Cardiovascular

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

TL;DR

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

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

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)

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

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)

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

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Citation

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