Bioabsorbable Stents: Is This the Future of SFA and ......

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  • Drug-Eluting Bioabsorbable Stents: Is This the Future of SFA and Popliteal Disease?

    Lewis B. Schwartz, M.D.

    Chicago Vascular Specialists Park Ridge, IL Clinical Associate University of Chicago Chicago, IL

  • Disclosures Speakers Bureau: None

    Honorarium: None

    Consultant: None

    Stockholder: Abbott Laboratories

    Grant/Research Support: None

    Medical/Scientific Boards: None

  • 1 month

    Representative photomicrographs of porcine coronary arteries, 2x

    6 months 1 year 2 years 4 years 3 years

    Onuma Y, Serruys PW, Perkins LEL, Okamura T, Gonzalo N, Garcia-Garcia HM, et al. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model. An attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circ. 2010;122:1912-24.

    Absorb

    Cypher

    Bioresorbable Vascular Scaffold (BVS)

  • Bioresorbable Coronary Scaffolds Device Study Drug Lesions n Outcome

    Igaki-Tamai

    Igaki-Tamai FIM none coronary 50 18% restenosis @ 12-months

    28% TLR @ 10-years

    AMS (BIOTRONIK)

    PROGRESS AMS none coronary 63 48% restenosis @ 12-months

    BIOSOLVE-I paclitaxel coronary 22 10% restenosis @ 6-months

    24 in-scaffold LLL 0.52 mm @ 12-months

    ReZolve (REVA)

    RESORB none coronary

    30 67% TLR @ 6-months

    RESTORE I 22 2 MACE @6-months

    Absorb (ABBOTT)

    ABSORB (A)

    everolimus coronary

    30 12% restenosis @ 6-months

    ABSORB (B) 45 2.4% restenosis @ 6-months

    ABSORB Extend

    56 3.5% restenosis @ 12-months 200 0.5% TLR @ 6-months

    DESolve (ELIXIR) DESolve I novolimus coronary 15 0% restenosis @6-months

    Fortitude (AMARANTH)

    MEND I none coronary 13 7.7% restenosis @6-months

    ART (ARTDIVA)

    ARTDIVA none coronary 26 10% TVR @6-months

  • ABSORB II

    Serruys PW, Chevalier B, Dudek D, Cequier A, Carri D, Iniguez A, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385:43-54.

    v.

    Absorb Xience

  • ABSORB II

    Serruys PW, Chevalier B, Dudek D, Cequier A, Carri D, Iniguez A, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385:43-54.

    Absorb - 22%

    Xience - 30%

  • ABSORB Clinical Studies

    Tamburino C, Latib A, Van Geuns R-J, Sabate M, Mehilli J, Gori T, et al. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective. Euroint. 2015;DOI: 10.4244/EIJY15M01_05.

    60,000 total implants!

  • ABSORB III + IV Clinical Trial Program

    ABSORB III 2,250 pts with up to 2 de novo lesions in different epicardial

    vessels enrolled, with follow-up for at least 5 years, at up to 122 US and non-US sites

    2,000 pts randomized 2:1 ABSORB v XIENCE (+50 lead-in pts and 200 pt non-randomized angio/IVUS/OCT/VM FU cohort)

    RVD: 2.50 - 3.75 mm; Lesion length: 24 mm

    Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 12, 18, and 28 mm

    Primary endpoint (n=2,000): TLF at 1 year (powered for noninferiority) US approval

    PIs: SG Ellis, DJ Kereiakes Study chairman: GW Stone

  • PLLA Igaki-Tamai (Remedy) Scaffold

    poly-L-lactic acid biodegradable scaffold

    Schmidt A. Bioabsorbable stents: The Igaki-Tamai Stent. 2010. www.CRTonline.com.

  • Patency of the Igaki-Tamai scaffold in the SFA

    Schmidt A. Bioabsorbable stents: The Igaki-Tamai Stent. 2010. www.CRTonline.com.

    IGAKI Kurz

    0 6 12 18 24 300

    20

    40

    60

    80

    100prim. Patencyass. prim. Patencysec. Patency

    Month

    Perc

    ent

    Restenosis > 50%

    n=45; lesion length 6 cm

  • Patency of the Igaki-Tamai scaffold in the SFA: The GAIA Study

    Werner M, Micari A, Cioppa A, et al. Evaluation of the biodegradable peripheral Igaki-Tamai Stent in the treatment of de novo lesions in the superficial femoral artery: The GAIA Study. J. Am. Coll. Cardiol. Cardiovasc. Interv. 2014; 7:305-312.

    n=30; mean lesion length =

    5.93.6 cm

  • Igaki-Tamai Scaffold v. Common Femoral Endarterectomy

    Linni K, Ugurluoglu A, Hitzl W, Aspalter M, Holzenbein T. Bioabsorbable stent implantation vs. common femoral artery endarterectomy: Early results of a randomized trial. J Endovasc Ther. 2014;21:493-502.

