bioabsorbable stents: is this the future of sfa and ......
TRANSCRIPT
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
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