BACKGROUND: In the Phase III PATENT-1 (NCT00810693) and CHEST-1 (NCT00855465) studies, riociguat demonstrated efficacy vs placebo in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Clinical effects were maintained at 2 years in the long-term extension studies PATENT-2 (NCT00863681) and CHEST-2 (NCT00910429). METHODS: This post hoc analysis of hemodynamic data from PATENT-1 and CHEST-1 assessed whether riociguat improved right ventricular (RV) function parameters including stroke volume index (SVI), stroke volume, RV work index, and cardiac efficiency. REVEAL Risk Score (RRS) was calculated for patients stratified by SVI and right atrial pressure (RAP) at baseline and follow-up. The association between RV function parameters and SVI and RAP stratification with long-term outcomes was assessed. RESULTS: In PATENT-1 (n = 341) and CHEST-1 (n = 238), riociguat improved RV function parameters vs placebo (p < 0.05). At follow-up, there were significant differences in RRS between patients with favorable and unfavorable SVI and RAP, irrespective of treatment arm (p < 0.0001). Multiple RV function parameters at baseline and follow-up were associated with survival and clinical worsening-free survival (CWFS) in PATENT-2 (n = 396; p < 0.05) and CHEST-2 (n = 237). In PATENT-2, favorable SVI and RAP at follow-up only was associated with survival and CWFS (p < 0.05), while in CHEST-2, favorable SVI and RAP at baseline and follow-up were associated with survival and CWFS (p < 0.05). CONCLUSION: This post hoc analysis of PATENT and CHEST suggests that riociguat improves RV function in patients with PAH and CTEPH.

2nd Department of Medicine Department of Cardiovascular Medicine 1st Faculty of Medicine Charles University and General University Hospital Prague Czech Republic

Centre de Référence de l'Hypertension Pulmonaire Sévère Service de Pneumologie et Réanimation Hôpital Bicêtre Université Paris Saclay Le Kremlin Bicêtre France; INSERM UMR_S999 LabEx LERMIT Hôpital Marie Lannelongue Le Plessis Robinson France

Centre for Pulmonary Hypertension Thoraxklinik at Heidelberg University Hospital German Center of Lung Research Heidelberg Germany

Centre for Pulmonary Vascular Disease and Lady Davis Institute Jewish General Hospital McGill University Montreal Quebec Canada

Department of Cardiology State Key Laboratory of Complex Severe and Rare Diseases Peking Union Medical College Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China

Department of Pulmonary and Critical Care Medicine Center of Respiratory Medicine China Japan Friendship Hospital Beijing China; Institute of Respiratory Medicine Chinese Academy of Medical Sciences Beijing China; National Clinical Research Center for Respiratory Diseases Beijing China; Chinese Academy of Medical Sciences Peking Union Medica Beijing China; WHO Collaboration Center for Tobacco Cessation and Respiratory Diseases Prevention Beijing China

Department of Respiratory Medicine Hannover Medical School German Center of Lung Research Hannover Germany

Division of Cardiology Fondazione IRCCS Policlinico S Matteo Pavia Italy

Division of Cardiovascular Medicine The Ohio State University Wexner Medical Center Ohio USA

Division of Pulmonary and Critical Care Medicine University of California San Diego La Jolla California

Employee of Chrestos Concept GmbH and Co KG Essen Germany

Global Medical Affairs Bayer AG Berlin Germany

University of Giessen and Marburg Lung Center German Center of Lung Research Giessen Germany; Department of Pneumology Kerckhoff Klinik Bad Nauheim Germany; Department of Medicine Imperial College London London UK

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The risk profile change in patients with severe chronic thromboembolic pulmonary hypertension treated with subcutaneous treprostinil

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ClinicalTrials.gov
NCT00863681, NCT00910429, NCT00810693