Abstract 14319: Riociguat in Pulmonary Arterial Hypertension: Application of the 4-strata COMPERA 2.0 Risk Assessment Tool in the PATENT Studies

Abstract

Background: The 2022 ESC/ERS treatment guidelines for pulmonary arterial hypertension (PAH) recommend using a four-strata risk assessment strategy at follow-up. COMPERA 2.0 is a refined four-strata risk assessment tool that subdivides patients at intermediate risk of mortality at 1 year into intermediate-low and intermediate-high risk groups for a more granular approach to risk prediction. Aim: This post-hoc analysis applied COMPERA 2.0 to the PATENT studies of riociguat in patients with PAH. Methods: COMPERA 2.0 was applied to patients who were pretreated with PAH therapy at PATENT-1 entry. Patients with missing data for COMPERA 2.0 variables were excluded. In PATENT-1, risk strata were assessed at baseline and Week 12; and 6-minute walking distance (6MWD) at Week 12 was analyzed by risk strata at baseline. All pretreated patients entering the PATENT-2 open-label extension were included in Kaplan-Meier analyses to assess association of risk strata at PATENT-1 baseline and Week 12 with clinical worsening and survival. Results: At PATENT-1 baseline (riociguat 2.5 mg n=102, placebo n=49), more patients were at intermediate-low risk than intermediate-high risk (Figure 1). At PATENT-1 Week 12, a higher proportion of patients were at low risk with riociguat vs placebo (Figure 1). At PATENT-1 Week 12, the following mean [SD] changes in 6MWD were seen in patients at intermediate-low risk (riociguat 24 m [57 m], placebo 10 m [60 m]) and intermediate-high risk (riociguat 34 m [56 m], placebo –2 m [70 m]) by COMPERA 2.0 at baseline. COMPERA 2.0 assessed at PATENT-1 baseline and Week 12 was able to discriminate between risk strata for clinical worsening and survival in PATENT-2 (n=167, log-rank tests: p≤0.001 for all analyses). Conclusion: This analysis confirmed the risk-reduction benefits of riociguat in patients with PAH and validated the utility of COMPERA 2.0 in the long-term risk assessment of patients from a clinical trial population.