French Multicentric Registry on LUMINOR Drug-Eluting Balloon for Superficial Femoral and Popliteal Arteries.

Abstract

Background: Endovascular interventions using drug-coated balloons (DCBs) have shown promise in improving outcomes for femoropopliteal revascularizations. Luminor, nanotechnology-based paclitaxel coated balloon, has demonstrated efficacy and safety in the Effpac trial. The LUMIFOLLOW registry, a large-scale, prospective, multicenter study, aims to assess the real-world performance of Luminor in femoropopliteal lesions.

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

Results: The mean age was 71.2 years, with 67.2% male patients. Prevalent comorbidities included diabetes (42.6% n=231/542), hypertension (72.1%, n=391/542), hyperlipidemia (56.3%, n=305/542) and current smoking (27.2%, n=147/540); 23.8% were classified as Rutherford classification (RC) 2 (n=129/542), 43.2% as RC 3 (n=234/542), 16.8% as RC 4 (n=91/542) and 16.2% as RC 5 (n=88/542). Lesions were located in the superficial femoral artery (57.5%, n=329/572) and could extend to the popliteal artery (42.5%, n=243/572), with 43.6% classified TASC II C-D; 24.2% were restenosis (n=139/575) with a 44.3% rate of total occlusions (n=255/576). Mean lesion length was 140.55±99.42mm. Provisional stenting was required in 43.1% (n=249/580) with a mean stent length shorter than the initial lesion length at 87.21±42.30mm. The acute procedural success rate was 99.4% (n=536/539), with 2 in-hospital deaths and one thrombosis of target lesion. Acute clinical success was achieved in 93.5% (n=504/539). The 12-month composite safety endpoint was 82.7% (5.7% all-cause mortality, 0.7% index limb major amputation) and estimated primary patency was 87.4% (95%CI: 84.1;90.1%), with f-TLR at 96.2% (95%CI: 93.9;97.6%) and from target vessel revascularization at 94.9% (95%CI: 92.5;96.6%). The EQ-5D-5L questionnaire indicated significant improvements in quality of life at 12 months, with 67.4% improved mobility, 63.5% reduced pain and discomfort, and 47.8% enhanced usual activities. Walking Impairment Questionnaire scores increased significantly in walking distance, speed, and stair-climbing ability (from 31.4±24.7 to 62.5±31.0, p<.001).

Conclusion: The LUMIFOLLOW registry demonstrates that Luminor DCBs are effective and safe for femoropopliteal interventions. The significant improvement in quality of life and walking ability, along with high primary patency and low complication rates, underscore the benefits of Luminor DCBs in real-world settings. However, the high rate of provisional stenting underscores the need for these devices to be used alongside other endovascular techniques in challenging lesions.