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Rationale and design of a study on D-dimer use to stratify patients after a first unprovoked venous thromboembolism for their risk of recurrence: extended low-dose Apixaban given only to patients with positive D-dimer results

The Apidulcis study

Authors

Gualtiero Palareti
gualtiero.palareti@fondazionearianna.org
Arianna Anticoagulazione Foundation, Bologna, Italy.
Paolo Prandoni
Arianna Anticoagulazione Foundation, Bologna, Italy.
Cristina Legnani
Arianna Anticoagulazione Foundation, Bologna, Italy.
Emilia Antonucci
Arianna Anticoagulazione Foundation, Bologna, Italy.
Serena Zorzi
Arianna Anticoagulazione Foundation, Bologna, Italy.
Alberto Tosetto
Department of Hematology, Center for Hemorrhagic and Thrombotic Diseases, AULSS8 Berica, Vicenza, Italy.
Lorenza Bertù
Research Center on Thromboembolic Diseases and Antithrombotic Therapies, University of Insubria, Varese, Italy.
Sophie Testa
Department of Laboratory Medicine, Haemostasis and Thrombosis Center, AO Istituti Ospitalieri, Cremona, Italy.
Vittorio Pengo
Thrombosis Research Laboratory, Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padua, Italy.
Walter Ageno
Department of Medicine and Surgery, University of Insubria, Varese, Italy.
Ida Martinelli
A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda - Ospedale Maggiore Policlinico, Milano, Italy.
Benilde Cosmi
Simple Departmental Structure - Angiology and Coagulation Diseases, IRCCS Bologna University Hospital, Università di Bologna, Italy.
Eugenio Bucherini
Simple Departmental Structure - Vascular Medicine and Angiology, Ospedale Civile Faenza, Faenza (RA), Italy.
Daniela Poli
Thrombosis Center, Careggi Hospital, Florence, Italy.

Optimal duration of anticoagulation in patients with a first venous thromboembolism (VTE) is still uncertain. Extended anticoagulant treatment beyond the first 3 to 6 months is recommended in patients with unprovoked VTE for their high risk of recurrence, provided the risk of bleeding during anticoagulation is not high. Recent meta-analyses indicated that only one-third of these patients have a recurrence 10 years after anticoagulation is stopped, whereas the risk of major bleeding is consistent and persistent during anticoagulation. We designed the prospective, multicenter Apidulcis study to test whether serial D-dimer measurements, using commercial assays with predefined sex-specific cutoffs (350 ng/mL and 500 ng/mL for men and women, respectively, for assays expressing results as fibrinogen equivalent units), may be useful to stratify patients for the risk of recurrence. Those presenting positive D-dimer results, considered at higher risk, will receive low dose Apixaban, 2.5 mg tablets BID for 18 months, whereas those with persistently negative D-dimer results, considered at lower risk, will remain without anticoagulant treatment. Outpatients with a first VTE (unprovoked or associated with weak risk factors), aged 18 to 74 years, who have already received anticoagulation for at least 12 months are eligible for the study.

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How to Cite



Rationale and design of a study on D-dimer use to stratify patients after a first unprovoked venous thromboembolism for their risk of recurrence: extended low-dose Apixaban given only to patients with positive D-dimer results: The Apidulcis study. (2022). Bleeding, Thrombosis and Vascular Biology, 1(1). https://doi.org/10.4081/btvb.2022.10
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