LEADERS FREE

LEADERS FREEは、1ヶ月の2剤抗血小板療法を受けた出血リスクの高い患者2466例を対象に、BioFreedom™薬剤コーテッドステントとGazelle™ベアメタルステントを比較する前向き二重盲検無作為化(1:1)臨床試験です。
その結果、1ヶ月間のDAPTを併用した場合、1年後の安全性と有効性の主要評価項目に関して、BioFreedom™薬剤コーテッドステントがGazelle™ベアメタルステントより優れていることが実証されました。
BioFreedom™ Ultraは、BioFreedom™のテクノロジーを引き継いでいます。

  • 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)

老夫婦

LEADERS FREEのイメージ

Trial design and
unique HBR patients^

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

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  • 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 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 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.

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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.

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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

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LEADERS FREE III

LEADERS FREE III

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

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11881-000-EN - Rev.03 + 11556-000-EN – Rev.01 + 11697-000-EN – Rev.01

アイコン

BIOFREEDOM™
FAMILY CLINICAL PROGRAM

BioFreedom™ - Company Managed Trials

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11855-000-EN_Rev.03d8

  • 1. BioLimus-A9™ coated thin strut stents in High Bleeding Risk patients Oral abstract presentation Eberli R. PCR e-course 2020
  • 2. Global Approach to High Bleeding Risk Patients With Polymer-Free Drug-Coated Coronary Stents: The LF II Study. M.W. Krucoff. Circ Cardiovasc Interv. 2020 Apr;13
  • 3. ePoster Dr Saito Euro PCR 2017
  • 4. Polymer-free Biolimus A9-coated stents in the treatment of de novo coronary lesions with short DAPT: 9-month angiographic and clinical follow-up of the prospective,
    multicenter BioFreedom USA clinical trial Waksman R. et al CRM 18 (2017) 475–481
  • 5. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. Garot P et al. JACC VOL.6 9, NO.2 , 2017
  • 6. Main results of the BioFreedom QCA trial. Sabate M. PCR e-course 2020
  • 7. Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial Costa R et al. J Am Coll Cardiol Intv 2016;9:51–64

BioFreedom™ - Physician Managed Trials

with support from Biosensors International*

特長

11855-000-EN_Rev.03d8

  • *   Biosensors has provided financial support for these PITs
  • 6. Randomised Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent with the Ultrathin Strut Biodegradable Polymer Sirol
    Treated with Percutaneous Coronary Intervention: The SORT OUT IX Trial. Published online Jensen L. 10.1161/CIRCULATIONAHA.119.0
  • 7. Safety and efficacy of polymer-free Biolimus eluting stents in all-comer patients: The RUDI FREE study Sardella G, et al. EuroIn
  • 8. Establishment of healing profile and neointimal transformation in the new polymer-free biolimus A9-coated coronary stent by lon
    assessments: the EGO-BIOFREEDOM study Lee SWL et al. EuroIntervention. 2018 Sep 20;14(7):780-788

BioFreedom™ - Trials

with no Biosensors International involvement

特長

11855-000-EN_Rev.03d8

  • 9. Angiographic and clinical performance of polymer-free biolimus-eluting stent in patients with ST-segment elevation acute myocardial infarction
    in a metropolitan public hospital: The BESAMI MUCHO study Gaspardone A Catheter Cardiovasc Interv.2017;00:1–8
  • 10. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk Windecker S, et al. N Engl J Med. 12th February 2020; 1-11

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