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CORONARY STENTS
Dr. Saurabh gupta
PG Medicine
Dept of Medicine
VMMC and SJH
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.
 Primary cause of restenosis in balloon angioplasty is
adverse vessel remodeling with constriction of the
vessel relative to the adjacent nondilated vessel.
TREATMENT OF CAD
Options
Angioplasty
(PCI)
Stenting
Drug-
Eluting
Bare Metal
Bioabsorba
ble
Balloon
Angioplasty
Surgery
(CABG)
Lifestyle
Changes
Medications
 Stents prevent this unfavorable constrictive remodeling
and provide metal scaffolding to the vessel.
 Drug-eluting stents not only prevent this constriction but
reduce the excessive neointimal growth as well.
 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- Schatz stent).
HISTORY
 The term “stent” derives from a dental prosthesis developed
by the London dentist Charles Stent (1807–1885).
 The first stents were implanted in human coronary arteries in
1986 by Ulrich Sigwart, Jacques Puel, and
colleagues,Switzerland) in the peripheral and coronary
arteries of eight patients.
 Cesare Gianturco and Gary Roubin developed a balloon-
expandable coil stent consisting of a wrapped stainless steel
wire resembling a clamshell.
 A phase II study evaluating the Gianturco-Roubin stent to
reverse POBA in acute or threatened vessel closure was
started in 1988, ultimately leading to United States Food and
Drug Administration (FDA) approval for this indication in
June 1993.
 Julio Palmaz devised a balloon-expandable slotted stainless
steel stent with rectangular diamond shaped slots is the mother
of all the modern stents.
GIANTURCO-ROUBIN II
(OUTDATED)
PALMAZ-SCHATZ
STENT
MECHANISM OF RESTENOSIS
Acute
Recoil
Noeintimal
Hyperplasia
Chronic
Recoil
 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.
 In these studies, there was 20% to 30% reduction in clinical and
angiographic restenosis compared with Plain old balloon
angioplasty(POBA).
INDICATIONS OF CORONARY STENTING/PCI
(AHA/ACC)
 STEMI -In patients with stable angina, medical
therapy is recommended as first-line therapy
unless one or more of the following indications for
cardiac catheterization and PCI or CABG are
present:
 A change in symptom severity
 Failed medical therapy
 High-risk coronary anatomy
 Worsening left ventricular (LV) dysfunction
 Rescue PCI
 NSTEMI/UA - guidelines recommend that an early
invasive approach (angiography and
revascularization within 24 hours) should be used to
treat patients pesenting with the following high-risk
features -
 Recurrent angina at rest or low level of activity
 PCI in the past 6 months or prior CABG
 New ST-segment depression
 Elevated cardiac biomarkers
 Signs or symptoms of heart failure or new or worsening
mitral regurgitation
 Hemodynamic instability
 Sustained ventricular tachycardia
 LV systolic function < 40%
 High risk score (eg, Thrombolysis in Myocardial
Infarction [TIMI] score <2)
SPECIAL CONDITIONS
 Diabetes mellitus
Higher rate of repeat revascularization in patients with diabetes
mellitus treated with PCI than with CABG
 Chronic kidney disease
CABG is associated with a greater survival benefit than PCI
among patients with severe renal dysfunction
 Previous CABG
similar rates of mid- and long-term survival after PCI or repeat
CABG procedures.
 Contraindication to Fibrinolysis
STENT VS CABG
PRO’s CON’s
Reduced restenosis after 6 months
Higher clinical success rates
Reduced need for subsequent
revascularisation
Late Stent thrombosis
Similar rates of major cardiac
events( SYNTAX trial)
Similar rates of sudden cardiac
death(MASS-II trial)
PCI VS MEDICAL THERAPY
 As an initial management strategy in patients with
stable coronary artery disease, PCI did not
reduce the risk of death, myocardial infarction, or
other major cardiovascular events when added to
optimal medical therapy. (COURAGE trial.)
 But the newer platinum-chromium ,everolimus
eluting stents have imroved these safety outcomes.
PLACEMENT OF STENT
 Blockage is defined through coronary angiography and Intravascular
ultrasonigraphy (IVUS) may be used to assess the lesion's
thickness and hardness ("calcification").
 Cardiac catheter is guided to the heart through femoral or brachial
artery .
 Guide wire is manipulated to lie across the blockage
 Heparin is a given to prevent clotting
 Stent balloon catheter is transported along the guide wire and is
positioned over the blockage
 Saline is pumped into the balloon to inflate it
 Balloon is inflated for 30 to 60 seconds to expand the stent
 The framework of the stent should in direct contact
with the walls of the vessel to minimize potential
complications such as blood clot formation.
FACTORS AFFECTING IDEAL STENT
SELECTION
 Deliverability- Indicates the overall ease with
which the whole stent system can be ‘delivered’ to
the lesion site.
 Trackability- The amount of effort or force needed
to move the stent through the coronary artery.
 Good strut apposition- The ability of the stent to
sufficiently expand so that its struts abut against the
vessel wall
GOOD ANGIOGRAPHIC PROPERTIES OF STENT
•Radioopacity- Visibility of the stent under flouroscopy.
•Scaffolding – The amount of metal supporting or covering the
vessel wall and preventing plaque prolapse.
•Conformability- The flexibility of the stent to conform the
vessel wall.
•Placement Accuracy- The ability to accurately place the stent
over the body of the lesion which depend upon the stent and
markerband visibility and recoil.
•Minimum balloon overhang- The amount of expanded balloon
outside the ends of stent. it is equated with the amount of
trauma caused to the healthy tissue beyond the lesion.
