BIOPACT RCT suggests Passeo-18 Lux DCB non-inferior to IN.PACT Admiral DCB


Koen Deloose (Dendermonde, Belgium) talks to Vascular News about the key one-year data from the BIOPACT randomised controlled non-inferiority trial, which evaluated the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) catheter (Biotronik) compared to the IN.PACT Admiral DCB (Medtronic).

Speaking at the 2022 Paris Vascular Insights (PVI) conference (23–25 November, Paris, France), Deloose notes that there was “no difference between the balloons” in terms of the primary efficacy endpoint (freedom from clinically-driven target lesion revascularisation at 12 months) as well the primary safety endpoint (a composite of freedom from device- and procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularisation through 12 months post-index procedure).

Deloose outlines the factors that dictate which device he chooses, including latest data, available sizing and economic considerations. He explains why these types of randomised head-to-head trials are so important, noting that “the more data we have available to show the safety of these kind of technologies, the better”.


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