Three-Year Outcomes of Drug-Coated Balloon Angioplasty in Chronic Limb-Threatening Ischemia Versus Claudicants: A Subgroup Analysis from the Lutonix Safe Dcb Registry

Document Type

Conference Proceeding

Publication Date

3-9-2026

Publication Title

JACC Cardiovasc Interv

Keywords

aged, amputation, angioplasty, cardiovascular disease, conference abstract, controlled study, critical limb ischemia, drug-coated balloon, female, human, major clinical study, male, mortality, percutaneous transluminal angioplasty, percutaneous transluminal angioplasty balloon, post hoc analysis, severity of illness index, target lesion revascularization, therapy

Abstract

BACKGROUND: Treating chronic limb-threatening ischemia (CLTI) remains a clinical challenge due to complex lesion characteristics and limited long-term data on the efficacy of drug-coated balloons (DCBs) in this population. Current endovascular guidelines recommend endovascular intervention of CLTI over claudicants highlighting the need to stratify outcomes by clinical presentation―claudicants versus CLTI―to better inform treatment decisions and align with real-world practice. In this study, we evaluate the long-term safety and efficacy of LutonixTM 035 DCB angioplasty in patients with CLTI (Rutherford categories 4-6) versus claudicants (Rutherford categories 1-3) through a post-hoc subgroup analysis of the Lutonix SAFE Registry). METHODS: This post hoc analysis included per-protocol patients from the Lutonix SAFE Registry, stratified by clinical presentation. Kaplan-Meier analyses were performed to assess freedom from target lesion revascularization (TLR), primary patency, and safety endpoints through 36 months. Mortality and major amputation rates were also evaluated. RESULTS: A total of 1005 subjects (1237 per protocol lesions) at 74 investigational sites were treated with the Lutonix® 035 DCB and were followed up to 36 months. The CLI population (n=340) was 36.6% female, 68.8% had at least one type of cardiovascular disease, and 58% of their lesions were moderate to severely calcified. Notably, there was a low bailout stenting rate of 1.8% and 10.9% non-bailout stents were used following DCB treatment. Freedom from TLR at 3 years was not statistically significant between CLTI and claudicants (72.0% (95% CI: 66.0%, 77.0%) vs. 74.7% (95% CI: 70.6%, 78.4%), p=0.335). Similarly, 12-month primary patency rates were 60.0% (CI: 95%: 51.7%, 67.9%) for CLTI and 63.8% (95% CI: 58.2%, 69.0%) for claudicants (p=0.4336). Safety outcomes at 30 days were also similar (97.6% (95% CI: 95.3%, 98.8%) CLTI vs. 98.7% (95% CI: 97.3%, 99.4%), claudicants, p=0.204,). However, CLTI patients experienced significantly higher 3-year mortality (30.8% vs. 13.9%), p<0.0001 and major amputation rates (12.3% vs. 0.5%), p <0.0001 compared to claudicants. Device- and procedure-related adverse events were low in both groups. CONCLUSION: This analysis demonstrates that LutonixTM DCB angioplasty provides durable efficacy and safety in both CLTI and claudicant populations. Despite higher mortality and amputation rates in CLTI patients―consistent with disease severity―DCB treatment remains a viable option.

Volume

19

Issue

5

First Page

S32

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