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 Speaker’s 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, Carrié 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, Carrié 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  =  

5.9±3.6  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  the  SFA  –  Clinical  Studies  

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