Drug-Coated balloon angioplasty in clinical practice for below the knee, popliteal and crural artery lesions causing critical limb ischaemia: One-year results from the Spanish Luminor Registry.

Luminor is a new drug-coated angioplasty balloon, European Conformity (EC)-market approved. The aim of the present study is to analyse the one-year results, in terms of effectiveness and safety, of the Luminor 14/14M and 35 Drug-Coated Balloons (DCBs) in a special cohort of critical limb ischaemia (CLI) of the Luminor Registry.LUMINOR is a phase IV, non-randomized, prospective, observational and multicentre clinical study. The current study includes patients with CLI to analyse the effectiveness, in terms of primary patency, and the safety defined by the major adverse effects: any cause mortality, major amputation and/or clinically driven target lesion revascularization (TLR). Both femoropopliteal (FP) as well as below-the-knee (BTK) infrapopliteal lesions were treated. All the endpoints were post-procedure assessed, at 30 days, 6 and 12 months thereafter.148 patients (101 males; mean age: 73.2±11.4 years) with CLI were included. 83.3% were classified as Rutherford´s class 5. Diabetes mellitus was diagnosed in 71.6%; hypertension, hyperlipidaemia, renal insufficiency and coronary disease were present in 87.2%, 57.4%, 29.7% and 39.2% of the sample, respectively. The average follow-up was 11.2±3.27 months. The primary patency and the freedom of clinically driven TLR, at one year, were 87.7% and 92.1%, respectively. Survival and freedom from major amputations were 85.1% and 84.7%, respectively.Even with a very sick population, the results at 12 months are highly satisfactory with reference to survival, freedom from amputation, patency and absence of reintervention.