With LEADERS FREE, BioFreedom™ becomes the standard of care for High Bleeding Risk (HBR) patients

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 Patients11NEJM (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

Trial design and unique HBR 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

LEADERS FREE - 1 year follow-up: BioFreedom™ is significantly safer and more efficacious than a BMS11

  • 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.

LEADERS FREE - Pre-specified ACS subgroup - Even greater safety and efficacy than the general LF population13

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.

LEADERS FREE - 2 years: Safety and Efficacy preserved

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.

LEADERS FREE II - Safety and Efficacy in a North American population

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



> CoCr DCS non-inferior to StS DCS for safety16
> CoCR DCS superior to BMS for efficacy16



11881-000-EN - Rev.04 + 11556-000-EN – Rev.01 + 11697-000-EN – Rev.01
Movie - ACS subgroup - Dr C. Naber
Watch Dr Christoph K. Naber's opinion
Movie - In Evidence Based Medicine, We Trust!
Watch Dr Hans-Peter Stoll's opinion (CMO from 2015 to 2020)
Main brochure

2-year follow-up brochure

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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