SlideShare una empresa de Scribd logo
1 de 10
BioFreedom: A Prospective
   Randomized Trial of Polymer-Free
    Biolimus A9-Eluting Stents and
      Paclitaxel-Eluting Stents in
     Patients with Coronary Artery
                Disease
     Eberhard Grube, MD, FACC, FSCAI
     on behalf of the BioFreedom Investigators
             International Heart Center Essen, Germany
Hospital A Oswaldo Cruz, Instituto Dante Pazzanese, São Paulo, Brazil
        Stanford University, School of Medicine, Stanford, CA
BioFreedom™
Selectively micro-structured surface holds drug
          in abluminal surface structures
                                                      Hypothesis: Polymer-free drug
                                                        release via porous-eluting
                                                      stents may reduce late events
                                                         caused by polymer stent
                                                                 coatings.

                                                            Potential advantage
                                                  •     Avoid long term late adverse
                                                        effects that might be
   Proprietary Highly Lipophilic Limus drug             attributable to the polymer
                                                  •     Improved surface integrity
                                                        since there is no polymer to be
                                                        sheared or peeled away from
                                                        the stent struts
                                                  •     Possible shorter need of dual
                                                        antiplatelet therapy
BioFreedom FIM Design
                            BioFreedom FIM
                                 182 patients
          First Cohort                                       Second Cohort
                             12 Month Clinical FU 99%


      4 Month Angio FU                             12 Month Angio FU
             75 patients                                   107 patients
      Angio FU 92%                                Angio FU 92%




BioFreedom   BioFreedom                   BioFreedom      BioFreedom
  standard        low      TAXUS®           standard           low        TAXUS®
    dose         dose      Liberté ®          dose            dose        Liberté ®
  (BFD SD)     (BFD LD)      N=24           (BFD SD)        (BFD LD)        N=36
    N=25         N=26                         N=35            N=36


          Enrollment Period                              Enrollment Period
         Sept 2008 – Jan 2009                           Jan 2009 – Jun 2009
BioFreedom FIM Study Design
                Symptomatic, ischemic heart disease
                Native coronary artery ≥ 2.25 mm and ≤ 3.0 mm
                Lesion length ≤ 14 mm
                Lesion amenable to percutaneous treatment with DES

     BioFreedom™                           BioFreedom™                      Taxus® Liberté®
Standard Dose 15.6 µg/mm                 Low Dose 7.8 µg/mm

Clinical Follow-Up
                                30 d   4 mo    12 mo      2yr        3yr   4yr       5yr

Angio and IVUS Follow-up
Primary Endpoint:          In-stent Late Lumen Loss (LL) at 12 months (2nd cohort)
                           Non-Inferiority, margin = 0.24 mm

Secondary Endpoints: In-stent Late Lumen Loss (LL) at 4 months (1st cohort)
                     MACE and stent thrombosis rate at 30 days, 4, 12 months, 2, 3, 4 & 5 yrs
                     Clinically-driven TLR, TVR and TVF at 4, 12 months, 2, 3, 4 & 5 yrs
                     In-stent/In-segment binary restenosis at 4 months
                     In-stent/In-segment Minimum Lumen Diameter (MLD) at 4 months
                     Neointimal hyperplasia volume at 4 months measured by IVUS
                     Biolimus A9 concentrations pre/post procedure at discharge & 30 days
DAPT recommended for a minimum of 6 months
12 Month Angiographic FU
             In-Stent Late Lumen Loss: 2nd Cohort
                       Primary Endpoint
                                                                                  Non – inferiority
                                               P = 0.001
                                                                                     P values
       0.4                                                       P = 0.21      0.35
                                                                            [0.22, 0.57]


       0.3
                                                   0.22
                                               [0.17, 0.66]
                   0.17
(mm)




       0.2      [0.09, 0.39]



       0.1


       0.0
                BFD SD                          BFD LD                      Taxus
                  N = 31                          N = 35                    N = 31
                               All values are presented as median [IQR] .
12 Month Angiographic FU
             In-Stent Late Lumen Loss: 2nd Cohort
                       Primary Endpoint
                                                                       Superiority P values
                                             P = 0.11
       0.4
                                                            P = 0.55       0.35

       0.3

                                               0.22
(mm)




       0.2         0.17


       0.1


       0.0
                  BFD SD                    BFD LD                        Taxus
                  N = 31                     N = 35                      N = 31
                           All values are presented as median.
12 Month MACE (KM Estimates)
            All Patients (1st + 2nd Cohorts)
                                                BFD SD              BFD LD            Taxus
                                                 N = 60             N = 62            N = 60

