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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

 

BioFreedom HBR

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*.

 

11523-000-EN - Rev.01 + 11524-000-EN - Rev.01 + 11881-000-EN - Rev.03
BioFreedom™
Movie - Who are HBR Patients?
LEADERS FREE
Webinar - PCR 2020 e-Course
As easy as 1,2,3! Evidence based PCI in Patients at High Bleeding Risk
BioFreedom™
HBR patients brochure

* European Heart Journal (2018)39, 213-254
1. Ueki et al. Validation of Bleeding Risk Criteria (ARC-HBR) in Patients Undergoing Percutaneous Coronary Intervention and Comparison with Contemporary Bleeding Risk Scores.
EuroIntervention. 2020 Feb 18. DOI: 10.4244/EIJ-D-20-00052
2. Data from BioFreedom. BioFreedom is the predicate device of BioFreedom Ultra. Garot P. et al. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. JACC VOL.6 9, NO.2, 2017
 
 

 

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