Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany; Centre for Thrombosis and Haemostasis, University Medical Centre Mainz, Germany.
Private Office for Vascular Diseases, Mannheim, Germany.
Eur J Vasc Endovasc Surg. 2021 Aug;62(2):241-249. doi: 10.1016/j.ejvs.2021.04.015. Epub 2021 Jun 29.
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.
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.
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/m). 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).
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.
浅静脉血栓形成（SVT）的管理和结局差异很大，且描述不佳。因此，在真实环境下，采用前瞻性数据收集的方式，开展了“调查 SVT 管理中显著健康趋势（INSIGHTS-SVT）”研究。
本研究为客观证实的急性孤立性 SVT 的前瞻性观察性研究。主要结局为 3 个月时症状性深静脉血栓形成（DVT）、肺栓塞（PE）和 SVT 扩展或复发的复合结局。主要安全性结局为临床相关出血。
共纳入 1150 例患者（平均年龄 60.2 ± 14.7 岁；64.9%为女性；平均 BMI 29.4 ± 6.3 kg/m2）。SVT 位于膝下 54.5%、膝上 26.7%、膝上下 18.8%。基线时，93.6%接受药物治疗（65.7%为磺达肝癸钠，23.2%为肝素，4.3%为直接口服抗凝药[DOAC]，14.5%为镇痛药），77.0%接受压迫治疗，1.9%接受手术治疗；6.4%未接受任何抗凝治疗。主要结局发生率为 5.8%；4.7%出现复发或扩展的 SVT，1.7%出现 DVT，0.8%出现 PE。发生临床相关非大出血 1.2%，大出血 0.3%。708 例（62.4%）报告 SVT 完全临床康复。经倾向评分和治疗持续时间校正后，磺达肝癸钠组的主要结局发生率低于低分子肝素组（4.4%比 9.6%；风险比[HR]0.51；95%置信区间[CI]0.3-0.9；p =.017）。多变量分析显示，主要结局的相关因素包括本次 SVT 事件前存在另一 SVT（HR 2.3）、年龄每年增加 1 岁（HR 0.97）、每周药物治疗时间增加 1 周（HR 0.92）和血栓长度增加 1cm（HR 1.03）。
在 3 个月随访时，尽管接受了抗凝治疗，孤立性 SVT 患者仍有发生血栓栓塞并发症（主要为复发或扩展的 SVT）的风险。在这项真实世界研究中，约有三分之一的患者接受了肝素、口服抗凝剂或未接受抗凝治疗。