DESIRABLE STENT CHARACTERISTICS
Low crossing profile
High Flexibility
High stent/host biocompatibililty
High radial strength
Low metallic surface area
Favourable radiographic properties
Good trackability
Easy deployment
TYPES OF STENTS
1. Mechanism of expansion -Balloon expandable
- Self Expanding
2. Materials -Stainless steel
-Chromium/cobalt based alloy
-Nitinol
-Tantalum
-Pt, Ir
-Inert coating
- Biodegradable
3. Forms -Sheet
-Wire
-Tube
4. Manufacturing methods --Laser cut
-Water jet cutting
-Photo itching
4. Geometric configurations/
Designs
-Mesh structure
-Coil
-Slotted tube
- Ring
-Multi design
5. Addition to stents -Grafts
-Radio opaque markers
- coatings
EVOLUTION OF STENTS
Bare Metal Stents(BMS)
Drug Eluting Stents (DES)
Biodegradable stents/ scaffolds
BMS(BARE METAL STENT)
Became known as the
“Achilles’ heel” of
coronary stenting
 Coronary restenosis 20-
30% at 6 months
Better than
POBA[STRESS and
BENESTENT-1 ]
DES(DRUG ELUTING STENTS)
THERAPEUTIC AGENTS
 Paclitaxel
 Promoting tubulin polymerization and cell cycle arrest at
G2/M phase
 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
 Sirolimus (Rapamycin)
 A macrocyclic lactone inhibiting mtor
 Inhibits the migration and proliferation of SMCs affecting G1 to S phase
 Zotarolimus
 The sirolimus analogues
 Extremely lipophilic property and low water solubility
 Everolimus
 Sirolimus analogue
 Absorbs to local tissue more rapidly and has a longer celluar residence
time and activity
 Biolimus
Comparison of DES( paclittaxel and sirolimus) with BMS
COMPARISON OF PACLITAXEL AND SIROLIMUS
RELEASING STENTS
OTHER AGENTS IN THE PIPELINE
 Tacrolimus
 Pimecrolimus
 Curcumin
 Resveratrol
 CD 34 antibody(gene stents)
 Anti-VEGF
GENERATIONS OF DRUG-ELUTING STENTS
STENT PLATFORMS
STENT MATERIALS- NON DEGRADABLE
MATERIAL
 316L stainless steel(FIRST GENERATION)-
 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)
 Taxus (paclitaxel-eluting stent, Boston Scientific,
Natick, MA)
SECOND GENERATION
CO-CR(COBALT -CHROMIUM)
 Superior radial strength and improved radiopacity
 Thinner stent struts
 The second generation DES,
 Xience V (everolimus-eluting stent,
Abott Vascular, CA)
 Endeavor (zotarolimus-eluting stent,
Medtronic Vascular, Santa Rosa, CA).
THIRD GENERATION
 Ta- tantalum
Ti(Titanium)
Pt-Ir , Pt-Cr
 Excellent corrosion resistant material
 Coated on 316L SS to improved biocompatibility
 High density and non-ferromagnetic properties
 Fluoroscopically visible and MRI compatible
 Less inflammatory reactions
BIODEGRADABLE METALLIC
MATERIALS(ABSORBED RAPIDLY)
 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
BIO-DEGRADABLE STENT MATERIALS
 Poly-L-lactic acid (PLA)
 Polyglycolic acid (PGA)
 Poly(D,L-lactide/glycolide) copolymer (PDLA)
 Polycaprolactone (PCL)
RATIONAL FOR BIODEGRADABLE STENTS
Metal stent drawbacks
 Cause permanent physical
irritation
 Risk of long term endothelial
dysfunction and chronic
inflammation
 Metal have thrombogenic
properties
 Inability for the vessel to
restore its a normal
physiology
Biodegradable stent advantages
 May eliminate early and late
complications of bare-metal
stents like Late Stent
Thrombosis(LST)
 Restore the vasoreactivity
 Allow a gradual transfer of the
mechanical load to the vessel
 Higher capacity for drug
incorporation and complex
release kinetics
 Facilitates repeat treatment at
the same site
The need for a permanent prosthesis decreases
dramatically 6 months post-implantation
BVS VS. DES
Drug – Eluting Stent Bioabsorbable stent
Polymer not biocompatible Polymers are biocompatible
All the drug is not eluted 100% drug is eluted in 4
months
Incomplete healing of
endothelium
Complete healing of
endothelium
Problems with late and
very late ST
No reports of ST from
phase I study
STENT DESIGN
 On the basis of design, stents can be divided into
three groups: coil, tubular mesh, and slotted tube.
A. Coil stents are characterised by metallic wires or strips
formed into a circular coil shape
B. Tubular mesh stents consist of wires wound together
in a meshwork, forming a tube.
C. Slotted tube stents are made from tubes of metal from
which a stent design is laser cut.
COIL VS. TUBE
 Coil design had greater strut width with gaps and
fewer or no connections between struts
 However, the design lack radial strength, and the
wide gap allow tissues to dangle.
 Tubularor corrugated stents are better than coil or
meshwire stents, in terms of a better acute and
midterm outcome.
COIL VS TUBE
 In tubular, there are two type of specification
 slotted tube and
 modular tube.
 Slotted tube stents resisted restenosis more than the
modular stents (22.1% vs 25.2%)
CLOSED CELL
 Sequential ring construction
 Regular peak-to-peak
connections.
 Optimal scaffolding
 Uniform surface, regardless
of the degree of bending.
 Less flexible than a similar
open-cell design.
 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
SLOTTED TUBE
STENT DESIGN IMPACTS DRUG
DELIEVERY
OTHER FACTORS AFFECTING CHOICE OF
STENT
 Long vs. Short
Short stent has lower cases of restenosis than long stent.
 Wide vs. Narrow
The wide diameter stent is more favorable than the narrow
one
 More struts vs. less
Less struts induce less chance of restenosis compare to
more struts.
 Thin strut vs thick strut
The stents with thinner struts is preferred for the design
of new stents.
 They can reduce angiographic and clinical restenosis
more than those with thicker struts
 Strut thickness was observed to be an independent
predictor of in-stent restenosis.
 Novel metallic materials such as cobalt-chromium
alloy are being used nowdays which have reduce
strut thickness while maintaining adequate
radiovisibility and radial strength.
 Stents with thinner struts and lower metal density
yield a lower risk of restenosis than those with
thicker struts, and should be used for high-risk
lesions such as those located in small vessels
where the risk of restenosis is often magnified.
SQUARE VS. ROUND STRUT CROSS-SECTION
Square vs. round strut cross-section
round strut cross-section without corners or sharp
edges is popular at present for smoothness design.
 Rough vs smooth stent design
 Increased biocompatibily
 Reduced thrombus adhesion and neointimal
growth.
ELEMENT OF STENT DESIGN- BALLOON
OVERHANG
DRUG DELIVERY VEHICLES – COATING
POLYMER- DRUG CARRIERS IN DESS
Non biodegradable polymers
 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)
BIODEGRADABLE STENTS DO THEIR JOB AND
DISSAPEAR !
 Biodegradable polymers
 Polylactic acid (PLLA)
 Polyglycolic acid (PGA)
 Polylactic-co-glycolic acid (PLGA)
 Polycaprolactone (PCL)
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
DES ARE NOT FOR EVERYONE !
 Cost is major limiting factor (60-70% more )
 Need for Chronic anticoagulants(DAPT)
 Patient not compliant for 12 mnth therapy
 High risk of bleeding
 Scheduled for any major surgery in next 12 mnths
 Late stent restenosis(6mnth – 1 year) is a major
adverse effect
 Bifurcated lesions have an unfavourable outcome
 No significant difference in MI and sudden death.
 Left main coronary involvement.
 Long lesion, small vessels and diabetics.
RADIO-OPACITY ENHANCEMENTS
 Stainless steel or nitinol - hard to see fluoroscopically.
 Biodegradable stents are also radiolucent .
