J Endovasc Ther. 2026 Jun 29:15266028261453224. doi: 10.1177/15266028261453224. Online ahead of print.
ABSTRACT
BACKGROUND: Several studies have demonstrated the efficacy of paclitaxel drug-coated balloons (DCBs) for the treatment of femoropopliteal (FP) lesions in patients with peripheral artery disease (PAD). Despite the available evidence, long-term real-world efficacy data are limited.
OBJECTIVES: To report the 3-year outcomes of the prospective, multicenter, single-arm real-world registry conducted in the United States, assessing the clinical use of the Lutonix 035 DCB in arteries of the superficial femoral artery (SFA) and popliteal artery (PA).
METHODS: In the SAFE-DCB US Registry, a total of 1005 subjects at 74 investigational sites were treated with the Lutonix 035 DCB and were followed up to 36 months. The per protocol included 966 patients (mean age 69.1 years; 56.7% male). A total of 1237 target lesions were treated, in which 93.3% were de novo, 85.2% were located in the SFA, and 88% had mild-to-severe calcification. Forty-five percent of the patients were Rutherford 3, and 35.1% had critical limb-threatening ischemia. The primary efficacy endpoint is target lesion revascularization (TLR) at 12 months. Secondary endpoints included rate of primary patency at 12 months and freedom from TLR and freedom from target vessel revascularization (TVR) evaluated through 36 months. The safety endpoints evaluated through 36 months were freedom from the composite of device- and/or procedure-related perioperative (≤30 day) death, TVR, and freedom from major amputation of the target limb.
RESULTS: Primary patency at 12 months post-index procedure by Kaplan-Meier estimates was 83.7%. Freedom from TLR at 12 months was 88.6%, 75.7% at 24 months, and 74.4% at 36 months. At 36 months, freedom from TVR post-index procedure by Kaplan-Meier estimates was 69.5%. Freedom from primary safety events at 30 days was 98.2%. Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death by Kaplan-Meier estimates at 12 months was 80.8%, at 24 months 67.4% and 58.4% at 36 months. Freedom from major amputation of the target limb at 36 months was 95.6%.
CONCLUSION: The results from the SAFE-DCB US Registry for femoral popliteal (FP) disease demonstrated sustained safety and efficacy over 3 years following the Lutonix 035 DCB intervention.Clinical ImpactThis prospective real-world population study supports long-term clinical outcomes of Lutonix and provides meaningful insights into the sustained efficacy of drug-coated balloon (DCB) therapy in real-world femoropopliteal population. The low-bailout stenting rate (1.7%), and the 36-month sustained Freedom from target lesion revascularization rate (74.4%) supporting DCB usage when a "leave nothing behind" approach is favored. Furthermore, these results reinforce the effectiveness of DCBs in the endovascular treatment peripheral artery disease.
PMID:42366790 | DOI:10.1177/15266028261453224