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直接口服抗凝剂时代静脉血栓栓塞症患者的抗凝策略与长期复发。

Anticoagulation strategies and long-term recurrence in patients with venous thromboembolism in the era of direct oral anticoagulants.

机构信息

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

出版信息

Eur J Intern Med. 2023 Dec;118:59-72. doi: 10.1016/j.ejim.2023.08.007. Epub 2023 Aug 11.

Abstract

BACKGROUND

There has been limited data on anticoagulation strategies and long-term recurrence in patients with venous thromboembolism (VTE) in the era of direct oral anticoagulant (DOAC).

METHODS

The COMMAND VTE Registry-2 is a multicenter retrospective cohort study enrolling 5197 consecutive patients with acute symptomatic VTE between January 2015 and August 2020 among 31 centers in Japan. In this primary report, the entire cohort was divided into 5 groups; major transient risk factors (N = 475, 9.1%), minor transient risk factors (N = 788, 15%), unprovoked (N = 1913, 37%), non-malignant persistent risk factors (N = 514, 9.9%), and active cancer (N = 1507, 29%) groups.

RESULTS

DOACs were administered in 79% of patients who received oral anticoagulants. Discontinuation of anticoagulant at 1 year was most frequent in the major transient risk factors group (57.2%, 46.3%, 29.1%, 32.0%, and 45.6%). The cumulative 5-year incidence of recurrent VTE was lowest in the major transient risk factors group (2.6%, 6.4%, 11.0%, 12.1%, and 10.1%, P < 0.001). The cumulative 5-year incidence of major bleeding was highest in the active cancer group (9.8%, 11.4%, 11.0%, 15.5%, and 20.4%, P < 0.001). After discontinuation of anticoagulation therapy, the cumulative 5-year incidence of recurrent VTE was highest in the unprovoked group (3.3%, 11.0%, 24.9%, 17.5%, and 11.8%, P < 0.001).

CONCLUSIONS

In this large real-world VTE registry, anticoagulation strategies and long-term recurrence widely differed depending on the baseline characteristics. Detailed risk stratifications of recurrent VTE could be useful for decision-making of anticoagulation strategies, whereas the bleeding-risk assessment might be especially important in the era of DOAC.

CLINICAL TRIAL REGISTRATION

URL: http://www.umin.ac.jp/ctr/index.htm Unique identifier: UMIN000044816.

摘要

背景

在直接口服抗凝剂(DOAC)时代,关于静脉血栓栓塞症(VTE)患者的抗凝策略和长期复发的数据有限。

方法

COMMAND VTE 登记-2 是一项多中心回顾性队列研究,纳入了 2015 年 1 月至 2020 年 8 月期间日本 31 个中心的 5197 例急性有症状 VTE 连续患者。在本初次报告中,整个队列分为 5 组;主要短暂风险因素(N=475,9.1%)、次要短暂风险因素(N=788,15%)、无诱因(N=1913,37%)、非恶性持续风险因素(N=514,9.9%)和活动性癌症(N=1507,29%)组。

结果

接受口服抗凝剂治疗的患者中,79%使用了 DOAC。在主要短暂风险因素组,1 年时停药最常见(57.2%、46.3%、29.1%、32.0%和 45.6%)。主要短暂风险因素组 5 年复发 VTE 的累积发生率最低(2.6%、6.4%、11.0%、12.1%和 10.1%,P<0.001)。活动期癌症组 5 年大出血累积发生率最高(9.8%、11.4%、11.0%、15.5%和 20.4%,P<0.001)。停止抗凝治疗后,无诱因组 5 年复发 VTE 的累积发生率最高(3.3%、11.0%、24.9%、17.5%和 11.8%,P<0.001)。

结论

在这项大型真实世界 VTE 登记研究中,基于基线特征,抗凝策略和长期复发存在广泛差异。对 VTE 复发的详细风险分层有助于抗凝策略决策,而在 DOAC 时代,出血风险评估可能尤为重要。

临床试验注册

网址:http://www.umin.ac.jp/ctr/index.htm 唯一标识符:UMIN000044816。

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