NEW YORK—Kim Hodgson, MD, president of the Society for Vascular Surgery, delivered a robust defense of the SVS position on the drug-coated balloon (DCB) and drug-eluting stent (DES) issue that is currently enveloping the vascular community during the 2019 iteration of the VEITHsymposium (Nov. 19–23) here.
During a session on new developments in lower-extremity related topics focused on the downsides of DCBs, Gary M. Ansel, MD, an interventional cardiologist with OhioHealth Heart and Vascular Physicians in Columbus, Ohio, and one of the session moderators, kicked off affairs by launching a broadside in the direction of the SVS over its stance on the paclitaxel issue, saying, “You are out of step with the times and isolationists.”
Once his turn to take to the podium arrived, Hodgson, also chair in the division of vascular surgery at Southern Illinois University School of Medicine in Springfield, Illinois, wasted little time in firing back, responding, “Thanks Dr. Ansel for the wonderful comments about our ‘isolationist’ views, which I will take exception to.”
He continued: “All of the other speakers fly through [their] disclosures. I’m going to sit here for a minute and let you know that I have received no personal income or gifts from industry for over four years other than for compensation serving on trial [CECs, etc.] so I think that gives me a certain level of objectivity.”
Hodgson proceeded with a point-by-point breakdown of what the SVS is doing in light of the status of paclitaxel-coated devices and why the society has taken the stance that it has.
“Obviously when the Katsanos publication came out in 2018, it created a great deal of stir. The SVS response to this was to put together a group of experts largely based on our VQI [Vascular Quality Initiative] analysis and our quality programs, and to take a look at the study of this situation,” he explained.
Hodgson said he would not delve into the original meta-analysis in any great detail except to reiterate the five-year results “in the 863 patients available for study, which did show significant increasing mortality in that group of patients.” He went on: “So the FDA [Food and Drug Administration] response to this originally in January of 2019 was that the FDA believed the benefits continued to outweigh the risks. But two months later, they recommended alternative treatment options should generally be used for most patients.
“So what happened in that period of time? Well, 975 patients from the three trials with five-year data showed a 50% increase in five-year mortality—so the data that the FDA looked at—and on the basis of this the FDA announced that they’d be convening a panel of experts to further evaluate the issue. So this panel was held June 19–20 of 2019.”
Hodgson added: “The data analysis at that point in time showed the maintained hazard ratio somewhat lessened but still significant at 1.38. The SVS focused on VQI analyses that could answer these questions because we still believe there are significant questions that need to be answered.”
About six weeks later came the FDA’s third physician advisory letter, the SVS president pointed out, and that “reiterated the presence of the paclitaxel mortality signal and noted, however, that there were significant problems in this analysis—significant concerns about the scientific rigor of this analysis for the reasons mentioned here [during the session].”
Hodgson continued: “They went on to say, however, that for many patients alternative treatment options to paclitaxel-coated balloons and paclitaxel-ballooning stents provide a more favorable benefit-risk profile based on currently available evidence. Well, the SVS response to the FDA panel conclusions—the SVS Paclitaxel Safety Task Force in collaboration with the Society for Clinical Vascular Surgery and the Vascular and Endovascular Surgery Society—concurred with the FDA decision to keep the devices available while more data is accumulated. We believe in science. We also agreed that lifestyle changes, exercise, medical therapies and other revascularization techniques may provide equal or better effectiveness for claudication, which is the primary and label indication for use of these devices, and that this really needs to be part of a candid discussion that physicians have with their patients.”
Where do things now stand from an SVS point of view? Hodgson asked as he drew his presentation to a close.
“The paclitaxel mortality effect appears to be real but the mechanism of harm remains unknown,” he said. “There are so many different drug formulations, doses, excipients used, doses actually delivered to patients depending upon the balloons and devices used—this is going to be a very challenging problem to sort out.”
Earlier in the session, the man whose research sparked the current debate, Konstantinos Katsanos, MD, of the School of Medicine, University of Patras, Patras, Greece, had given an update on his meta-analysis.
And during his allotted slot, Michael Jaff, DO, vice president, clinical affairs, innovation and technology, peripheral interventions at Boston Scientific, Marlborough, Massachusetts, spoke of the “proven benefit” of drug-coated balloons and stents for patients, delivering a measured comment in the direction of Katsanos as he drew his presentation to a close. “Dr. Katsanos has been quite clear on his position so I give him great credit in his standing towards his conviction that paclitaxel is guilty until proven innocent. None of us wants to use these devices to hurt patients. We all want to do the right thing.”