XTOSI study interim findings suggest “highly promising” safety and efficacy of sirolimus DCB

Edward Choke (Singapore) talks to BLearning Peripheral at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about the first-in-man clinical study—XTOSI—which looked at the safety and efficacy of a sirolimus drug-coated balloon (DCB) in the treatment of peripheral arterial disease.

The interim findings showed that primary patency at six months in the XTOSI below-the-knee (BTK) patients was 74%. This, notes Choke, is “highly promising”, particularly when compared to a recent study by separate investigators which looked at a paclitaxel DCB in BTK patients and showed patency of just 40% at six months. Choke outlines some of the challenges with the critical limb ischaemia (CLI) patient cohort, including the strong prevalence of diabetes (90% of patients) and the “complexity of the lesions themselves”.

He concludes by discussing the next steps, including the need to gather level one data from a larger population of patients and also highlights two upcoming randomised controlled trials, FUTURE-SFA and FUTURE-BTK.

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