- Medtronic released five-year data Tuesday from the IN.PACT Admiral drug-coated balloon study in patients with peripheral artery disease that showed no statistical difference in all-cause mortality between patients treated with the device and those who underwent plain balloon angioplasty.
- The results appear to contradict the conclusion of a meta-analysis, published last month in the Journal of the American Heart Association, which warned of increased risk of death two years after treatment with paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs.
- The JAHA article, which urged further investigation, prompted FDA to send a letter to physicians flagging an increased mortality risk with paclitaxel-coated balloons and paclitaxel-eluting stents.
FDA is investigating the issues raised in the JAHA study and said last week it is looking at specific causes of death, the paclitaxel dose delivered and patient characteristics. The review will include an evaluation of long-term follow-up data from studies that supported approval of paclitaxel-coated balloons and paclitaxel-eluting stents as well as additional statistical analyses to determine the magnitude of any long-term risks.
The specific cause of the increased mortality rate seen in the meta-analysis has not yet been determined, FDA and the authors said. The agency has said it believes the benefits of the devices continue to outweigh the risks.
Balloon angioplasty involves inserting a catheter with a small balloon at the tip to widen a blocked or narrowed blood vessel. Drug-coated balloons allow medication to transfer to the wall of the artery to help prevent scar tissue from forming and re-clogging the vessel.
Medtronic, in a press release, said an independently performed survival analysis demonstrated no correlation between paclitaxel dose and long-term survival in patients treated with its IN.PACT Admiral drug-coated balloon. The analysis was performed by the Baim Institute for Clinical Research and led by Gheorghe Doros, professor of biostatistics at Boston University School of Public Health. Results were presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany.
The safety analysis included 1,837 patients from all IN.PACT DCB clinical programs followed for five years, the company said. All-cause mortality at five years was 9.3% in the drug-coated balloon group and 11.2% in the plain balloon arm, which was not statistically significant.The data found no correlation between paclitaxel dose and long-term survival, and no difference in mean nominal dose of paclitaxel between overall survival in patients treated with the drug-coated balloon and those who died.
Separately, VIVA Physicians, a not-for-profit organization focused on education and research in the field of vascular medicine, announced Monday it would lead an industry initiative to independently analyze patient safety data for PAD treatment above the knee, partnering with companies like BD, Boston Scientific, Cook Medical, Medtronic and Phillips.
"Due to recent discussion around the safety of paclitaxel-eluting devices, both VIVA and our industry partners firmly believe in the need for an analysis of this nature to better address some of these concerns," said Krishna Rocha-Singh, the physician who will manage the project.