Jump to Navigation USA site JAPAN site Contact us Members Only Clinical 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. 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 Significantly greater safety and efficacy than BMS11 * 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. 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. 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 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. Top menu Home About Products & Technology Clinical Program Newsroom Treatments for CAD Events & Resources Products & Technology Cardiovascular History of Firsts BioFreedom™ BA9™ (Biolimus A9™) Micro-structured Surface High Bleeding Risk Patients Clinical Evidence Real World Experience BioMatrix Alpha™ BioMatrix NeoFlex™ BioMatrix Flex™ Axxess™ Excel Chroma™ Gazelle™ BioStream™ Powerline™ Endovascular Critical Care Nuclear Cardiac Imaging Multimedia In evidence based medicine… we trust! Leaders Free ACS subgroup… Dr Naber's opinion Downloads LEADERS Free Brochure LEADERS 2 years follow-up Site Map | Privacy Policy | Terms of Use Copyright © 2010-2017 Biosensors International Group, Ltd. All Rights Reserved