Replacement effectiveness of standard anticoagulant therapy of patients with deep vein thrombosis in the inferior vena cava system
Aim: to evaluate the clinical effectiveness of standard anticoagulant therapy replacement to sulodexide in the treatment of patients experienced deep vein thrombosis (DVT) in the inferior vena cava system. Patients and Methods: this study included 746 patients who underwent proximal DVT of the lower extremities, took standard anticoagulant therapy for 6 months, and then received acetylsalicylic acid (ASA) in a dosage of 100 mg (group 1) by randomization of 350 patients, whereas 389 patients took sulodexide in 500 dosage units daily for 6 months (group 2). To assess the effectiveness of the treatment, the following parameters were used: Villalta Score for Post-thrombotic Syndrome (PTS); Visual Analogue Scale (VAS) for pain measurement; Venous Clinical Severity Score (VCSS); circumference measurement of the limbs on the thigh and lower leg; lower extremities vein Color Doppler Imaging (CDI). Results: 739 patients completed the study. As a result of the conducted treatment, the convulsive syndrome in the calf muscles completely regressed in all patients of group 2. In group 1, 24.3% of patients complained of convulsive syndrome, and by the end of the sixth month of taking ASA, these complaints remained in 11.5% of patients (p=0.0861). There was a significant decrease in the complaints frequency of heaviness sensation and fatigue in the lower extremities under static loads in both groups from 26.3% to 9.4% (p=0.2414). The thigh circumference perimeter on the affected limb statistically significantly decreased only in group 2, in the middle tercile - from 53.7 cm to 51.1 cm (p<0.05), in the middle tercile of the lower leg - from 36.8 cm to 33.8 cm (p<0.05) and in the lower tercile of the lower leg - from 23.4 cm to 21.5 cm (p<0.05). According to VAS, there was a decrease in pain syndrome in the lower extremities in both groups: in group 1 - from 55.36±24.71 mm to 31.44±17.07 mm (p=0.05), in group 2 - from 58.54±16.64 mm to 18.56±04 mm (p=0.0005). During the study of Villalta and VCSS questionnaires, the PTS severity of patients in group 1 was 13.5 points (PTS moderate severity), and in group 2 - 7.6 points (PTS mild severity). VCSS index decreased from 5.93±1.79 to 4.79±2.01 points in group 2-21% (p=0.0002). In group 1, the VCSS index decreased from 5.96±1.41 to 5.49±1.71 points -10.1% (p=0.04). When studying the lower extremities vein CDI data, it was found that deep vein recanalization ranged from 12% to 25% after 6 months of standard anticoagulant therapy in patients of both groups. After 6 months of the study, deep vein recanalization ranged from 42% to 64% in group 1, and from 75% to 85% in group 2. Conclusion: the sulodexide use in 500 dosage units daily for 6 months in patients with PTS of clinical classes C3-C6, according to CEAP, is effective and pathogenetically justified.