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. BioFreedom™ is the predicate device for BioFreedom™ Ultra.
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
BioFreedom™ is the only Drug-Coated 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.
> LEADERS FREE is the first randomized clinical trial dedicated to HBR patients who received 1 month of DAPT followed by single antiplatelet therapy
> Such patients are often excluded from stent and drug trials, constitute a rapidly growing proportion of PCI candidates and suffer high event rates
> Together with an ultra short one-month only DAPT course, the use of BioFreedom™ (a Biolimus A9™ polymer and carrier free DCS) was both significantly safer and more effective than a control BMS in HBR patients.
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.
Reproducibility of LEADERS FREE findings
> Safety of DCS with 30 day DAPT in HBR patients15
> Effectiveness of DCS with 30 day DAPT in HBR patients15
> BioFreedom™ Ultra non-inferior to BioFreedom™ for safety16
> BioFreedom™ superior to BMS for efficacy16
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
15. M.W. Krucoff. Global Approach to High Bleeding Risk Patients With Polymer-Free Drug-Coated Coronary Stents: The LF II Study. Circ Cardiovasc Interv. 2020 Apr;13
16. Biolimus-A9™ coated thin strut stent in high bleeding risk patients. Oral Abstract presentation, F. Eberli, PCR eCourse 2020
* 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
^ Rationale and Design of the LEADERS FREE Trial: A Randomized Double-Blind Comparison of the BioFreedom Drug-Coated Stent vs the Gazelle Bare Metal Stent in Patients at High Bleeding Risk Using a Short (1 Month) Course of Dual Antiplatelet Therapy Urban p. Am Heart J . 2013 May;165(5):704-9
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