 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
COMPLICATION OF STENTING
 Stent Thrombosis(ST)
Perforation(0.2% to 1.0%)
Dissection
Infectious Endarteritis
Allergic Reactions
Stent embolization
Side branch occlusion
Vascular complications related to site
of access
IMMEDIATE COMPLICATION OF
STENTING IS ST
RISK FACTORS FOR STENT
THROMBOSIS
Patientbased
• Smoking
• Diabetes
• Chronic
kidney
disease
• Thrombocytos
is
• Discontinuatio
n of
antiplatelet
therapy
• Surgical
procedures
Lesionbased
• Diffuse disease
• Small vessel
disease
• Bifurcating
disease
• Thrombus
containing
lesions
Stentbased
• Poor stent
expansion
• Edge dissection
limiting inlow
• Thicker struts
• Strut fractures
• Hypersensitivity
to any polymer
of DES
ORAL ANTIPLATELET THERAPY:
RECOMMENDATIONS
 Patients already taking daily aspirin therapy
should take 81 mg to 325 mg before PCI.
 Patients not on aspirin therapy should be given
nonenteric aspirin 325 mg before PCI.
 After PCI, use of aspirin should be continued
indefinitely(75 mg/day).
 A loading dose of a P2Y12 receptor inhibitor
should be given to patients undergoing PCI with
stenting. Options include
 Clopidogrel 600 mg (ACS and non-ACS patients)
 Prasugrel 60 mg (ACS patients)
 Ticagrelor 180 mg (ACS patients)
 The loading dose of clopidogrel for patients undergoing
PCI after fibrinolytic therapy should be 300 mg within 24
hours and 600 mg more than 24 hours after receiving
fibrinolytic therapy.
 In patients receiving a stent (BMS or DES) during PCI for
ACS, P2Y12 inhibitor therapy should be given for at least
12 months. Options include clopidogrel 75 mg
daily,prasugrel 10 mg daily, and ticagrelor 90 mg twice
daily.
 In patients receiving DES for a non-ACS indication,
clopidogrel 75 mg daily should be given for at least 12
months if patients are not at high risk of bleeding.
 In patients receiving BMS for a non-ACS indication,
clopidogrel should be given for a minimum of 1 month
and ideally up to 12 months (unless the patient is at
increased risk of bleeding; then it should be given for a
minimum of 2 weeks).
 Prasugrel should not be administered to patients with a
prior history of stroke or transient ischemic attack
Gp IIb/IIIa inhibitors
 STEMI- Administer iv or intracoronary during PCI
- Not beneficial when administered upstream
 NSTEMI- Beneficial at the time of PCI in patients not pretreated with
bivalirudin or clopidogrel
1. Abciximab: 0.25 mg/kg as an i.v. bolus, followed by 0.125mcg/kg/min
(maximum 10 mcg/min) for 12 hr
2. Eptifibatide: two 180-mcg i.v. boluses 10 minutes apart,followed by 2.0
mcg/kg/min i.v. for 12–24 hr
3. Tirofiban: 25 mcg/kg as an i.v. bolus, followed by 0.15 mcg/kg/min for 24
hr
 An additional dose of 0.3 mg/kg IV enoxaparin should be
administered at the time of PCI to patients who have
received fewer than 2 therapeutic subcutaneous doses (eg,
1 mg/kg) or received the last subcutaneous enoxaparin
dose 8 to 12 hours before PCI.
 For patients with heparin-induced thrombocytopenia, it is
recommended that bivalirudin or argatroban be used to
replace UFH
BMS VS DES VS BIOABSORBABLE STENTS
0
5
10
15
20
25
30
35
BMS Taxus Cypher Xience BVS
Patients(%)
MACE
TLR
Restenosis
Stent
Thrombosis
MATRIX OF STENT FEATURES
Bare-Metal
Stents
Drug-eluting
Stent
Bioabsorbabl
e drug-
eluting Stent
Reduced Dual-
Antiplatelet
Therapy
No neointimal
hyperplasia
Restoration of
Vasomotion
Material
(Biocompatible)
FUTURE OF STENTING
 Different drug combination on stent to
combat restenosis
 Drug combination to increase endothelial
healing
Drug filled stents(polymer free)
 Bioabsorbable stents
 Stents with progenitor cells/stem cells
 Gene therapy stents {anti cd34 ab}
 Diamond –carbon coated stents
COMMONLY USED
CORONARY STENTS IN
CLINICAL PRACTICE
Stent Manufactu
rer
Drug Base Form/Desi
gn
Polymer Diameter Length
XIENCE
Xpedition
Abott
vascular
FDA
Approved
Everolimus
100μg/cm2
L-605 CoCr Hybrid cell
Multilink
0.0032" strut
thickness,
laser cut
PBMA
Non erodible
SV-2.25
MV-
2.5,2.75,3.0,3.
25,3.5,4.0
LL
2.5,2.75,3.0,
3.25,3.5,4.0
8,12,15,18,23
,28
33,38
XIENCE V Abott
vascular
FDA
Approved
Everolimus
100μg/cm2
Multi-layer
Coating
MULTI-LINK
VISION CoCr
stent
Hybrid cell
Multilink
0.0032" strut
thickness,
laser cut,
PBMA
Non erodible
2.25,2.5,2.75,
3.0,3.5,4.0
8,12,15,18,23
,28
XINCE
PRIME
Abott
vascular
FDA
Approved
Everolimus
100μg/cm2
Cobalt
Chromium
Hybrid cell
Multilink
0.0032" strut
thickness,las
er cut,
biocompatibl
e fluorinated
copolymer
SV-2.25
MV
2.5,2.75,3.0,
3.5,4.0
LL-
2.5,2.75,3.0,
3.5,4.0
8,12,15,18,23
,28
Same
33,38
Stent Manufactur
er
Drug Base Form/Desi
gn
Polymer Diameter Length
Promus element
Plus
Boston scientific Everolimus Platinum
Chromium
Tubular open
cell,thin
strut,high radial
strength,good
delieverality &
trackability
Thin, fluorinated
copolymer
matrix for
controlled drug
release (100%
drug elution in
120 days)
2.25,2.5,2.75,3.0
,3.5,4.0
8,12,16,20,24,28
,32,38
Endeavor Sprint Medtronic Zotarolimus-
Eluting
10μg/mm
cobalt-based
alloy (cobalt,
nickel,
chromium, and
molybdenum)
Modular
design,Sinusoid
al form
wire,helical
wrap,laser fused
Phosphorylcholi
ne polymer
2.25,2.5,2.75,3.0
,3.5,4.0
8,12,14,18,22,26
,30,34,38
Resolut Integrity Medtronic Zotarolimus
eluting
cobalt-based
alloy (cobalt,
nickel,
chromium, and
molybdenum)
Modular
design,Sinusoidal
form wire,helical
wrap,laser fused
BioLinx
biocompatible
polymer
2.25,2.5,2.75,3.0
,3.5,4.0
8,12,14,18,22,26
,30,34,38
Stent Manufactur
er
Drug Base Form/Desi
gn
Polymer Diameter Length
Taxus Liberte Boston Scientific Paclitaxel
1 μg/mm2
paclitaxel in a
slow release
(SR)*
316L surgical
grade stainless
steel
Sinusoidal ring
modules linked
via curved link
elements
SIBS
[poly(styrene-b-
isobutylene-b-
styrene)], a tri-
block copolymer
(trade name:
Translute)
2.50, 2.75, 3.00,
3.50, 4.00
8, 12, 16, 20, 24,
28, 32
TAXUS Express Boston Scientific Paclitaxel
1μg/mm2
paclitaxel in a
slow release
(SR)
316L surgical
grade stainless
steel
modular ring
strut pattern
consists of two
separate module
designs: short,
narrow
sinusoidal Micro
elements linked
via straight
articulations to
long, wide
sinusoidal Macro
elements
SIBS
[poly(styrene-b-
isobutylene-b-
styrene)], a tri-
block copolymer
(trade name:
Translute)
2.50, 2.75, 3.00,
3.50
8, 12, 16, 20, 24,
28, 32
Taxus Element Boston Scientific Paclitaxel
1.0 μg/mm2
Platinum
Chromium
Sinusoidal ring
modules
consisting of
alternating long
and short
SIBS
[poly(styrene-b-
isobutylene-b-
styrene)], a tri-
block copolymer
2.25,2.50,2.75,3.
