Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study
| Autor: | Olivier Sitbon, Christian Meier, Raymond L. Benza, Marc Lambelet, Adaani E. Frost, Sylvia Nikkho, Marius M. Hoeper, Athénaïs Boucly, Hossein Ardeschir Ghofrani, Sameer Bansilal, Harrison W. Farber, Claudia Rahner |
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| Rok vydání: | 2022 |
| Předmět: |
Pulmonary and Respiratory Medicine
Pulmonary Arterial Hypertension Transplantation medicine.medical_specialty Framingham Risk Score business.industry Proportional hazards model Placebo Riociguat Mean difference Pyrimidines Treatment Outcome Double-Blind Method Risk Factors Internal medicine medicine Humans Pyrazoles Surgery In patient Background risk Cardiology and Cardiovascular Medicine business Risk assessment medicine.drug |
| Zdroj: | The Journal of Heart and Lung Transplantation. 41:411-420 |
| ISSN: | 1053-2498 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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