DIFFERENT

CORONARY
STENT DESIGN

DR AWADHESH KUMAR SHARMA

DEPARTMENT OF CARDIOLOGY
PGIMER & DR RML HOSPITAL,NEW DELHI
BACKGROUND
 The introduction of angioplasty led to the
development of a completely new approach to treat
CAD.
 Until 1994, the percutaneous transluminal coronary
angioplasty (PTCA) was the alone treatment for
coronary artery disease.
 However, the incidence of restenosis of coronary
arteries was an important problem, necessitating
repeated interventional procedures in 30% of
patients treated with PTCA alone.

NEJM 1994;331:489-95
 Coronary artery stents were developed to provide a
metal scaffolding for the angio-plastied vessel, in an
attempt to limit negative re-modelling.
 Sigwart et al first reported the efficacy of stents in
reducing restenosis rates in 1987.
 By 1994, the Food and Drug Administration (FDA)
had approved two stents (Gianturco-Roubin stent
and the Palmaz- SchatzTM stent).
Journal of Invasiv Cardiology.2001;13:634-639
GIANTURCO-ROUBIN II

 Flat wire coil attached

to a single longitudinal
strut
 316 L stainless steel
 The first coronary stent
approved by the FDA in
June 1993.

J. clinical pathology.2005,aug;58(8):795-804
PALMAZ-SCHATZ

 Balloon expandable;
slotted tube
 316 L stainless steel

J. clinical pathology.2005,aug;58(8):795-804
 The wide acceptance of coronary stenting was based on
the results of the BElgian NEtherlands STENT
(BENESTENT) and the STent REStenosis Study
(STRESS) trials, which showed the superiority of stenting
over balloon angioplasty.

 After the wide acceptance of coronary stents the primary

concern of stent development is the need to reduce device
profiles and to increase flexibility to facilitate safe delivery.

N Engl J Med,1994;331:489-95.
STENT SELECTION
STENT SELECTION-PERFORMANCE &
EASE OF USE
STENT SELECTION-GOOD ACUTE
ANGIOGRAPHIC RESULTS
JACC 2003;41:1283-1288
TYPES OF STENTS
 Mechanism of expansion (self-expanding or balloon-

expandable)
 Materials (stainless steel, cobalt-based alloy, tantalum,

nitinol, Pt,Ir,Cr, inert coating, biodegradable)

 Forms (sheet, wire or tube)
 Manufacturing methods (laser cut, water-jet cutting, photo-
etching)
 Geometrical configurations/design (mesh structure, coil, slotted
tube, ring, multi-design)
 Addition to stent (grafts, radio-opaque markers, coatings)
Min Invas Ther & Allied Technol
2002;11:137-47.
STENT GEOMETRIC DESIGN

 MECHANISM OF EXPANSION

 Balloon-expandable stents

 The stent is pre-mounted on a balloon and the inflation of

the balloon plastically expands the stent with respect to

the balloon diameter.

 Self-expanding stents- The smart material auto expands to

a calculated size.
Journal of invasive cardiology 1995;7:127-
134
MATERIALS

 Corrosion resistance

 Biocompatibility

 Adequately radio-opaque

 Create minimal artifacts during MRI

STENT PLATFORMS
STENT MATERIALS- NON DEGRADABLE MATERIAL
 316L stainless steel-
 Excellent mechanical properties and corrosion
resistance
 Ferromagnetic nature and low density make it a non-
MRI compatible
 Poorly visible fluoroscopic material
 First generation DESs, Cypher (sirolimus-eluting stent,
Cordis, Warren, NJ) and Taxus (paclitaxel-eluting stent,
Boston Scientific, Natick, MA)
JACC 1996;27:53
CO-CR

 Superior radial strength and improved radiopacity

 Thinner stent struts
 The second generation DES, Xience V (everolimus-
eluting stent, Abott Vascular, CA) and Endeavor
(zotarolimus-eluting stent,Medtronic Vascular,
Santa Rosa, CA).

