Critical Diagnostics announced today, Circulation, an American Heart Association Journal, released online the first study evaluating the power of ST2 to predict development of heart failure and other adverse outcomes in the general population titled, "Prognostic Utility of Novel Biomarkers of Cardiovascular Stress: The Framingham Heart Study".
“The potential impact in clinical care from these results is compelling”
The Framingham Heart Study Cohort evaluated over 3,400 individuals to determine the prognostic utility of ST2 individually, and when combined with other biomarkers, to predict heart failure and other adverse events in people who are not medically perceived to be at risk. The study participants were followed for an average of just over 11 years.
As the study authors note, "sST2 [soluble ST2] is an emerging biomarker that has been shown to predict adverse outcomes and death in individuals with established heart failure." The inclusion of ST2, a unique marker for cardiac remodeling and fibrosis, makes this study "the first to examine the prognostic value of sST2 measurements in the general population, showing that higher levels of circulating sST2 (comparable to those found in hospitalized patients) can be detected in apparently healthy individuals and precede adverse outcomes."
When ST2 was used individually in the study as a marker of risk in fully adjusted statistical models, elevated levels resulting in heart failure or death were 45% and 32% greater respectively.
To put that into perspective, a contemporary analysis from the same study cohort recently reported that elevations of galectin-3, a biomarker offered by BG Medicine (NASDAQ: BGMD), had associated likelihood of heart failure or death of only 23% and 15% greater respectively.
Comparing the results, then, ST2 had twice the predictive value for heart failure or death of galectin-3. Moreover, when galectin-3 values were adjusted for kidney function, the association with incident heart failure was not statistically relevant.
When the study group measured soluble ST2, growth differentiation factor-15, high-sensitivity troponin I, hsCRP and BNP as a multi-marker panel in the 3,428 participants, individuals with scores in the highest quartile had a 3-fold higher risk of death, 2-fold higher risk of cardiovascular events, and a 6-fold higher risk of heart failure. Again, by comparison, that is three times the predictive value for heart failure as galectin-3. The multimarker score was also superior to a model containing current standard-of-care cardiac biomarkers hsCRP, BNP, and clinical risk factors.
Among the individuals in the study who were initially classified as low risk with existing clinical methods but later developed heart failure, by using ST2 as the measurement of risk, 36% were re-classified to high risk, while another 21% who were classified as low risk using existing clinical methods, but later died, were up-classified under guidelines based on ST2 measurements. As the study then shows, proper classification of patients using ST2, may result in significantly improved outcomes for such individuals.