Department of Vascular Medicine, Herz-Zentrum, Bad Krozingen, Germany.
J Vasc Surg. 2010 Nov;52(5):1246-50. doi: 10.1016/j.jvs.2010.05.094. Epub 2010 Jul 13.
Treatment of isolated calf muscle vein thrombosis (ICMVT) is controversial. There are no data from prospective, controlled studies. Objective of this article was to compare the efficacy and safety of a short-term course of anticoagulation with compression therapy alone.
We prospectively randomized patients with symptomatic, sonographically proven ICMVT in the soleal and/or gastrocnemial muscle veins in two treatment arms. The first received low-molecular-weight heparin for 10 days at therapeutic dosage (nadroparin 180 anti-activated factor X units once daily) and compression therapy for three months, and the second received compression therapy alone. Primary efficacy endpoint of the study was sonographically proven progression of ICMVT into the deep veins and clinical pulmonary embolism (PE) as confirmed by objective testing. Secondary efficacy and primary safety endpoints were major bleeding, death not due to PE, and complete sonographically proven recanalization of the muscle vein. We assessed transient and permanent risk factors for venous thromboembolism.
One-hundred seven patients were finally ruled eligible for evaluation: 89% outpatients, 11% hospitalized patients. In the heparin group (n=54) progression to deep vein thrombosis (DVT) occurred in two patients (3.7%), in the group compression therapy alone (n=53) progression to DVT occurred in two patients (n.s.). No clinical PE and no death occurred. Thrombus recanalization after 3 months was not statistically significant different between the two study groups. No major bleeding occurred.
The data do not show superiority of a short-term regimen of low-molecular-weight heparin and compression therapy in comparison with compression therapy alone in patients with ICMVT in a rather low-risk population.
孤立性小腿肌静脉血栓（ICMVT）的治疗存在争议。目前尚无前瞻性对照研究的数据。本文的目的是比较短期抗凝联合压迫治疗与单纯压迫治疗的疗效和安全性。
我们前瞻性地将症状性、超声证实的比目鱼肌和/或腓肠肌静脉内 ICMVT 患者随机分为两组。一组接受低分子肝素 10 天（达肝素 180 抗活化因子 X 单位，每日一次）和 3 个月的压迫治疗，另一组仅接受压迫治疗。研究的主要疗效终点是超声证实 ICMVT 进展为深静脉血栓和临床肺栓塞（PE），并通过客观检查证实。次要疗效和主要安全性终点是主要出血、非 PE 相关死亡和肌肉静脉完全超声再通。我们评估了静脉血栓栓塞的短暂和永久性危险因素。
最终有 107 例患者符合评估条件：89%为门诊患者，11%为住院患者。肝素组（n=54）有 2 例（3.7%）进展为深静脉血栓（DVT），单纯压迫治疗组（n=53）有 2 例（n.s.）进展为 DVT。无临床 PE 和死亡发生。3 个月后血栓再通在两组间无统计学差异。无重大出血发生。
数据显示，在低危人群中，与单纯压迫治疗相比，短期低分子肝素和压迫治疗方案并不优于单纯压迫治疗。
