Original Title: Biolimus A9 drug-coated stent vs. bare metal stent in patients presenting with ACS. A pre-specified LEADERS FREE ACS sub-study.
Presenter: C.K. Naber.
In ACS patients with high bleeding risk, guidelines recommend 3 to 6 months of dual ATP treatment for DES implantation or one month in case of conventional stenting.
The aim of the present pre-specified sub-analyzis was to assess the safety and efficacy of BioFreedom DES implantation followed by just one month of dual ATP in ACS patients at high bleeding risk.
The LEADERS FREE was a double blind trial including 2466 patients randomized to the polymer free coated stent BioFreedom vs. bare metal stent with an efficacy primary end point (target vessel revascularization at 12 months) and safety end point (cardiovascular death, infarction or definite/probable stent thrombosis). Of this population, 662 patients received PCI in the context of ACS.
Target vessel revascularization rate at 12 months was 3.9% for the BioFreedom arm and 9% for the conventional bare metal stent arm (HR: 0.41; p=0.009). As regards the combined end point of safety, rates were 9.3% and 18.5% respectively (HR: 0.48; p=0.009). There was a clear trend towards the reduction of thrombosis risk with the BioFreedom (p=0,099).
Conclusion
In patients with ACS and high risk of bleeding, the BioFreedom with only one month DATP showed superior safety and efficacy compared to bare metal stents.
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