A Randomised Open-Label Trial Comparing Long-term Sub-Cutaneous Low-Molecular-weight Heparin Compared with Oral-Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis
A Randomised Open-Label Trial Comparing Long-term Sub-Cutaneous Low-Molecular-weight Heparin Compared with Oral-Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis
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DOI：
10.1016/j.ejvs.2008.11.030
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发表时间：
2009-03-01
影响因子：
5.7
通讯作者：
Lapiedra, O.
中科院分区：
文献类型：
--
作者：
Romera, A.;Cairols, M. A.;Lapiedra, O.
目的：评估低分子肝素（LMWH）在长期治疗深静脉血栓（DVT）时是否能与口服抗维生素 K 药物（AVK）同等（或更佳）有效。 设计：一项随机、开放标签试验。 材料和方法：在该试验中，纳入了 241 例经双功能超声扫描证实有症状的塔肢近端 DVT 患者。初始 LMWH 后，患者接受 6 个月的全治疗剂量亭扎肝素或醋硝香豆素治疗。主要结局是 12 个月内有症状的复发性静脉血栓栓塞 (VTE) 的发生率。在 6 个月和 12 个月时进行双重扫描。 结果：在 12 个月期间，接受 LMWH 的 119 名患者中有 6 名 (5%) 接受 AVK 的 122 名患者中有 13 名 (10.7%) 出现复发性 VTE (p = 0.11)。在癌症患者中，LMWH 组的复发性 VTE 往往较低（36 例中的 2 例 [5.5%]），而 33 例中的 7 例 [21.2%]； p = 0.06）。 LMWH 组发生 1 例大出血，AVK 组发生 3 例大出血。 LMWH 组的静脉再通率在 6 个月（73.1% vs. 47.5%）和 12 个月（91.5% vs. 69.2%）时显着增加。 结论：亭扎肝素在实现腿部血栓再通方面比 AVK 更有效。长期服用亭扎肝素在预防 VTE 复发方面至少与 AVK 一样有效和安全，特别是对于癌症患者。皇冠版权所有 (C) 2008 由 Elsevier Ltd 代表欧洲血管外科学会出版。版权所有。
Objective: To evaluate whether low-molecular-weight heparin (LMWH) could be equally (or more) effective than oral anti-vitamin-K agents (AVK) in the long-term treatment of deep venous thrombosis (DVT).Design: A randomised, open-Label trial.Material and methods: In this trial, 241 patients with symptomatic proximal DVT of the tower limbs confirmed by duplex ultrasound scan were included. After initial LMWH, patients received 6 months of treatment with full therapeutic dosage of tinzaparin or acenocoumarol. The primary outcome was the 12-month incidence of symptomatic recurrent venous thromboembolism (VTE). Duplex scans were performed at 6 and 12 months.Results: During the 12-month period, six patients (5%) of 119 who received LMWH and 13 (10.7%) of 122 who received AVK had recurrent VTE (p = 0.11). In patients with cancer, recurrent VTE tended to be lower in the LMWH group (two of 36 [5.5%]) vs. seven of 33 [21.2%]; p = 0.06). One major bleeding occurred in the LMWH group and three in the AVK group. Venous re-canalisation increased significantly at 6 months (73.1% vs. 47.5%) and at 12 months (91.5% vs. 69.2%) in the LMWH group.Conclusions: Tinzaparin was more effective than AVK in achieving re-canalisation of leg thrombi. Long-term tinzaparin was at least as efficacious and safe as AVK for preventing recurrent VTE, especially in patients with cancer. Crown Copyright (C) 2008 Published by Elsevier Ltd on behalf of European Society for Vascular Surgery. All rights reserved.