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.

IF 5 2区医学 Q1 HEMATOLOGY

Journal of Thrombosis and Haemostasis Pub Date : 2025-08-11 DOI:10.1016/j.jtha.2025.07.034

Daniela Poli, Roberto Parisi, Emilia Antonucci, Luca Barcella, Eugenio Bucherini, Antonio Chistolini, Angela Di Giorgio, Rosella Di Giulio, Marcello Di Nisio, Giovanna Elmi, Marco Marzolo, Roberta Pancani, Paola Stefania Preti, Piera Sivera, Sophie Testa, Andrea Toma, Vincenzo Tonelli, Luca Puccetti, Beniamino Zalunardo, Gualtiero Palareti, Alessandro Squizzato

{"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.","authors":"Daniela Poli, Roberto Parisi, Emilia Antonucci, Luca Barcella, Eugenio Bucherini, Antonio Chistolini, Angela Di Giorgio, Rosella Di Giulio, Marcello Di Nisio, Giovanna Elmi, Marco Marzolo, Roberta Pancani, Paola Stefania Preti, Piera Sivera, Sophie Testa, Andrea Toma, Vincenzo Tonelli, Luca Puccetti, Beniamino Zalunardo, Gualtiero Palareti, Alessandro Squizzato","doi":"10.1016/j.jtha.2025.07.034","DOIUrl":null,"url":null,"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.","PeriodicalId":17326,"journal":{"name":"Journal of Thrombosis and Haemostasis","volume":" ","pages":""},"PeriodicalIF":5.0000,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Thrombosis and Haemostasis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jtha.2025.07.034","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEMATOLOGY","Score":null,"Total":0}

引用次数: 0

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.

查看原文本刊更多论文

低剂量直接口服抗凝剂用于二级预防因静脉血栓栓塞事件复发史或严重血栓症复发风险高的患者：意大利START2注册的回顾性分析

背景：静脉血栓栓塞（VTE）复发风险高（HRR）患者推荐长期抗凝治疗。关于复发性静脉血栓栓塞和/或严重血栓形成患者的信息有限。此外，这些患者没有被纳入评估低剂量直接口服抗凝剂（DOACs）长期治疗的研究。方法：在START2注册的2520名静脉血栓栓塞患者中，我们回顾性分析了有复发性静脉血栓栓塞和/或严重血栓形成病史的患者（HRR患者）的管理。目的：本研究的目的是1)记录HRR患者使用的药物和剂量，2)记录随访期间发生的不良事件。结果：共分析了487例HRR患者。11/487例患者（2.3%）停止使用抗凝药物，176例患者（36.1%）继续使用全剂量抗凝药物，311例患者（63.9%）在中位时间1.3年（0.5-20.2年）后转入低剂量doac（阿哌沙班2.5 mg bid组61.4%，利伐沙班10 mg bid组38.6%）。在随访期间，停止治疗的患者无不良事件记录。在继续治疗的患者中，10例静脉血栓栓塞复发（发生率0.4 × 100 pt-年），19例出血（发生率0.9 × 100 pt-年）。静脉血栓栓塞复发的风险在全剂量抗凝患者和低剂量抗凝患者之间相似。全剂量组患者出血风险增高(相对危险度2.2；95% ci 0.7-9.0)。结论：长期接受低剂量DOACs治疗的有非诱发性复发性静脉血栓栓塞病史的HRR患者和/或严重血栓形成患者复发和出血事件的风险较低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Thrombosis and Haemostasis 医学-外周血管病

CiteScore

24.30

自引率

3.80%

发文量

321

审稿时长

1 months

期刊介绍： The Journal of Thrombosis and Haemostasis (JTH) serves as the official journal of the International Society on Thrombosis and Haemostasis. It is dedicated to advancing science related to thrombosis, bleeding disorders, and vascular biology through the dissemination and exchange of information and ideas within the global research community. Types of Publications: The journal publishes a variety of content, including: Original research reports State-of-the-art reviews Brief reports Case reports Invited commentaries on publications in the Journal Forum articles Correspondence Announcements Scope of Contributions: Editors invite contributions from both fundamental and clinical domains. These include: Basic manuscripts on blood coagulation and fibrinolysis Studies on proteins and reactions related to thrombosis and haemostasis Research on blood platelets and their interactions with other biological systems, such as the vessel wall, blood cells, and invading organisms Clinical manuscripts covering various topics including venous thrombosis, arterial disease, hemophilia, bleeding disorders, and platelet diseases Clinical manuscripts may encompass etiology, diagnostics, prognosis, prevention, and treatment strategies.