MACE*                                          3 (6.1%)            7 (11.6%)          3 (5.5%)
(All Death, MI, Emergent Bypass or TLR)

  All Death                                    1 (1.8%)            0 (0.0%)           0 (0.0%)
  MI                                           1 (1.8%)            1 (1.6%)           0 (0.0%)
       Q Wave MI                               0 (0.0%)            0 (0.0%)           0 (0.0%)
       Non-Q Wave MI                           1 (1.8%)           1 (1.6%)**          0 (0.0%)
  Emergent Bypass                              0 (0.0%)            0 (0.0%)           0 (0.0%)
  TLR                                          1 (1.8%)            6 (10.0%)          3 (5.5%)

*Time to first event
**In-hospital MI

                                     All p values are non significant.
                    Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus.
12 Month Stent Thrombosis
 All Patients (1st + 2nd Cohorts)

                                   BFD SD             BFD SD             Taxus
                                    N = 60             N = 62            N = 60

   Acute (%)                            0                  0               0

   Sub-acute (%)                        0                  0               0

   Late (%)                             0                  0               0

Possible, probable or definite stent thrombosis as per ARC Definition.




                        All P values are non significant.
       Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus.
Summary & Conclusions - 1
• Primary endpoint (In-Stent LL at 12 months)
  met: BioFreedom SD non-inferior to Taxus.

• In-Stent LL for BioFreedom SD (0.17 mm)
  demonstrated a trend towards superiority at 12
  months compared to Taxus (0.35 mm).

• Both BioFreedom SD and BioFreedom LD
  demonstrated sustained safety up to 12
  months, including absence of stent thrombosis.
Summary & Conclusions - 2
• BioFreedom: first polymer-free drug coated stent
  demonstrating comparable efficacy in inhibiting
  NIH (as assessed by independent QCA analysis)
  vs. a currently available DES with durable polymer
  at 12 months in a randomized clinical trial.

• Larger trial with longer term follow-up warranted to
  confirm these encouraging results.

Más contenido relacionado

Similar a Biofreedom tct10 press final

Eluting balloons, the mechanism of action, indications for use Ivan. G. Horvath
Eluting balloons, the mechanism of action, indications for use Ivan. G. HorvathEluting balloons, the mechanism of action, indications for use Ivan. G. Horvath
Eluting balloons, the mechanism of action, indications for use Ivan. G. HorvathChaichuk Sergiy
 
2009 Convegno Malattie Rare Benedetti [22 01]
2009 Convegno Malattie Rare Benedetti [22 01]2009 Convegno Malattie Rare Benedetti [22 01]
2009 Convegno Malattie Rare Benedetti [22 01]cmid
 
IGRT & IMRT In Head Neck Cancer
IGRT & IMRT In Head Neck CancerIGRT & IMRT In Head Neck Cancer
IGRT & IMRT In Head Neck CancerSapna Nangia
 
Martin nielsen challenges in image analysis
Martin nielsen challenges in image analysisMartin nielsen challenges in image analysis
Martin nielsen challenges in image analysisLeica-Microsystems
 
Kupelian 2nd talk prostate igrt hyderabad 2013 (kupelian)
Kupelian 2nd talk prostate igrt hyderabad 2013 (kupelian)Kupelian 2nd talk prostate igrt hyderabad 2013 (kupelian)
Kupelian 2nd talk prostate igrt hyderabad 2013 (kupelian)Dr. Vijay Anand P. Reddy
 
SRS-ROSE CASE FOR PITUITARY ADENOMA
SRS-ROSE CASE FOR PITUITARY ADENOMASRS-ROSE CASE FOR PITUITARY ADENOMA
SRS-ROSE CASE FOR PITUITARY ADENOMAKanhu Charan
 

Similar a Biofreedom tct10 press final (12)

Randil
RandilRandil
Randil
 
Eluting balloons, the mechanism of action, indications for use Ivan. G. Horvath
Eluting balloons, the mechanism of action, indications for use Ivan. G. HorvathEluting balloons, the mechanism of action, indications for use Ivan. G. Horvath
Eluting balloons, the mechanism of action, indications for use Ivan. G. Horvath
 
Dmt m strust_nov12_final
Dmt m strust_nov12_finalDmt m strust_nov12_final
Dmt m strust_nov12_final
 
2009 Convegno Malattie Rare Benedetti [22 01]
2009 Convegno Malattie Rare Benedetti [22 01]2009 Convegno Malattie Rare Benedetti [22 01]
2009 Convegno Malattie Rare Benedetti [22 01]
 
IGRT & IMRT In Head Neck Cancer
IGRT & IMRT In Head Neck CancerIGRT & IMRT In Head Neck Cancer
IGRT & IMRT In Head Neck Cancer
 
