Prognosis Prediction and Shared Decision-Making for Personalized Anticoagulant Therapy after Unprovoked Venous Thromboembolism: The MORPHEUS Project.
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Couturaud Francis, Jiménez David, Sanchez Olivier, Turrini Mauro, Odeberg Jacob, Klok Frederikus A, Presles Emilie, Bourgain Catherine, Konstantinides Stavros V, Huisman Menno V, Morange Pierre Emmanuel, Germain Marine, Svendsen Mette N, Ollier Edouard, Tromeur Cecile, Salaun Pierre-Yves, Tregouet David Alexandre, Yaiche Sarhan, Bresson Ladegaard Knox Jeanette, Munsch Gaëlle, Fortin-Prunier Hélène, Righini Marc, Pruszczyk Piotr, Schreiber Karen, Patteri Tijana, Van de Merwe Lisa, Camilleri Eleonora, Eikenboom Anna, Becker Dorothea, Martin Nadine, Dissaux Brieg, Bourhis David, Bertoletti Laurent, Fischer Susanne, Murano Maria Cristina, Hartlev Mette, Hurst Samia, Laporte Silvy, Lemarié Catherine
Аннотация
OBJECTIVES: To develop and validate time-dependent, multicomponent risk prediction scores and socio-anthropological scales (TDMI) integrated in a shared decision-making process to optimize long-term anticoagulation management after unprovoked VTE.
METHODS: MORPHEUS is an international, multidisciplinary research programme conducted in eight European countries. The TDMI will combine clinical, biological, imaging, and pharmacological biomarkers with socio-anthropological scales reflecting patients' lived experiences, preferences, and perceptions of risk. Candidate components will be identified through systematic literature review, Delphi consensus, qualitative interviews with patients and physicians, and pooled analyses of large prospective European VTE cohorts including clinical outcomes, biobanks, and imaging data. Dynamic, multi-level, time-dependent prediction models for recurrent VTE and anticoagulant-related bleeding will be derived using advanced statistical and machine-learning approaches. The clinical effectiveness and acceptability of TDMI integrated in a shared decision-making process will be evaluated in a stepped-wedge cluster randomized trial enrolling 2,400 patients with a first unprovoked VTE.
RESULTS: The TDMI is expected to improve individualized risk stratification, reduce unnecessary extended anticoagulation, lower bleeding complications, and improve patient satisfaction, treatment adherence, and quality of life.
CONCLUSION: The MORPHEUS project will support personalized anticoagulation decisions and improve long-term outcomes in patients after unprovoked VTE.