04 February 2019 by Cassandra Lickert

Multiparameter Risk Assessment Tools Applied to the Functional Class(FCII) Cohort from the EARLY(AC-052364) Clinical Trial


The 2015 European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines provide multi-parameter risk assessment for use at diagnosis and follow-up of Pulmonary Arterial Hypertension (PAH) patients. Patients are categorized as low, intermediate or high risk for estimated one-year mortality. We aim at investigating if patients with mild PAH defined as patients in World Health Organization (WHO) Functional Class (FC) II are at low risk of one-year mortality.


In a post-hoc analysis, of the EARLY trial in which only FC II patients were enrolled (Galiè 2008), the REVEAL Risk Score (RRS) (Benza 2010, 2012) and COMPERA Risk Score (CRS) (Hoeper, 2017) were applied at baseline(BL) and month 6. Low risk, intermediate risk, and high risk of estimated 1-year mortality were assigned for each patient according to the CRS described in Hoeper, 2017 and for the RRS, risk score of 1-7 was classified as low risk, 8-9 intermediate risk, and ≥ 10, as high risk. Proportion of low, intermediate and high risk patients were calculated at BL, month 6, and change at month 6.


185 patients >12 years who were enrolled in the study were analyzed. Assessment of the RRS and of the CRS showed that, respectively, 35% and 89% of patients were not at low risk at baseline and 37% and
82% of patients were not at low risk at month 6. By 6 months, 12% and 7% had a worsening in risk as (RRS) and (CRS) indicated, respectively (Table 1).


This study used two different risk assessment methods to analyze the FC II cohort from the EARLY trial. Both indicated that even in FC II, patients are not all at low risk. In addition, patients at low risk may rapidly deteriorate and should not be considered stable.

table 66.PNG

About the author

profile picture of Cassandra Lickert

Cassandra Lickert

Associate Director Medical Affairs

Actelion Pharmaceuticals /Janssen

United States

Key Contributors

Nick H Kim, MD 1, Cassandra Lickert, MD 2, Janis Pruett, EDd 2, Loïc Perchenet, PhD 3, Carol Zhao, MS 2, Adele Morganti, PhD 3, William Drake, PharmD 2 : 1 University of California San Diego; 2 Actelion Pharmaceuticals, US, Inc., South San Francisco; 3 Actelion Pharmaceuticals, Ltd, Allschwil, Switzerland

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