REVEAL risk scores applied to riociguat-treated patients in PATENT-2: Impact of changes in risk score on survival

JOURNAL OF HEART AND LUNG TRANSPLANTATION

卷:37

Article

Benza, Raymond L.¹  Farber, Harrison W.²  Frost, Adaani^3,4  Ghofrani, Hossein-Ardeschir^5,6  Gomez-Sanchez, Miguel A.⁷  Langleben, David^8,9  Rosenkranz, Stephan^10,11  Busse, Dennis¹²  Meier, Christian¹³  Nikkho, Sylvia¹⁴  Hoeper, Marius M.¹⁵ 

[1] Allegheny Gen Hosp, Cardiovasc Inst, 320 E North Ave, Pittsburgh, PA 15212 USA

[2] Boston Univ, Sch Med, Ctr Pulm, Boston, MA 02118 USA

[3] Houston Methodist Hosp, Houston, TX USA

[4] Weill Cornell Med Coll, Houston, TX USA

[5] Univ Giessen & Marburg Lung Ctr, German Ctr Lung Res, Giessen, Germany

[6] Imperial Coll London, Dept Med, London, England

[7] Hosp Gen Nuestra Senora del Prado, Ctr Invest Biomed Red Enfermedade Resp CIBERES, Talavera De La Reina, Spain

[8] McGill Univ, Jewish Gen Hosp, Ctr Pulm Vasc Dis, Montreal, PQ, Canada

[9] McGill Univ, Jewish Gen Hosp, Lady Davis Inst, Montreal, PQ, Canada

[10] Univ Hosp Cologne, Heart Ctr, Dept Cardiol, Cologne, Germany

[11] Univ Hosp Cologne, Heart Ctr, Cardiovasc Res Ctr Cologne, Cologne, Germany

[12] Chrestos Concept GmbH & Co KG, Essen, Germany

[13] Bayer AG, Global Med Affairs, Berlin, Germany

[14] Bayer AG, Global Clin Dev, Berlin, Germany

[15] Hannover Med Sch, Clin Resp Med, German Ctr Lung Res, Hannover, Germany

关键词: pulmonary arterial hypertension;    risk assessment;    soluble guanylate cyclase stimulator;    right heart failure;    survival;    clinical worsening;   

DOI  :  10.1016/j.healun.2017.11.006

来源: Elsevier

【 摘 要 】

BACKGROUND: The Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) risk score (RRS) calculator was developed using data derived from the REVEAL registry, and predicts survival in patients with pulmonary arterial hypertension (PAH) based on multiple patient characteristics. Herein we applied the RRS to a pivotal PAH trial database, the 12-week PATENT-1 and open-label PATENT-2 extension studies of riociguat. We examined the effect of riociguat vs placebo on RRS in PATENT-1, and investigated the prognostic implications of change in RRS during PATENT-1 on long-term outcomes in PATENT-2. METHODS: RRS was calculated post hoc for baseline and Week 12 of PATENT-1, and Week 12 of PATENT-2. Patients were grouped into risk strata by RRS. Kaplan-Meier estimates were made for survival and clinical worsening-free survival in PATENT-2 to evaluate the relationship between RRS in PATENT-1 and long-term outcomes in PATENT-2. RESULTS: A total of 396 patients completed PATENT-1 and participated in PATENT-2. In PATENT-1, riociguat significantly improved RRS (p = 0.031) and risk stratum (p = 0.018) between baseline and Week 12 compared with placebo. RRS at baseline, and at PATENT-1 Week 12, and change in RRS during PATENT-1 were significantly associated with survival (hazard ratios for a 1-point reduction in RRS: 0.675, 0.705 and 0.804, respectively) and clinical worsening-free survival (hazard ratios of 0.736, 0.716 and 0.753, respectively) over 2 years in PATENT-2. CONCLUSIONS: RRS at baseline and Week 12, and change in RRS, were significant predictors of both survival and clinical worsening-free survival. These data support the long-term predictive value of the RRS in a controlled study population. (C) 2018 The Authors. Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation. All rights reserved.

【 授权许可】

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