0,3.5,4.0,4.5
8,12,16,20,24,28
,32,38
Stent Manufactur
er
Drug Base Form/Design Polymer Diameter Length
Coracto Alvimedica Rapamycin Stainless
steel
Tubular,open cell
design
Ultrathin
polymer layer
absobes 100%
in 10-12 week
2.5,2.75,2.90,3
.00,3.5,4.0
9,13,17,21,26,
28,32
Coroflex
please
B.Braun Paclitaxel
1μg/cumm
Stainless
steel
Multicellular ring
design,Hybrid
Superb
radioopacity
P matrix-
polysulfone
coating
2.5,2.75,3.0,3.
5,4.0
8,13,16,19,25,
28,32
Cypher cordis Sirolimus
100% drug
release with in 1
month
Stainless
steel
Tubular,laser
cut,sinusoidal
pattern,closed cell
two non-erodible
polymers:
polyethylene-co-
vinyl acetate
(PEVA) and poly
n-butyl
methacrylate
(PBMA)
2.50, 2.75, 3.00,
3.50
8, 13, 18, 23, 28,
33
Stent Manufactu
rer
Drug Base Form/Desi
gn
Polymer Diameter Length
YUKON
Choice 4DES
Translumina,
German
CE mark
Sirolimus Medical
Stainless
Steel, 316
LVM, Surface
containing
micro-pores
1million
pores/sqcm
Balloon marker
material
Platinum /
Iridium
microporous
PEARL
Surface
Strut thickness
0,0034” / 87
μm
Hybrid design
Non
polymeric
Shellac resin
bio
compatible
resin
6 to 8 weeks
release
2.0,2.25,2.50,2
.75,3.0,3.5,4.0
8,12,16,18,21,
24,28,32,40
GEN X Sync MIV
therapeutics
India pvt ltd
Sirolimus Co Cr Open cell,
alternate S
link,uniform
sinusoidal strut
design
Bio resorb
PLLA-poly L
lactic acid
polymer
Ultrathin
coating(3μm)
Drug sudden
release f/b
release upto 40-
50 days.
2.0,2.25,2.50,2
.75,3.00,3.50,4
.0,4.5
8,13,16,19,24,
29,32,37
Supralimus Sahajanand
Medical
Technologies
Pvt Ltd, India
Sirolimus Sainless steel Hybrid biodegradable
drug-
carrier ,50%
drug release in
7 days next
50% in 41days
2.5,2.75,3.0,3.
5
8,12,16,20,24,
2832,36,40
Supralimus-
Core
Sahajanand
Medical
Technologies
Pvt Ltd, India
Sirolimus cobalt-
chromium
Hybrid biodegradable
drug-
carrier ,50%
drug release in
7 days next
50% in 41days
same same
Stent Manufactu
rer
Drug Base Form/Desi
gn
Polymer Diameter Length
BioMatrix Biosensors
Inc, Newport
Beach, Calif
CE mark
biolimus A9
highly
lipophilic,
semi
synthetic
sirolimus
analogue
(≈15.6 μg/mm
of stent
length)
S-Stent (316
L) stainless
steel stent
with a strut
thickness of
0.0054 inches
(137 μm)
laser-cut,
tubular stent
S-Stent
platform
Open cell,
quadrature
link
Biodegradabl
e,
Polylactic
acid (PLA)
applied to the
abluminal
surface
2.25,2.50,2.7
5,3.0,3.5,4.0
8,11,14,18,24
,28,33,36
Pronova Vascular
concepts,UK
Sirolimus Co Cr Hybrid
S shaped
articulations
Biocompatibl
e,biostable
polymer,drug
release upto
30 days
2.25,2.50,2.7
5,3.0,3.25,3.5
0,4.0
13,18,23,28,3
3,38
Biomime Meril Life
Sciences,
India
Sirolimus
1.25μgm/sqm
m of stent
surface,30 day
elution kinetics
Co Cr Hybrid cell
design
65μm strut
thickness
Biodegradabl
e polymer
2.5,2.75,3.0,3
.5,4.0,4.5
8,13,16,19,24
,29,32,37,40
Stent Manufactur
er
Drug Base Form/Desi
gn
Polymer Diameter Length
ACTIVE&
ACTVE small
IHT Paclitaxel Stainless steel Open
cell,tubular
P5 -
Biocompatible
polymer
2.0,2.25,2.5,2.
75,3.0,3.5,4.0,
4.5
9,14,18,19,23,
28,36
EVERLITE Unimark
remedies
Everolimus
Low drug dose
1.2μg/sqmm
Co Cr Open
cell,Sinosoidal
strut
design,alternativ
e S link,ultrathin
strut 65μm
Biodegradable 2.25,2.5,2.75,3.0
,3.5,4.0,4.5
8,13,16,19,24,29
,32,37,40
Flexy Rap Lancer medical
technology
Rapamycin
1μg/sqmm
Co Cr Open
cell, Radial star
segments
combined with
flexible
links,Strut 65μm,
Biodegradable
polymer
2.25,2.5,2.75,3.0
,3.5,4.0
7,10,13,15,17,20
,24,28,33,38,42
INDOLIMUS
Ce mark
Sahajanand
medical
sirolimus Co Cr Open cell,laser
cut,seamless
tube,60 micm
strut thickness
Biodegradable
polymer matrix
2.5,2.75,3.0,3.5 8,12,16,20,24,28
,32,36,40
SCHOLARY SOURCES
 Journal of Invasiv Cardiology.2001;13:634-639
 N Engl J Med,1994, 2007.
