information to the physician helpful in guiding care and management of their heart failure patients.”
“We want to get to a place with heart failure where we have a better understanding of what is happening in the heart at a molecular level, and we want to be able to better identify the sickest patients who are at greatest risk for being hospitalized and would benefit most from intensive therapies,” said Dr. Ahmad, MD, MPH, who led the HF-ACTION study, in a report published in March, 2012, on the Duke Clinical Research Institute’s website. “ST2 is one of the exciting new emerging tools in heart failure. It may give us unique insights into the pathophysiology of heart failure, and provide independent prognostic information about patient outcomes.”
ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis. 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.
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.
Dennis Dalangin, +1 877-700-1250
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