At least 40%1of PCI patients are High Bleeding Risk (HBR) where there is a need to avoid prolonged dual antiplatelet therapy (DAPT).1
LEADERS FREE III (with BioFreedom™ Ultra as study device) has confirmed the LEADERS FREE results that demonstrated that the BioFreedom™ Drug-Coated Stent (DCS) is significantly safer and significantly more efficacious than a BMS in High Bleeding Risk patients, with a DAPT regime of only one month, the shortest DAPT regime mandated for all patients in a published, double-blind randomized controlled trial.2
By directly delivering BA9™ - an effective anti-restenotic agent - without polymer or carrier, becoming a BMS at 28 days, the DAPT regime can be shortened when treating patients with the BioFreedom™ Ultra stent.1,2
In LEADERS FREE, High bleeding risk patients include, but are not exhaustively: Age >75 OACs, Renal Failure, planned surgery within the next 12 months, anemia of recent TF, Cancer, hospitalisation for bleeding, poor DAPT compliance, NSAIDS steroids, thrombocytopenia, stroke <1 year, severe liver disease, prior intracerebral bleed.
BioFreedom™, predicate device to BioFreedom™ Ultra, is listed as stent of choice in ESC DAPT guidelines, for 1 month-ultra short DAPT in patients with stable CAD in whom longer DAPT regimes poses safety concerns*.