Clinical outcomes of drug-coated balloon angioplasty for venous in-stent restenosis: A prospective clinical study

Background: In-stent restenosis (ISR) is still a significant barrier in achieving long-term benefits from venous stent placement for patients suffering from iliofemoral deep vein thrombosis (IFDVT). An innovative way for local drug delivery is with drug-coated balloon angioplasty (DCBs). Objective: The goal of this research was to compare the therapeutic effectiveness, clinical outcomes, and improved quality of life of drug-coated balloon angioplasty versus standard balloon angioplasty in patients with recurrent venous in-stent restenosis (RSI). Methods: A polycentric clinical study was conducted on 44 patients suffering RSI after venous stent placement. Patients were non-randomly assigned either to DCB (Group A, N=22) or standard balloon angioplasty (Group B, N=22). Restenosis was measured using duplex ultrasound with luminal narrowing criteria, and clinical outcomes, including pain intensity and quality of life associated with health and mobility, were assessed using the EQ-5D mobility domain and VAS. Results: During the 24-month study, the rate of restenosis in Group A was slightly lower than in Group B (9.2% vs 24.2%; p < 0.05). Patients treated with DCBs had notably better VAS scores (3.45 vs. 5.68; p < 0.01), pain scores and mobility. The DCB group had a mobility score of 80% compared to 20% in the standard balloon angioplasty group. Conclusion: Localized delivery of antiproliferative medications, such as paclitaxel, can be achieved with DCB therapy, thereby limiting systemic exposure, enhancing venous patency, and improving functional outcomes. Drug-coated stents based on sirolimus can be helpful for patients, underscoring the pharmacological relevance and future scope of this study.