JACC 1996;27:53
TA- TANTALUM

 Excellent corrosion resistant material

 Coated on 316L SS to improve corrosion properties
and biocompatibility
 High density and non-ferromagnetic properties
 Fluoroscopically visible and MRI compatible
 Higher rates of recoil- poor mechanical properties

JACC 1996;27:53
TI

 Excellent biocompatibility and corrosion resistance

 Low tensile strength and ductility
 Ti alloys in combination with Ni-Ti
 Ti-nitride oxide coating on 316L SS

JACC 1996;27:53
NI-TI

 Good biocompatibility, radial force and shape

memory
 Coated by some materials such as polyurethane, Ti
nitride and polycrystalline oxides to improve the
corrosion resistance
 Inadequate visibility under fluoroscopy

American J of cardiology.2008;86:1073-
1079
PT-IR

 Pt-Ir alloy of 90% platinum and 10% iridium

 Excellent radiopacity and a reduction in both
thrombosis and neointimal proliferation with less
inflammatory reactions
 Recoiling percentage was much higher (16%) than
the 316L SS stents

Journal of invasive cardiology 1995;7:127-

134
BIODEGRADABLE METALLIC
MATERIALS

 Pure Fe
 Oxidation of Fe into ferrous and ferric irons

 Mg alloys
 There are two Mg alloys, AE2153 and WE4357,
used for making stents
 Radiolucent
Biomaterials.2006;27:1728-1734
RATIONAL FOR BIODEGRADABLE
STENTS
Metal stent drawbacks Biodegradable stent advantages
 Cause permanent physical  May eliminate early and late

irritation complications of bare-metal

 Risk of long term endothelial
dysfunction and chronic
inflammation
 Metal have thrombogenic
properties
 Inability for the vessel to
restore its a normal
physiology
stents
 Restore the vasoreactivity
 Allow a gradual transfer of the
mechanical load to the vessel
 Higher capacity for drug
incorporation and complex
release kinetics

The need for a permanent prosthesis decreases

dramatically 6 months post-implantation
STENT DESIGN

 On the basis of design, stents can be divided into

three groups: coil, tubular mesh, and slotted tube.
 Coil stents are characterised by metallic wires or
strips formed into a circular coil shape
 Tubular mesh stents consist of wires wound
together in a meshwork, forming a tube.
 Slotted tube stents are made from tubes of metal
from which a stent design is laser cut.
Eur Heart J 1997;18:1536–47
COIL VS. TUBE

 Coil design had greater strut width with gaps and

fewer or no connections between struts
 The strut width is greater; there are gap between
struts, and no connections between struts which
give it more flexibility.
 However, the design lack radial strength, and the
wide gap allow tissues to dangle.

Singapore Medical Journal, 2004.

COIL VS TUBE
 As a result, coil design has become obsolete and
replace by the more superior in radial strength, the
tube design.
 In tubular, there are two type of specification, a
slotted tube and modular tube.

Singapore Medical Journal, 2004.

SLOTTED TUBE VS. MODULAR
(TUBULAR)
MODULAR DESIGN
SLOTTED TUBE VS. MODULAR
(TUBULAR)

 Slotted tube stents resisted restenosis more than

the modular stents (22.1% vs 25.2%)
 Slotted tube- Closed cell design, and open cell
design
CLOSED CELL

 Sequential ring construction

 All Internal inflection points of the structural
members are connected by bridging elements.
 Regular peak-to-peak connections.
 Optimal scaffolding and a uniform surface,
regardless of the degree of bending.
 Less flexible than a similar open-cell design.