    Endarterectomy

    Absorbable Stent

  • STANZA Bioresorbable Scaffold

    www.480biomedical.com

  • a1

    a2

    a1

    a2

    STANZA in the mid-SFA

    The STANCE clinical trial

  • Bioresorbable Scaffold

    Bioresorbable Coating Everolimus

    Omnilink Elite Delivery System

    Poly (L-lactide) (PLLA)

    Naturally resorbed, fully metabolized

    Designed for SFA and Iliac Arteries

    Poly (D,L-lactide) (PDLLA) coating

    Naturally resorbed, fully metabolized

    Same dose density as Absorb

    Balloon-Expandable delivery system

    035 OTW platform

    Esprit Bioresorbable Vascular Scaffold (BVS)

    Schwartz LB. Bioresorbable scaffolds for peripheral use: Everolimus eluting bioresorbable vascular scaffolds (BVS) for superficial femoral (SFA) and below-the-knee (BTK) arteries. Local Drug Delivery Meeting and Cardiovascular Course on Revascularization and Molecular Strategies (LDDR); 2012 February 04; Geneva, Switzerland.

  • Iliofemoral stent implantation in the porcine model

    Hip Extension Schwartz LB. Bioresorbable scaffolds for peripheral use: Everolimus eluting bioresorbable vascular scaffolds (BVS) for superficial femoral (SFA) and below-the-knee (BTK) arteries. Local Drug Delivery Meeting and Cardiovascular Course on Revascularization and Molecular Strategies (LDDR); 2012 February 04; Geneva, Switzerland.

    Hip Flexion

  • Peripheral Bioresorbable Vascular Scaffold (BVS) Acute implanta[on in a porcine iliac artery

    Oversized Ni+nol SES BVS

    Schwartz LB. Bioresorbable scaffolds for peripheral use: Everolimus elu+ng bioresorbable vascular scaffolds (BVS) for superficial femoral (SFA) and below-the-knee (BTK) arteries. Local Drug Delivery Mee+ng and Cardiovascular Course on Revasculariza+on and Molecular Strategies (LDDR); 2012 February 04; Geneva, Switzerland.

  • Oversized Ni+nol SES

    BVS

    Peripheral Bioresorbable Vascular Scaffold (BVS) 6-mos. a\er implanta[on in a porcine iliac artery

    Schwartz LB. Bioresorbable scaffolds for peripheral use: Everolimus elu+ng bioresorbable vascular scaffolds (BVS) for superficial femoral (SFA) and below-the-knee (BTK) arteries. Local Drug Delivery Mee+ng and Cardiovascular Course on Revasculariza+on and Molecular Strategies (LDDR); 2012 February 04; Geneva, Switzerland.

  • Lammer J. ESPRIT I clinical study 1-year results. Leipzig Interventional Course. Leipzig, Germany, January 28, 2014.

    Esprit BVS (N=35)

    Age (yrs) 65.3

    Male (%) 77%

    Family history of CAD (%) 24%

    Diabetes (%) 26%

    Dyslipidemia (%) 86%

    Hypertension (%) 71%

    Smoking history (%) 83%

    ESPRIT I Pa[ent Demographics

  • *Site-reported value. All other data reported are from angiographic core laboratory. Lammer J. ESPRIT I clinical study 1-year results. Leipzig Interventional Course. Leipzig, Germany, January 28, 2014.

    Esprit BVS (N=35)

    External Iliac (%) SFA (%)

    11% 89%

    Proximal 14%

    Mid 31%

    Distal 54%

    Target lesion length (mm) 35.7 Total occlusions (%) 22.9* Occlusion length (mm) 30.6*

    ESPRIT I Lesion Characteris[cs

  • Pre-procedure Implantation Post-procedure 6-months

    ESPRIT I

    12-months 12-months

    Lammer J. ESPRIT I clinical study. Leipzig Interventional Course. Leipzig, Germany, January 28, 2014.

  • *Includes two cases involving restenosis with a TLR where the PSVR were not evaluable. Lammer J. ESPRIT I clinical study 1-year results. Leipzig Interventional Course. Leipzig, Germany, January 28, 2014.

    ESPRIT I Duplex Ultrasound and Angiographic Results

    Pre-Procedure (N=35)

    Post-Procedure (N=35)

    12-Month (N=27)

    In-segment RVD (mm) 4.9 4.9 5.0 In-segment MLD (mm) 1.0 4.2 3.1 In-segment diameter stenosis (%) 80% 14% 35%

    Post-Procedure

    (N=24)

    6-Month (N=30)

    12-Month (N=29)

    PSVR 1.27 1.35 1.66

    Binary restenosis NA 0% 12.9% (4/31*)

  • Device Study Drug n Status

    Remedy

    PERSEUS

    None

    45 50% restenosis @ 6-months

    GAIA 30 70% restenosis @ 12-months

    v. CFA endarterectomy 80

    80% patency at 12-months (inferior to endarterectomy)

    Stanza

    STANCE None 60 Not yet reported

    Esprit

    ESPRIT I Everolimus 30 13% restenosis @ 12-months

    Bioresorbable Scaffolds in