Panelists at the Drug-Coated Balloon (DCB) Safety Town Hall on the last day of Cardiovascular Research Technologies (CRT) 2019 said there is a safety signal for paclitaxel-coated devices used in the femoral and popliteal arteries. They also said that physicians recommending the use of these devices should have a discussion with patients about this safety signal.
The town hall’s focus was on the scrutiny that paclitaxel-coated devices have received since a meta-analysis by Konstantinos Katsanos, MD, PhD, MSc, EBIR, of Patras University Hospital, Greece, and colleagues, published in December in the Journal of the American Heart Association. Katsanos and colleagues’ manuscript reported higher all-cause mortality in patients undergoing treatment of femoropopliteal disease with paclitaxel-coated devices compared to control groups in 28 randomized controlled trials.
Katsanos himself was at the town hall Tuesday. He explained and defended the paper under some intense questioning about statistical methods used in reporting the meta-analysis.
The panel and presenters represented interventional cardiologists, researchers, biostatisticians and industry. At the end, panelists voted on four questions and discussed them.
The first was, “Given the data from the meta-analysis and other data that was presented today, is there a safety signal for paclitaxel DCB in the SFA (superficial femoral artery)?” The tally of votes, taken anonymously, was 10 yes, zero no and four “I don’t know.”
The second was, “Should the current labeling for DCB and DES (drug-eluting stent) with paclitaxel be restricted, changed or unchanged?” The tally was three votes for restricted, three for changed and eight for unchanged.
“Changed” was indefinite, CRT Course Chairman Ron Waksman, MD, FSCAI, pointed out, as it could include expanding or restricting the use.
The third question was, “Should patients be informed about the paclitaxel controversy prior to intervention with a paclitaxel device?” Jeffrey J. Popma, MD, FSCAI, of Beth Israel Deaconess Medical Center, Boston, who was a co-moderator of the town hall, polled the audience. Nearly all audience members raised their hands to indicate that patients should be informed. Popma said the vote was similar with the panel: 10 voted yes, patients should be informed, and one voted “I don’t know.”
The fourth and final question was, “Is the patient-level data of all paclitaxel systems poolable for definitive analysis?” The tally was nine yes, one no and four “I don’t know.”
After the daylong town hall, Popma summed up the current state of the paclitaxel device debate: “I came in with uncertainty, and now I’m going away with uncertainty, but we made tremendous progress.”
Town hall co-moderator David E. Kandzari, MD, FSCAI, of Piedmont Heart Institute, Atlanta, added: “I know I don’t know, and I want to thank everybody, our audience, for attending and staying with us for a full day of terrific presentations.”