PB0952 - Bleeding rate of patients with hereditary thrombophilia during anticoagulation for venous thromboembolism: a multicenter cohort study

Monday, June 24, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Presenting Author(s)

CS

Chiara Simion

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

Co-Author(s)

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
EB

Elena Maria Bicego

Resident in Geriatrics
University of Padova, Department of Medicine - DIMED
Padova, Veneto, Italy
LS

Luca Spiezia

Assistant Professor at Department of Medicine
Padua University Hospital
Padova, Veneto, Italy
DT

Daniela Tormene

Researcher
University of Padova, Department of Medicine - DIMED
Padova, Veneto, Italy
GL

Giulia Libralon

Resident in Internal Medicine
University of Padova, Department of Medicine - DIMED
Padova, Veneto, Italy
MS

Maria Teresa Sartori

MD
University of Padova, Department of Medicine - DIMED
Padova, Veneto, Italy
DC

Davide Ceccato

MD
Angiology Unit, Padova University Hospital
Padova, Veneto, Italy
GT

Giacomo Turatti

MD
Angiology Unit, Padova University Hospital
Padova, Veneto, Italy
MM

Marta Milan

MD
Internal Medicine Unit, Azienda ULSS 5 Polesana
Rovigo, Veneto, Italy
SC

Stefano Cuppini

Head of Clinical Medicine
Azienda ULSS 5 Polesana
Rovigo, Veneto, Italy
CZ

Chiara Zurlo

MD
University of Padova, Department of Medicine - DIMED
Padova, Veneto, Italy
AV

Adriana Visonà

Head of Angiology Unit
Azienda ULSS 2 Marca Trevigiana
Castelfranco Veneto, Veneto, Italy
FC

Francesca Curri

Resident in Geriatrics
University of Padova, Department of Medicine - DIMED
Padova, Veneto, Italy
PP

Paolo Prandoni

MD, PhD
Fondazione Arianna
Padova, Veneto, Italy
Paolo Simioni, MD, PhD

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

Background: Hereditary gene mutations like factor V Leiden (FVL) and prothrombin G20210A mutation (PTM) may reduce anticoagulation-related bleeding risk in patients with venous thromboembolism (VTE). However, evidence is limited.

Aims: To assess whether carriers of mild thrombophilia are at a lower risk of bleeding during anticoagulation for VTE compared to patients without thrombophilia.

Methods: In this nationwide, multi-centre, retrospective cohort study, we included all consecutive patients with acute proximal deep vein thrombosis and/or pulmonary embolism undergoing thrombophilia screening, treated with full-dose anticoagulant therapy for at least 3 months. Outcomes were fatal, major, or clinically relevant non-major (CRNM), defined by the ISTH. Incidence rates (IR) were determined per 100 person-years of anticoagulation. A Cox proportional hazards model analyzed the association between thrombophilia and bleeding during anticoagulation. The study protocol received approval from the Local Ethical Committee.

Results: Of 756 patients, 314 (41.5%) were carriers of FVL and/or PTM, and 442 (58.5%) were negative for any thrombophilic condition. Carriers were younger, more frequently had a positive family and personal history of VTE, and had a longer anticoagulant treatment duration versus non-carriers (Table 1). Overall, carriers had a similar risk of bleeding during anticoagulation compared to non-carriers (IR 1.1 [95% CI 0.7-1.7] per 100 person-months, with relative risk 1.1 [95% CI 0.7-1.6]) (Figure 1). No significant difference was detected in fatal and major bleeding, while a trend of enhanced IR of CRNM bleeding was observed in carriers. Similar findings were observed when considering individually FVL or PTM carriers versus non-carriers, and considering only patients aged over 65. Multivariate Cox regression analysis, including comorbidities, antiplatelet use, and duration of anticoagulation, yielded consistent results (HR 1.1 [95% CI 0.7-1.7]).

Conclusion(s): Carriers of FVL and PTM do not exhibit a significant risk of bleeding complications during anticoagulant therapy compared to non-carriers, although CRNM are slightly more frequent in carriers.