Author + information
- Received August 26, 2015
- Revision received October 21, 2015
- Accepted December 17, 2015
- Published online April 11, 2016.
- Andrej Schmidt, MDa,∗ (, )
- Michael Piorkowski, MDb,
- Henrik Görner, MDa,
- Sabine Steiner, MD, MSca,
- Yvonne Bausback, MDa,
- Susanne Scheinert, MDa,
- Ursula Banning-Eichenseer, PhDa,
- Holger Staab, MDc,
- Daniela Branzan, MDc,
- Ramon L. Varcoe, MDd and
- Dierk Scheinert, MDa
- aDepartment of Interventional Angiology, University Hospital Leipzig and Center of Vascular Medicine, Angiology and Vascular Surgery Park Hospital Leipzig, Germany
- bCardioangiological Center Bethanien, Frankfurt, Germany
- cDepartment of Vascular Surgery, University Hospital Leipzig, Germany
- dDepartment of Surgery, Prince of Wales Hospital and University of New South Wales, Sydney, Australia
- ↵∗Reprint requests and correspondence:
Priv. Doz. Dr. med. Andrej Schmidt, Department of Interventional Angiology, University Hospital Leipzig, Philipp-Rosenthal-Strasse 27c, Haus P, 04301 Leipzig, Germany.
Objectives The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions.
Background Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear.
Methods Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression.
Results Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon.
Conclusions These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.
Priv. Doz. Dr. med. Schmidt is a consultant for Abbott Vascular, C.R. Bard, Boston Scientific, Biotronik, Cook Medical, Cordis, Covidien, Medtronic, Spectranetics, and Upstream Peripheral; and has received speaker fees from C.R. Bard, Boston Scientific, and Medtronic. Dr. Steiner is a consultant for C.R. Bard and Abbott Vascular. Dr. Varcoe is a consultant for Abbott Vascular, Boston Scientific, Gore, and Medtronic; and is on the advisory board of Abbott Vascular. Dr. D. Scheinert is a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Gardia Medical, Hemoteq, Medtronic/Covidien, TriReme Medical, Trivascular, and Upstream Peripheral Technologies; and is a former stockholder of IDEV Technologies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 26, 2015.
- Revision received October 21, 2015.
- Accepted December 17, 2015.
- American College of Cardiology Foundation