2. University Hospital Jena, Center for Clinical Studies, Jena, Germany
3. University Hospital Jena, Department of Radiology, Am Klinikum 1, Jena, Germany
4. University Hospital Leipzig, Department of Angiology, Liebigstraße 20, Leipzig, Germany
5. Heart Center Bad Krozingen, Südring 15, Bad Krozingen, Germany
6. Ihre-Radiologen Berlin Radiology Associates, Budapester Str. 15-19, Berlin, Germany
7. SRH Clinic Karlsbad- Langensteinbach, Guttmannstr. 1, Karlsbad, Germany
8. Clinic of Angiology Arnsberg, Stolte Ley 5, Arnsberg, Germany
9. Angiologikum Hamburg, Wördemanns Weg 25-27, Hamburg, Germany
10. Angiologikum Hamburg, Wördemanns Weg 25-27, Hamburg, Germany
11. Heart Center Bad Krozingen, Südring 15, Bad Krozingen, Germany
12. University Hospital Jena, Department of Radiology, Am Klinikum 1, Jena, Germany; Army Hospital Bundeswehrkrankenhaus Ulm, Radiology Department VIII, Oberer Eselsberg 40, Ulm, Germany
13. REGIOMED Clinics GmbH, MedinosClinics LK Sonneberg GmbH, Abt. Angiology/Cardiology/Diabetology, Neustadter Str. 61, Sonneberg, Germany.
14. Department Vascular Medicine, Westpfalz-Hospital, Kusel, Germany
15. Center Internal Medicine, Ruprecht-Karls-University Heidelberg, Germany.
16. Center Internal Medicine, Ruprecht-Karls-University Heidelberg, Germany.
17. Martin-Luther-Hospital, Berlin, Germany.
18. Hospital Clínic de Barcelona, Barcelona, Spain.
19. Medical Epidemiology, Martin-Luther- University Halle, Germany
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Methods and results:- This multicenter trial randomly assigned 171 patients with stenotic and occlusive lesions of the femoropopliteal artery to angioplasty with the novel DCB or uncoated POBA. The primary endpoint late lumen loss at 6 months was 0.92 mm lower in the DCB group (95%CI: -1.36 mm; -0.49 mm, P<0.001). Patients showed improved walking after DCB treatment at 6 months (P=0.021). In the DCB group, 44.6%/50% of the patients improved by three Rutherford-Becker classification stages after 6/12 months (POBA: 27.8%/36.8%). Only one patient needed TLR (1.3%) in the DCB group, compared to 14 (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) vs. 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.
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