New results for BioFreedom Biolimus A9 (umirolimus) drug-coated stent show benefits in PCI- Biosensors International

Biosensors International announced that the LEADERS FREE clinical trial demonstrated superior safety and efficacy for BioFreedom Biolimus A9 Drug-coated stent compared with a bare-metal stent (BMS). LEADERS FREE is a double-blinded randomized study comparing BioFreedom – a polymer-free stent coated with Biolimus A9 (umirolimus) – with an uncoated BMS (Gazelle) in patients at high risk of bleeding undergoing percutaneous coronary intervention (PCI) with only one month of dual anti-platelet therapy (DAPT). The new results of LEADERS FREE showed a 50% reduction in the need for repeat revascularisation, the primary efficacy endpoint: 5.1% of patients receiving BioFreedom experienced clinically driven target lesion revascularization (TLR) at 390 days versus 9.8% of patients receiving a BMS.

Patients in the BioFreedom arm also had a 29% reduction in risk of cardiac death, myocardial infarction or stent thrombosis: 9.4% of BioFreedom patients versus 12.9% of BMS patients at 390 days. The difference between groups was statistically highly significant for both the safety and efficacy endpoints. The results were presented by Dr Philip Urban, Principal Investigator for LEADERS FREE, at the Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation, and simultaneously published in the New England Journal of Medicine.