 Singapore Medical Journal, 2004.
 HEART JOURNAL
 JACC
 Harrisons priciples of internal mdicine (18th edition)
 Aha journals( CIRCULATION)
 medscape

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Coronarystents phpapp02

  • 1. CORONARY STENTS Dr. Saurabh gupta PG Medicine Dept of Medicine VMMC and SJH
  • 2.
  • 3. 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.  Primary cause of restenosis in balloon angioplasty is adverse vessel remodeling with constriction of the vessel relative to the adjacent nondilated vessel.
  • 4. TREATMENT OF CAD Options Angioplasty (PCI) Stenting Drug- Eluting Bare Metal Bioabsorba ble Balloon Angioplasty Surgery (CABG) Lifestyle Changes Medications
  • 5.  Stents prevent this unfavorable constrictive remodeling and provide metal scaffolding to the vessel.  Drug-eluting stents not only prevent this constriction but reduce the excessive neointimal growth as well.  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- Schatz stent).
  • 6. HISTORY  The term “stent” derives from a dental prosthesis developed by the London dentist Charles Stent (1807–1885).  The first stents were implanted in human coronary arteries in 1986 by Ulrich Sigwart, Jacques Puel, and colleagues,Switzerland) in the peripheral and coronary arteries of eight patients.  Cesare Gianturco and Gary Roubin developed a balloon- expandable coil stent consisting of a wrapped stainless steel wire resembling a clamshell.  A phase II study evaluating the Gianturco-Roubin stent to reverse POBA in acute or threatened vessel closure was started in 1988, ultimately leading to United States Food and Drug Administration (FDA) approval for this indication in June 1993.  Julio Palmaz devised a balloon-expandable slotted stainless steel stent with rectangular diamond shaped slots is the mother of all the modern stents.
  • 8.
  • 10.  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.  In these studies, there was 20% to 30% reduction in clinical and angiographic restenosis compared with Plain old balloon angioplasty(POBA).
  • 11. INDICATIONS OF CORONARY STENTING/PCI (AHA/ACC)  STEMI -In patients with stable angina, medical therapy is recommended as first-line therapy unless one or more of the following indications for cardiac catheterization and PCI or CABG are present:  A change in symptom severity  Failed medical therapy  High-risk coronary anatomy  Worsening left ventricular (LV) dysfunction  Rescue PCI
  • 12.  NSTEMI/UA - guidelines recommend that an early invasive approach (angiography and revascularization within 24 hours) should be used to treat patients pesenting with the following high-risk features -  Recurrent angina at rest or low level of activity  PCI in the past 6 months or prior CABG  New ST-segment depression  Elevated cardiac biomarkers  Signs or symptoms of heart failure or new or worsening mitral regurgitation  Hemodynamic instability  Sustained ventricular tachycardia  LV systolic function < 40%  High risk score (eg, Thrombolysis in Myocardial Infarction [TIMI] score <2)
  • 13. SPECIAL CONDITIONS  Diabetes mellitus Higher rate of repeat revascularization in patients with diabetes mellitus treated with PCI than with CABG  Chronic kidney disease CABG is associated with a greater survival benefit than PCI among patients with severe renal dysfunction  Previous CABG similar rates of mid- and long-term survival after PCI or repeat CABG procedures.  Contraindication to Fibrinolysis
  • 14. STENT VS CABG PRO’s CON’s Reduced restenosis after 6 months Higher clinical success rates Reduced need for subsequent revascularisation Late Stent thrombosis Similar rates of major cardiac events( SYNTAX trial) Similar rates of sudden cardiac death(MASS-II trial)
  • 15. PCI VS MEDICAL THERAPY  As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (COURAGE trial.)  But the newer platinum-chromium ,everolimus eluting stents have imroved these safety outcomes.
  • 16.
  • 17. PLACEMENT OF STENT  Blockage is defined through coronary angiography and Intravascular ultrasonigraphy (IVUS) may be used to assess the lesion's thickness and hardness ("calcification").  Cardiac catheter is guided to the heart through femoral or brachial artery .  Guide wire is manipulated to lie across the blockage  Heparin is a given to prevent clotting  Stent balloon catheter is transported along the guide wire and is positioned over the blockage  Saline is pumped into the balloon to inflate it  Balloon is inflated for 30 to 60 seconds to expand the stent
  • 18.  The framework of the stent should in direct contact with the walls of the vessel to minimize potential complications such as blood clot formation.
  • 19. FACTORS AFFECTING IDEAL STENT SELECTION  Deliverability- Indicates the overall ease with which the whole stent system can be ‘delivered’ to the lesion site.  Trackability- The amount of effort or force needed to move the stent through the coronary artery.  Good strut apposition- The ability of the stent to sufficiently expand so that its struts abut against the vessel wall
  • 20. GOOD ANGIOGRAPHIC PROPERTIES OF STENT •Radioopacity- Visibility of the stent under flouroscopy. •Scaffolding – The amount of metal supporting or covering the vessel wall and preventing plaque prolapse. •Conformability- The flexibility of the stent to conform the vessel wall. •Placement Accuracy- The ability to accurately place the stent over the body of the lesion which depend upon the stent and markerband visibility and recoil. •Minimum balloon overhang- The amount of expanded balloon outside the ends of stent. it is equated with the amount of trauma caused to the healthy tissue beyond the lesion.
