Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Suman Rathbun, Ryan Zander, Richard A Marlar, Pravina Kota, Ying Zhang, Thomas Whitsett and Julie A Stoner
Objective: Endovenous foam sclerotherapy (EFS) is widely performed in the U.S, but there is a paucity of studies evaluating clinical predictors of outcomes, including biomarkers, in patients with venous disorders.
Methods: Patients undergoing EFS monotherapy for venous disorders were enrolled. Evaluation at baseline, 1 week, 12 weeks, and 26 weeks included clinical characteristics and biomarker analysis.
Results: 100 patients with venous disease were treated. At one week follow-up, 44% underwent a second injection. At 3 months, 100% of patients had obliteration of at least 80% of their affected veins, and 96% reported improved venous stasis symptoms. Adverse events were minor and deep vein thrombosis was found 4 patients at 3 months. D-dimer levels were significantly higher at week one, but returned to baseline by week 12; fibrin monomer decreased and PPL increased at one week and 3 months relative to baseline.
Conclusion: EFS monotherapy is effective in treating signs and symptoms of venous disease with few adverse effects. D-dimer levels are significantly associated with obliteration of venous segments suggesting an association between vein obliteration and activation of coagulation.