Ann Ist Super Sanita 2007;43,no1:89-100

CYPHER STENT BY CORDIS
OPEN CELL

 Some or all the internal inflection points of the

structural members are not connected by bridging
Ann Ist Super Sanita 2007;43,no1:89-100
elements.
 Periodic peak-to-peak connections, peak-to-valley
connections, and mid-strut to mid strut connections
 The unconnected structural elements contribute to
longitudinal flexibility.
OPEN CELL DESIGN
STENT DESIGN IMPACTS DRUG
DELIEVERY
LENGTH & DIAMETER OF STENT

 Long vs. Short

 Stent length is associated with restenosis rate and
clinical events (mainly target lesion revascularization)
 Short stent has lower cases of restenosis than long
stent.
 Wide vs. Narrow
 The wide diameter stent is more favorable than the
narrow one
European Heart Journal 2001;22:1585-
1593
NUMBER OF STRUTS

 More struts vs. less

 Less struts induce less chance of restenosis
compare to more struts.
THIN STRUT VS THICK STRUT
STRUT THICKNESS
 Although the immediate stent performance may be
improved by increasing strut thickness (which increases
radiovisibility, radial strength and arterial wall support)
excessive strut thickness, on the other hand, may impart
more vascular injury, trigger more intimal hyperplasia, and
engender a higher risk for restenosis than thinner struts.
 Strut thickness was observed to be an independent
predictor of in-stent restenosis
ISAR STEREO study(Circulation 2001;103:2816-21)
ISAR-STEREO-2 trial(J Am Coll Cardiol 2003;41:1283-8.)
 In an effort to further reduce strut thickness while
maintaining adequate radiovisibility and radial
strength, novel metallic materials such as cobalt-
chromium alloy are being used for the production of
stent.
THICK VS. THIN STRUTS

 The stents with thinner struts is preferred for the

design of new stents as they can reduce
angiographic and clinical restenosis more than
those with thicker struts

ISAR-STEREO and ISAR-STEREO 2

trials
SQUARE VS. ROUND STRUT CROSS-
SECTION

 The round strut cross-section without corners or

sharp edges is popular at present

 Round strut cross-section area is ideal for

smoothness design.

 Square strut cross-section area in not recommend

because it interferes with blood flow due to their

sharp edge which can slice blood cells.

Kluwer Academic Publishers 2012

SQUARE VS. ROUND STRUT CROSS-
SECTION
ROUGH VS. SMOOTH SURFACE

 Smoothness of a stent can affect the performance and

biocompatibily of the stent.

 Smooth surface can reduce thrombus adhesion and neointimal

growth.

 To obtain smoothness, the stent need to be treated with acid-

pickling and then electrochemical polishing.

 The process removes slag which includes depositions and

burrs, formed on the surface of stents due to the laser cutting

production process. Seminars in interventional

cardiology1998;3:139-144
ELEMENT OF STENT DESIGN-
BALLOON OVERHANG
DRUG DELIVERY VEHICLES – COATING
POLYMER- DRUG CARRIERS IN DESS
 Nonbiodegradable and biodegradable polymers

 Non biodegradable polymers

 First and the second generation of DESs

 The first generation of DES

 Cypher - polyethylene-co-vinyl acetate (PEVA)/poly-n-butyl methacrylate

(PBMA)

 Taxus - polystyrene-b-isobutylene-b-styrene (SIBS)

 The second generation of DES

 Xience V – fluoropolymer

 Endeavor - phosphorylcholine (PC)

Eurointervention,2005;1:266-272
 Biodegradable polymers
 Polylactic acid (PLA)
 Polyglycolic acid (PGA)
 Polylactic-co-glycolic acid (PLGA)

 NON POLYMER
 Titanium–nitric oxide alloy
 Microporous stainless steel stent (Yukon, Translumina, Germany)
 A nanoporous hydroxyapetite (a biocompatible crystalline derivative of calcium
phosphate) coating
 Magnetic nanoparticles (MNPs)
Eurointervention,2005;1:266-272
YUKON Choice DES system: Translumina modified stent surface containing micropores to
enable the adsorption of different organic substances.