  • 21. DESIRABLE STENT CHARACTERISTICS Low crossing profile High Flexibility High stent/host biocompatibililty High radial strength Low metallic surface area Favourable radiographic properties Good trackability Easy deployment
  • 22. TYPES OF STENTS 1. Mechanism of expansion -Balloon expandable - Self Expanding 2. Materials -Stainless steel -Chromium/cobalt based alloy -Nitinol -Tantalum -Pt, Ir -Inert coating - Biodegradable 3. Forms -Sheet -Wire -Tube
  • 23. 4. Manufacturing methods --Laser cut -Water jet cutting -Photo itching 4. Geometric configurations/ Designs -Mesh structure -Coil -Slotted tube - Ring -Multi design 5. Addition to stents -Grafts -Radio opaque markers - coatings
  • 24. EVOLUTION OF STENTS Bare Metal Stents(BMS) Drug Eluting Stents (DES) Biodegradable stents/ scaffolds
  • 25. BMS(BARE METAL STENT) Became known as the “Achilles’ heel” of coronary stenting  Coronary restenosis 20- 30% at 6 months Better than POBA[STRESS and BENESTENT-1 ]
  • 27. THERAPEUTIC AGENTS  Paclitaxel  Promoting tubulin polymerization and cell cycle arrest at G2/M phase  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
  • 28.  Sirolimus (Rapamycin)  A macrocyclic lactone inhibiting mtor  Inhibits the migration and proliferation of SMCs affecting G1 to S phase  Zotarolimus  The sirolimus analogues  Extremely lipophilic property and low water solubility  Everolimus  Sirolimus analogue  Absorbs to local tissue more rapidly and has a longer celluar residence time and activity  Biolimus
  • 29. Comparison of DES( paclittaxel and sirolimus) with BMS
  • 30. COMPARISON OF PACLITAXEL AND SIROLIMUS RELEASING STENTS
  • 31. OTHER AGENTS IN THE PIPELINE  Tacrolimus  Pimecrolimus  Curcumin  Resveratrol  CD 34 antibody(gene stents)  Anti-VEGF
  • 33. STENT PLATFORMS STENT MATERIALS- NON DEGRADABLE MATERIAL  316L stainless steel(FIRST GENERATION)-  Excellent mechanical properties and corrosion resistance  Ferromagnetic nature and low density make it a non-MRI compatible  Poorly visible fluoroscopic material
  • 34.  First generation DESs,  Cypher (sirolimus-eluting stent, Cordis, Warren, NJ)  Taxus (paclitaxel-eluting stent, Boston Scientific, Natick, MA)
  • 35. SECOND GENERATION CO-CR(COBALT -CHROMIUM)  Superior radial strength and improved radiopacity  Thinner stent struts  The second generation DES,  Xience V (everolimus-eluting stent, Abott Vascular, CA)  Endeavor (zotarolimus-eluting stent, Medtronic Vascular, Santa Rosa, CA).
  • 36. THIRD GENERATION  Ta- tantalum Ti(Titanium) Pt-Ir , Pt-Cr  Excellent corrosion resistant material  Coated on 316L SS to improved biocompatibility  High density and non-ferromagnetic properties  Fluoroscopically visible and MRI compatible  Less inflammatory reactions
  • 37.
  • 38. BIODEGRADABLE METALLIC MATERIALS(ABSORBED RAPIDLY)  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
  • 39. BIO-DEGRADABLE STENT MATERIALS  Poly-L-lactic acid (PLA)  Polyglycolic acid (PGA)  Poly(D,L-lactide/glycolide) copolymer (PDLA)  Polycaprolactone (PCL)
  • 40. RATIONAL FOR BIODEGRADABLE STENTS Metal stent drawbacks  Cause permanent physical irritation  Risk of long term endothelial dysfunction and chronic inflammation  Metal have thrombogenic properties  Inability for the vessel to restore its a normal physiology Biodegradable stent advantages  May eliminate early and late complications of bare-metal stents like Late Stent Thrombosis(LST)  Restore the vasoreactivity  Allow a gradual transfer of the mechanical load to the vessel  Higher capacity for drug incorporation and complex release kinetics  Facilitates repeat treatment at the same site The need for a permanent prosthesis decreases dramatically 6 months post-implantation
  • 41. BVS VS. DES Drug – Eluting Stent Bioabsorbable stent Polymer not biocompatible Polymers are biocompatible All the drug is not eluted 100% drug is eluted in 4 months Incomplete healing of endothelium Complete healing of endothelium Problems with late and very late ST No reports of ST from phase I study
  • 42. STENT DESIGN  On the basis of design, stents can be divided into three groups: coil, tubular mesh, and slotted tube. A. Coil stents are characterised by metallic wires or strips formed into a circular coil shape B. Tubular mesh stents consist of wires wound together in a meshwork, forming a tube. C. Slotted tube stents are made from tubes of metal from which a stent design is laser cut.
  • 43. COIL VS. TUBE  Coil design had greater strut width with gaps and fewer or no connections between struts  However, the design lack radial strength, and the wide gap allow tissues to dangle.  Tubularor corrugated stents are better than coil or meshwire stents, in terms of a better acute and midterm outcome.
  • 45.  In tubular, there are two type of specification  slotted tube and  modular tube.  Slotted tube stents resisted restenosis more than the modular stents (22.1% vs 25.2%)
  • 46.
  • 47. CLOSED CELL  Sequential ring construction  Regular peak-to-peak connections.  Optimal scaffolding  Uniform surface, regardless of the degree of bending.  Less flexible than a similar open-cell design.  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 SLOTTED TUBE
  • 48.
  • 49.
  • 50. STENT DESIGN IMPACTS DRUG DELIEVERY
  • 51. OTHER FACTORS AFFECTING CHOICE OF STENT  Long vs. Short Short stent has lower cases of restenosis than long stent.  Wide vs. Narrow The wide diameter stent is more favorable than the narrow one  More struts vs. less Less struts induce less chance of restenosis compare to more struts.
  • 52.  Thin strut vs thick strut The stents with thinner struts is preferred for the design of new stents.  They can reduce angiographic and clinical restenosis more than those with thicker struts
  • 53.  Strut thickness was observed to be an independent predictor of in-stent restenosis.  Novel metallic materials such as cobalt-chromium alloy are being used nowdays which have reduce strut thickness while maintaining adequate radiovisibility and radial strength.  Stents with thinner struts and lower metal density yield a lower risk of restenosis than those with thicker struts, and should be used for high-risk lesions such as those located in small vessels where the risk of restenosis is often magnified.
  • 54. SQUARE VS. ROUND STRUT CROSS-SECTION Square vs. round strut cross-section round strut cross-section without corners or sharp edges is popular at present for smoothness design.  Rough vs smooth stent design  Increased biocompatibily  Reduced thrombus adhesion and neointimal growth.
  • 55.
  • 56. ELEMENT OF STENT DESIGN- BALLOON OVERHANG
  • 57. DRUG DELIVERY VEHICLES – COATING POLYMER- DRUG CARRIERS IN DESS Non biodegradable polymers  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)
  • 58. BIODEGRADABLE STENTS DO THEIR JOB AND DISSAPEAR !  Biodegradable polymers  Polylactic acid (PLLA)  Polyglycolic acid (PGA)  Polylactic-co-glycolic acid (PLGA)  Polycaprolactone (PCL)
  • 59. 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
  • 60.
  • 61. DES ARE NOT FOR EVERYONE !  Cost is major limiting factor (60-70% more )  Need for Chronic anticoagulants(DAPT)  Patient not compliant for 12 mnth therapy  High risk of bleeding  Scheduled for any major surgery in next 12 mnths  Late stent restenosis(6mnth – 1 year) is a major adverse effect  Bifurcated lesions have an unfavourable outcome  No significant difference in MI and sudden death.  Left main coronary involvement.  Long lesion, small vessels and diabetics.
