title: Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial.
abstract: The hypothesis that paclitaxel-eluting balloon angioplasty provides higher 1-year patency rates in femoropopliteal artery in-stent restenosis compared with standard percutaneous transluminal angioplasty (PTA) was tested.
  
  
  
  Several trials have demonstrated that paclitaxel-eluting balloon angioplasty reduces late luminal loss in comparison with PTA.
  
  
  
  In a prospective, randomized, single-blind, dual-center study, 74 patients with symptomatic peripheral artery disease due to in-stent restenosis were treated with either paclitaxel-based drug-eluting balloon (DEB) angioplasty (n = 35) or standard PTA (n = 39). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.
  
  
  
  The mean lesion length was 17.3 ± 11.3 cm in the DEB group and 18.4 ± 8.8 cm in the PTA group. A single major complication (bleeding) was observed once (1.4%). The mean ankle-brachial index before endovascular treatment was 0.65 ± 0.16 in both groups and 0.79 ± 0.2 versus 0.84 ± 0.3 (p = 0.70, Student t test) in the DEB versus PTA group at 12 months. The 12-month primary patency rates were 40.7% (95% confidence interval [CI]: 0.26 to 0.64) versus 13.4% (95% CI: 0.05 to 0.36) (log-rank p = 0.02) in the DEB versus PTA group. The odds ratio for PTA over DEB angioplasty for experiencing an event was estimated at 2.8 (95% CI: 1.2 to 6.6). Freedom from clinically driven target lesion revascularization was 49.0% (95% CI: 0.32 to 0.75) versus 22.1% (95% CI: 0.10 to 0.48) (log-rank p = 0.11) in the DEB versus PTA group. Clinical improvement by ≥1 Rutherford-Becker category was 68.8% versus 54.5% (p = 0.87) in the DEB versus PTA group at 12 months.
  
  
  
  When treating peripheral artery disease in patients with in-stent restenosis in the femoropopliteal artery, paclitaxel-eluting balloon angioplasty provides significantly higher patency rates than standard PTA. (Paclitaxel Balloon Versus Standard Balloon in In-Stent Restenoses of the Superficial Femoral Artery [PACUBA I Trial] [PACUBA 1]; NCT01247402).
authors.affiliation: Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
authors.forename: Christian M
authors.initials: CM
authors.lastname: Kinstner
authors.affiliation: Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.affiliation: Division of Angiology, Department of Medicine II, Medical University of Vienna, Vienna, Austria.
authors.forename: Andrea
authors.initials: A
authors.lastname: Willfort-Ehringer
authors.affiliation: Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Matzek
authors.affiliation: Division of Angiology, Department of Medicine II, Medical University of Vienna, Vienna, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Gschwandtner
authors.affiliation: Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
authors.forename: Domagoj
authors.initials: D
authors.lastname: Javor
authors.affiliation: Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
authors.forename: Martin
authors.initials: M
authors.lastname: Funovics
authors.affiliation: Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
authors.forename: Maria
authors.initials: M
authors.lastname: Schoder
authors.affiliation: Division of Angiology, Department of Medicine II, Medical University of Vienna, Vienna, Austria.
authors.forename: Renate
authors.initials: R
authors.lastname: Koppensteiner
authors.affiliation: Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Loewe
authors.affiliation: Section for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
authors.forename: Robin
authors.initials: R
authors.lastname: Ristl
authors.affiliation: Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria. Electronic address: florian.wolf@meduniwien.ac.at.
authors.forename: Florian
authors.initials: F
authors.lastname: Wolf
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D001317:Austria; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D012008:Recurrence; D019233:Retreatment; D012307:Risk Factors; D016037:Single-Blind Method; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: drug-eluting balloon; femoropopliteal artery; in-stent restenosis; peripheral artery disease