Purpose: Previous studies have indicated mixed short-term outcomes between drug-coated balloon (DCB) angioplasty and percutaneous transluminal angioplasty (PTA) in the treatment of infrapopliteal lesions. However, the long-term durability of DCB angioplasty remains uncertain. The objective of this study is to present the long-term outcomes of DCB angioplasty for infrapopliteal lesions in patients with critical limb ischemia (CLI).
Materials and methods: The AcoArt II-BTK Trial was a prospective, multicenter, randomized, single-blinded trial that enrolled 120 patients with CLI. The patients were randomized 1:1 to DCB angioplasty or PTA. Assessments over 5 years included freedom from all-cause death, freedom from clinically driven target lesion revascularization, and occurrence of major amputation. Additional endpoints included the rate of composite major adverse events.
Results: Over 5 years, patients treated with DCB angioplasty demonstrated a higher rate of freedom from all-cause death than patients treated with PTA (Kaplan-Meier estimate 74.6% vs 57.2%; log-rank p=0.04). The major amputation rate was 5.2% for DCB angioplasty compared with 1.8% for PTA (log-rank p=0.347). Freedom from clinically driven target lesion revascularization was 70.5% and 53.7%, respectively (log-rank p=0.058). The rate of composite major adverse events was 34.5% for DCB angioplasty and 56.1% for PTA (log-rank p=0.013), and this statistically significant difference persisted throughout the 5-year follow-up period. Conclusion:Infrapopliteal artery revascularization in patients with CLI using Litos/Tulip DCB angioplasty showed superior 5-year overall survival compared with PTA. The DCB angioplasty group had a consistently lower rate of major adverse events within 5 years of follow-up.
Clinical impact: The use of DCB in infrapopliteal arterial lesions has been controversial regarding both early and mid-term outcomes, with limited data on long-term results. However, this article demonstrates that the Litos/Tulip DCB exhibits favorable long-term outcomes in infrapopliteal artery lesions. These positive findings provide robust evidence supporting the use of DCB in treating infrapopliteal artery disease.
Keywords: below-the-knee artery; critical limb ischemia; drug-coated balloon; infrapopliteal artery lesion; paclitaxel device; randomized clinical trial.