OBJECTIVES:

Post-thrombotic syndrome (PTS) is a common chronic complication of deep vein thrombosis. The pharmacological approach for PTS includes direct oral anticoagulants (DOACs) and venoactive drugs (VADs) for prevention and treatment, respectively. Sulodexide can be used both in long-term prevention and in the treatment of PTS. To better understand the efficacy of the main drugs used in the prevention (sulodexide or DOACs) and the treatment of PTS (sulodexide or VADs), we conducted a pairwise meta-analyses of observational studies and RCTs

METHODS:

A literature search in MEDLINE, Embase, and Cochrane Library for observational studies and RCTs was performed. Incidence of PTS, reduction in PTS signs or symptom and proportion of patients with complete venous ulcer healing were the primary outcomes for prevention and treatment of PTS, respectively. Fixed and Random effect models meta-analyes were performed. Heterogeneity and publications bias were assessed. R® software was used for the analysis.

RESULTS:

893 articles were identified during the search. Of the 11 studies included in the qualitative synthesis, 8 observational studies (6 for DOACs and 2 for sulodexide) and 2 RCTs for sulodexide were included in the prevention and treatment of PTS, respectively. Meta-analyses of observational studies showed an overall incidence of PTS of 15% ( 95% CI 5-13) for sulodexide, and a 50% reduction of PTS signs and/or symptoms for rivaroxaban compared to warfarin (OR, 0.50; 95% CI, 0.38-0.65). The overall estimate of the two sulodexide RCTs showed a significant improvement in complete ulcer healing, with an OR of 2.32 (95% CI, 1.49-3.63).

CONCLUSIONS:

A low incidence of PTS for sulodexide and a reduction in the risk of PTS in patients receiving rivaroxaban compared to warfarin were found. These results highlight the need to move from the traditional single-pillar approach with elastic compression stocking to a more effective multi-pillar approach, tailoring the treatment to each individual patient.