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Comparative Effectiveness of Peripheral Angioplasty Strategies for 1-Year Restenosis in Lower Limb Artery Disease: A
Ioannis Skalidis1,2, Livio D'Angelo1, Youcef Lounes1
1Institut Cardiovasculaire Paris-Sud, Hôpital Jacques Cartier, 91300 Massy, France.
Insights
Drug-coated balloon (DCB) angioplasty showed lower 1-year restenosis rates in peripheral artery disease (PAD) patients compared to stent or plain balloon angioplasty. This real-world study suggests DCB may be a beneficial strategy for selected PAD lesions.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Endovascular Therapy
Background:
- Optimal endovascular treatment strategies for lower limb peripheral artery disease (PAD) are debated, especially concerning 1-year restenosis rates.
- Real-world data is crucial for comparing different angioplasty techniques in PAD management.
Purpose of the Study:
- To evaluate the association between drug-coated balloon (DCB)-based angioplasty and 1-year restenosis.
- To compare DCB angioplasty outcomes against stent-based and plain balloon angioplasty strategies in a real-world PAD cohort.
Main Methods:
- Retrospective analysis of 283 consecutive lower limb angioplasty patients (2010-2023).
- Treatment strategies included: direct stent, pre-dilatation + stent, stent + post-dilatation, DCB ± bailout stent, and plain old balloon angioplasty (POBA).
- Primary endpoint: 1-year restenosis (≥50% diameter reduction); analyzed using Kaplan-Meier curves and multivariable Cox regression.
Main Results:
- Overall 1-year restenosis rate was 28.7%.
- DCB ± stent group had significantly lower restenosis (15.4%) compared to non-DCB strategies (34.2%-38.1%, p=0.004).
- Adjusted analysis showed DCB ± stent associated with lower restenosis hazard versus direct stent (HR 0.52) and POBA with higher hazard (HR 1.89). Periprocedural complications were low and similar across groups.
Conclusions:
- In this real-world PAD cohort, DCB-based angioplasty was independently associated with reduced 1-year restenosis compared to stent and plain balloon strategies.
- No excess procedural complications were observed with DCB use.
- Findings support the hypothesis-generating potential for broader DCB use in appropriately selected PAD lesions.
Abstract:
Background: Optimal endovascular strategy for lower limb peripheral artery disease (PAD) remains debated, particularly regarding 1-year restenosis. Aim: To evaluate the association between drug-coated balloon (DCB)-based angioplasty and 1-year restenosis compared with stent-based and plain balloon strategies in a real-world PAD cohort. Methods: We performed a single-center retrospective analysis of 283 consecutive patients (mean age 67.5 ± 11.2 years, 79% male) undergoing lower limb angioplasty between 2010 and 2023. Patients were treated with one of five strategies: direct stent, pre-dilatation + stent, stent + post-dilatation, DCB ± bailout stent, or plain old balloon angioplasty (POBA). Restenosis at 12 months (≥50% diameter reduction on Doppler, CT angiography, or angiography) was the primary endpoint. Kaplan-Meier curves and multivariable Cox regression adjusted for clinical and lesion characteristics were used. The prespecified main comparison was DCB ± stent versus non-DCB strategies. Results: Overall, 1-year restenosis occurred in 81 patients (28.7%). Restenosis rates were 15.4% with DCB ± stent versus 34.2%, 29.8%, 31.5%, and 38.1% with direct stent, pre-dilatation + stent, stent + post-dilatation, and POBA, respectively (p = 0.004). In adjusted analysis, DCB ± stent was associated with a lower hazard of restenosis compared with direct stent (HR 0.52; 95% CI 0.31-0.87), whereas POBA was associated with a higher hazard versus DCB ± stent (HR 1.89; 95% CI 1.01-3.53). Periprocedural complication rates were low and similar across groups (overall 6.3%). Conclusions: In this real-world PAD cohort, DCB-based angioplasty was independently associated with lower 1-year restenosis compared with stent-based and plain balloon strategies, without an excess of procedural complications. Given the observational design and lesion-driven strategy selection, these findings should be interpreted as hypothesis-generating but support broader use of DCB in appropriately selected lesions.
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