Dmt g pday_oct12
Dmt g pday_oct12Dmt g pday_oct12
Dmt g pday_oct12
 
2013 MS Research Update
2013 MS Research Update2013 MS Research Update
2013 MS Research Update
 
Martin nielsen challenges in image analysis
Martin nielsen challenges in image analysisMartin nielsen challenges in image analysis
Martin nielsen challenges in image analysis
 
Kupelian 2nd talk prostate igrt hyderabad 2013 (kupelian)
Kupelian 2nd talk prostate igrt hyderabad 2013 (kupelian)Kupelian 2nd talk prostate igrt hyderabad 2013 (kupelian)
Kupelian 2nd talk prostate igrt hyderabad 2013 (kupelian)
 
MON 2011 - Slide 22 - W. Weder - Surgery
MON 2011 - Slide 22 - W. Weder - SurgeryMON 2011 - Slide 22 - W. Weder - Surgery
MON 2011 - Slide 22 - W. Weder - Surgery
 
SRS-ROSE CASE FOR PITUITARY ADENOMA
SRS-ROSE CASE FOR PITUITARY ADENOMASRS-ROSE CASE FOR PITUITARY ADENOMA
SRS-ROSE CASE FOR PITUITARY ADENOMA
 
Cutaneous melanomas by A. Shaha
Cutaneous melanomas by A. ShahaCutaneous melanomas by A. Shaha
Cutaneous melanomas by A. Shaha
 

Más de Trimed Media Group

Innovative technologies at ACC.15
Innovative technologies at ACC.15Innovative technologies at ACC.15
Innovative technologies at ACC.15Trimed Media Group
 
10 Sessions You Can’t Miss at ACC.15
10 Sessions You Can’t Miss at ACC.1510 Sessions You Can’t Miss at ACC.15
10 Sessions You Can’t Miss at ACC.15Trimed Media Group
 
6 simple tips to help you avoid a lawsuit
6 simple tips to help you avoid a lawsuit6 simple tips to help you avoid a lawsuit
6 simple tips to help you avoid a lawsuitTrimed Media Group
 
Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf final
Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf finalAos 213 01 nelson rivaroxaban effectiveness and safety in nvaf final
Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf finalTrimed Media Group
 
Shorr and bria innovation at the point-of-care rethinking the doctor-patient...
Shorr and bria  innovation at the point-of-care rethinking the doctor-patient...Shorr and bria  innovation at the point-of-care rethinking the doctor-patient...
Shorr and bria innovation at the point-of-care rethinking the doctor-patient...Trimed Media Group
 
Kuperman Health Information Exchange & Care Coordination
Kuperman Health Information Exchange & Care CoordinationKuperman Health Information Exchange & Care Coordination
Kuperman Health Information Exchange & Care CoordinationTrimed Media Group
 
Safran info sage & disruptive innovation
Safran  info sage & disruptive innovationSafran  info sage & disruptive innovation
Safran info sage & disruptive innovationTrimed Media Group
 
[Hongsermeier] clinical decision support services amdis final
[Hongsermeier] clinical decision support services amdis final[Hongsermeier] clinical decision support services amdis final
[Hongsermeier] clinical decision support services amdis finalTrimed Media Group
 
Hamann big institution to community care
Hamann big institution to community careHamann big institution to community care
Hamann big institution to community careTrimed Media Group
 
Hongsermeier app store for health
Hongsermeier  app store for healthHongsermeier  app store for health
Hongsermeier app store for healthTrimed Media Group
 
Kibbe expect direct health information exchange in the context of state 2 mea...
Kibbe expect direct health information exchange in the context of state 2 mea...Kibbe expect direct health information exchange in the context of state 2 mea...
Kibbe expect direct health information exchange in the context of state 2 mea...Trimed Media Group
 
Crotty engaging patients in new ways from open notes to social media
Crotty  engaging patients in new ways from open notes to social mediaCrotty  engaging patients in new ways from open notes to social media
Crotty engaging patients in new ways from open notes to social mediaTrimed Media Group
 
Karson approaching innovation with commercial ehrs
Karson approaching innovation with commercial ehrsKarson approaching innovation with commercial ehrs
Karson approaching innovation with commercial ehrsTrimed Media Group
 
Ong approaching innovation with commercial ehrs
Ong approaching innovation with commercial ehrsOng approaching innovation with commercial ehrs
Ong approaching innovation with commercial ehrsTrimed Media Group
 
