Prevention of post-thrombotic syndrome with Hidrosmina: A prospective pilot study

Objective: In a previous study we demonstrated the beneficial effect of some venoactive drugs when administered to patients with established post-thrombotic syndrome (PTS). The aim of the present study was to assess prospectively the efficacy of one of such drugs in preventing the development of PTS signs. Design: Prospective, randomized, open study. Patients: 100 consecutive patients with a first episode of deep vein thrombosis (DVT), whose diagnosis had been verified with either venography or real-time ultrasonography, were entered in the study. Interventions: In addition to anticoagulant therapy, and immediately prior to discharge, patients were randomly allocated to receive Hidrosmina (Venosmil, FAES, Spain) 600 mg daily or no additional treatment. Each patient was followed-up in our outpatient clinic at 4-monthly intervals for a 3-year period. At each visit, patients were carefully examined for the presence of oedema, pigmentation, induration and ulceration. A simple scoring system, as reported by the SVS and the ISCS, was used to assess the severity of symptoms and signs. Results: After excluding 17 patients with recurrent DVT, there remained 83 patients, 10 of whom had bilateral DVT. No signs of PTS were found during the 3-year period in 65 out of 93 limbs (70%). Class 1 signs were found in 21 out of 93 limbs (23%), class 2 in 6 out of 93 limbs (6%) and class 3 signs in one limb. PTS was more commonly found in patients in whom DVT had involved the popliteal vein (20/50 vs. 8/43; p<0.05). Furthermore, PTS developed in 7 out of 46 limbs (15%) in patients taking Hidrosmina vs. 21 out of 47 limbs (45%) in patients not taking the drug (p < 0.005). Conclusions: In this pilot study our findings demonstrate that long-term therapy with Hidrosmina may be useful in preventing the development of PTS signs.