Journal article

Publication year: 2022

Pages: 411-420

Journal: The Journal of Heart and Lung Transplantation

Volume number: 41

Issue number: 3

ISSN: 1053-2498

eISSN: 1557-3117

DOI Link: https://doi.org/10.1016/j.healun.2021.10.013

Publisher: Elsevier

Abstract: 

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. (C) 2021 The Author(s). Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation.

Harvard Citation style: Benza, R., Boucly, A., Farber, H., Frost, A., Ghofrani, H., Hoeper, M., et al. (2022) Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study, The Journal of Heart and Lung Transplantation, 41(3), pp. 411-420. https://doi.org/10.1016/j.healun.2021.10.013

APA Citation style: Benza, R., Boucly, A., Farber, H., Frost, A., Ghofrani, H., Hoeper, M., Lambelet, M., Rahner, C., Bansilal, S., Nikkho, S., Meier, C., & Sitbon, O. (2022). Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. The Journal of Heart and Lung Transplantation. 41(3), 411-420. https://doi.org/10.1016/j.healun.2021.10.013