Debulking Combined with Drug-Coated Balloon for the Treatment of Femoropopliteal In-Stent Restenosis: A Systematic
Chen Cheng1, Yanhua Zhen1, Yuan Hu1
1Department of Radiology,Shengjing Hospital of China Medical University, Shenyang, 110004, China.
Insights
Debulking with drug-coated balloon angioplasty (DCB) lowers amputation risk and target lesion revascularization (TLR) for femoropopliteal in-stent restenosis (FP-ISR). This combined treatment shows promise for long or occlusive lesions, improving patency rates.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomaterials in Medicine
Background:
- Femoropopliteal in-stent restenosis (FP-ISR) poses a significant challenge in peripheral artery disease management.
- Drug-coated balloon angioplasty (DCB) is a common treatment, but its efficacy in complex FP-ISR remains under investigation.
- Debulking procedures prior to DCB may improve outcomes by removing obstructive tissue.
Purpose of the Study:
- To evaluate the safety and efficacy of combining debulking techniques with DCB angioplasty for treating FP-ISR.
- To compare outcomes of debulking plus DCB versus DCB alone in FP-ISR patients.
- To assess the impact on technical success, patency rates, and adverse events like amputation and target lesion revascularization (TLR).
Main Methods:
- A systematic literature search was conducted across Embase, PubMed, and Cochrane Library databases (2004-2025).
- A meta-analysis included seven studies (3 RCTs, 4 retrospective cohorts) involving 584 patients with FP-ISR.
- Outcomes assessed included technical success, bailout stenting, embolization, amputation, primary patency (6 & 12 months), and 12-month TLR.
Main Results:
- No significant differences in technical success, bailout stenting, embolization, or 6/12-month patency were observed between debulking + DCB and DCB alone.
- Debulking with DCB significantly reduced amputation rates (RR 0.37) and 12-month TLR risk (RR 0.58) compared to DCB alone.
- Subgroup analysis revealed improved 12-month primary patency (RR 1.66) and reduced TLR (RR 0.35) for lesions >20 cm or Tosaka type III.
Conclusions:
- Combining debulking with DCB angioplasty is a safe and effective strategy for FP-ISR, particularly for long or occlusive lesions.
- This approach demonstrates a significant reduction in amputation risk and 12-month TLR.
- Further research is warranted to confirm these benefits due to the limited number of included studies.
Purpose:
To evaluate the safety and efficacy of debulking with drug-coated balloon angioplasty (DCB) for femoropopliteal in-stent restenosis (FP-ISR) treatment.
Methods:
Embase, PubMed, and the Cochrane Library were searched from January 2004 to August 2025 for studies evaluating debulking with DCB treatment of FP-ISR. A meta-analysis was performed to assess the technical success, bailout stenting, postoperative embolization, amputation, 6- and 12-month primary patency rates, and 12-month target lesion revascularization (TLR).
Results:
Seven studies (three randomized controlled trials and four retrospective cohort studies) involving 584 patients were included; 281 underwent debulking with DCB and 303 underwent DCB alone. The technical success, bailout stenting, postoperative embolization, and 6- and 12-month primary patency rates did not differ between groups. However, debulking with DCB was associated with a lower amputation rate than that with DCB alone ([RR] 0.37, 95% CI 0.18-0.75, P = 0.006) and reduced TLR risk at 12 months ([RR] 0.58, 95% CI 0.38-0.88, P = 0.01). Subgroup analysis indicated that the combined treatment was associated with improved 12-month primary patency ([RR] 1.66, 95% CI 1.19-2.34, P = 0.003) and reduced TLR ([RR] 0.35, 95% CI 0.18-0.69, P = 0.002) for lesion length >20 cm or Tosaka type III lesions.
Conclusion:
Debulking with DCB reduces amputation risk and 12-month TLR in patients with FP-ISR, particularly those with long lesions (>20 cm) or occlusive lesions (Tosaka type III), in whom it may improve 12-month primary patency. However, the advantages require further confirmation because of the limited number of studies.
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