Ulf Teichgräber1, Thomas Lehmann2, Marcus Thieme3, Kersten-Uwe Wahl4, Christian Stelzner5, Albrecht Bormann6, Linda Götz7, Tobias Kroeßner8, Harald Boden9, Lars Maiwald10, René Aschenbach11. 1. Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. ulf.teichgraeber@med.uni-jena.de. 2. Center for Clinical Studies, Jena University Hospital, Jena, Germany. 3. REGIOMED Klinikum Sonneberg, Sonneberg, Germany. 4. Oberlausitz Kliniken, Bautzen, Germany. 5. Städtisches Krankenhaus Dresden-Friedrichstadt, Dresden, Germany. 6. Klinikum Altenburger Land, Altenburg, Germany. 7. Saale-Unstrut Klinikum Naumburg, Naumburg, Germany. 8. SRH-Waldklinikum Gera, Gera, Germany. 9. Ilm-Kreis-Kliniken Arnstadt-Ilmenau, Ilmenau, Germany. 10. Kreiskrankenhaus Torgau, Torgau, Germany. 11. Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.
Abstract
PURPOSE: This study intended to assess effectiveness and safety of the drug-coated balloon (DCB) angioplasty of infrapopliteal atherosclerotic lesions in patients with critical limb ischaemia (CLI) in a real-world setting. METHODS: Consecutive patients with critical limb ischaemia who underwent infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB were enrolled into the prospective, multicentre, single-arm observational registry. Primary outcome was clinical improvement at 6 and 12 months. Secondary outcomes were change in quality of life, primary patency, freedom from repeat revascularisation, and amputation-free survival at 6 and 12 months. RESULTS: A total of 164 patients (74.7 ± 9.2 years) with CLI were included at nine German sites between November 2015 and September 2017. The majority (79.9%) of patients had diabetes mellitus, 57.3% had renal insufficiency, and 35.3% had coronary artery disease. Mean lesion length was 71.2 ± 76.5 mm. The Rutherford category improved by 3.0 ± 2.0 (p < 0.0001) within 12 months, resulting in a clinical improvement by at least one Rutherford category in 80.2% of the patients. Walking impairment questionnaire score, European Quality of Life index, and patient-reported pain improved significantly from baseline to 6 and 12 months. Primary patency was 68.5%, freedom from target lesion revascularisation 90.6%, and amputation-free survival 83.5% at 12 months. CONCLUSION: Infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB in patients with critical limb ischaemia was efficacious and safe over the medium term. The study is registered with Clinical.Trials.gov (Identifier: NCT02539940).
PURPOSE: This study intended to assess effectiveness and safety of the drug-coated balloon (DCB) angioplasty of infrapopliteal atherosclerotic lesions in patients with critical limb ischaemia (CLI) in a real-world setting. METHODS: Consecutive patients with critical limb ischaemia who underwent infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB were enrolled into the prospective, multicentre, single-arm observational registry. Primary outcome was clinical improvement at 6 and 12 months. Secondary outcomes were change in quality of life, primary patency, freedom from repeat revascularisation, and amputation-free survival at 6 and 12 months. RESULTS: A total of 164 patients (74.7 ± 9.2 years) with CLI were included at nine German sites between November 2015 and September 2017. The majority (79.9%) of patients had diabetes mellitus, 57.3% had renal insufficiency, and 35.3% had coronary artery disease. Mean lesion length was 71.2 ± 76.5 mm. The Rutherford category improved by 3.0 ± 2.0 (p < 0.0001) within 12 months, resulting in a clinical improvement by at least one Rutherford category in 80.2% of the patients. Walking impairment questionnaire score, European Quality of Life index, and patient-reported pain improved significantly from baseline to 6 and 12 months. Primary patency was 68.5%, freedom from target lesion revascularisation 90.6%, and amputation-free survival 83.5% at 12 months. CONCLUSION: Infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB in patients with critical limb ischaemia was efficacious and safe over the medium term. The study is registered with Clinical.Trials.gov (Identifier: NCT02539940).
Authors: Philip Goodney; Samir Shah; Yiyuan David Hu; Bjoern Suckow; Scott Kinlay; David G Armstrong; Patrick Geraghty; Megan Patterson; Matthew Menard; Manesh R Patel; Michael S Conte Journal: J Vasc Surg Date: 2022-01-24 Impact factor: 4.860