从前瞻性观察登记中评估癌症患者和非癌症患者的直接口服抗凝剂剂量策略

IF 3.4 3区医学 Q2 HEMATOLOGY

Research and Practice in Thrombosis and Haemostasis Pub Date : 2025-05-01 DOI:10.1016/j.rpth.2025.102878

Danielle T. Vlazny , Robert D. McBane , Ana I. Casanegra , David O. Hodge , Teresa Lang , Waldemar E. Wysokinski , Lisa Peterson , Damon E. Houghton

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引用次数: 0

摘要

低剂量直接口服抗凝剂（DOACs）在治疗剂量6个月后延长预防静脉血栓栓塞（VTE）的随机对照试验中进行了研究。目的：本研究通过对真实世界癌症患者的专门分析，检验了低剂量doac的有效性、安全性和利用率。方法：2013年3月1日至2022年12月31日，梅奥诊所静脉血栓栓塞登记中心（Mayo Clinic VTE Registry）连续登记的患者，前瞻性随访静脉血栓栓塞复发、大出血（MB）和临床相关非MB （CRNMB）。在前3个月内发生事件的患者被排除在外。使用利伐沙班或阿哌沙班抗凝治疗3个月后，通过Cox回归和巢式病例对照研究评估患者继续抗凝治疗的特征和结果。结果低剂量doac组共466例（71%为阿哌沙班，29%为利伐沙班），全剂量组2273例。各组之间的人口统计数据基本相似。在总体低剂量DOAC组中，以活动性癌症作为诱发因素的患者较少。Cox回归分析显示，两组间静脉血栓栓塞复发无明显差异。在非肿瘤患者中，低剂量组CRNMB下降，但MB未下降(危险比[HR]， 4.97；P & lt;措施)。在癌症患者中，低剂量DOACs对MB有保护作用(HR, 4.48；P = .001)和CRNMB (HR, 6.81；P & lt;措施)。在巢式病例对照分析中，出血结局也相同。结论减少剂量维持了较低的复发率，但也减少了出血，在肿瘤人群中效果最为显著。

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Evaluation of extended direct oral anticoagulant dosing strategies in patients with and without cancer from a prospective observational registry

Background

Low-dose direct oral anticoagulants (DOACs) have been studied in randomized controlled trials for extended prevention of venous thromboembolism (VTE) after 6 months at therapeutic doses.

Objectives

This study examined the effectiveness, safety, and utilization of low-dose DOACs in a real-world cohort with dedicated analysis of cancer patients.

Methods

Consecutive patients enrolled in the Mayo Clinic VTE Registry from March 1, 2013, to December 31, 2022, were followed prospectively for VTE recurrence, major bleeding (MB), and clinically relevant non-MB (CRNMB). Patients with events during the first 3 months were excluded. After anticoagulation for 3 months with either rivaroxaban or apixaban, characteristics and outcomes of patients continuing anticoagulation were evaluated by Cox regression and a nested case-control study.

Results

In total, 466 patients (71% apixaban and 29% rivaroxaban) were identified on low-dose DOACs and 2273 in the full-dose group. Demographics between groups were mostly similar. Patients with active cancer as a provoking factor were less common in the overall low-dose DOAC group. In Cox regression analysis, VTE recurrence was not different between any groups. In noncancer patients, CRNMB but not MB was decreased in the low-dose group (hazard ratio [HR], 4.97; P < .001). In patients with cancer, low-dose DOACs were protective for MB (HR, 4.48; P = .001) and CRNMB (HR, 6.81; P < .001). Bleeding outcomes were the same in nested case-control analysis as well.