French multicentric registry on LUMINOR drug-eluting balloon for superficial femoral and popliteal arteries

Endovascular interventions using drug-coated balloons (DCBs) have shown promise in improving outcomes for femoropopliteal (FP) revascularizations. Luminor, a nanotechnology-based paclitaxel coated balloon, has demonstrated efficacy and safety in Effpac (Effectiveness of Paclitaxel-coated Luminor Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis). The LUMIFOLLOW (European All-comers' Multicentric Prospective REGISTRY on LUMINOR Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up) registry, a large-scale, prospective, multicenter study, aims to assess the real-world performance of Luminor in FP lesions. 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 end points 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 and/or binary restenosis); secondary end points included acute device success, procedural and clinical success, major adverse events, and functional assessments. The mean patient age was 71.2 years, with 67.2% male patients. Prevalent comorbidities included diabetes (n = 231/542 [42.6%]), hypertension (n = 391/542 [72.1%]), hyperlipidemia (n = 305/542 [56.3%]), and current smoking (n = 147/540 [27.2%]); 23.8% were classified as Rutherford category 2 (n = 129/542), 43.2% as Rutherford category 3 (n = 234/542), 16.8% as Rutherford category 4 (n = 91/542), and 16.2% as Rutherford category 5 (n = 88/542). Lesions were located in the superficial femoral artery (n = 329/572 [57.5%]) and could extend to the popliteal artery (n = 243/572 [42.5%]), with 43.6% classified as Trans-Atlantic Inter-Society Consensus II C or D; 24.2% were restenosis (n = 139/575) with a 44.3% rate of total occlusions (n = 255/576). The mean lesion length was 140.55 ± 99.42 mm. Provisional stenting was required in 43.1% of patients (n = 249/580), with a mean stent length shorter than the initial lesion length at 87.21 ± 42.30 mm. The acute procedural success rate was 99.4% (n = 536/539), with two 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 end point was 82.7% (5.7% all-cause mortality, 0.7% index limb major amputation) and the