A randomized double‐blind study of low‐molecular‐weight heparin (parnaparin) for superficial vein thrombosis: STEFLUX (Superficial ThromboEmbolism and Fluxum)

Abstract

Summary. Background: Optimal doses and duration of lowmolecular-weight heparin (LMWH) for the treatment of superficial vein thrombosis (SVT) are still uncertain. Objectives: To compare the efficacy and safety of different doses and durations of LMWH parnaparin for symptomatic lower limb SVT. Patients and methods: Outpatients with at least a 4-cmlong SVT of long or short saphenous veins or their collaterals were randomized to receive parnaparin either 8500 UI once daily ( o.d.) for 10 days followed by placebo for 20 days (group A) or 8500 UI o.d. for 10 days followed by 6400 UI once daily (o.d.) for 20 days (group B) or 4250 UI o.d. for 30 days (group C) in a double-blind fashion in 16 clinics. Primary outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and relapse and/or symptomatic or asymptomatic SVT recurrence in the first 33 days with 60 days followup. Results: Among 664 patients, primary outcome occurred in 33/212 (15.6%), 4/219 (1.8%) and 16/217 (7.3%) subjects in groups A, B and C, respectively (B vs. A: absolute risk reduction [ARR]: 13.7%, 95% confidence intervals [CI]: 8-18.9 P < 0.001; B vs. C: ARR: 5.5%; 95% CI: 1.6-9.4 P = 0.011; C vs. A: ARR: 8.2%, 95% CI: 2-14 P = 0.012). During days 0-93, the event rate was higher in group A (22.6%) than either in group B (8.7%; P = 0.001) or C (14.3%, P = 0.034). No major hemorrhages occurred. Conclusions: An intermediate dose of parnaparin for 30 days is superior to either a 30-day prophylactic dose or a 10-day intermediate dose for lower limb SVT treatment.

Annual diagnosis rate of superficial vein thrombosis of the lower limbs: the STEPH community‐based study

“…While strategies for the treatment of lower limb SVT are still debated [4,17,[22][23][24], this study provides useful information for future research on the management of this disease and its potential impact in terms of health care resource utilization and costs. This impact might call for implementing preventive strategies, for example, against varicose veins, which constitute the main risk factor for this disease.…”

Risk of venous and arterial thrombotic events in patients diagnosed with superficial vein thrombosis: a nationwide cohort study

“…9 Two other trials have confirmed these findings. 10,11 As a result, current guidelines now recommend this treatment regimen for patients with SVT of at least 5 cm in length on a lower limb. 12 Recently, Prandoni and colleagues performed a subanalysis of CALISTO trial data to examine whether SVT is associated with increased risk of subsequent arterial cardiovascular events.…”

Management of superficial venous thrombosis of the leg

“…Two studies of LMWH have evaluated the efficacy of different dose regimens of parnaparin and nadroparin (neither licensed in the UK) in patients with SVT 20,21…”