0
Pulmonary Vascular Disease |

Application of REVEAL Risk Score to Patients With PAH Receiving Riociguat in the PATENT-2 Study FREE TO VIEW

Raymond Benza; Adaani Frost; Harrison Farber; Hossein Ardeschir Ghofrani; Miguel Gómez-Sánchez; David Langleben; Stephan Rosenkranz; Dennis Busse; Christian Meier; Sylvia Nikkho; Marius Hoeper
Author and Funding Information

Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, PA; Division of Cardiovascular Diseases, Baylor College of Medicine, Houston, TX; Pulmonary Center, Boston University School of Medicine, Boston, MA; Department of Internal Medicine, University of Giessen and Marburg Lung Center (UGMLC), Member of the German Center of Lung Research (DZL), Giessen, Germany; Unidad de I. Cardiaca e HipertensiÌ_n Pulmonar, Hospital Universitario 12 de Octubre, Madrid, Spain; Center for Pulmonary Vascular Disease, Lady Davis Institute for Medical Research, Jewish General Hospital, McGill University, Montréal, QC, Canada; Department of Cardiology, Heart Center at the University of Cologne, Cologne, Germany; Global Data Sciences and Analytics, Bayer Pharma AG, Wuppertal, Germany; Global Medical Affairs CVRM, Bayer Pharma AG, Berlin, Germany; Clinic for Respiratory Medicine, Hannover Medical School, Hannover, Germany


Chest. 2015;148(4_MeetingAbstracts):930A. doi:10.1378/chest.2280692
Text Size: A A A
Published online

Abstract

SESSION TITLE: Predictors of Outcomes in PAH

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Tuesday, October 27, 2015 at 08:45 AM - 10:00 AM

PURPOSE: REVEAL risk score (RRS) has been applied to risk-stratify pts with PAH and predict 1-yr survival. Here, we examined the relationships between treatment with riociguat and RRS, and RRS and long-term outcomes in the 12-wk PATENT-1 study and the PATENT-2 open-label LTE cohort.

METHODS: RRS was calculated at PATENT-1 BL, PATENT-1 Wk 12 (PATENT-2 BL), and PATENT-2 Wk 12. Missing data were imputed using the LOCF method.

RESULTS: 396 pts entered PATENT-2 (former riociguat n=287, former pbo n=109). At PATENT-1 BL, mean ±SD RRS were 6.9±2.0 in riociguat pts and 6.8±1.8 in pbo pts, reflecting a low mortality risk. At PATENT-1 Wk 12, RRS were 6.2±2.0 and 6.7±2.2, respectively. At PATENT-2 Wk 12, RRS had further decreased to 5.8±2.2 in former riociguat pts and to 6.2±2.1 in former pbo pts, a similar reduction in both treatment arms after 12 wks on riociguat. By PATENT-2 Wk 12, 74% of former riociguat and 60% of former pbo pts had improved RRS. At BL, pts were grouped by RRS into 5 risk strata: low, average, moderately high, high, and very high; at this point 233 (59%) were in the low, 84 (21%) in the average, and 79 (20%) in the 3 higher risk strata. Pts were then restratified by RRS at PATENT-1 Wk 12 and PATENT-2 Wk 12. Riociguat reduced the proportion of pts in higher risk strata from 22% at BL to 15% at PATENT-1 Wk 12, and to 13% at PATENT-2 Wk 12. The proportion of higher risk pbo pts increased from 15% at BL to 19% at PATENT-1 Wk 12, then decreased to 16% by PATENT-2 Wk 12 after switching to riociguat. Riociguat pts in the low risk stratum increased from 58% at BL to 71% at PATENT-1 Wk 12, and 78% at PATENT-2 Wk 12. In pbo pts the proportions were 61%, 64%, and 71%, respectively. In higher risk strata, 63% of riociguat pts had improved RRS by PATENT-1 Wk 12 vs 38% of pbo pts. Low, average, and higher risk strata at BL and PATENT-1 Wk 12 were associated with low, medium, and high rates of CW. Survival at 1 yr for riociguat pts in higher risk strata at BL was 98% compared with the 1-yr survival of <90% predicted by BL RRS. In pts in the higher risk strata at PATENT-1 Wk 12, survival rates at 1, 2, and 3 yrs were 98, 86, and 82%, respectively, for riociguat pts, and 90, 80, and 73% for former pbo pts.

CONCLUSIONS: These data show that riociguat improved RRS in pts enrolled in PATENT-1 and -2, and increased the proportion of pts with a low risk score.

CLINICAL IMPLICATIONS: This is the first time that RRS has been applied to a single intervention and demonstrates the use of RRS in a clinical trial setting.

DISCLOSURE: Raymond Benza: Grant monies (from industry related sources): Received funding from Bayer Pharma AG. Adaani Frost: Consultant fee, speaker bureau, advisory committee, etc.: Received grant support for clinical studies from VentriPoint, Inc; GlaxoSmithKline plc; Actelion Pharmaceuticals US, Inc; Gilead; Pfizer Inc; United Therapeutics Corporation/ Lung Rx LLC (a subsidiary of United Therapeutics Corporation); InterMune; Stromedix (Biogen Idec); Bayer AG; and Novartis AG. , Consultant fee, speaker bureau, advisory committee, etc.: Received honoraria for service on steering committees or advisory boards (or as a consultant) to Actelion Pharmaceuticals US, Inc/CoTherix, Inc; Gilead; Pfizer Inc; United Therapeutics Corporation/Lung Rx LLC (a subsidiary of United Therapeutics Corporation); GlaxoSmithKline plc; Eli Lilly and Company/ ICOS Corporation; Bayer AG; Ikaria, Inc; and Arena Pharmaceuticals, Inc. Harrison Farber: Grant monies (from industry related sources): Received grant support from Gilead, and United Therapeutics., Consultant fee, speaker bureau, advisory committee, etc.: Speakers programs for Gilead, Actelion, and Bayer., Consultant fee, speaker bureau, advisory committee, etc.: Advisory board and consultancy fees from Gilead, Actelion, United Therapeutics, Bayer, and Bellerophon. Hossein Ardeschir Ghofrani: Consultant fee, speaker bureau, advisory committee, etc.: Received fees for consultancies from Actelion, Bayer, Ergonex, Gilead, GSK, Merck, Novartis, and Pfizer., Consultant fee, speaker bureau, advisory committee, etc.: Speakers bureaus for Actelion, Bayer, Ergonex, Gilead, GSK, Novartis, and Pfizer. Miguel Gómez-Sánchez: Consultant fee, speaker bureau, advisory committee, etc.: Received talk fees from Bayer, Ferrer, GSK, Pfizer, Actelion. David Langleben: Grant monies (from industry related sources): Grant support from Bayer., Consultant fee, speaker bureau, advisory committee, etc.: Personal fees and non-financial support from Bayer. Stephan Rosenkranz: University grant monies: Research grant Deutsche Forschungsgemeinschaft (DFG), University grant monies: Research grant Center for Molecular Medicine Cologne (CMMC), Grant monies (from industry related sources): Research grant, Bayer Health Care, Consultant fee, speaker bureau, advisory committee, etc.: Occasional remunerations for lectures and advisory boards. Dennis Busse: Employee: Full-time employee of Bayer Pharma AG Christian Meier: Employee: Full-time employee of Bayer Pharma AG Sylvia Nikkho: Employee: Full-time employee of Bayer Pharma AG Marius Hoeper: Consultant fee, speaker bureau, advisory committee, etc.: Actelion, Bayer, GSK, Pfizer

No Product/Research Disclosure Information


Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543