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急性肺栓塞患者需要二级血栓预防,在停止口服抗凝剂后 5 年内为获得最大获益,最佳的口服抗凝治疗时间长度。

Optimal length of oral anticoagulant treatment for maximum benefit within 5 years after discontinuation of oral anticoagulants in patients with acute pulmonary embolism who require secondary thromboprophylaxis.

机构信息

Department of Pulmonary and Critical Care Medicine, Punan Hospital, Pudong New District, Shanghai, China.

Department of Pulmonary and Critical Care Medicine, Chongming Hospital, Shanghai University of Medicine and Health Science, Shanghai, China.

出版信息

BMJ Open Respir Res. 2023 Aug;10(1). doi: 10.1136/bmjresp-2023-001856.

Abstract

BACKGROUND

Extended oral anticoagulant (OA) use is recommended in patients with acute pulmonary embolism (PE) who require secondary thromboprophylaxis. Nevertheless, the optimal length of OA use for the maximum long-term benefit in this patient population has been undefined to date.

METHODS

A retrospective study was performed to explore the role of different length of overall OA use (group 1 (≥1 year of OA use and <2 years of OA use), group 2 (≥2 years of OA use and <3 years of OA use), group 3 (≥ 3 years of OA use)) in outcomes within 5 years after OA discontinuation in patients with acute PE, who required secondary thromboprophylaxis. The primary outcome was mortality rates. The secondary outcomes comprised venous thromboembolism (VTE) recurrence, major bleeding during OA use and net clinical benefit. Net clinical benefit was defined as the composite of recurrent VTE and major bleeding.

RESULTS

For a total of 385 patients in group 1 (n=220), group 2 (n=110) and group 3 (n=55), the PE-related mortality in group 1 was higher than that in group 2 (p=0.034) and 3 (p=0.040), respectively, whereas were similar between groups 2 and 3 (p=1.000). The net clinical benefit in group 1 was less than that in group 2 (p=0.024), whereas similar with that in group 3 (p=0.526). The net clinical benefit was comparable between groups 2 and 3 (p=0.716). The length of OA use was positively associated with major bleeding (HR, 2.510 (0.293 to 3.485), p=0.001), whereas negatively associated with PE-related mortality (HR, 0.668 (0.196 to 2.832), p=0.025) and VTE recurrence (HR, 0.694 (0.174 to 2.300), p=0.036), respectively. The sensitivity and specificity of the length of OA use for the tendency of PE-related mortality was 70.2% and 46.2%, respectively. The area under the curve (AUC) was 0.654 (0.514 to 0.793) (p=0.029). The sensitivity and specificity of the length of OA use for the tendency of net clinical benefit was 86.8% and 64.3%, respectively. The AUC was 0.628 (0.565 to 0.690) (p<0.001) CONCLUSIONS: For patients with acute PE who require secondary thromboprophylaxis, 2 to 3 years (30 months preferred) of overall OA use after a diagnosis of acute PE could be an optimal length to achieve maximum benefit within 5 years after OA discontinuation.

摘要

背景

对于需要二级血栓预防的急性肺栓塞(PE)患者,建议延长口服抗凝剂(OA)的使用时间。然而,迄今为止,尚未确定在该患者人群中使用 OA 的最佳时间长度以获得最大的长期获益。

方法

进行了一项回顾性研究,以探讨不同 OA 使用总时长(组 1(≥1 年且<2 年的 OA 使用时间)、组 2(≥2 年且<3 年的 OA 使用时间)、组 3(≥3 年的 OA 使用时间))对急性 PE 患者停止 OA 治疗后 5 年内结局的影响,这些患者需要二级血栓预防。主要结局是死亡率。次要结局包括 OA 使用期间的静脉血栓栓塞(VTE)复发、主要出血以及净临床获益。净临床获益定义为 VTE 复发和主要出血的复合事件。

结果

在组 1(n=220)、组 2(n=110)和组 3(n=55)的 385 名患者中,组 1 的 PE 相关死亡率高于组 2(p=0.034)和组 3(p=0.040),而组 2 与组 3之间无显著差异(p=1.000)。组 1 的净临床获益小于组 2(p=0.024),与组 3相当(p=0.526)。组 2 和组 3 的净临床获益相当(p=0.716)。OA 使用时间的长短与主要出血呈正相关(HR,2.510(0.293 至 3.485),p=0.001),而与 PE 相关的死亡率(HR,0.668(0.196 至 2.832))和 VTE 复发(HR,0.694(0.174 至 2.300))呈负相关,p 值分别为 0.025 和 0.036。OA 使用时间对 PE 相关死亡率趋势的敏感性和特异性分别为 70.2%和 46.2%。曲线下面积(AUC)为 0.654(0.514 至 0.793)(p=0.029)。OA 使用时间对净临床获益趋势的敏感性和特异性分别为 86.8%和 64.3%。AUC 为 0.628(0.565 至 0.690)(p<0.001)。

结论

对于需要二级血栓预防的急性 PE 患者,在急性 PE 诊断后使用 2 至 3 年(30 个月为佳)的 OA 可能是在停止 OA 治疗后 5 年内获得最大获益的最佳时长。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d40/10441053/ceebe6d9fd8c/bmjresp-2023-001856f01.jpg

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