Drug-Coated Balloon Angioplasty in Clinical Practice for Below-the-Knee, Popliteal, and Crural Artery Lesions Causing Critical Limb Ischemia: 1-Year Results from the Spanish Luminor Registry

Ann Vasc Surg . 2020 Jan;62:387-396. doi: 10.1016/j.avsg.2019.06.035. Epub 2019 Aug 23.

Fecha de la publicación: 23/08/2019

Autor: Vicente Riambau (1), Francisco Acín (2), Mariano Juan de Blas (3), Manuel Alonso (4), Antonio Giménez-Gaibar (5), Luminor Collaborators




1Vascular Surgery Division, Hospital Clínic, University of Barcelona, Barcelona, Spain. Electronic address: VRIAMBAU@clinic.cat.

2Angiology and Vascular Surgery Division, Hospital Universitario de Getafe, Getafe, Madrid, Spain.

3Angiology and Vascular Surgery Division, Hospital Universitario Donostia, San Sebastian, Spain.

4Vascular Surgery Division, Hospital Universitario Central de Asturias, Oviedo, Spain.

5Vascular Surgery Division, Hospital Parc Taulí, Barcelona, Spain.


Background: Luminor is a new drug-coated angioplasty balloon, which is approved by the European Conformity market. The aim of the present study is to analyze the 1-year results, in terms of effectiveness and safety, of the Luminor® 14/14M and 35 drug-coated balloons (iVascular, Sant Vicenç dels Horts, Barcelona, Spain) in a special cohort of critical limb ischemia (CLI) of the Luminor registry.

Methods: Luminor is phase IV, nonrandomized, prospective, observational, and multicenter clinical study. The present study includes patients with CLI to analyze 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 and below-the-knee infrapopliteal lesions were treated. All the end points were assessed after the procedure, at 30 days, 6 and 12 months thereafter.

Results: About 148 patients (101 males; mean age, 73.2 ± 11.4 years) with CLI were included. About 83.3% were classified as Rutherford’s class 5. Diabetes mellitus was diagnosed in 71.6%; hypertension, hyperlipidemia, 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 1 year, were 87.7% and 92.1%, respectively. Survival and freedom from major amputations were 85.1% and 84.7%, respectively.

Conclusions: Even with a very sick population, the results at 12 months are highly satisfactory with reference to survival, freedom from amputation, patency, and the absence of reintervention.