James Hermiller, MD, FACC, FSCAI The St Vincent Medical Group The St Vincent Heart Center of Indiana Indianapolis, IN Drug-Eluting Stents 2013: Current Data and Future Advances Hilton La Jolla Torrey Pines La Jolla, California - Oct 3 rd , 2013 B L 2 Y
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James Hermiller, MD, FACC, FSCAI The St Vincent Medical Group The St Vincent Heart Center of Indiana Indianapolis, IN Drug-Eluting Stents 2013: Current.
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James Hermiller, MD, FACC, FSCAI The St Vincent Medical Group The St Vincent Heart Center of
Indiana Indianapolis, IN
James Hermiller, MD, FACC, FSCAI The St Vincent Medical Group The St Vincent Heart Center of
Indiana Indianapolis, IN
Drug-Eluting Stents 2013: Current Data and Future
Advances
Drug-Eluting Stents 2013: Current Data and Future
Advances
Hilton La Jolla Torrey Pines La Jolla, California - Oct 3rd, 2013
BL
2Y
Disclosures
• Consulting Fees/Honoraria
• Speaker Bureau
• Abbott, BSC, Medtronic and St Jude
• Medicines Company
Affiliation/Financial Relationship Company
OutlineOutline
• Introduction
• Current Data• Advances to Date
• Future Directions• Metallic DES Bioabsorbable Polymer• Metallic DES with No Polymer• Completetly Bioabsorbable DES
• Conclusions and Summary
• Introduction
• Current Data• Advances to Date
• Future Directions• Metallic DES Bioabsorbable Polymer• Metallic DES with No Polymer• Completetly Bioabsorbable DES
• Conclusions and Summary
Introduction: DES TalksIntroduction: DES Talks
First Generation DES P
ES
Polyolefin derivative Paclitaxel Express2
Drug Polymer Stent
SE
S
PEVA + PBMA blendSirolimus BX Velocity
1st Gen Drug-Eluting StentsThe good, the bad, and the ugly!
1st Gen Drug-Eluting StentsThe good, the bad, and the ugly!
7 years
40 mos
BMS DES
Incompleteapposition
Late stentthrombosis
Abn Vasomotion
*P<0.001 vs. control
Sirolimus Control
* *
Delayed Healing!
Angioscopy
BMS
DESLate loss = 0
Eos
Giant cells
IVUS
Inflammation
Second Generation DESZ
ES
BioLinx copolymerZotarolimus Integrity
Drug Polymer
EE
S
VDF + HFP copolymerEverolimus
Vision
OO
OO
OO OO HOHO
OO
OO
OOOOHHOO
OOOO
NNOO
HHOO
Stent
Omega
Stent EES - PROMUS
ZES - Resolute
EES - Xience Expedition
Underlying Stent PtCr – Element (Omega)
CoCr –Integrity
CoCr – Modified Vision
Strut Thickness 0.0032” 0.0036” 0.0032”
Strut Pattern
Lengths (mm)(Diameters 2.25 to 4.0 mm)
8,12,16,20,24,28, 32, and 38 mm(38 for >2.75 mm diameter)
9,12,15,18,22,26, 30, 34 and 38 mm(34 and 38 for >3.0 mm diameter)
8,12,15,18,23,28, 33, and 38 mm(33 and 38 mm for >2.5 mm diameter)
Current Stent Attributes
Stent EES – PROMUS ELEMENT
ZES - Resolute EES – Expedition
Max Expansion (mm)
2.25 to 2.752.5 & 2.75 to 3.53.0 & 3.5 to 4.254.0 to 5.25
2.25 – 2.75 to 3.25 3.0 – 4.0 to 4.75
2.25 & 2.5 to 3.25 2.75 &3.0 to 3.75 3.5 & 4.0 to 4.75
Sidebranch Cell Size (Max Expansion)
2.25 to 4.182.5 & 2.75 to 4.73.0 & 3.5 to 5.754.0 to 7.44
2.25 to 4.0 to 9.24 mm
6 Cresst -- 2.25 to 3.0 to 3.5mm9 Crest – 3.5 & 4.0 to 4.2 mm
• Longitudinal stent compression: Manifests itself as a dark band in the region of compression (also called stent “accordion”, “concertina”, “wrinkling”, etc.)
