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Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT
Raymond L Benza1, Athénaïs Boucly2, Harrison W Farber3
1Department of Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio.
Insights
Riociguat improved the REVEAL Lite 2 risk score in pulmonary arterial hypertension (PAH) patients, demonstrating its benefit in risk reduction and long-term outcomes. This study validates the REVEAL Lite 2 score for PAH risk assessment.
Area of Science:
- Cardiology
- Pulmonary Medicine
- Pharmacology
Background:
- Pulmonary arterial hypertension (PAH) management necessitates accurate risk assessment.
- The REVEAL Lite 2 score is a simplified tool for evaluating PAH risk.
- Riociguat is a medication used in PAH treatment.
Purpose of the Study:
- To evaluate the impact of riociguat on the REVEAL Lite 2 risk score in PAH patients.
- To assess the association between riociguat treatment, REVEAL Lite 2 score changes, and long-term clinical outcomes.
Main Methods:
- Analysis of data from the PATENT-1 (randomized, double-blind) and PATENT-2 (open-label extension) studies.
- REVEAL Lite 2 scores were calculated at baseline and various time points.
- Patients were stratified into low, intermediate, and high-risk groups.
- Kaplan-Meier and Cox proportional hazards analyses were used to assess outcomes.
Main Results:
- Riociguat significantly improved REVEAL Lite 2 scores compared to placebo.
- A greater proportion of patients on riociguat achieved a low-risk status.
- Both baseline and Week 12 REVEAL Lite 2 scores, and their changes, were strongly associated with survival and clinical worsening-free survival (CWFS).
- Distinct survival and CWFS outcomes were observed across different risk strata at baseline and Week 12.
Conclusions:
- Riociguat demonstrates significant risk-reduction benefits in PAH patients.
- The REVEAL Lite 2 score is validated as a useful tool for PAH risk assessment and outcome prediction.
- Improved risk status with riociguat is linked to better long-term patient outcomes.
Background:
Risk assessment is essential in pulmonary arterial hypertension (PAH) management. We investigated the effect of riociguat on REVEAL Lite 2 score, an abridged version of the REVEAL risk score, and its association with long-term outcomes in PATENT.
Methods:
PATENT-1 was a randomized, double-blind study of riociguat vs placebo in patients with PAH. In the PATENT-2 open-label extension, all patients received riociguat up to 2.5 mg three times daily (n = 396). REVEAL Lite 2 scores were calculated at baseline, PATENT-1 Week 12, and PATENT-2 Week 12, with patients stratified as low- (1-5), intermediate- (6-7), or high-risk (≥8). Kaplan-Meier and Cox proportional hazards analyses assessed association of riociguat with survival and clinical worsening-free survival (CWFS).
Results:
REVEAL Lite 2 score improved with riociguat 2.5 mg at PATENT-1 Week 12 (least-squares mean difference vs placebo: -0.8; p = 0.0004). More patients receiving riociguat 2.5 mg stabilized or improved risk stratum at PATENT-1 Week 12 vs placebo (p = 0.0005) and achieved low-risk status. REVEAL Lite 2 score at baseline and PATENT-1 Week 12 were associated with survival and CWFS (all p < 0.0001), as was change in score from baseline to Week 12 (p = 0.0002 and p < 0.0001, respectively). Survival and CWFS differed between risk strata at baseline (p < 0.0001) and PATENT-1 Week 12 (p < 0.0001).
Conclusions:
This analysis confirms the risk-reduction benefits of riociguat in patients with PAH and further contributes to the validation of REVEAL Lite 2 in facilitating PAH risk assessment.
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