  • 62. RADIO-OPACITY ENHANCEMENTS  Stainless steel or nitinol - hard to see fluoroscopically.  Biodegradable stents are also radiolucent .  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
  • 63. COMPLICATION OF STENTING  Stent Thrombosis(ST) Perforation(0.2% to 1.0%) Dissection Infectious Endarteritis Allergic Reactions Stent embolization Side branch occlusion Vascular complications related to site of access
  • 65. RISK FACTORS FOR STENT THROMBOSIS Patientbased • Smoking • Diabetes • Chronic kidney disease • Thrombocytos is • Discontinuatio n of antiplatelet therapy • Surgical procedures Lesionbased • Diffuse disease • Small vessel disease • Bifurcating disease • Thrombus containing lesions Stentbased • Poor stent expansion • Edge dissection limiting inlow • Thicker struts • Strut fractures • Hypersensitivity to any polymer of DES
  • 66. ORAL ANTIPLATELET THERAPY: RECOMMENDATIONS  Patients already taking daily aspirin therapy should take 81 mg to 325 mg before PCI.  Patients not on aspirin therapy should be given nonenteric aspirin 325 mg before PCI.  After PCI, use of aspirin should be continued indefinitely(75 mg/day).  A loading dose of a P2Y12 receptor inhibitor should be given to patients undergoing PCI with stenting. Options include  Clopidogrel 600 mg (ACS and non-ACS patients)  Prasugrel 60 mg (ACS patients)  Ticagrelor 180 mg (ACS patients)
  • 67.  The loading dose of clopidogrel for patients undergoing PCI after fibrinolytic therapy should be 300 mg within 24 hours and 600 mg more than 24 hours after receiving fibrinolytic therapy.  In patients receiving a stent (BMS or DES) during PCI for ACS, P2Y12 inhibitor therapy should be given for at least 12 months. Options include clopidogrel 75 mg daily,prasugrel 10 mg daily, and ticagrelor 90 mg twice daily.  In patients receiving DES for a non-ACS indication, clopidogrel 75 mg daily should be given for at least 12 months if patients are not at high risk of bleeding.  In patients receiving BMS for a non-ACS indication, clopidogrel should be given for a minimum of 1 month and ideally up to 12 months (unless the patient is at increased risk of bleeding; then it should be given for a minimum of 2 weeks).  Prasugrel should not be administered to patients with a prior history of stroke or transient ischemic attack
  • 68. Gp IIb/IIIa inhibitors  STEMI- Administer iv or intracoronary during PCI - Not beneficial when administered upstream  NSTEMI- Beneficial at the time of PCI in patients not pretreated with bivalirudin or clopidogrel 1. Abciximab: 0.25 mg/kg as an i.v. bolus, followed by 0.125mcg/kg/min (maximum 10 mcg/min) for 12 hr 2. Eptifibatide: two 180-mcg i.v. boluses 10 minutes apart,followed by 2.0 mcg/kg/min i.v. for 12–24 hr 3. Tirofiban: 25 mcg/kg as an i.v. bolus, followed by 0.15 mcg/kg/min for 24 hr  An additional dose of 0.3 mg/kg IV enoxaparin should be administered at the time of PCI to patients who have received fewer than 2 therapeutic subcutaneous doses (eg, 1 mg/kg) or received the last subcutaneous enoxaparin dose 8 to 12 hours before PCI.  For patients with heparin-induced thrombocytopenia, it is recommended that bivalirudin or argatroban be used to replace UFH
  • 69. BMS VS DES VS BIOABSORBABLE STENTS 0 5 10 15 20 25 30 35 BMS Taxus Cypher Xience BVS Patients(%) MACE TLR Restenosis Stent Thrombosis
  • 70. MATRIX OF STENT FEATURES Bare-Metal Stents Drug-eluting Stent Bioabsorbabl e drug- eluting Stent Reduced Dual- Antiplatelet Therapy No neointimal hyperplasia Restoration of Vasomotion Material (Biocompatible)
  • 71. FUTURE OF STENTING  Different drug combination on stent to combat restenosis  Drug combination to increase endothelial healing Drug filled stents(polymer free)  Bioabsorbable stents  Stents with progenitor cells/stem cells  Gene therapy stents {anti cd34 ab}  Diamond –carbon coated stents
  • 72. COMMONLY USED CORONARY STENTS IN CLINICAL PRACTICE
  • 73. Stent Manufactu rer Drug Base Form/Desi gn Polymer Diameter Length XIENCE Xpedition Abott vascular FDA Approved Everolimus 100μg/cm2 L-605 CoCr Hybrid cell Multilink 0.0032" strut thickness, laser cut PBMA Non erodible SV-2.25 MV- 2.5,2.75,3.0,3. 25,3.5,4.0 LL 2.5,2.75,3.0, 3.25,3.5,4.0 8,12,15,18,23 ,28 33,38 XIENCE V Abott vascular FDA Approved Everolimus 100μg/cm2 Multi-layer Coating MULTI-LINK VISION CoCr stent Hybrid cell Multilink 0.0032" strut thickness, laser cut, PBMA Non erodible 2.25,2.5,2.75, 3.0,3.5,4.0 8,12,15,18,23 ,28 XINCE PRIME Abott vascular FDA Approved Everolimus 100μg/cm2 Cobalt Chromium Hybrid cell Multilink 0.0032" strut thickness,las er cut, biocompatibl e fluorinated copolymer SV-2.25 MV 2.5,2.75,3.0, 3.5,4.0 LL- 2.5,2.75,3.0, 3.5,4.0 8,12,15,18,23 ,28 Same 33,38
  • 74. Stent Manufactur er Drug Base Form/Desi gn Polymer Diameter Length Promus element Plus Boston scientific Everolimus Platinum Chromium Tubular open cell,thin strut,high radial strength,good delieverality & trackability Thin, fluorinated copolymer matrix for controlled drug release (100% drug elution in 120 days) 2.25,2.5,2.75,3.0 ,3.5,4.0 8,12,16,20,24,28 ,32,38 Endeavor Sprint Medtronic Zotarolimus- Eluting 10μg/mm cobalt-based alloy (cobalt, nickel, chromium, and molybdenum) Modular design,Sinusoid al form wire,helical wrap,laser fused Phosphorylcholi ne polymer 2.25,2.5,2.75,3.0 ,3.5,4.0 8,12,14,18,22,26 ,30,34,38 Resolut Integrity Medtronic Zotarolimus eluting cobalt-based alloy (cobalt, nickel, chromium, and molybdenum) Modular design,Sinusoidal form wire,helical wrap,laser fused BioLinx biocompatible polymer 2.25,2.5,2.75,3.0 ,3.5,4.0 8,12,14,18,22,26 ,30,34,38
