Ulf Teichgräber1, MD, MBA; Thomas Lehmann2, PhD; René Aschenbach1, MD; Dierk Scheinert3, MD; Thomas Zeller4, MD; Klaus Brechtel5, MD; Erwin Blessing6, MD; Michael Lichtenberg7, MD; Sebastian Sixt8, MD; Steffen Brucks8, MD; Ulrich Beschorner4, MD; Christof Tobias Klumb1,9, MD; Markus Thieme10, MD; Peter von Flotow11, MD; Britta Heilmeier12, MD; Christian Erbel12, MD; Michael Werk13, MD; Vicenç Riambau14, MD; Andreas Wienke15, MD
1. Department of Radiology, University Hospital Jena, Jena, Germany; 2. Center for Clinical Studies, University Hospital Jena, Jena, Germany; 3. Department of Angiology, University Hospital Leipzig, Leipzig, Germany;; 4. Heart Center Bad Krozingen, Bad Krozingen, Germany; 5. Ihre-Radiologen Berlin Radiology Associates, Berlin, Germany; 6. SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany; 7. Clinic of Angiology Arnsberg, Arnsberg, Germany; 8. Angiologikum Hamburg, Hamburg, Germany; 9. Army Hospital Bundeswehrkrankenhaus Ulm, Ulm, Germany; 10. REGIOMED Clinics GmbH, MedinosClinics LK Sonneberg GmbH, Sonneberg, Germany; 11. Department Vascular Medicine, Westpfalz-Hospital, Kusel, Germany; 12. Center Internal Medicine, Ruprecht-Karls-University Heidelberg, Germany; 13. Martin-Luther-Hospital, Berlin, Germany; 14. Hospital Clínic de Barcelona, Barcelona, Spain; 15. Medical Epidemiology, Martin-Luther- University Halle, Germany
Aims: Although paclitaxel drug-coated balloon (DCB) angioplasty is an established endovascular treatment for peripheral artery disease, restenosis remains a major concern. Thus, we compared a novel paclitaxel-coated DCB with nano-coating technology with uncoated plain old balloon angioplasty (POBA).
Methods and results: This multicentre trial randomly assigned 171 patients with stenotic and occlusive lesions of the femoropopliteal artery to angioplasty with a novel DCB or uncoated POBA. The primary endpoint, late lumen loss at six months, was 0.92 mm lower in the DCB group (95% CI: −1.36 to −0.49 mm, p<0.001). Patients showed improved walking after DCB treatment at six months (p=0.021). In the DCB group, 44.6% and 50% of the patients improved by three Rutherford-Becker classification stages after six to 12 months, respectively (POBA: 27.8% and 36.8%, respectively). Only one patient needed TLR (1.3%) in the DCB group, compared to 14 patients (18.7%) in the POBA group after 12 months (relative risk [RR]=0.08, 95% CI: 0.01-0.53, p<0.001). Primary patency was 90.3% (DCB group) versus 65.3% (POBA group) after 12 months (RR=1.38, 95% CI: 1.14-1.67, p<0.001).
Conclusions: The novel DCB was effective and safe for inhibiting restenosis. Moreover, it demonstrated a better improvement in walking than POBA and showed no mortality concerns due to paclitaxel application after 12 months. Clinical Trials Identifier: NCT02540018
Visual summary. Patient flow, Kaplan-Meier survival curves for primary patency, and change in Rutherford-Becker category over 12 months.
