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[Long-term sequelae of deep venous thrombosis of the legs. Experience with mesoglycan]
Insights
Mesoglycan did not significantly improve outcomes for deep-vein thrombosis (DVT) patients compared to placebo. However, mesoglycan showed a trend towards fewer DVT recurrences and pulmonary embolism events.
Area of Science:
- Vascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Deep-vein thrombosis (DVT) is a significant vascular condition requiring effective long-term management.
- Post-thrombotic sequelae can severely impact patient quality of life.
- Mesoglycan is a glycosaminoglycan investigated for its potential antithrombotic and vasculoprotective properties.
Purpose of the Study:
- To evaluate the efficacy of mesoglycan in preventing post-thrombotic sequelae after a 12-week anticoagulant treatment for DVT.
- To assess the impact of mesoglycan on DVT recurrence and pulmonary embolism.
- To investigate correlations between clinical outcomes and objective venous assessments.
Main Methods:
- Ninety DVT patients received standard anticoagulation, then were randomized to one year of mesoglycan or placebo in a double-blind trial.
- All patients used graduated compression stockings.
- Follow-up included clinical evaluation, impedance plethysmography, and Doppler ultrasound over 5-48 months.
Main Results:
- After a mean 3-year follow-up, 80% of patients were asymptomatic with only 6.6% experiencing severe post-thrombotic sequelae.
- No significant difference was observed in post-thrombotic sequelae between mesoglycan and placebo groups.
- Mesoglycan showed a non-significant trend towards reduced DVT recurrence (6.6% vs 11.1%) and pulmonary embolism, with placebo patients experiencing the only PE deaths.
Conclusions:
- Mesoglycan did not demonstrate a significant benefit over placebo in preventing severe post-thrombotic sequelae in DVT patients.
- Objective venous assessments did not correlate with the development of post-thrombotic sequelae.
- A potential, though not statistically significant, benefit of mesoglycan in reducing DVT recurrence and pulmonary embolism warrants further investigation.
Abstract:
Ninety consecutive patients, affected by venographically proven deep-vein thrombosis (DVT) of the lower limbs, were given full-dose heparin followed by oral anticoagulants for 12 weeks, and then selected randomly to receive, for one year, either mesoglycan (72 mg/day orally) or placebo with a double-blind protocol. All patients wore elastic graduated compression stockings, and were prospectively followed for a period ranging from 5 to 48 months. In each scheduled examination programmed every three months for one year and then twice per year, an accurate clinical evaluation was performed and a predetermined objective score was applied. Furthermore, impedance plethysmography and Doppler ultrasound tests were executed serially to assess the persistence of venous obstruction and/or the development of valve incompetence. After a mean follow-up of 3 years, 80% of the patients were totally asymptomatic, and severe post-thrombotic sequelae (ulcer and/or edema associated with skin induration) were recorded in only 6 patients (6.6%). We failed to identify any correlation between post-thrombotic sequelae and persistence of venous obstruction (as shown by impedance plethysmography) or development of valve incompetence (as shown by Doppler ultrasound test). The behaviour of patients treated with mesoglycan did not differ from that of patients treated with placebo. However, objectively documented recurrences of DVT and/or pulmonary embolism were less frequent in patients treated with mesoglycan (6.6 vs 11.1%, non-significant difference), and the only two deaths attributable to pulmonary embolism occurred among the patients treated with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)