Five-year data from the THUNDER trial demonstrated a 59% relative reduction in target lesion revascularisation rates in popliteal arteries of patients with peripheral arterial disease (PAD) treated with the Cotavance drug-eluting balloon (Medrad) with Paccocath technology compared to standard balloon angioplasty. Additionally, for patients requiring target lesion revascularisation, the average time to revascularisation before target lesion revascularisation was extended by 448 days in patients treated with the Cotavance catheter.
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 target lesion revascularisation outcomes in comparison to standard balloons,” said Gunnar Tepe, Klinikum Rosenheim, Rosenheim, Germany, principal investigator of the trial. “The results demonstrate clear long-term benefits for patients with the Cotavance paclitaxel eluting balloon for reducing the number of target lesion revascularisation procedures and extending the time before a revascularisation might be needed in peripheral artery disease patients.”
Thomas Zeller, Herz-Zentrum, Bad Krozingen, Germany, who presented the data at the TCT symposium, commented, “Beginning as early as the first year and continuing through year five, a consistent 30 to 40 per cent improvement was seen with the Cotavance catheter in avoiding target lesion revascularisation. TCT was an excellent venue to share these ground-breaking data.”
Data from THUNDER at five years were as follows:
- Target lesion revascularisation rates were 22.9% for the Cotavance catheter (11 of 48 patients) compared to 55.6% for (30 of 54 patients)
- The mean time to target lesion revascularisation was 792.5 days in Cotavance catheter treated patients compared to 344.0 days with standard balloon angioplasty, p=0.007
- Estimates for freedom from target lesion revascularisation at five years (based on Kaplan-Meier curves) were 76% for the Cotavance group compared to 42.7% for the standard balloon angioplasty group, and overall the long-term target lesion revascularisation probability was lower with the Cotavance catheter compared to standard balloon angioplasty (log-rank p
- 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
Cotavance is available in Europe, but not yet approved in the USA. Medrad is currently moving forward with the investigational device exemption process as one of the steps in gaining FDA approval for Cotavance product in the United States.
