My View: Paclitaxel Use in Peripheral Arterial Disease

The bottom line from the June FDA meeting is that important questions still exist in the eyes of not only the FDA, but the interventionalists doing these procedures. I think that there is no real change, in that we should not be using these devices routinely. Our hospital system is contemplating pulling them from all our hospitals. There are two striking difficulties in the information that was presented. First, the clinical results have a signal of late mortality and morbidity, and second, animal studies by veterinarians hired by the FDA have also shown unequivocally that distal material is shed and can be detrimental to tissue downstream. I feel other treatments should be considered, such as standard balloon or focal balloon dilation, perhaps following atherectomy or other therapies. There also are some very encouraging early studies done with other carriers such as sirolimus, which of course has been very effective in the coronary tree with balloons and stents. Lastly, for long superficial femoral artery (SFA) lesions, I think we will have the answer with the Detour (PQ Bypass), which appears to have as good or better results in terms of patency as fempop bypass (without the prolonged hospitalization, morbidity, and mortality associated with traditional bypass). 

Disclosure: Dr. Richard Heuser reports he is a co-inventor of PQ Bypass and a major investor.

Dr. Richard Heuser can be contacted at richard.heuser@steward.org.