Abizaid A , and Costa J R Circ Cardiovasc Interv

2010;3:384-393

Copyright © American Heart Association

THERAPEUTIC AGENTS
 Sirolimus (Rapamycin)

 A macrocyclic lactone

 Inhibits the migration and proliferation of SMCs

 Zotarolimus

 The sirolimus analogues

 Developed by Abbott laboratories

 Extremely lipophilic property and low water solubility

 Everolimus

 Sirolimus analogue

 Immunosuppressive agent

 Absorbs to local tissue more rapidly and has a longer celluar residence time and activity

 Biolimus
PACLITAXEL AND ITS ANALOGUES
 Paclitaxel
 Promoting tubulin polymerization and cell cycle arrest
 Inhibiting the migration and proliferation of SMCs
 Coroxane
 Nanoparticle albumin bound paclitaxel (nab-paclitaxel)
 To improve the solubility
 Docetaxel
 Semi-synthetic analogue
 Better anti-proliferative properties
OTHERS

 Tacrolimus
 Pimecrolimus
 Curcumin
 Resveratrol
 CD 34 antibody
 Anti-VEGF
RADIO-OPACITY ENHANCEMENTS

 Stainless steel or nitinol - hard to see

fluoroscopically
 To improve X-ray visibility, markers are often
attached to the stents.
 These additions are typically made from gold,
platinum or tantalum
 Electroplating (with gold) is also being used to
enhance X-ray visibility
COATINGS
 To increase biocompatibility
 Heparin was one of the first. Its mode of action is to
reduce the coagulation cascade (and thus possibly the
thrombogenic risk) after the deployment of a stent.
 Phosphorylcoline and silicon-carbide have been used in
order to reduce platelet activation and interaction, thus
possibly controlling their adhesion to the stent struts
during the acute phase of stent re-endothelization.
 Passive coverage has been also shown to be
useful.
 Indeed, covered stents have been created, in which
a PTFE layer was put between two stents (Jostent
graft, Jomed) or one stent was covered by a inner
and an outer layer of PTFE (Symbiot, Boston
Scientific)
COMMONLY USED CORONARY
STENTS IN CLINICAL PRACTICE
 XIENCE FAMILY OF STENTS
Stent Manufactu Drug Base Form/ Polymer Diameter Length
rer Design

XIENCE Abott Everolimus L-605 CoCr Hybrid cell PBMA SV-2.25 8,12,15,18,23
Xpedition vascular 100μg/cm2 Multilink Non erodible MV- ,28
FDA 0.0032" strut 2.5,2.75,3.0,3.
Approved thickness, 25,3.5,4.0
laser cut LL
2.5,2.75,3.0, 33,38
3.25,3.5,4.0

XIENCE V Abott Everolimus MULTI-LINK Hybrid cell PBMA 2.25,2.5,2.75, 8,12,15,18,23

vascular 100μg/cm2 VISION CoCr Multilink Non erodible 3.0,3.5,4.0 ,28
FDA Multi-layer stent 0.0032" strut
Approved Coating thickness,
laser cut,

XINCE Abott Everolimus Cobalt Hybrid cell biocompatibl SV-2.25 8,12,15,18,23

PRIME vascular 100μg/cm2 Chromium Multilink e fluorinated MV ,28
FDA 0.0032" strut copolymer 2.5,2.75,3.0, Same
Approved thickness,las 3.5,4.0 33,38
er cut, LL-
2.5,2.75,3.0,
3.5,4.0
THE XIENCE XPEDITION EVEROLIMUS
ELUTING CORONARY STENT SYSTEM
(ABOTT VASCULAR) FDA, CE MARK
 The drug-coated stent and the balloon expandable
delivery system
 22% less force used to deliever than prime.
 Ultra low distal seal technology for outstanding
crossability.
 Unique 3.25mm diameter for more accurate vessel
sizing.
 More flexible multilayered balloon with flatter
compliance.
Stent Manufactur Drug Base Form/ Polymer Diameter Length
er Design

Promus element Boston scientific Everolimus Platinum Tubular open Thin, fluorinated 2.25,2.5,2.75,3.0 8,12,16,20,24,28
Plus Chromium cell,thin copolymer ,3.5,4.0 ,32,38
strut,high radial matrix for
strength,good controlled drug
delieverality & release (100%
trackability drug elution in
120 days)