  • 75. Stent Manufactur er Drug Base Form/Desi gn Polymer Diameter Length Taxus Liberte Boston Scientific Paclitaxel 1 μg/mm2 paclitaxel in a slow release (SR)* 316L surgical grade stainless steel Sinusoidal ring modules linked via curved link elements SIBS [poly(styrene-b- isobutylene-b- styrene)], a tri- block copolymer (trade name: Translute) 2.50, 2.75, 3.00, 3.50, 4.00 8, 12, 16, 20, 24, 28, 32 TAXUS Express Boston Scientific Paclitaxel 1μg/mm2 paclitaxel in a slow release (SR) 316L surgical grade stainless steel modular ring strut pattern consists of two separate module designs: short, narrow sinusoidal Micro elements linked via straight articulations to long, wide sinusoidal Macro elements SIBS [poly(styrene-b- isobutylene-b- styrene)], a tri- block copolymer (trade name: Translute) 2.50, 2.75, 3.00, 3.50 8, 12, 16, 20, 24, 28, 32 Taxus Element Boston Scientific Paclitaxel 1.0 μg/mm2 Platinum Chromium Sinusoidal ring modules consisting of alternating long and short SIBS [poly(styrene-b- isobutylene-b- styrene)], a tri- block copolymer 2.25,2.50,2.75,3. 0,3.5,4.0,4.5 8,12,16,20,24,28 ,32,38
  • 76. Stent Manufactur er Drug Base Form/Design Polymer Diameter Length Coracto Alvimedica Rapamycin Stainless steel Tubular,open cell design Ultrathin polymer layer absobes 100% in 10-12 week 2.5,2.75,2.90,3 .00,3.5,4.0 9,13,17,21,26, 28,32 Coroflex please B.Braun Paclitaxel 1μg/cumm Stainless steel Multicellular ring design,Hybrid Superb radioopacity P matrix- polysulfone coating 2.5,2.75,3.0,3. 5,4.0 8,13,16,19,25, 28,32 Cypher cordis Sirolimus 100% drug release with in 1 month Stainless steel Tubular,laser cut,sinusoidal pattern,closed cell two non-erodible polymers: polyethylene-co- vinyl acetate (PEVA) and poly n-butyl methacrylate (PBMA) 2.50, 2.75, 3.00, 3.50 8, 13, 18, 23, 28, 33
  • 77. Stent Manufactu rer Drug Base Form/Desi gn Polymer Diameter Length YUKON Choice 4DES Translumina, German CE mark Sirolimus Medical Stainless Steel, 316 LVM, Surface containing micro-pores 1million pores/sqcm Balloon marker material Platinum / Iridium microporous PEARL Surface Strut thickness 0,0034” / 87 μm Hybrid design Non polymeric Shellac resin bio compatible resin 6 to 8 weeks release 2.0,2.25,2.50,2 .75,3.0,3.5,4.0 8,12,16,18,21, 24,28,32,40 GEN X Sync MIV therapeutics India pvt ltd Sirolimus Co Cr Open cell, alternate S link,uniform sinusoidal strut design Bio resorb PLLA-poly L lactic acid polymer Ultrathin coating(3μm) Drug sudden release f/b release upto 40- 50 days. 2.0,2.25,2.50,2 .75,3.00,3.50,4 .0,4.5 8,13,16,19,24, 29,32,37 Supralimus Sahajanand Medical Technologies Pvt Ltd, India Sirolimus Sainless steel Hybrid biodegradable drug- carrier ,50% drug release in 7 days next 50% in 41days 2.5,2.75,3.0,3. 5 8,12,16,20,24, 2832,36,40 Supralimus- Core Sahajanand Medical Technologies Pvt Ltd, India Sirolimus cobalt- chromium Hybrid biodegradable drug- carrier ,50% drug release in 7 days next 50% in 41days same same
  • 78. Stent Manufactu rer Drug Base Form/Desi gn Polymer Diameter Length BioMatrix Biosensors Inc, Newport Beach, Calif CE mark biolimus A9 highly lipophilic, semi synthetic sirolimus analogue (≈15.6 μg/mm of stent length) S-Stent (316 L) stainless steel stent with a strut thickness of 0.0054 inches (137 μm) laser-cut, tubular stent S-Stent platform Open cell, quadrature link Biodegradabl e, Polylactic acid (PLA) applied to the abluminal surface 2.25,2.50,2.7 5,3.0,3.5,4.0 8,11,14,18,24 ,28,33,36 Pronova Vascular concepts,UK Sirolimus Co Cr Hybrid S shaped articulations Biocompatibl e,biostable polymer,drug release upto 30 days 2.25,2.50,2.7 5,3.0,3.25,3.5 0,4.0 13,18,23,28,3 3,38 Biomime Meril Life Sciences, India Sirolimus 1.25μgm/sqm m of stent surface,30 day elution kinetics Co Cr Hybrid cell design 65μm strut thickness Biodegradabl e polymer 2.5,2.75,3.0,3 .5,4.0,4.5 8,13,16,19,24 ,29,32,37,40
  • 79. Stent Manufactur er Drug Base Form/Desi gn Polymer Diameter Length ACTIVE& ACTVE small IHT Paclitaxel Stainless steel Open cell,tubular P5 - Biocompatible polymer 2.0,2.25,2.5,2. 75,3.0,3.5,4.0, 4.5 9,14,18,19,23, 28,36 EVERLITE Unimark remedies Everolimus Low drug dose 1.2μg/sqmm Co Cr Open cell,Sinosoidal strut design,alternativ e S link,ultrathin strut 65μm Biodegradable 2.25,2.5,2.75,3.0 ,3.5,4.0,4.5 8,13,16,19,24,29 ,32,37,40 Flexy Rap Lancer medical technology Rapamycin 1μg/sqmm Co Cr Open cell, Radial star segments combined with flexible links,Strut 65μm, Biodegradable polymer 2.25,2.5,2.75,3.0 ,3.5,4.0 7,10,13,15,17,20 ,24,28,33,38,42 INDOLIMUS Ce mark Sahajanand medical sirolimus Co Cr Open cell,laser cut,seamless tube,60 micm strut thickness Biodegradable polymer matrix 2.5,2.75,3.0,3.5 8,12,16,20,24,28 ,32,36,40
  • 80.
  • 81. SCHOLARY SOURCES  Journal of Invasiv Cardiology.2001;13:634-639  N Engl J Med,1994, 2007.  Singapore Medical Journal, 2004.  HEART JOURNAL  JACC  Harrisons priciples of internal mdicine (18th edition)  Aha journals( CIRCULATION)  medscape

Editor's Notes

  1. YUKON ChoiceDES DES system: Translumina modified stent surface containing micropores to enable the adsorption of different organic substances. The coating solution fills the pores completely and creates a uniform layer after evaporation of the solvent. After the drug is fully released, the microporous PEARL Surface favors the adhesion of endothelial cells.