At least 20% of PCI patients are High Bleeding Risk (HBR) where there is a need to avoid prolonged dual antiplatelet therapy (DAPT).1-9
The BioFreedomTM 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.10
By directly delivering BA9TM - an effective anti-restenotic therapy - without polymer or carrier, becoming a BMS at 28 days, the DAPT regime can be shortened when treating patients with the BioFreedom stent.10
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 is now 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*.
*European Heart Journal (2018)39, 213-254
1. Rao et al. AHJ 2013;166:273-281.e4
2. Rittger H et al. Herz 2014;39(2):212-8
3. Faxon et al. Circ Cardiovasc Interv 2011;4:522-34
4. De Biase et al. Transl Med 2015;11(3):14-23
5. To et al. Circ Cardiovasc Interv-2009;2:213-21
6. Wiviott et al. NEJM 2007;357:2001-15
7. Pilgrim et al. Circ Cardiovasc Interv. 2012;5:202-210
8. Shanmugam VB et al. Journal of Geriatric Cardiology 2015;12:174−184
9. Urban P. et al. Am Heart J 2013;165:704-9
10. Urban P et al. N Engl J Med 2015;373:2038-47