In this penultimate episode of a special five-part series on the history of drug-coated balloons (DCBs), Jos van den Berg (Lugano, Switzerland) is joined by Gunnar Tepe (Rosenheim, Germany) and Thomas Zeller (Bad Krozingen, Germany), with the trio discussing major highlights from the IN.PACT Global real-world study, which showed consistent outcomes with the IN.PACT SFA randomised controlled trial despite including patients with longer and more calcified lesions and those with in-stent restenosis.
Tepe elaborates on some of the key differences between the IN.PACT SFA trial, which had stringent exclusion criteria, to the IN.PACT Global study. The latter, notes Tepe, allows us to “really learn how this DCB works in the real world”.
Zeller compares some of the key findings between the two, noting that at five years freedom from clinically-driven target lesion revascularisation in the SFA trial was 74.5% compared to 69.4% in the IN.PACT Global study. The SFA trial was “very selective”, adds Zeller, with mean lesion lengths of about 8cm compared to the Global study which had a mean lesion length of more than 12cm, and going up to 35cm. The comparable results between the two sets of data show that the device “performs well not only in standard lesions but also in complex lesions”. Overall, this gives Zeller confidence that the IN.PACT Admiral DCB is “very efficient, regardless of what kind of lesion you are treating” and that lesion length only has a “mild impact on overall outcome”.
These favourable outcomes are “related to the unique formulation of a high dose of paclitaxel combined with urea and also the mechanism of action of this balloon,” says van den Berg. He also emphasises the importance of such data, concluding that it “really guides me in my choices in my personal practice”.
This video is sponsored by Medtronic.
Episode 5: The impact of long-term DCB outcomes on patients’ quality of life