Abstract
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/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). 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.
Highlights
Superficial vein thrombosis (SVT) describes partial or total thrombotic obstruction of the lumen of the affected vein and inflammatory alterations of the vessel wall.[1,2] Because of the inflammatory processes, SVT requires considerable time to heal and is associated with pain and discomfort
It has become clear that SVT, deep vein thrombosis (DVT), and pulmonary embolism (PE) are related entities, and they may occur concomitantly or in sequence
Of 1 159 patients who were documented at inclusion, 1 150 (99.2%) were available at three months for the primary outcome analysis, and 918 (79.2%) at one year
Summary
Superficial vein thrombosis (SVT) describes partial or total thrombotic obstruction of the lumen of the affected vein and inflammatory alterations of the vessel wall.[1,2] Because of the inflammatory processes, SVT requires considerable time to heal and is associated with pain and discomfort. SVT frequently manifests in the saphenous veins of the lower limbs, predominantly in varicose veins. In a retrospective cohort study in The Netherlands, the incidence of coded SVT events in primary care was 1.3 per 1 000 patient years.[3] Despite its frequent occurrence, SVT is less well studied than deep vein thrombosis (DVT). SVT was erroneously considered to be a minor, self limiting disease that is diagnosed on clinical grounds and that requires only symptomatic treatment.[4,5] it has become clear that SVT, DVT, and pulmonary embolism (PE) are related entities, and they may occur concomitantly or in sequence. According to a metaanalysis by Di Minno et al based on 4 358 patients in 21 studies, the concomitant prevalence of DVT and PE at SVT diagnosis was 18.1% (95% confidence interval [CI] 13.9 e 23.3%) and 6.9% (95% CI 3.9 e 11.8%), respectively.[6]
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