PB0440 - Progestin drugs are not associated with an increased risk of thrombotic events in patients with severe inherited thrombophilia. A single-center retrospective cohort study

Sunday, June 23, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Presenting Author(s)

Nicola Perin, MD

Resident
Internal Medicine Unit, Thrombotic and Hemorrhagic Diseases Unit, Department of Medicine, University of Padua
Padua, Veneto, Italy

Co-Author(s)

LS

Luca Spiezia

Assistant Professor at Department of Medicine
Padua University Hospital
Padova, Veneto, Italy
Ariela Hoxha, PhD, MSc

Assistant Professor
Internal Medicine Unit, Thrombotic and Hemorrhagic Diseases Unit, Department of Medicine, University of Padua
Padua, Veneto, Italy
Elena Campello, PhD

Assistant Professor
General Internal Medicine Unit and Thrombotic and Hemorrhagic Disease Unit, Department of Medicine, Padova University Hospital, Padova, Italy
Padova, Veneto, Italy

Co-Author(s)

AN

Angela Napolitano

Post-graduate student in internal medicine
Padua University Hospital
Padova, Veneto, Italy

Co-Author(s)

AA

Alessandra Aquilone

Internal Medicine Unit, Thrombotic and Hemorrhagic Diseases Unit, Department of Medicine
University of Padua
ferrara, Emilia-Romagna, Italy
CS

Chiara Simion

PhD Student in Hematological and Geriatric Sciences
University of Padua, Department of Medicine -DIMED
Padova, Veneto, Italy
AP

Alessia Pacorini

Post-graduate student in internal medicine
Padua University Hospital
Padova, Veneto, Italy
Paolo Simioni, MD, PhD

Head of Department of Medicine
University of Padova, Padova University Hospital
Padova, Veneto, Italy

Background: The use of combined estrogen-progestin contraception (COC) is a recognized risk factor for the development of thrombotic events. Therefore, such therapies are generally avoided in patients with hereditary thrombophilia. While several studies have provided evidence about the safety of progestin-only contraception (POC) in the general population, few data are available for patients with hereditary thrombophilia.

Aims: The purpose of this study is to assess the incidence of thrombotic events in carriers of antithrombin, protein C, or protein S hereditary deficiency assuming POC and to compare the risk of thrombotic events between POC and COC hormonal regimens and between POC and no-hormone regimens.

Methods: A retrospective single-center cohort study was performed. Medical records of 196 consecutive women of childbearing age, carriers of severe thrombophilia, and attending the Thrombotic and Hemorrhagic Center at University of Padua from 2006 to 2023 were included.
Exclusion criteria were active cancer, acquired thrombophilia, and long-term anticoagulant therapy. Non-parametric descriptive and analytical statistical methods were used.

Results: Thirty-four (17.3%) had antithrombin deficiency, 64 (32.7%) had protein C deficiency, and 98 (50%) had protein S deficiency. One-hundred and twenty-four (63.2%) women were treated with hormonal therapy, of whom 35 (28.2%) with POC for a median time of 21 months (IQR, 10-32), and 89 (71.7%) with COC for a median time of 24 months (IQR, 12-60). Overall, 32 patients developed a VTE event: 30 (33%) in the COC group, 2 (2.7%) in the non-therapy group, and no VTE event was registered in the POC group. There was a significantly higher rate of VTE events in the COC group compared to the POC one (p < 0.001). There was no difference between the POC group and the no-therapy one (p=0.34).

Conclusion(s): Our findings confirm that POC therapy was not associated with an increased risk of VTE events in carriers of severe hereditary thrombophilia.