Author + information
- Received June 5, 2014
- Revision received July 18, 2014
- Accepted July 31, 2014
- Published online January 1, 2015.
- Gunnar Tepe, MD∗∗ (, )
- Beatrix Schnorr, DVM†,
- Thomas Albrecht, MD‡,
- Klaus Brechtel, MD§,
- Claus D. Claussen, MD§,
- Bruno Scheller, MD‖,
- Ulrich Speck, PhD† and
- Thomas Zeller, MD¶
- ∗RoMed Clinic Rosenheim, Rosenheim, Germany
- †Department of Radiology, Experimental Radiology, Charité, University Hospital, Berlin, Germany
- ‡Institute of Radiology and Interventional Therapy, Vivantes Klinikum Neukölln, Berlin, Germany
- §Department of Diagnostic and Interventional Radiology, University Hospital, Tuebingen, Germany
- ‖Department of Internal Medicine III, University of Saarland, Homburg/Saar, Germany
- ¶Department of Angiology, Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
- ↵∗Reprint requests and correspondence:
Prof. Dr. Gunnar Tepe, Institute for Diagnostic and Interventional Radiology, RoMed Clinic Rosenheim, Pettenkoferstrasse 10, 83022 Rosenheim, Germany.
Objectives The purpose of this study was to evaluate the 5-year follow-up (FU) data of the THUNDER (Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries).
Background The THUNDER trial was the first study to investigate the treatment of femoropopliteal arteries with a paclitaxel-coated balloon (PCB).
Methods In 154 patients, femoropopliteal arteries were treated with PCB, with angioplasty with paclitaxel in contrast medium, or no paclitaxel (control). The primary endpoint was 6-month late lumen loss (LLL). Secondary endpoints included freedom from target lesion revascularization (TLR), binary restenosis rate, and amputation. The 5-year FU compares outcomes in patients treated with PCB and control subjects. Additionally, LLL at 6 months and TLR up to 5-year FU were analyzed in terms of sex and lesion length.
Results Over the 5-year period, the cumulative number of patients with TLR remained significantly lower in the PCB group (21%) than in the control group (56%, p = 0.0005). In the small group of patients with angiographic and duplex sonographic follow-up, PCB was associated with a lower rate of binary restenosis (17% vs. 54%; p = 0.04). No signs of aneurysm formation or constrictive fibrosis were detected. Whereas LLL at 6-month FU did not differ between men and women in the PCB group, the TLR rate was lower in men than in women at 5-year FU. A benefit of PCB treatment in terms of LLL and TLR was seen independent of lesion length.
Conclusions The reduced TLR rate following PCB treatment was maintained over the 5-year FU period. No signs of drug-related local vessel abnormalities were detected. (Thunder Trial—Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries [THUNDER]; NCT00156624)
This work was supported by Medrad, Inc. Prof. Tepe receives study support from and serves on the advisory board of Medtronic; and has received speaking fees and research grants from Medrad. Prof. Albrecht has received lecture fees from Medtronic. Dr. Brechtel has received lecture fees and research grants from Medrad. Profs. Scheller and Speck are coinventors of a patent by Charité University Hospital, Berlin, for various methods of inhibiting restenosis including the formulation used in this trial. Prof. Zeller has lectured and received research grants from Medrad; and has served as a medical advisor to Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 5, 2014.
- Revision received July 18, 2014.
- Accepted July 31, 2014.
- 2015 American College of Cardiology Foundation