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Drug-Coated Balloon Versus Drug-Eluting Stent for Femoropopliteal Lesions: A 3-Year Propensity Score-Matched Analysis
Osamu Iida1, Mitsuyoshi Takahara2,3, Yoshimitsu Soga4
1Cardiovascular Division, Osaka Keisatsu Hospital, Osaka, Japan.
Insights
Drug-eluting stents (DES) and drug-coated balloons (DCB) showed similar 3-year target lesion revascularization rates for femoropopliteal disease. However, DES had a lower restenosis rate, and balloon choice may impact DCB efficacy.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Drug-eluting treatments are first-line for femoropopliteal (FP) lesions.
- Long-term comparative data for drug-eluting stents (DES) versus drug-coated balloons (DCB) in real-world FP disease are limited.
Purpose of the Study:
- To compare the 3-year clinical outcomes of DES versus DCB in patients with symptomatic FP disease.
- To evaluate the efficacy and safety of DES and DCB in a real-world setting.
Main Methods:
- Retrospective analysis of the multicenter CILANTRO study registry.
- Inclusion of patients treated with DES or DCB for symptomatic FP lesions.
- 1:1 propensity score matching to minimize selection bias, with primary outcome of clinically driven target lesion revascularization (TLR) and secondary outcome of restenosis.
Main Results:
- After propensity score matching (912 pairs), 3-year TLR rates were similar between DCB and DES groups (23.3% vs. 18.8%; P=0.16).
- Interaction analysis indicated a higher TLR risk with DCB in patients using semi-compliant or not using non-compliant balloons (P=0.017 and 0.018).
- The 3-year restenosis rate was significantly higher in the DCB group compared to the DES group (38.1% vs. 26.3%; P<0.001).
Conclusions:
- In this propensity score-matched analysis, DES and DCB showed comparable 3-year TLR rates for FP disease.
- DES demonstrated a significantly lower restenosis rate compared to DCB.
- DCB remains a viable option, with balloon selection potentially influencing treatment efficacy.
Objective:
While drug-eluting treatment is a first-line therapy for femoropopliteal (FP) lesions, long-term comparative data between drug-eluting stents (DES) and drug-coated balloons (DCB) in real-world practice are scarce. We aimed to compare the 3-year outcomes of DES versus DCB for symptomatic FP disease.
Methods:
We conducted a retrospective analysis of the CILANTRO study, a multicenter registry combining data from the CAPSICUM, POPCORN, and POPCORN Type R studies. Patients treated with either DES or DCB for symptomatic FP lesions were included. To minimize selection bias, we performed 1:1 propensity score matching. The primary outcome was clinically driven target lesion revascularization (TLR), while secondary outcomes included restenosis.
Results:
A total of 2651 patients treated with DCB and 972 with DES were identified. Propensity score matching extracted 912 pairs with well-balanced baseline characteristics. The median follow-up period was 31.6 months. The 3-year rate of TLR was not significantly different between the DCB and DES groups (23.3% vs. 18.8%; hazard ratio, 1.19 [95% confidence interval, 0.93-1.53]; p = 0.16). Interaction analysis revealed that a more marked increased risk of TLR in the DCB group in patients with semi-compliant balloon use or without non-compliant balloon use (p = 0.017 and 0.018). The 3-year rate of restenosis was significantly higher in the DCB group than in the DES group (38.1% vs. 26.3%; hazard ratio, 1.77 [1.43-2.19]; p < 0.001).
Conclusions:
In this propensity score-matched analysis, the 3-year rate of TLR was not significantly different between DCB and DES, although DES demonstrated lower restenosis rate. Nevertheless, DCB remains a clinically viable option, and our sub-analysis suggests that balloon selection for pre-dilatation may influence its efficacy.