Endeavor Sprint Medtronic Zotarolimus- cobalt-based Modular Phosphorylcholi 2.25,2.5,2.75,3.0 8,12,14,18,22,26

Eluting alloy (cobalt, design,Sinusoida ne polymer ,3.5,4.0 ,30,34,38
10μg/mm nickel, l form
chromium, and wire,helical
molybdenum) wrap,laser fused

Resolut Integrity Medtronic Zotarolimus cobalt-based Modular BioLinx 2.25,2.5,2.75,3.0 8,12,14,18,22,26

eluting alloy (cobalt, design,Sinusoidal biocompatible ,3.5,4.0 ,30,34,38
form wire,helical
nickel, wrap,laser fused polymer
chromium, and
molybdenum)
Stent Manufactur Drug Base Form/ Polymer Diameter Length
er Design

Taxus Liberte Boston Scientific Paclitaxel 316L surgical Sinusoidal ring SIBS 2.50, 2.75, 3.00, 8, 12, 16, 20, 24,
1 μg/mm2 grade stainless modules linked [poly(styrene-b- 3.50, 4.00 28, 32
paclitaxel in a steel via curved link isobutylene-b-
slow release elements styrene)], a tri-
(SR)* block copolymer
(trade name:
Translute)

TAXUS Express Boston Scientific Paclitaxel 316L surgical modular ring SIBS 2.50, 2.75, 3.00, 8, 12, 16, 20, 24,
1μg/mm2 grade stainless strut pattern [poly(styrene-b- 3.50 28, 32
paclitaxel in a steel consists of two isobutylene-b-
slow release separate module styrene)], a tri-
(SR) designs: short, block copolymer
narrow (trade name:
sinusoidal Micro Translute)
elements linked
via straight
articulations to
long, wide
sinusoidal Macro
elements

Taxus Element Boston Scientific Paclitaxel Platinum Sinusoidal ring SIBS 2.25,2.50,2.75,3. 8,12,16,20,24,28
1.0 μg/mm2  Chromium modules [poly(styrene-b- 0,3.5,4.0,4.5 ,32,38
consisting of isobutylene-b-
alternating long styrene)], a tri-
and short block copolymer
crowns linked (trade name:
Stent Manufactur Drug Base Form/Design Polymer Diameter Length
er

Coracto Alvimedica Rapamycin Stainless Tubular,open cell Ultrathin 2.5,2.75,2.90,3 9,13,17,21,26,

steel design polymer layer .00,3.5,4.0 28,32
absobes 100%
in 10-12 week

Coroflex B.Braun Paclitaxel Stainless Multicellular ring P matrix- 2.5,2.75,3.0,3. 8,13,16,19,25,

please 1μg/cumm steel design,Hybrid polysulfone 5,4.0 28,32
Superb coating
radioopacity

Cypher cordis Sirolimus Stainless Tubular,laser two non-erodible 2.50, 2.75, 3.00, 8, 13, 18, 23, 28,
100% drug steel cut,sinusoidal polymers: 3.50 33
release with in 1 pattern,closed cell polyethylene-co-
month vinyl acetate
(PEVA) and poly
n-butyl
methacrylate
(PBMA)
Stent Manufactu Drug Base Form/ Polymer Diameter Length
rer Design
YUKON Translumina, Sirolimus Medical microporous Non 2.0,2.25,2.50,2 8,12,16,18,21,
Choice 4DES German Stainless PEARL polymeric .75,3.0,3.5,4.0 24,28,32,40
CE mark Steel, 316 Surface Shellac resin
LVM, Surface Strut thickness bio
containing 0,0034” / 87 compatible
micro-pores μm resin
1million Hybrid design 6 to 8 weeks
pores/sqcm release
Balloon marker
material
Platinum /
Iridium

GEN X Sync MIV Sirolimus Co Cr Open cell, Bio resorb 2.0,2.25,2.50,2 8,13,16,19,24,
therapeutics alternate S PLLA-poly L .75,3.00,3.50,4 29,32,37
India pvt ltd link,uniform lactic acid .0,4.5
sinusoidal strut polymer
design Ultrathin
coating(3μm)
Drug sudden
release f/b
release upto 40-
50 days.

