This article is more than 5 years old. Information may no longer be current.
Drug-, device-induced effects on HF markers did not predict mortality benefit
Wessler BS. Circ Heart Fail.2011;doi: 10.1161/circheartfailure.111.961573.
Click Here to Manage Email Alerts
In an analysis of trial level data from different eras, the average drug- and device-induced effects on peak oxygen consumption, 6 minute walk distance and two biomarkers among patients with HF and reduced ejection fraction was not predictive of long-term therapeutic effects on mortality.
The study featured a total 20,820 patients from 109 trials that were published between January 1966 to September 2009. All trials determined the role of the functional markers peak oxygen consumption (VO2) and 6 minute walk distance, and natriuretic peptide biomarkers (BNP and NT-proBNP) in predicting mortality in patients with HF and left ventricular dysfunction. As a requisite, the trials were randomized controlled trials, and determined mortality in at least 500 patients over a period of at least 6 months.
Overall, there was no significant association between mortality and therapy-induced placebo-corrected change in peak VO2 or in natriuretic peptides. Researchers did observe a modest correlation between drug- or device-induced average change in 6 minute walk distance and an increased odds ratio for mortality (P= 0.036). However, with regards to the latter finding, James E. Udelson, MD, with Tufts Medical Center, Boston, and study investigator, told Cardiology Today that because the correlation was so weak, “it is clear that you could never really use change in 6 minute walk distance as a predictor of mortality in any clinical sense.”
As a result, Udelson and colleagues concluded in the study that while drug- or device-induced changes in these markers may objectively reflect therapeutic effects on functional capacity and represent pathophysiologic changes that are seen in HF, “our findings do not provide support for their use as surrogates for an intervention’s effect on long-term mortality. Continued work is needed to validate potential markers and find novel surrogates for research trials of therapies in HF.” – by Brian Ellis
Disclosures: Dr. Udelson has received research funding from Otsuka, NHLBI, Cytori, Angioblast, Medtronic and Athersys.
 |
Follow CardiologyToday.com on Twitter. |