LEADERS FREE is a prospective, double-blind, randomized (1:1) clinical trial comparing the BioFreedom™ drug coated stent (DCS) to the Gazelle™ bare metal stent (BMS) in 2466 High Bleeding Risk (HBR) patients with 1 month dual anti-platelet therapy (DAPT).
The results demonstrated that BioFreedom™ is superior to a bare metal stent with respect to the primary safety and efficacy endpoints at 1 year when used with a 1-month course of DAPT11.
LEADERS FREE is currently the only published trial to exclusively enroll HBR patients with 1 month DAPT.
LEADERS FREE, at 1 year proved that BioFreedom is the only active stent with 1 month DAPT that demonstrated significantly superior outcomes to BMS in High Bleeding Risk Patients11. NEJM (October 2015)
LEADERS FREE 2 year follow-up maintains that BioFreedom and 1 month DAPT followed by SAPT alone should be the treatment strategy of choice for HBR patients undergoing PCI. JACC (January 2017)
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 concerns12
The pre-specified Acute Coronary Syndrome sub-group of the LEADERS FREE trial was presented as a late breaking clinical trial at Euro PCR 2016 by Dr Christoph K. Naber and published13.
This sub-group analysis reinforces the benefit of the BioFreedom DCS vs BMS in HBR patients. The improvement in safety and efficacy achieved with BioFreedom is even greater in the high risk HBR ACS patient population.
In HBR patients with ACS, BioFreedom combined with 1-month DAPT displays significantly better efficacy and safety, with significantly lower cardiac mortality and myocardial infarction than a BMS.
High Bleeding Risk patients: safety and efficacy benefits of BioFreedom™ Drug-Coated Stent over BMS are maintained at two years14.
LEADERS FREE: Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated stents14
BioFreedom™ is the only active stent with CE mark for ultra-short 1 month DAPT in High Bleeding Risk (HBR) patients, supported by clinical data from a double-blind randomized controlled trial.
11. Urban et al. New England Journal of Medicine 2015; published ahead of print October 14.DOI: 10.1056/NEJMoa1503943
12. European Heart Journal (2018) 39, 213–254
13. Naber et al. European Heart Journal. 2016; doi:10.1093/eurheartj/ehw203
14. Philippe Garot et al. JACC 2016. DOI: 10.1016/j.jacc.2016.10.009
* Relative Risk Reduction. Percentages are Kaplan–Meier estimates at 390 days. Presented by Philip Urban at TCT 2015. Biolimus-Coated vs. Bare-Metal Coronary Stents in High Bleeding Risk Patients.