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Multicenter Study
. 2025 Jul 1:430:133180.
doi: 10.1016/j.ijcard.2025.133180. Epub 2025 Mar 20.

Sex differences in pulmonary arterial hypertension: Insights from the FOCUS-PAH registry

Matteo Pagnesi  1 , Mauro Riccardi  2 , Giulio Savonitto  3 , Pietro Ameri  4 , Simonetta Monti  5 , Mauro Driussi  6 , Piero Gentile  7 , Claudia Specchia  8 , Chiara Oriecuia  8 , Marianna Adamo  2 , Matteo Toma  9 , Alberto Giannoni  5 , Emma Di Poi  10 , Luciana D'Angelo  11 , Valentina Colombo  11 , Veronica Vecchiato  9 , Edoardo Airo  5 , Massimo Imazio  6 , Andrea Garascia  11 , Gianfranco Sinagra  3 , Francesco Lo Giudice  12 , Marco Metra  2 , Davide Stolfo  13 , Carlo Mario Lombardi  2
Affiliations
Multicenter Study

Sex differences in pulmonary arterial hypertension: Insights from the FOCUS-PAH registry

Matteo Pagnesi et al. Int J Cardiol. .

Abstract

Background: Despite the higher incidence of pulmonary arterial hypertension (PAH) in women, sex differences in terms of clinical presentation and prognosis are still uncertain. We assess the impact of sex in patients with PAH.

Methods: Sex differences were evaluated in the multicenter FOCUS-PAH registry, that included patients diagnosed with PAH at 7 tertiary care centers between 2001 and 2022. Patients' characteristics and outcomes were compared in men vs. women, and factors independently associated with long-term outcomes were assessed. The primary endpoint was overall survival.

Results: Among 410 included patients, 273 (66.6 %) were women and 137 (33.4 %) were men. Despite similar age, men had more cardio-renal-metabolic comorbidities and history of HIV infection, whereas women had more connective tissue disorders and scleroderma, and worse functional capacity. Dual therapy was more commonly prescribed in women (39.9 % vs. 27.0 %). At multivariable Cox regression analysis, female sex was independently associated with a lower risk of all-cause mortality (adjusted hazard ratio 0.60, 95 % confidence interval 0.38-0.95, p = 0.031). Age, European Society of Cardiology (ESC) / European Respiratory Society (ERS) risk score, glomerular filtration rate and scleroderma were independently associated with long-term mortality in women, whereas only age and ESC/ERS risk score independently predicted this endpoint in men.

Conclusions: In this real-world registry, women represented 2 out of 3 patients with PAH and female sex was independently associated with a lower risk of mortality. There were differences in the variables associated with long-term mortality between sexes, suggesting that individualized approach to risk stratification should also include sex.

Keywords: FOCUS-PAH; Females; Males; Mortality; Pulmonary arterial hypertension; Sex.

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Conflict of interest statement

Declaration of competing interest Dr. Pagnesi has received personal fees from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Novartis, Roche Diagnostics and Vifor Pharma. Dr. Stolfo has been an advisory board member for Merck, Novo Nordisk, Acceleron, Janssen, Novartis and has received speaker fees from Novartis, none related to the present study. Dr. Ameri has received speaker and/or advisor fees from Janssen, MSD, and Gossamer Bio generally related to the topic of PAH, and speaker and/or advisor fees from Boehringer Ingelheim and Daiichi-Sankyo outside the scopes of the present work. Dr. Lo Giudice has received speaker and/or advisor fees from Janssen and MSD related to the topic of PAH but not to the scope of this paper. Prof. Metra has received consulting honoraria as a member of trial committees or advisory boards for Abbott Vascular, Actelion, Amgen, Bayer, Edwards Therapeutics, Servier, Vifor Pharma and Windtree Therapeutics. The other authors have no relevant conflict to disclose.

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