OC 60.1 - Efficacy and safety of direct oral anticoagulants for treatment of venous thromboembolism in patients with renal insufficiency in a long-term follow-up. A real-life italian registry (MAC Project)

Tuesday, June 25, 2024

14:45 – 15:00 ICT

Room: Plenary Hall

Presenting Author(s)

Giuseppe Camporese

Assistant Professor
Padua University Hospital
Padova, Veneto, Italy

Co-Author(s)

EB

Enrico Bernardi

Chief of Emergency Department
Hospital of Treviso
Treviso, Veneto, Italy
CB

Cristiano Bortoluzzi

Assistant At Department of Internal Medicine
Hospital of Venice
Venice, Veneto, Italy
FN

Franco Noventa

President of QUOVADIS Association
QUOVADIS Association no-profit
Padova, 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
CS

Chiara Simion

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

Luca Spiezia

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

Fabio Dalla Valle

Assistant At Department of Internal Medicine
Padua University Hospital
Padova, Veneto, Italy
PS

Paolo Scarinzi

Assistant At Department of Internal Medicine
Padua University Hospital
Padova, Veneto, Italy
NV

Ngoc Vo Hong

Assistant At Department of Internal Medicine
Hospital of Venice
Venice, Veneto, Italy
EI

Egidio Imbalzano

Assistant Professor at Department of Medicine
University of Messina
Messina, Sicilia, Italy
PD

Pierpaolo Di Micco

Assistant At Department of Internal Medicine
PO A Rizzoli, ASL Napoli 2 Nord
Napoli, Campania, Italy
GG

Gaia Gagliardi

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

Chiara Di Gesù

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

Alessia Pacorini

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

Angela Napolitano

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

Chiara Tonello

Clinical Nurse Specialist at Unit of Angiology
Padua University Hospital
Padova, Veneto, Italy
MN

Michela Nardin

Clinical Nurse Specialist at Department of Medicine
Hospital of Venice
Venice, Veneto, Italy
Paolo Simioni, MD, PhD

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

Background: Anticoagulation with direct oral Xa inhibitors (DOACs) in patients with venous thromboembolism (VTE) and renal insufficiency still is matter of debate and long-term data is lacking

Aims: We report on patients enrolled in the real-life italian MAC registry, given DOACs as extended-phase anticoagulation in patients with VTE and different degrees of renal insufficency

Methods: The MAC Project is a prospective cohort, multi-center, observational, no-profit study. The project aims to collect real-life clinical information in unselected patients investigated in Italian hospital-based clinical centres and given DOACs for venous thromboembolism over a 5-year follow-up period. There are no exclusion criteria, except for life expectancy < 6 months and refusal to sign the informed consent form or to attend the planned follow-up visit. All patients are followed-up prospectively with clinical controls scheduled at 3, 6, and 12 months after the index event, and then annually for up to 5 years. All DOACs are prescribed according to current standards of care and regulations and not provided by any sponsor. The primary efficacy and safety outcomes are symptomatic recurrent VTE and major bleeding.

Results: From September 2018 a total of 1528 consecutive patients have been included. Of them, 989 had a valid creatinine clearance (CrCl) value. Overall, 754 (76.2%) had a CrCl 50-79 ml/min, 201 (20.3%) a CrCl 30-50 ml/min, and 34 (3.5%) a CrCl 15-29 ml/min. No significant statistical difference was found for VTE recurrrence among the three groups (8.0%, 8.0%, and 5.9%, respectively; p=0.907). A significant statistical difference was found for total bleeding among the three groups (5.3%, 10.4%, and 14.7%, respectively; p=0.006)

Conclusion(s): In patients with different degrees of renal insufficiency, the use of DOACs for VTE treatment has been shown to be equivalent in preventing VTE recurrence, but showed an increased risk of bleeding as renal function worsened