The recommendations are fair at this point. The FDA’s main mission is safety, and the current recommendations really leave it up to the physicians to take responsibility in looking at the current data and weighing the risk benefit they see for their individual patient. Realistically, this is what proceduralists should be doing for every patient they evaluate and treat.
I am not sure what the FDA is really planning except to look at more data. I cannot conceive of a way to move to any registry or trial that could be completed or would really answer the question of mortality raised.
We will have to continue to obtain good patient-level data from the current, in-process and planned randomized datasets to help us see the potential answer more clearly.
Who should and should not be treated with paclitaxel-coated devices at this juncture is an important question. Though many will state that it is the patients with critical limb ischemia that should be treated, I feel that each patient has their own set of values and variables for risk and benefit. A shared decision-making process between the physician and patient will be the correct process.
The VIVA independent patient-level data analysis that was obtained in partnership with industry continues to provide us with very important datasets, and all final data and insights are not in yet. Certainly, if there is no dose-response that is evident, the mortality association with paclitaxel becomes much weaker. However, if there is a dose association with mortality, then we have a lot more science to figure out.
Gary M. Ansel, MD, FACC, FSCAI
Cardiology Today’s Intervention Editorial Board Member
Disclosures: Ansel reports he consults for Boston Scientific, Cook Medical, Medtronic, Phillips, Surmodics and W.L. Gore and Associates.