Sirolimus Versus Paclitaxel Drug-Coated Ballons for Femoropopliteal Disease: The LIMUS FLOW Trial.
Christos Rammos, Olga Petrikhovich, Berna Akan et al.
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In 30 seconds
The LIMUS FLOW proof-of-concept randomized controlled trial compared sirolimus-coated balloons (SCBs) with paclitaxel-coated balloons (PCBs) for severe femoropopliteal peripheral artery disease in 70 patients. At 12 months, endothelial function improved more with SCBs than PCBs (40% improvement with SCBs versus 22% with PCBs, P =0.023). The improvement was associated with reduced inflammatory markers at 1 month after sirolimus application. Despite these differences in endothelial function and inflammation, the groups did not differ in primary patency or freedom from target lesion revascularization at 12 months.
Key findings
- At 12 months, endothelial function improved by 40% with SCBs versus 22% with PCBs (P =0.023).
- Improved endothelial function was associated with reduced inflammatory markers 1 month after sirolimus application.
- Primary patency and freedom from target lesion revascularization did not differ between groups after 12 months.
Why it matters
The trial examines whether balloon drug choice affects vascular recovery beyond restenosis-related clinical outcomes. Its findings suggest that sirolimus-coated balloons may produce greater improvement in endothelial function and lower inflammatory markers, while showing no observed advantage in the reported 12-month clinical outcomes. These mechanistic results may inform further comparative research but do not establish superior clinical effectiveness.
What to keep in mind
This was a proof-of-concept trial with 70 patients and 12-month clinical outcome assessment; the abstract reports no between-group difference in clinical outcomes.