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outpace the body of research in their support. Progress can be brought to a standstill when an unexpected result or a safety concern is raised, and the body of evidence is not strong enough to refute it.


The finding of an increased mortality signal associated with paclitaxel drug- eluting therapy was really unexpected. It didn’t make sense. The therapy was established in coronary artery intervention, for example, with no such safety concerns. But we know you can’t dispute data with logic, so we needed more data.


Having done this project, it’s given me a new perspective on the importance of good, quality research and how to engage with it.


What were your key takeaways? HB: Firstly, to address that initial safety concern, the evidence scale has now tilted toward there being no increased mortality signal with paclitaxel drug-eluting balloons and stents in the femoropopliteal artery. This was acknowledged by the FDA in July 2023, and we have also shown no statistically significant difference in target limb major amputation or thrombosis rates with these devices, further attesting to their safety.


Not only are they safe, but they’re effective. The data has additionally shown improved and durable patency rates with a significantly lower risk of clinically driven target lesion revascularization. I think the main takeaway is that paclitaxel drug-eluting therapy warrants reconsideration in the treatment of femoropopliteal arterial disease.


What impact do you think these findings may have? HB: I think the now strong body of evidence in support of the efficacy of drug-eluting therapies will be recognized, and in turn we’ll see an upturn in clinical use, but I anticipate it will take time. It’s taken nearly half a decade to definitively refute the safety concerns that were raised in 2018, and during this time, IRs were getting used


Forest plot of all-cause mortality at 12 months, random-effects analysis model. CI = confidence interval; df = degrees of freedom; IV = inverse variance.


to alternate non-drug eluting devices in this region. So, I’m sure everyone will be able to appreciate that changing the treatment paradigm will be difficult. But in light of these positive findings, it’s important to reflect on our practice and identify if there are patients in which these devices would confer benefit.


Will these findings impact your own practice or treatment paradigm? HB: In my center, drug-eluting therapy is not used at the moment, and it’s not something that has really been on a lot of IRs’ radars. For me, these findings demonstrate the need to educate on the updates and raise awareness of new findings and the absence of safety concerns.


What are the next steps with this research? HB: Now that the absence of a mortality risk has been achieved, I think it’s important to recognize that the improved primary patency rates and lower risk of restenosis are likely to see an increase in drug-eluting therapy use in this space, which will in turn lead to an increased number of clinical trials. I hope that trial design does consider the need for long-term patient level data to push progress in IR and not leave it vulnerable to stagnation, like what happened in this example. That’s step one.


The next steps involve tackling the nuances of patient and lesion factors that may affect outcomes, addressing the differences in devices—including devices with varying paclitaxel concentrations—and comparing balloons with stents. There were nuances that we chose not to look at in our study, since our primary goal was to determine if the mortality signal persisted in modern data. But all of these factors warrant consideration and further analysis before widespread use of paclitaxel drug-eluting therapy is going to be welcomed.


One thing we did note was sparse reporting on aneurysmal dilatation of the superficial femoral artery after endovascular paclitaxel exposure. This is something that was an emerging potential concern. Anecdotally, we just noted that very few trials were commenting on this, so it’s something that I feel warrants consideration in future trials.


Read the full article on jvir.org. irq.sirweb.org | 27


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