Two-Year Outcomes of the French Multicentric Registry on LUMINOR Drug-Eluting Balloon for Superficial Femoral and Popliteal Arteries (LUMIFOLLOW)

Background

Drug-coated balloon (DCB) technology is demonstrating increasing potential in lower limb revascularization; 1-year results demonstrate acceptable levels of safety and efficacy and quality of life improvements. This follow-up study assessed whether these advantages persisted over 2 years with the Luminor DCB.

Methods

The LUMIFOLLOW registry enrolled 542 patients with 580 lesions across 15 centers. It included both de novo and restenotic lesions and calcified and/or long occlusions. Primary endpoints were medical safety (freedom from periprocedural death, index limb amputation, and/or all-cause mortality) and efficacy (primary patency defined as freedom from target lesion revascularization (f-TLR) and/or restenosis). Secondary endpoints included device, procedural and clinical success, major adverse events, and functional assessments.

Results

The mean age was 71.2 years, with 67.2% men; 23.8% were Rutherford classification (RC) 2, 43.2% were RC 3, 16.8% RC were 4, and 16.2% were RC 5; 57.5% of lesions were in the superficial femoral artery (SFA), 42.5% extended to the popliteal artery, with 24.2% restenosis and 44.3% total occlusions. Mean lesion length was 140.55 ± 99.42 mm. Provisional stenting was required in 43.1%. Acute clinical success was 93.5%. By 2 years, 351 of 542 (64%) patients remained in the study group, 48 patients had died. Estimated primary patency was 73.9% (95% CI: 69.3–77.9%); f-TLR was 92.0% (95% CI: 88.7–94.4%). Subgroup analyses showed no differences between f-TLR and primary patency rates between disease severity (TASC classification), de-novo versus in stent restenosis, and lesion location. Improvements in quality of life (QOL) were 63.1% improved mobility, 60.2% reduced pain, and 40.2% enhanced usual activities. Walking Impairment Questionnaire scores demonstrated sustained improvements (61.2 ± 30.0, P < 0.001).

Conclusion

Luminor DCBs are safe and effective for femoropopliteal interventions, with equity in results in severe arterial disease, restenosis, SFA, and popliteal territories Significant improvement in QOL, walking ability, high primary patency, and low complication rates underscore the benefits of Luminor DCBs in real-world settings.