Major bleedings in mechanical prosthetic heart valves patients on Vitamin K antagonist treatment. Data from the PLECTRUM Study

Published: 27 July 2022
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  • Daniela Poli Center of Atherothrombotic Disease, Careggi University Hospital, Firenze, Italy.
  • Emilia Antonucci Arianna Anticoagulazione Foundation, Bologna, Italy.
  • Gualtiero Palareti Arianna Anticoagulazione Foundation, Bologna, Italy.
  • Roberto Facchinetti Test Lab, Ospedale Civile Maggiore Integrated University Hospital, Borgo Trento, Italy.
  • Pietro Falco Medical Pontino Specialist Outpatient Clinic, Latina, Italy.
  • Giuseppina Serricchio Test Lab, Sant'Anna Hospital, San Fermo della Battaglia, & Lariana Local Health Unit, Como, Italy.
  • Teresa Lerede Thrombosis and Hemostasis Center, Immunohematology and Transfusion Medicine, Papa Giovanni XXIII Hospital, Bergamo, Italy.
  • Lucilla Masciocco Department of Internal Medicine, Lastaria Hospital, Lucera, Italy.
  • Paolo Gresele Department of Medicine, Section of Internal and Cardiovascular Medicine, University of Perugia, Italy.
  • Sophie Testa Haemostasis and Thrombosis Centre, Cremona Local Health Unit, Cremona, Italy.

Patients with mechanical prosthetic heart valves (MHV) need vitamin K antagonist (VKA) treatment, due to the high thrombotic risk. The need to evaluate the bleeding risk of these patients is of great clinical relevance. This is an observational retrospective multicenter study among Centers affiliated to the Italian Federation of Anticoagulation Clinics on MHV patients, with the aim to evaluate the risk of major bleeding (MB) and associated risk factors. 2357 patients with MHV were included in the study, patients were followed for 24.081 pt-years; 246 patients had MB (rate 1.0 ×100 pt-yrs), 54 were intracranial hemorrhage (rate 0.22 ×100 pt-yrs). Patients with MB were significantly older, more affected by peripheral obstructive arterial disease (POAD) and atrial fibrillation (AF), and presented a history of previous MB, with respect to patients who did not bleed. Patients with MB showed a trend for lower time in therapeutic range (TTR), and a significant number of patients had a TTR in the lower quartile. Patients with MB had a higher mortality rate with respect to patients who did not bleed (p=0.001). The history of previous bleeding, the presence of POAD or of AF, and a TTR in the lowest quartile, were significantly associated with MB. MHV patients treated with VKAs followed by Anticoagulation Clinics, showed a low bleeding risk. Risk factors associated with major bleeding are older age, the presence of POAD or AF, the history of previous bleeding, and poor quality of anticoagulation. Patients who experienced MB during anticoagulation are at high risk of death.

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Poli, D., Antonucci, E., Palareti, G., Facchinetti, R., Falco, P., Serricchio, G., Lerede, T., Masciocco, L., Gresele, P., & Testa, S. (2022). Major bleedings in mechanical prosthetic heart valves patients on Vitamin K antagonist treatment. Data from the PLECTRUM Study. Bleeding, Thrombosis, and Vascular Biology, 1(2).


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