3D Volume Echocardiography: Answering the Challenges of the Right Heart
3D Volume Echocardiography: Answering the Challenges of the Right Heart3D Volume Echocardiography: Answering the Challenges of the Right Heart
3D Volume Echocardiography: Answering the Challenges of the Right HeartTrimed Media Group
 

Más de Trimed Media Group (20)

Himss cvb sessions
Himss cvb sessionsHimss cvb sessions
Himss cvb sessions
 
Innovative technologies at ACC.15
Innovative technologies at ACC.15Innovative technologies at ACC.15
Innovative technologies at ACC.15
 
10 Sessions You Can’t Miss at ACC.15
10 Sessions You Can’t Miss at ACC.1510 Sessions You Can’t Miss at ACC.15
10 Sessions You Can’t Miss at ACC.15
 
6 simple tips to help you avoid a lawsuit
6 simple tips to help you avoid a lawsuit6 simple tips to help you avoid a lawsuit
6 simple tips to help you avoid a lawsuit
 
RSNA 2014
RSNA 2014RSNA 2014
RSNA 2014
 
Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf final
Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf finalAos 213 01 nelson rivaroxaban effectiveness and safety in nvaf final
Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf final
 
Acep 10-15-13
Acep 10-15-13Acep 10-15-13
Acep 10-15-13
 
Shorr and bria innovation at the point-of-care rethinking the doctor-patient...
Shorr and bria  innovation at the point-of-care rethinking the doctor-patient...Shorr and bria  innovation at the point-of-care rethinking the doctor-patient...
Shorr and bria innovation at the point-of-care rethinking the doctor-patient...
 
Kuperman Health Information Exchange & Care Coordination
Kuperman Health Information Exchange & Care CoordinationKuperman Health Information Exchange & Care Coordination
Kuperman Health Information Exchange & Care Coordination
 
Safran info sage & disruptive innovation
Safran  info sage & disruptive innovationSafran  info sage & disruptive innovation
Safran info sage & disruptive innovation
 
[Hongsermeier] clinical decision support services amdis final
[Hongsermeier] clinical decision support services amdis final[Hongsermeier] clinical decision support services amdis final
[Hongsermeier] clinical decision support services amdis final
 
[Teich] amdis
[Teich] amdis[Teich] amdis
[Teich] amdis
 
Hamann big institution to community care
Hamann big institution to community careHamann big institution to community care
Hamann big institution to community care
 
Hongsermeier app store for health
Hongsermeier  app store for healthHongsermeier  app store for health
Hongsermeier app store for health
 
Mandl app store for health
Mandl  app store for healthMandl  app store for health
Mandl app store for health
 
Kibbe expect direct health information exchange in the context of state 2 mea...
Kibbe expect direct health information exchange in the context of state 2 mea...Kibbe expect direct health information exchange in the context of state 2 mea...
Kibbe expect direct health information exchange in the context of state 2 mea...
 
Crotty engaging patients in new ways from open notes to social media
Crotty  engaging patients in new ways from open notes to social mediaCrotty  engaging patients in new ways from open notes to social media
Crotty engaging patients in new ways from open notes to social media
 
Karson approaching innovation with commercial ehrs
Karson approaching innovation with commercial ehrsKarson approaching innovation with commercial ehrs
Karson approaching innovation with commercial ehrs
 
Ong approaching innovation with commercial ehrs
Ong approaching innovation with commercial ehrsOng approaching innovation with commercial ehrs
Ong approaching innovation with commercial ehrs
 
3D Volume Echocardiography: Answering the Challenges of the Right Heart
3D Volume Echocardiography: Answering the Challenges of the Right Heart3D Volume Echocardiography: Answering the Challenges of the Right Heart
3D Volume Echocardiography: Answering the Challenges of the Right Heart
 

