BACKGROUND: Registry data suggest that disease progression in pulmonary arterial hypertension (PAH) is indicative of poor prognosis. However, the prognostic relevance of PAH-related morbidity has not been formally evaluated in randomized controlled trials. OBJECTIVES: The purpose of these analyses was to assess the impact of morbidity events on the risk of subsequent mortality using the landmark method and data from the SERAPHIN and GRIPHON studies. METHODS: For each study, the risk of all-cause death up to the end of the study was assessed from the landmark time point (months 3, 6, and 12) according to whether a patient had experienced a primary endpoint morbidity event before the landmark. Each analysis was conducted using data from all patients who were available for survival follow-up at the landmark. RESULTS: In the SERAPHIN study, on the basis of the 3-month landmark time point, patients who experienced a morbidity event before month 3 had an increased risk of death compared with patients who did not (hazard ratio [HR]: 3.39; 95% confidence interval [CI]: 1.94 to 5.92). In the GRIPHON study, on the basis of the 3-month landmark time point, there was also an increased risk with a HR of 4.48; (95% CI: 2.98 to 6.73). Analyses based on 6-month and 12-month landmarks also showed increased risk in patients who experienced morbidity events, albeit with a reduced HR. CONCLUSIONS: These results demonstrate the prognostic relevance of PAH-related morbidity as defined in the SERAPHIN and GRIPHON studies, highlighting the importance of preventing disease progression in patients with PAH and supporting the clinical relevance of SERAPHIN and GRIPHON morbidity events. (Study of Macitentan [ACT-064992] on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension [SERAPHIN]; NCT00660179; Selexipag [ACT-293987] in Pulmonary Arterial Hypertension [GRIPHON]; NCT01106014).

Actelion Pharmaceuticals Ltd Allschwil Switzerland

Cardiopulmonary Department Ignacio Chávez National Heart Institute Mexico City Mexico

CARE Hospitals Hyderabad India

Cedars Sinai Medical Center Los Angeles California

Charles University Prague Czech Republic

Department of Respiratory Medicine Hannover Medical School and German Centre for Lung Research Hannover Germany

Division of Cardiovascular Medicine University of Michigan Ann Arbor Michigan

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

Hôpital de Bicêtre Paris France

INCOR Heart Institute University of São Paulo São Paulo Brazil

Istituto di Malattie dell'Apparato Cardiovascolare Università di Bologna Bologna Italy

Massachusetts General Hospital Harvard Medical School Boston Massachusetts

Medical Centre for Postgraduate Education CMKP European Health Centre Otwock Poland

Medical University of Vienna Department of Internal Medicine 2 Division of Cardiology Allgemeines Krankenhaus Vienna Austria

National Pulmonary Hypertension Unit Mater Misericordiae University Hospital Dublin Ireland

Respirology Division London Health Sciences Centre Western University London Ontario Canada

University Hospitals Leuven Leuven Belgium

University of Giessen and Marburg Lung Center Giessen Germany; Department of Medicine Imperial College London London United Kingdom

University of Texas Southwestern Dallas Texas

J Am Coll Cardiol. 2018 Feb 20;71(7):764-765. doi: 10.1016/j.jacc.2017.12.029. PubMed

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ClinicalTrials.gov
NCT00660179, NCT01106014