• Longitudinal stent elongation: Appears like a fracture in the stent (pseudo-fracture)
Longitudinal elongation with
pseudo-fracture
Longitudinal compression
Longitudinal compression
Longitudinal compression
Retrospective analysis of longitudinal stent deformation in the “real world”: Study
2,936 Promus Element stents implanted in 2,839 lesions in 1,295 pts at a single center over 22 months
LSD occurred in:
1.4% (n=20) of pts (95%CI 0.9%-2.2%)
0.7% of lesions (95%CI 0.4%-1.1%)
0.7% of Promus Element stents (95%CI 0.4%-1.1%)
Multivariable predictors of LSD:
# and length of stents, ostial and bifurcation lesions
30 Day MACE in pts with LSD = 5.0% (1 NQMI)
Leibundgut G et al. CCI 2012: doi: 10.1002/ccd.24472
Promus PREMIER Everolimus-Eluting Stent
Additional connectors on proximal end Provide increased axial strength
TLF = cardiac death, target vessel MI, or ischemic-driven TLR
Stone GW et al. JACC 2011 (abstract)
~2.6%/yr event rate after year 1
OutlineOutline
• Introduction
• Current Data• Advances to Date
• Future Directions• Metallic DES Bioabsorbable Polymer• Metallic DES with No Polymer• Completetly Bioabsorbable DES
• Conclusions and Summary
• Introduction
• Current Data• Advances to Date
• Future Directions• Metallic DES Bioabsorbable Polymer• Metallic DES with No Polymer• Completetly Bioabsorbable DES
• Conclusions and Summary
Persistent LimitationsPersistent Limitations
• Uncovered stent struts with or without late malapposition (thrombosis)
• Chronic inflammation due to late foreign body reactions and polymer hypersensitivity
• Strut fracture
• Lack of vasomotion
• Neoatherosclerosis
Biolimus-A9 Eluting Stent
• Biolimus is a semi-synthetic sirolimus analogue with 10x higher lipophilicity and similar potency as sirolimus.
• Biolimus is immersed at a concentration of 15.6 g/mm into a biodegradable polymer, polylactic acid, and applied solely to the abluminal stent surface by a fully automated process.
• Biolimus is co-released with polylactic acid and completely desolves into carbon dioxide and water after a 6-9 months period.
• The stainless steel stent platform has a strut thickness of 120 m with a quadrature link design.
LEADERS 5-Year Results
Serruys P, et al. J Am Coll Cardiol Intv 2013;6:777–89
LEADERS: Definate Stent Thrombosis
Serruys P, et al. J Am Coll Cardiol Intv 2013;6:777–89
LEADERS: Definate Stent Thrombosis
Serruys P, et al. J Am Coll Cardiol Intv 2013;6:777–89
What is the Minimum Duration of Radial Scaffolding?
After DES Placement, Scaffolding of the Vessel is Only a Transient Need
Serruys PW, et al., Circulation 1988; 77: 361.
n = 342 patients (n = 93 at 30-day F/U; n = 79 at 60-day F/U; n = 82 at 90-day F/U; n = 88 at 120-day F/U)
The lumen appears to stabilize approximately three months after PTCA.
p < 0.00001
p < 0.00001
Quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months
Dudek D. ABSORB Cohort B 2-year data, ACC 2012.
Similar Rates of MACE Compared to Historical XIENCE Data
ABSORB Extend Clinical Results - MACE
Intent to Treat (ITT) Analysis; Interim Snapshot
Post-stenting 6-month 24-month
Complete strut apposition
Late acquired incomplete stent apposition with
tissue bridges between fractured struts
Corrugated endolumen
Smooth endoluminal lining
Struts largely disappeared although remnant just visible
(arrow)
Absorb Trial (BVS cohort A): OCT Results
Serruys PW et al. Lancet 2009;373:897-910.
6 m
on
ths
60
mon
ths
The Final Golden tube
Sealing and shielding of plaques as a result of scaffold implantation : can the scaffold cap the plaque? … and Late lumen enlargement
Presented by PW Serruys at TCT2012, accessed at www.tctmd.com
ABSORB Cohort BTemporal Lumen Dimensional Changes
ABSORBCohort B
Serial Analysis*
Lumen Area 6.53 mm2
6.36 mm2 6.85 mm2
n = 33 n = 33 n = 33
ScaffoldArea
1.7%
LumenArea
7,2%
Post-PCI 6 Months 2 Years
Very late lumen enlargement noted from 6 months to 2 years
*Serruys, PW., TCT 2011
ABSORB Vasomotor Function Testing
in
Vess
el D
iam
eter
(mm
)
Methergine
Acetylcholine
-1
-0.5
0
0.5
1
(n=15)
6 Months1
(n=6) (n=19)
12 Months2
(n=13) (n=9)
24 Months3
(n=7)
Vaso
dila
tion
Vaso
cons
tric
tion
ABSORB Cohort B1 ABSORB Cohort B2 ABSORB Cohort A
(pre
-dru
g in
fusi
on to
pos
t-dr
ug in
fusi
on)
1. Adapted from Serruys, PW. ACC 2011 2. Adapted from Serruys, PW. ACC 2011 3. Adapted from Serruys, PW, et al. Lancet 2009; 373: 897-910.
OutlineOutline
• Introduction
• Current Data• Advances to Date
• Future Directions• Metallic DES Bioabsorbable Polymer• Metallic DES with No Polymer• Completetly Bioabsorbable DES
• Conclusions and Summary
• Introduction
• Current Data• Advances to Date
• Future Directions• Metallic DES Bioabsorbable Polymer• Metallic DES with No Polymer• Completetly Bioabsorbable DES
• Conclusions and Summary
Conclusions: Current and future directions in stenting
• Current DES have appreciably improved safety and efficacy profiles in ACS and stable CAD compared to first generation devices
• By utilizing small amounts of a bioabsorbable polymer, polymer-free systems, or fully bioresorbable scaffolds, future generation DES will likely further reduce stent thrombosis and improve late outcomes
The Bar is High – For Advanced Devices
Thanks for your attention!Thanks for your attention!