Universität zu Köln

Benza, Raymond L., Farber, Harrison W., Frost, Adaani, Ghofrani, Hossein-Ardeschir, Gomez-Sanchez, Miguel A., Langleben, David, Rosenkranz, Stephan, Busse, Dennis, Meier, Christian, Nikkho, Sylvia and Hoeper, Marius M. (2018). REVEAL risk scores applied to riociguat-treated patients in PATENT-2: Impact of changes in risk score on survival. J. Heart Lung Transplant., 37 (4). S. 513 - 520. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1557-3117

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Benza, Raymond L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Farber, Harrison W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Frost, Adaani UNSPECIFIED UNSPECIFIED UNSPECIFIED Ghofrani, Hossein-Ardeschir UNSPECIFIED UNSPECIFIED UNSPECIFIED Gomez-Sanchez, Miguel A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Langleben, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosenkranz, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Busse, Dennis UNSPECIFIED UNSPECIFIED UNSPECIFIED Meier, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Nikkho, Sylvia UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoeper, Marius M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-191171
DOI:	10.1016/j.healun.2017.11.006
Journal or Publication Title:	J. Heart Lung Transplant.
Volume:	37
Number:	4
Page Range:	S. 513 - 520
Date:	2018
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1557-3117
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PULMONARY ARTERIAL-HYPERTENSION; DISEASE MANAGEMENT REVEAL; LONG-TERM EXTENSION; REGISTRY; DIAGNOSIS; OUTCOMES Multiple languages Cardiac & Cardiovascular Systems; Respiratory System; Surgery; Transplantation Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19117