Biofreedom tct10 press final

  • 1. BioFreedom: A Prospective Randomized Trial of Polymer-Free Biolimus A9-Eluting Stents and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease Eberhard Grube, MD, FACC, FSCAI on behalf of the BioFreedom Investigators International Heart Center Essen, Germany Hospital A Oswaldo Cruz, Instituto Dante Pazzanese, São Paulo, Brazil Stanford University, School of Medicine, Stanford, CA
  • 2. BioFreedom™ Selectively micro-structured surface holds drug in abluminal surface structures Hypothesis: Polymer-free drug release via porous-eluting stents may reduce late events caused by polymer stent coatings. Potential advantage • Avoid long term late adverse effects that might be Proprietary Highly Lipophilic Limus drug attributable to the polymer • Improved surface integrity since there is no polymer to be sheared or peeled away from the stent struts • Possible shorter need of dual antiplatelet therapy
  • 3. BioFreedom FIM Design BioFreedom FIM 182 patients First Cohort Second Cohort 12 Month Clinical FU 99% 4 Month Angio FU 12 Month Angio FU 75 patients 107 patients Angio FU 92% Angio FU 92% BioFreedom BioFreedom BioFreedom BioFreedom standard low TAXUS® standard low TAXUS® dose dose Liberté ® dose dose Liberté ® (BFD SD) (BFD LD) N=24 (BFD SD) (BFD LD) N=36 N=25 N=26 N=35 N=36 Enrollment Period Enrollment Period Sept 2008 – Jan 2009 Jan 2009 – Jun 2009
  • 4. BioFreedom FIM Study Design Symptomatic, ischemic heart disease Native coronary artery ≥ 2.25 mm and ≤ 3.0 mm Lesion length ≤ 14 mm Lesion amenable to percutaneous treatment with DES BioFreedom™ BioFreedom™ Taxus® Liberté® Standard Dose 15.6 µg/mm Low Dose 7.8 µg/mm Clinical Follow-Up 30 d 4 mo 12 mo 2yr 3yr 4yr 5yr Angio and IVUS Follow-up Primary Endpoint: In-stent Late Lumen Loss (LL) at 12 months (2nd cohort) Non-Inferiority, margin = 0.24 mm Secondary Endpoints: In-stent Late Lumen Loss (LL) at 4 months (1st cohort) MACE and stent thrombosis rate at 30 days, 4, 12 months, 2, 3, 4 & 5 yrs Clinically-driven TLR, TVR and TVF at 4, 12 months, 2, 3, 4 & 5 yrs In-stent/In-segment binary restenosis at 4 months In-stent/In-segment Minimum Lumen Diameter (MLD) at 4 months Neointimal hyperplasia volume at 4 months measured by IVUS Biolimus A9 concentrations pre/post procedure at discharge & 30 days DAPT recommended for a minimum of 6 months
  • 5. 12 Month Angiographic FU In-Stent Late Lumen Loss: 2nd Cohort Primary Endpoint Non – inferiority P = 0.001 P values 0.4 P = 0.21 0.35 [0.22, 0.57] 0.3 0.22 [0.17, 0.66] 0.17 (mm) 0.2 [0.09, 0.39] 0.1 0.0 BFD SD BFD LD Taxus N = 31 N = 35 N = 31 All values are presented as median [IQR] .
  • 6. 12 Month Angiographic FU In-Stent Late Lumen Loss: 2nd Cohort Primary Endpoint Superiority P values P = 0.11 0.4 P = 0.55 0.35 0.3 0.22 (mm) 0.2 0.17 0.1 0.0 BFD SD BFD LD Taxus N = 31 N = 35 N = 31 All values are presented as median.
  • 7. 12 Month MACE (KM Estimates) All Patients (1st + 2nd Cohorts) BFD SD BFD LD Taxus N = 60 N = 62 N = 60 MACE* 3 (6.1%) 7 (11.6%) 3 (5.5%) (All Death, MI, Emergent Bypass or TLR) All Death 1 (1.8%) 0 (0.0%) 0 (0.0%) MI 1 (1.8%) 1 (1.6%) 0 (0.0%) Q Wave MI 0 (0.0%) 0 (0.0%) 0 (0.0%) Non-Q Wave MI 1 (1.8%) 1 (1.6%)** 0 (0.0%) Emergent Bypass 0 (0.0%) 0 (0.0%) 0 (0.0%) TLR 1 (1.8%) 6 (10.0%) 3 (5.5%) *Time to first event **In-hospital MI All p values are non significant. Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus.
  • 8. 12 Month Stent Thrombosis All Patients (1st + 2nd Cohorts) BFD SD BFD SD Taxus N = 60 N = 62 N = 60 Acute (%) 0 0 0 Sub-acute (%) 0 0 0 Late (%) 0 0 0 Possible, probable or definite stent thrombosis as per ARC Definition. All P values are non significant. Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus.
  • 9. Summary & Conclusions - 1 • Primary endpoint (In-Stent LL at 12 months) met: BioFreedom SD non-inferior to Taxus. • In-Stent LL for BioFreedom SD (0.17 mm) demonstrated a trend towards superiority at 12 months compared to Taxus (0.35 mm). • Both BioFreedom SD and BioFreedom LD demonstrated sustained safety up to 12 months, including absence of stent thrombosis.
  • 10. Summary & Conclusions - 2 • BioFreedom: first polymer-free drug coated stent demonstrating comparable efficacy in inhibiting NIH (as assessed by independent QCA analysis) vs. a currently available DES with durable polymer at 12 months in a randomized clinical trial. • Larger trial with longer term follow-up warranted to confirm these encouraging results.