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Effects of defibrotide in patients with chronic deep insufficiency. The PROVEDIS study
S Coccheri1, G M Andreozzi, M D'Addato
1Unit of Angiology, University of Bologna, Bologna, Italy.
Insights
Defibrotide treatment, combined with compression, improved chronic venous insufficiency symptoms and reduced thrombotic events in patients with chronic deep vein insufficiency, particularly those with post-thrombotic syndrome.
Area of Science:
- Vascular Medicine
- Pharmacology
- Thrombosis Research
Background:
- Chronic venous insufficiency (CVI) affects many patients, often stemming from deep vein obstruction or reflux.
- Post-thrombotic syndrome (PTS) is a common complication of deep vein obstruction, leading to significant morbidity.
- Effective management strategies for CVI and PTS are crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of defibrotide in patients with chronic deep vein insufficiency (CDVI).
- To assess the impact of defibrotide on clinical symptoms and thrombotic complications in CDVI patients.
- To investigate defibrotide's role as an adjunct to elastic compression therapy.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial.
- 288 patients with ultrasound-confirmed CDVI were randomized to receive oral defibrotide (800 mg/day) or placebo for 1 year.
- Patients with active or previous leg ulcers were excluded; focus on obstructive changes and reflux.
Main Results:
- Defibrotide significantly reduced ankle circumference from day 120 to 360.
- Patients receiving defibrotide reported improved pain and edema scores.
- Defibrotide significantly lowered the incidence of superficial and deep vein thrombosis, especially in PTS patients.
Conclusions:
- Defibrotide, alongside elastic compression, offers clinical benefits for patients with objectively assessed CDVI.
- The treatment effectively prevents harmful thrombotic complications in CDVI, particularly those related to PTS.
- Defibrotide represents a promising therapeutic option for managing chronic venous insufficiency and its sequelae.
Aim:
In the present study the effect of defibrotide, an antithrombotic and profibrinolytic agent, was investigated in patients with chronic venous insufficiency (CVI) due to deep vein obstruction and/or reflux (chronic deep vein insufficiency, CDVI).
Methods:
The study was a multicenter, randomized, double blind placebo controlled trial in which only patients with CDVI confirmed by ultrasound were enrolled. All patients were treated with adequate elastic compression and randomized to receive either oral defibrotide (800 mg/die) or matching placebo for 1 year. Patients with active or previous leg ulcer were excluded.
Results:
A total of 288 patients were randomized and 159 completed the study. At baseline ultrasound investigation, obstructive changes were found in 2/3 of all patients thus ascertaining a post-thrombotic syndrome (PTS). The primary endpoint, ankle circumference, was significantly reduced under defibrotide from day 120 throughout 360. Scores for pain and edema were improved. The number of episodes of superficial thrombophlebitis and deep vein thrombosis was significantly lower under defibrotide (n=2) than under placebo (n=10). The majority of these events occurred in the subset of patients with documented PTS.
Conclusion:
Treatment with defibrotide in addition to elastic compression in patients with objectively assessed CDVI, mostly due to PTS, resulted in clinical benefits and prevented thrombotic complications harmful to the limb conditions.
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