Author + information
- Received September 2, 2015
- Revision received March 24, 2016
- Accepted April 7, 2016
- Published online July 11, 2016.
- Christian M. Kinstner, MDa,
- Johannes Lammer, MDa,
- Andrea Willfort-Ehringer, MDb,
- Wolfgang Matzek, MDa,
- Michael Gschwandtner, MDb,
- Domagoj Javor, MDa,
- Martin Funovics, MDa,
- Maria Schoder, MDa,
- Renate Koppensteiner, MDb,
- Christian Loewe, MDa,
- Robin Ristl, PhDc and
- Florian Wolf, MDa,∗ ()
- aDivision of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria
- bDivision of Angiology, Department of Medicine II, Medical University of Vienna, Vienna, Austria
- cSection for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria
- ↵∗Reprint requests and correspondence:
Dr. Florian Wolf, Department of Biomedical Imaging and Image-Guided Therapy, Division of Cardiovascular and Interventional Radiology, Medical University of Vienna, Vienna General Hospital, Waehringerguertel 18-20, Vienna A-1090, Austria.
Objectives 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.
Background Several trials have demonstrated that paclitaxel-eluting balloon angioplasty reduces late luminal loss in comparison with PTA.
Method 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.
Results 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.
Conclusions 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)
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 2, 2015.
- Revision received March 24, 2016.
- Accepted April 7, 2016.
- American College of Cardiology Foundation