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imageClinical Evidence

LEADERS FREE - NEJM October 2015

Leaders Free a prospective, double-blind, randomized (1:1) clinical trial comparing the BioFreedom™ DCS to the GazelleTM BMS in High Bleeding Risk (HBR) patients with 1 month DAPT.

Leaders Free is currently the only published trial of complex patients and lesions to exclusively enroll HBR patients mandating a 1 month DAPT for all.

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BioFreedom is the only active stent with 1 month DAPT that has demonstrated superior outcomes to BMS11

With Leaders Free, BioFreedom becomes the standard of care for High Bleeding Risk (HBR) patients11

11. Urban et al. New England Journal of Medicine 2015; published ahead of print October 14.DOI: 10.1056/NEJMoa1503943

Trial design and unique HBR patients

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Significantly greater safety and efficacy than BMS11

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* Relative Risk Reduction.
Percentages are Kaplan–Meier estimates at 390 days. Urban P. et al. Polymer-free Drug-Coated Stents in Patients at High Bleeding. NEJM 2015; published ahead of print October 14; DOI:10.1056/ NEJMoa1503943.
11. Urban et al. New England Journal of Medicine 2015; published ahead of print October 14.DOI: 10.1056/NEJMoa1503943

  • Leaders Free is the first randomized clinical trial dedicated to HBR patients
  • 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 a one-month only DAPT course, the use of a BA9-DCS was both significantly safer and more effective than a control BMS in HBR patients

Even greater safety and efficacy than the general LF population

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 Christophe Naber.

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.

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In HBR patients with an ACS, BioFreedom combined with 1-month DAPT displays significantly better efficacy and safety, with significantly lower cardiac mortality and myocardial infarction than a BMS.

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12. Tada et al. Circulation: Cardiovascular Interventions. 2010;3:174-183


LEADERS FREE 2 years: Safety and Efficacy preserved

High Bleeding Risk patients: safety and efficacy benefits of BioFreedom™ Drug-Coated Stent over BMS are preserved up to two years

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LEADERS FREE: Two-Year Outcomes of High Bleeding Risk Patients after Polymer-Free Drug-Coated Stents, P. Urban et al.
TCT 2016 presentation, JACC online publication. 11697-000-EN - Rev.01.

 

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 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.



BA9TM
The drug designed for vascular stent technologies
Polymer and carrier free drug delivery
BioFreedom's Selectively Micro-Structured Surface
Who are High Bleeding Risk (HBR) patients?
Clinical Evidence: with Leaders Free
BioFreedom becomes the standard of care for HBR patients

CAUTION: The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the "Instructions for Use" supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.

Biosensors’ interventional cardiology and endovascular products, including BioMatrix Flex™, BioMatrix Flex™ BTK, BioMatrix NeoFlex™, BioMatrix Alpha™, BioMatrix™, Axxess™, BioFreedom™, Chroma™, BioStream™, BMX-J®, Excel, BioPath™, Gazelle™, Juno™, S-Stent™, Powerline™, Quadrature Link™ and MultiPleat™, are not available for sale in the United States and certain other countries.

BioMatrix Flex, BioMatrix Flex BTK, BioMatrix NeoFlex, BioMatrix Alpha, BioMatrix, Axxess, BioFreedom, Chroma, BioStream, BMX-J, BioPath, Gazelle, Juno, S-Stent, Powerline, Quadrature Link, MultiPleat, Accutrans, Biotrans and SafetyWedge are trademarks or registered trademarks of Biosensors International Group, Ltd. All other cited trademarks are the property of their respective owners.