Drug-coated balloon angioplasty resulted in lower restenosis rates, better pain scores, and improved mobility compared to standard balloon angioplasty in patients with recurrent venous in-stent restenosis over a 24-month follow-up period.
Key Findings
Results
Drug-coated balloon angioplasty resulted in a lower restenosis rate compared to standard balloon angioplasty over 24 months.
Restenosis rate in Group A (DCB) was 9.2% versus 24.2% in Group B (standard balloon angioplasty)
The difference was statistically significant (p < 0.05)
Restenosis was measured using duplex ultrasound with luminal narrowing criteria
The study followed patients over a 24-month period
Results
Patients treated with drug-coated balloons had notably better VAS pain scores compared to those treated with standard balloon angioplasty.
VAS scores were 3.45 in the DCB group versus 5.68 in the standard balloon angioplasty group
The difference was statistically significant (p < 0.01)
Pain intensity was assessed using the Visual Analogue Scale (VAS)
Results
The DCB group demonstrated substantially better mobility outcomes compared to the standard balloon angioplasty group.
The DCB group had a mobility score of 80% compared to 20% in the standard balloon angioplasty group
Mobility was assessed using the EQ-5D mobility domain
Both pain and mobility outcomes favored the DCB group
Methods
The study was a polycentric prospective clinical study involving 44 patients with recurrent venous in-stent restenosis after venous stent placement.
44 patients with recurrent in-stent restenosis (RSI) after venous stent placement were enrolled
Patients were non-randomly assigned to either DCB (Group A, N=22) or standard balloon angioplasty (Group B, N=22)
The study population had a history of iliofemoral deep vein thrombosis (IFDVT)
The study design was polycentric (multicenter)
Discussion
DCB therapy using paclitaxel provides localized delivery of antiproliferative medication, limiting systemic exposure while enhancing venous patency and functional outcomes.
Localized delivery of antiproliferative medications such as paclitaxel was identified as the mechanism of action for DCBs
The authors noted that drug-coated stents based on sirolimus may also be helpful for patients
The approach was described as enhancing venous patency and improving functional outcomes while limiting systemic exposure
Rodoplu O. (2026). Clinical outcomes of drug-coated balloon angioplasty for venous in-stent restenosis: A prospective clinical study.. Pakistan journal of pharmaceutical sciences. https://doi.org/10.36721/PJPS.2026.39.5.REG.15966.1