Low-dose direct oral anticoagulants for secondary prevention in patients at high risk for recurrence due to history of recurrent venous thromboembolic events or severe thrombophilia: a retrospective analysis of the Italian Survey on anTicoagulated pAtients RegisTry 2.
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| Title: | Low-dose direct oral anticoagulants for secondary prevention in patients at high risk for recurrence due to history of recurrent venous thromboembolic events or severe thrombophilia: a retrospective analysis of the Italian Survey on anTicoagulated pAtients RegisTry 2. |
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| Authors: | Poli D; Center of Atherothrombotic Disease, Dipartimento Cardiotoraco-Vascolare, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy. Electronic address: polida@aou-careggi.toscana.it., Parisi R; Unità Operativa Semplice Dipartimentale Ipertensione e Patologie Endocrine Metaboliche Angiologiche, Ospedale SS. Giovanni e Paolo, Venezia, Italy., Antonucci E; Fondazione Arianna Anticoagulazione, Bologna, Italy., Barcella L; Immunohematology and Transfusion Medicine, Hospital Papa Giovanni XXIII, Bergamo, Italy; European Reference Network-EuroBloodNet, European Reference Network on Rare Hematological Diseases., Bucherini E; Medicina Vascolare, Poliambulatorio Physiomedica, Faenza, Italy., Chistolini A; Dipartimento di Medicina Traslazionale e di Precisione Sapienza, Università di Roma, Roma, Italy., Di Giorgio A; Angiologia e diagnostica vascolare non invasiva, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica del Sacro Cuore, Roma, Italy., Di Giulio R; Unità Operativa Programma Dipartimentale di Ecografia, Azienda Unità Sanitaria Locale, Bologna, Italy., Di Nisio M; Department of Medicine and Ageing Sciences, University 'G.D'Annunzio,' Chieti-Pescara, Italy., Elmi G; Unità Operativa Programma Dipartimentale di Ecografia, Azienda Unità Sanitaria Locale, Bologna, Italy., Marzolo M; Unità Operativa Semplice di Angiologia Medica, Ospedale di Rovigo, Rovigo, Italy., Pancani R; Unità Operativa di Pneumologia, Dipartimento Cardiotoraco-Vascolare, Azienda Ospedaliero Universitaria Pisana, Ospedale di Cisanello, Pisa, Italy., Preti PS; Unità Operativa Semplice di Emostasi e Trombosi-Medicina Generale 1, Università degli Studi di Pavia, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico S. Matteo, Pavia, Italy., Sivera P; S.C.D.U. Ematologia, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy., Testa S; Laboratory Medicine Department, Haemostasis and Thrombosis Centre, Azienda Socio-Sanitaria Territoriale Cremona, Cremona, Italy., Toma A; UOC Medicina di Laboratorio, Ambulatorio Terapia Anticoagulante Orale Arzignano (VI), Azienda Unità Locale Socio-Sanitaria 8 'Berica', Vicenza, Italy., Tonelli V; Unità Operativa Semplice Dipartimentale di Angiologia, Ospedale Sant'Eugenio, Azienda Sanitaria Locale Roma 2, Roma, Italy., Puccetti L; Hemostasis and Thrombosis Unit, Aziensa Ospedaliero Universitaria Siena, Dipartimento di Scienze Mediche, Chirurgiche e Neuroscienze, University of Siena, Siena, Italy., Zalunardo B; Unità Operativa Complessa Angiologia, Azienda Unità Locale Socio-Sanitaria 2 Marca Trevigiana, Ospedale San Giacomo Apostolo, Castelfranco, Veneto, Italy., Palareti G; Fondazione Arianna Anticoagulazione, Bologna, Italy., Squizzato A; Struttura Complessa di Medicina Interna, SCUD struttura complessa a direzione universitaria, Azienda Socio Sanitaria Territoriale Lariana, Ospedale Sant'Anna, Como, Italy. |
| Source: | Journal of thrombosis and haemostasis : JTH [J Thromb Haemost] 2025 Nov; Vol. 23 (11), pp. 3625-3632. Date of Electronic Publication: 2025 Aug 11. |
| Publication Type: | Journal Article; Multicenter Study; Observational Study |
| Language: | English |
| Journal Info: | Publisher: Elsevier Country of Publication: England NLM ID: 101170508 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1538-7836 (Electronic) Linking ISSN: 15387836 NLM ISO Abbreviation: J Thromb Haemost Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2023- : [New York] : Elsevier Original Publication: Oxford : Blackwell Pub. |
| MeSH Terms: | Anticoagulants*/administration & dosage , Anticoagulants*/adverse effects , Factor Xa Inhibitors*/administration & dosage , Factor Xa Inhibitors*/adverse effects , Secondary Prevention*/methods , Thrombophilia*/drug therapy , Thrombophilia*/diagnosis , Thrombophilia*/blood , Venous Thromboembolism*/diagnosis , Venous Thromboembolism*/prevention & control , Venous Thromboembolism*/drug therapy , Venous Thromboembolism*/blood , Venous Thromboembolism*/epidemiology, Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Administration, Oral ; Hemorrhage/chemically induced ; Italy ; Recurrence ; Registries ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Rivaroxaban/administration & dosage ; Rivaroxaban/adverse effects ; Severity of Illness Index ; Time Factors ; Treatment Outcome |
