Objective

Management and outcomes of superficial vein thrombosis (SVT) are highly variable and not well described. Therefore, the INvestigating SIGnificant Health TrendS in the management of SVT (INSIGHTS-SVT) study collected prospective data under real life conditions.

Methods

Prospective observational study of objectively confirmed acute isolated SVT. The primary outcome was a composite of symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), and extension or recurrence of SVT at three months. The primary safety outcome was clinically relevant bleeding.

Results

A total of 1 150 patients were included (mean age 60.2 ± 14.7 years; 64.9% women; mean BMI 29.4 ± 6.3 kg/m²). SVT was below the knee in 54.5%, above the knee in 26.7%, above and below the knee in 18.8%. At baseline, 93.6% received pharmacological treatment (65.7% fondaparinux, 23.2% heparins, 4.3% direct oral anticoagulants [DOACs], 14.5% analgesics), 77.0% compression treatment, and 1.9% surgery; 6.4% did not receive any anticoagulation. The primary outcome occurred in 5.8%; 4.7% had recurrent or extended SVT, 1.7% DVT, and 0.8% PE. Clinically relevant non-major bleeding occurred in 1.2% and major bleeding in 0.3%. Complete clinical recovery of SVT was reported in 708 patients (62.4%). Primary outcome adjusted by propensity score and for treatment duration was lower with fondaparinux compared with low molecular weight heparin (4.4% vs. 9.6%; hazard ratio [HR] 0.51; 95% confidence interval [CI] 0.3 – 0.9; p = .017). On multivariable analysis, associated factors for primary outcome included another SVT prior to the present SVT event (HR 2.3), age per year (HR 0.97), duration of drug treatment per week (HR 0.92), and thrombus length (HR 1.03).

Conclusion

At three month follow up, patients with isolated SVT are at risk of thromboembolic complications (mainly recurrent or extended SVT), despite anticoagulation. In this real life study, about one third had received either heparins, oral anticoagulants, or no anticoagulation.

中文翻译：

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现实生活条件下孤立性浅静脉血栓形成患者的管理和结果 (INSIGHTS-SVT)

客观的

浅静脉血栓形成 (SVT) 的管理和结果变化很大并且没有很好地描述。因此，调查 SVT 管理中的重要健康趋势 (INSIGHTS-SVT) 研究收集了现实生活条件下的前瞻性数据。

方法

客观证实的急性孤立性 SVT 的前瞻性观察研究。主要结局是有症状的深静脉血栓形成 (DVT)、肺栓塞 (PE) 和 SVT 延长或三个月时复发的复合结局。主要安全性结局是临床相关的出血。

结果

共纳入 1 150 名患者（平均年龄 60.2 ± 14.7 岁；64.9% 为女性；平均 BMI 29.4 ± 6.3 kg/m ²）。SVT 膝以下为 54.5%，膝以上为 26.7%，膝以上和以下为 18.8%。基线时，93.6% 接受药物治疗（磺达肝素 65.7%、肝素 23.2%、直接口服抗凝剂 [DOAC] 4.3%、镇痛剂 14.5%）、加压治疗 77.0% 和手术 1.9%；6.4% 未接受任何抗凝治疗。主要结局发生率为 5.8%；4.7% 有复发或延长的 SVT，1.7% DVT 和 0.8% PE。临床相关的非大出血发生率为 1.2%，大出血发生率为 0.3%。据报道，708 名患者 (62.4%) 的 SVT 临床完全康复。与低分子量肝素相比，磺达肝素根据倾向评分和治疗持续时间调整的主要结果较低（4.4% vs. 9.6%；风险比 [HR] 0.51；95% 置信区间 [CI] 0.3 – 0.9；p  = .017）。在多变量分析中，主要结果的相关因素包括本次 SVT 事件之前的另一次 SVT (HR 2.3)、每年年龄 (HR 0.97)、每周药物治疗持续时间 (HR 0.92) 和血栓长度 (HR 1.03)。

结论

在三个月的随访中，尽管进行了抗凝治疗，但孤立性 SVT 患者仍有发生血栓栓塞并发症（主要是复发性或延长性 SVT）的风险。在这项现实生活研究中，大约三分之一接受了肝素、口服抗凝剂或未接受抗凝治疗。