Supralimus Sahajanand Sirolimus Sainless steel Hybrid biodegradable 2.5,2.75,3.0,3. 8,12,16,20,24,

Medical drug- 5 2832,36,40
Technologies carrier ,50%
Pvt Ltd, India drug release in
7 days next
50% in 41days

Supralimus- Sahajanand Sirolimus cobalt- Hybrid biodegradable same same

Core Medical chromium drug-
Technologies carrier ,50%
Pvt Ltd, India drug release in
7 days next
50% in 41days
Stent Manufactur Drug Base Form/ Polymer Diameter Length
er Design

YUKON Choice Translumina, Rapamycin Medical microporous The 2.0,2.50,2.75,3.0 8,12,16,18,21,24

PC German (Sirolimus) Stainless Steel, PEARL Surface biodegradable ,3.5,4.0 ,28,32,40
CE mark Release of 316 LVM, Strut thickness components
sirolimus up to 4 Surface 0,0034” / 87 μm polylactide and
weeks containing Hybrid design shellac
micro-pores
1million
pores/sqcm
Favours better
endothelialisatio
n
Balloon marker
material
Platinum /
Iridium
Stent Manufactu Drug Base Form/ Polymer Diameter Length
rer Design

BioMatrix Biosensors biolimus A9 S-Stent (316 laser-cut, Biodegradabl 2.25,2.50,2.7 8,11,14,18,24

Inc, Newport highly L) stainless tubular stent  e, 5,3.0,3.5,4.0 ,28,33,36
Beach, Calif lipophilic, steel stent S-Stent Polylactic
CE mark semi with a strut platform acid (PLA)
synthetic thickness of Open cell, applied to the
sirolimus 0.0054 quadrature abluminal
analogue inches (137 link surface
(≈15.6 μg/mm μm)
of stent
length)

Pronova Vascular Sirolimus Co Cr Hybrid Biocompatibl 2.25,2.50,2.7 13,18,23,28,3

concepts,UK S shaped e,biostable 5,3.0,3.25,3.5 3,38
articulations polymer,drug 0,4.0
release upto
30 days

Biomime Meril Life Sirolimus Co Cr Hybrid cell Biodegradabl 2.5,2.75,3.0,3 8,13,16,19,24

Sciences, 1.25μgm/ design e polymer .5,4.0,4.5 ,29,32,37,40
India sqmm of stent 65μm strut
surface,30 day thickness
elution kinetics
Stent Manufactur Drug Base Form/ Polymer Diameter Length
er Design

ACTIVE& IHT Paclitaxel Stainless steel Open P5 - 2.0,2.25,2.5,2. 9,14,18,19,23,

ACTVE small cell,tubular Biocompatible 75,3.0,3.5,4.0, 28,36
polymer 4.5

EVERLITE Unimark Everolimus Co Cr Open Biodegradable 2.25,2.5,2.75,3.0 8,13,16,19,24,29

remedies Low drug dose cell,Sinosoidal ,3.5,4.0,4.5 ,32,37,40
1.2μg/sqmm strut
design,alternativ
e S link,ultrathin
strut 65μm

Flexy Rap Lancer medical Rapamycin Co Cr Open cell, Radial Biodegradable 2.25,2.5,2.75,3.0 7,10,13,15,17,20
technology 1μg/sqmm star segments polymer ,3.5,4.0 ,24,28,33,38,42
combined with
flexible
links,Strut 65μm,

INDOLIMUS Sahajanand sirolimus Co Cr Open cell,laser Biodegradable 2.5,2.75,3.0,3.5 8,12,16,20,24,28

Ce mark medical cut,seamless polymer matrix ,32,36,40
tube,60 micm
strut thickness
THANKS