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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. 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.

Trial design and unique HBR patients^


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

 


LEADERS FREE III

> BioFreedom™ Ultra non-inferior to BioFreedom™ for safety16
> BioFreedom™ superior to BMS for efficacy16

 


11881-000-EN - Rev.04 + 11556-000-EN – Rev.01 + 11697-000-EN – Rev.01
LEADERS FREE
Movie - ACS subgroup - Dr C. Naber
Watch Dr Christoph K. Naber's opinion
LEADERS FREE
Movie - In Evidence Based Medicine, We Trust!
Watch Dr Hans-Peter Stoll's opinion (CMO from 2015 to 2020)
LEADERS FREE
Webinar - PCR 2020 e-Course
As easy as 1,2,3! Evidence based PCI in Patients at High Bleeding Risk
LEADERS FREE
Complex PCI with short DAPT
The trade-off between ischaemia and bleeding in HBR patients
LEADERS FREE
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

BIOFREEDOM™ FAMILY CLINICAL PROGRAM

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Biosensors’ interventional cardiology products, including BioMatrix NeoFlex™, BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, BMX-J® and RISE™ NC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT GmbH. Blue Sail Medical Co., Ltd is the ultimate parent company of NVT GmbH and Biosensors International Group, Ltd. and its subsidiaries are collaborating for the commercialization of the ALLEGRA™ device.

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