Drug-coated balloons have taken the lead from metallic drug-eluting stents for peripheral artery disease, but the race is far from over with the introduction of newer stent technologies, according to , executive director of the Cardiovascular Research Foundation's Skirball Center for Innovation.
In this exclusive ľֱ video, the interventional cardiologist reviews the applications for drug-coated balloons, comparing them with bare metal stents and drug-eluting stents.
A transcript follows:
Right now, drug-coated balloons are approved only for peripheral vascular indication in the U.S. In Europe, based on CE Mark approval, old technologies are pretty much approved for coronary and peripheral use. I would say, in Europe, where pretty much the technology originated from, the use is widely adopted in SFA [superficial femoral artery] intervention -- less in BTK [below-the-knee] intervention -- in the absence of stents for SFA indication, and in the coronaries mainly for in-stent restenosis.
There are certain groups in Europe using drug-coated balloons for de novo lesions, but I would say for the coronary applications, the drug-coated balloon use in the coronary territory is pretty much used for in-stent restenosis.
So all the literature today supports the use of drug-coated balloons for in-stent restenosis in the coronary territory. Especially for bare-metal stents, the data seems to be very consistent in terms of the current in-stent restenosis rate at six months and one year. For drug-eluting stents, due to the aggressiveness of the disease, the effectiveness is not as clear.
The efficacy is not as clear as it's seen for bare-metal stent restenosis. For de novo lesions in the coronary territory ... the use of this technology is very unclear and needs to be studied more carefully. In the peripheral territory though, I would say the drug-coated balloon use is preferred over metallic drug-eluting stents. The main reason is because people don't want to leave a lot of stent material behind.
But things are changing with the new designs and the new generation drug-eluting stents. And I think for peripheral vascular applications we need comparative, randomized, controlled studies to really know which technology will prevail in this particular territory.
So in summary, I would say coronary use would be in-stent restenosis, and each application, like a small vessel bifurcations and so forth. For peripheral territory until now, balloons over stents because of the length of disease and aggressiveness of disease, but still more data is needed to really know which technology will prevail in peripheral vascular applications.