Long-term clinical outcomes of paclitaxel-coated balloon angioplasty in chronic deep vein thrombosis: A multicenter retrospective study

Background: Chronic deep vein thrombosis (DVT) is a persistent clinical condition that often results in venous obstruction, post-thrombotic syndrome and impaired quality of life. Conventional endovascular dilation is limited by elastic recoil and high rates of restenosis caused by neointimal hyperplasia. Paclitaxel-based localized venous therapy enables targeted delivery of antiproliferative agents directly to the venous wall, offering a pharmacological strategy to suppress pathological vascular remodeling and improve long-term outcomes. Objectives: To evaluate the efficacy and safety of paclitaxel-based localized venous therapy in improving long-term venous patency and reducing restenosis in patients with chronic DVT, compared with conventional angioplasty. Methods: This retrospective multicenter study analyzed patient records from three vascular centers between 2019 and 2024. A total of 245 patients with chronic DVT were included, of whom 127 received paclitaxel-based localized therapy and 118 underwent conventional angioplasty. Primary endpoints were venous patency and restenosis rates. Secondary endpoints included freedom from clinically driven reintervention and quality-of-life outcomes. Clinical and imaging follow-up was conducted at baseline and at 6, 12 and 24 months. Multivariate regression analysis was performed using SPSS version 28. Results: At 24-month follow-up, primary venous patency was significantly higher in the paclitaxel-based therapy group than in the conventional angioplasty group (82.7% vs. 61.9%), with lower restenosis rates (11.8% vs. 29.7%). Paclitaxel-based localized therapy was associated with greater freedom from reintervention (hazard ratio 0.42; 95% CI 0.29–0.61; p < 0.001). Quality-of-life scores improved significantly in the paclitaxel group (mean difference 14.3 points; p = 0.002). No significant differences were observed in major complications or thrombotic events between groups. Conclusion: Paclitaxel-based localized therapy provides superior long-term venous patency, reduced restenosis and improved quality of life without compromising safety. These findings highlight the pharmaceutical relevance of localized antiproliferative drug delivery in the management of chronic venous disease.