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CORONARY STENTS Dr. Saurabh gupta PG Medicine Dept of Medicine VMMC and SJH

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CORONARY STENTS

Dr. Saurabh guptaPG 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

Bioabsorbable

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(OUTDATED)PALMAZ-SCHATZ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

HyperplasiaChronic

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 mellitusHigher rate of repeat revascularization in patients with diabetes

mellitus treated with PCI than with CABG

Chronic kidney diseaseCABG is associated with a greater survival benefit than PCI

among patients with severe renal dysfunction

Previous CABGsimilar 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 STENTS1. 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 thrombogenicproperties

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 fromphase 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

THROMBOSISP

atie

nt b

ase

d • Smoking

• Diabetes

• Chronic kidney disease

• Thrombocytosis

• Discontinuation of antiplatelettherapy

• Surgical procedures

Le

sio

n b

ase

d • Diffuse disease

• Small vessel disease

• Bifurcating disease

• Thrombus containing lesions

Ste

nt based • 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

Pa

tie

nts

(%

)

MACE

TLR

Restenosis

StentThrombosis

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

crowns linked

SIBS

[poly(styrene-b-

isobutylene-b-

styrene)], a tri-

block copolymer

(trade name:

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/cummStainless

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

Sirolimus1.25μgm/sqmm 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/sqmmCo 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