REVEAL Lite 2 risk assessment prognostic of long-term outcomes in pulmonary hypertension
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The REVEAL Lite 2 risk assessment tool is prognostic of long-term outcomes in patients with pulmonary arterial hypertension and also detected response to treatment, a presenter said at the CHEST Annual Meeting.
“Risk assessment, as we know, is key for optimal management of patients with pulmonary arterial hypertension,” Raymond L. Benza, MD, cardiologist in the division of cardiovascular diseases at The Ohio State University Wexner Medical Center, said during a presentation. “REVEAL Lite 2 is a noninvasive risk assessment tool for pulmonary arterial hypertension.”
Benza reported results of a post hoc analysis of the GRIPHON study, in which the REVEAL Lite 2 risk assessment was applied to assess its prognostic and predictive values in patients with PAH who were randomly assigned to selexipag (Uptravi, Janssen) or placebo.
The researchers used REVEAL Lite 2 to calculate each patient’s risk score as low, intermediate or high risk at baseline and then at months 4, 6 and 12. Researchers performed analyses to evaluate the association between risk category and change in risk category with time to first morbidity/mortality event and selexipag treatment effect on long-term outcomes by risk category.
At baseline, 41% of patients were classified as low risk, 26% as intermediate risk and 33% as high risk. Risk category at baseline predicted time to first morbidity/mortality event with selexipag, with an HR of 2.09 for intermediate vs. low risk and an HR of 5.38 for high risk vs. low risk. For placebo, the HR was 2.41 for intermediate vs. low risk and the HR was 3.5 for high risk vs. low risk. C-index values with selexipag were 0.68 at baseline, 0.74 at 4 months, 0.76 at 6 months and 0.73 at 12 months and with placebo were 0.65, 0.67, 0.66 and 0.7, respectively, according to the results.
Improvement in risk category correlated with reduction in morbidity and mortality rate, Benza said. The HR vs. no change in risk was 0.43 at 4 months, 0.39 at 6 months and 0.42 at 12 months. In contrast, worsened risk category was associated with an increase in morbidity and mortality rate, he said, with an HR vs. no change of 2.82 at 4 months, 3.05 at 6 months and 3.77 at 12 months.
Treatment with selexipag was twice as likely to improve a patient’s risk profile compared with placebo (OR = 2 at 4 months; OR = 1.8 at 6 months; OR = 1.9 at 12 months). Compared with placebo, selexipag reduced the morbidity and mortality rate across all baseline risk categories (HR = 0.57 for low-risk; HR = 0.42 for intermediate-risk; HR = 0.71 for high-risk).
“The REVEAL Lite 2 risk category and change in risk category are prognostic for long-term patient outcomes. Selexipag treatment improved risk profile and long-term outcomes compared with placebo. Selexipag treatment on long-term outcome was strongest for patients at low and intermediate risk at baseline,” Benza said. “... Simple risk assessment tools may have utility for treatment monitoring, and importantly, as an endpoint in PAH clinical trials.”