The biggest buzz topic in the endovascular world at the 2013 Transcatheter Cardiovascular Therapeutics (TCT) conference was definitely drug-coated balloons (DCBs).
The discussion kicked off with a late-breaking presentation of 6-month data from Bard's LEVANT-2 study. This is the largest peripheral DCB study to date, and it is meant to support the FDA approval of Bard's Lutonix DCB. There are currently no peripheral DCBs available in the US the device has been hotly anticipated for many years, as evidenced by the packed auditorium for this presentation.
The presenters highlighted the trial design, and kept underscoring how rigorous the trial was. This rigorousness included a focus on trying to eliminate biases caused from bail-out stenting that have been observed in other DCB trials. The investigators believe that this caused a more pure comparison of DCB to standard plain old balloon angioplasty (POBA). The session's panel applauded the investigators for this attention to detail, and appreciated this effort to be fair (eliminating this bias did make their positive results slightly less impressive than they would have been with the bias included).
I wondered if a pure comparison of DCB treatment to POBA really tells us much though we already know PTA-with-stent typically offers better long-term patency results than POBA. Isn't the point of using a DCB to eliminate the need for stenting (and the fracture and restenosis risk that comes with it) while providing similar efficacy. Even if DCBs are shown to be better than POBA, does that really have any clinical implications for physicians choosing between device types Of course, the LEVANT-2 study is designed to seek FDA approval of the Lutonix balloon, and comparison to POBA is the best way to go about that. But I still want to know how DCB compares to stents and especially drug-eluting stents (DES)!
My questions were echoed in a DCB session the next day that featured many of the leading KOLs in this field, including Dr. Zeller, Dr. Tepe, Dr. Dake, and Dr. Gray.
This rock-star group of endovascular-specialist interventional cardiologists (ICs) discussed currently available DCB data to try and answer the question where does DCB fit into my practice. This culminated in a (mock) debate between Dr. Dake and Dr. Gray, arguing whether DCBs or DES would be the dominant player for lower-extremity lesions. They were both clearly in the can for DCBs, but the debate proceeded nonetheless.
Dr. Dake's argument for DES was that there is currently no bridging clinical data comparing DCB to DES. We know DCBs are better than POBA, and that DES are better than BMS but really nothing beyond that. Data for the Zilver PTX is quite good, and there will always be a need for stents, meaning that DES aren't going anywhere.
One of the most interesting arguments for DCBs (that hasn't come up as often as I would have expected) is how easy the device is to use compared to DES. Good results can be widespread and replicable in the hands of many physicians. Another unique argument made by Dr. Gray was that DCBs are good for hospital purchasing departments although there are none available yet, we expect 3 to 5 separate manufacturers to come out with a DCB in the US in the near future, whereas Cook still holds a monopoly on peripheral DES. Competition among DCB manufacturers will give power to hospitals. Along with all of these positives, DCB efficacy looks similar to DES (although no direct comparison exists).
A vote followed, and DCB won the room albeit it was a room of ICs that were interested enough in DCBs that they were willing to stay past 6pm on the last day of the conference for the debate.