| Abstract: | Background: Long-term anticoagulation is recommended in patients with venous thromboembolism (VTE) deemed at high risk for recurrence (HRR). Limited information is available on patients with recurrent VTE and/or severe thrombophilia. In addition, these patients were not included in studies evaluating long-term treatment with low doses of direct oral anticoagulants (DOACs). Objectives: The aims of our study were to (1) record the drugs and dosages used in HRR patients, and (2) to record adverse events occurring during follow-up. Methods: Among 2520 VTE patients enrolled in the Survey on anTicoagulated pAtients RegisTry 2, we retrospectively analyzed the management of patients with a history of recurrent VTE and/or severe thrombophilia (HRR patients). Results: A total of 487 HRR patients were analyzed. Anticoagulants were stopped in 11 of 487 patients (2.3%), full-dose DOACs were continued in 176 patients (36.1%), and 311 patients (63.9%) were shifted to low-dose DOACs (61.4% with apixaban 2.5 mg twice a day and 38.6% with rivaroxaban 10 mg once a day) after a median time of 1.3 years (range, 0.5-20.2 years). During follow-up, no adverse events were recorded in patients who stopped treatment. Among patients who continued treatment, 10 had recurrent VTE (rate, 0.4 × 100 patient-years) and 19 had bleeding (rate, 0.9 × 100 patient-years). The risk of recurrent VTE was similar between patients on full-dose and low-dose anticoagulation. Patients on full-dose anticoagulation had a trend toward a higher bleeding risk (relative risk, 2.2; 95% CI, 0.7-9.0). Conclusion: HRR patients with a history of unprovoked recurrent VTE and/or patients with severe thrombophilia treated with long-term low-dose DOACs showed a low risk for recurrence and bleeding events. (Copyright © 2025 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.) |
| Contributed Indexing: | Keywords: bleeding risk; low-dose direct oral anticoagulants; venous thromboembolism; venous thromboembolism recurrence |
| Substance Nomenclature: | 0 (Anticoagulants) 0 (Factor Xa Inhibitors) 9NDF7JZ4M3 (Rivaroxaban) |
| Entry Date(s): | Date Created: 20250813 Date Completed: 20251025 Latest Revision: 20251203 |
| Update Code: | 20251204 |
| DOI: | 10.1016/j.jtha.2025.07.034 |
| PMID: | 40803569 |
| Database: | MEDLINE |
Nájsť tento článok vo Web of Science | Abstract: | Background: Long-term anticoagulation is recommended in patients with venous thromboembolism (VTE) deemed at high risk for recurrence (HRR). Limited information is available on patients with recurrent VTE and/or severe thrombophilia. In addition, these patients were not included in studies evaluating long-term treatment with low doses of direct oral anticoagulants (DOACs).<br />Objectives: The aims of our study were to (1) record the drugs and dosages used in HRR patients, and (2) to record adverse events occurring during follow-up.<br />Methods: Among 2520 VTE patients enrolled in the Survey on anTicoagulated pAtients RegisTry 2, we retrospectively analyzed the management of patients with a history of recurrent VTE and/or severe thrombophilia (HRR patients).<br />Results: A total of 487 HRR patients were analyzed. Anticoagulants were stopped in 11 of 487 patients (2.3%), full-dose DOACs were continued in 176 patients (36.1%), and 311 patients (63.9%) were shifted to low-dose DOACs (61.4% with apixaban 2.5 mg twice a day and 38.6% with rivaroxaban 10 mg once a day) after a median time of 1.3 years (range, 0.5-20.2 years). During follow-up, no adverse events were recorded in patients who stopped treatment. Among patients who continued treatment, 10 had recurrent VTE (rate, 0.4 × 100 patient-years) and 19 had bleeding (rate, 0.9 × 100 patient-years). The risk of recurrent VTE was similar between patients on full-dose and low-dose anticoagulation. Patients on full-dose anticoagulation had a trend toward a higher bleeding risk (relative risk, 2.2; 95% CI, 0.7-9.0).<br />Conclusion: HRR patients with a history of unprovoked recurrent VTE and/or patients with severe thrombophilia treated with long-term low-dose DOACs showed a low risk for recurrence and bleeding events.<br /> (Copyright © 2025 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.) |
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| ISSN: | 1538-7836 |
| DOI: | 10.1016/j.jtha.2025.07.034 |