Here at VIVA13, physicians have been treated to late-breaking results from 15 trials, covering a wide range of topics! Here are some reactions to the data.
PV is a data desert no more!
A panellist commented that PV treatment used to be a data-free zone, and it was easy to hide behind clinical experience to justify treatment choices. We have seen this week that PV data is really maturing with several trials reporting 3 or 4 year results?including positive results from the Zilver PTX trial. Now the focus is on data quality.
Big results from small companies
Both Aptus Endosystems and Trivascular received high praise for their EVAR trials. Aptus Endosystems, with its EVAR anchoring system, was commended for its wide-reaching patient inclusion criteria and "cool" device. They reported acute technical success of 99.5% in primary stent graft placement, creating excitement that this device may help extend the EVAR treatable patient population.
Trivascular wowed with a 100% success rate in the 2-year data for its low-profile EVAR device. The panel said this data is a "big wow"! In addition, over 40% of these procedures were performed percutaneously, demonstrating the versatility of this device.
Drug-coated ballons work, how can we make them even better?
Two DCB trials were presented that went beyond just the basic function of these devices.
The highly anticipated Definitive AR pilot study showed that using atherectomy in conjunction with a DCB raised technical success from 64% (DCB alone) to 90% at one month and lowered rates of dissection compared to DCB POBA.
The FAIR trial looked at the role of DCB in SFA in-stent restenosis and found greater freedom from TLR using a DCB compared with standard PTA (96% vs 62%).
Of course, these US physicians can't adopt this technology in their practices yet, but they are eagerly awaiting the day that they can.
Stenting, stenting and more stenting
Lots of stage time was given to stenting trials including 4-year data from Zilver PTX that showed continued effectiveness for this stent over this long time period. A collective sigh of relief was heard from skeptical physicians who were expecting the drug coating to lose effectiveness in the long term.
The Durability II trial, looking at SFA stenting, showed 60% freedom from loss of patency over 3 years. It was noted that there is a subset of patients that seem to do well with these stents, and it would be great if that population could be identified.
The assembly was also treated to positive data for renal and carotid stenting from the Hercules trial and Choice trials, respectively. Although it was noted that neither trial was randomized, both were described as having "impressive" data. A quick poll showed that the Choice trial results caused nearly 50% of physicians in the room to either change their mind on carotid stenting or consider changing their minds.
The faculty here at VIVA commented regularly on the impressive job that manufacturers have done with trial design and contributing to the scientific body of knowledge and not just pursuing device approval. The bar has been raised for clinical trials in the peripheral vascular space.