November 14, 2011 – Medrad Inc. announced that five-year data from the THUNDER trial  demonstrated a 59 percent relative reduction in target lesion revascularization (TLR) rates in popliteal arteries of patients with peripheral arterial disease (PAD) treated with the Cotavance drug-eluting balloon with Paccocath technology compared to standard balloon angioplasty (POBA). Additionally, for patients requiring TLR, the average time to revascularization before TLR was extended by 448 days in patients treated with the Cotavance catheter, which is available in Europe, but not yet approved in the United States. Medrad is currently moving forward with the investigational device exemption (IDE) process as one of the steps in gaining U.S. Food and Drug Administration (FDA) approval for Cotavance product in the United States.
The data were presented at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, in San Francisco as part of a TCT-sponsored symposium titled, "Drug-Coated Balloons: Clinical Data and Applications."
"These data with Bayer HealthCare's Paccocath technology represent the only five-year clinical TLR outcomes in comparison to standard balloons," said Professor Gunnar Tepe, M.D., of Klinikum Rosenheim in Rosenheim, Germany, principal investigator of THUNDER. "The results demonstrate clear long-term benefits for patients with the Cotavance paclitaxel eluting balloon for reducing the number of TLR procedures and extending the time before a revascularization might be needed in PAD patients." Thomas Zeller, M.D., of Herz-Zentrum, Bad Krozingen, Germany, who presented the data at the TCT symposium, added, "Beginning as early as the first year and continuing through year five, a consistent 30 to 40 percent improvement was seen with the Cotavance catheter in avoiding TLR. TCT was an excellent venue to share these ground-breaking data."
Details of the data from THUNDER at five years were as follows:
- TLR rates were 22.9 percent for the Cotavance catheter (11 of 48 patients) compared to 55.6 percent for POBA (30 of 54 patients)
- The mean time to TLR was 792.5 days in Cotavance catheter treated patients compared to 344.0 days with POBA, p=0.007
- Estimates for freedom from TLR at five years (based on Kaplan-Meier curves) were 76 percent for the Cotavance group compared to 42.7 percent for the POBA group, and overall the long-term TLR probability was lower with the Cotavance catheter compared to POBA (log-rank p< 0.01)
- Long-term results were similar comparing dissected arteries vs. non-dissected arteries
- No differences were seen between groups for patient deaths or those lost to follow-up
For more information: www.medrad.com
1. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008;358:689-699.