Xcience Patient Guide Int En

8/8/2019 Xcience Patient Guide Int En

1/40

Patient

Inormation

Guide

Everolimus Eluting Coronary Stent System


2/40


3/40

Table o Contents

Coronary Artery Disease (CAD) 4Causes 5Symptoms o CAD 6Risk Factors o CAD 8Diagnosis o CAD 9

Your Treatment Options 11Angioplasty 12Coronary Artery Stents 14Restenosis 16Drug Eluting Stents (DES) 17XIENCE V Everolimus ElutingCoronary Stent System 18

When XIENCE V Stent SystemShould Not be Used (Contraindicated) 20Know the Risks and Beneits oTreatment with the XIENCE V Stent System 21Your Drug Eluting Stent Procedure 27Preparing or Your Procedure 27Your Angioplasty and Stent Placement Procedure 28

Making a Swit Recovery 30Medications 31Getting on with Lie 33

Deinition o Medical Terms 35


4/40

Aortic ArchPlaque

Let Pulmonary

Let Main Trun

Let Anterior Descending(LAD)

Circumex (CX)

First Septal

Obtuse Marginal (OM)

Diagonal

Let Anterior Descending (LAD)

PosteriorDescending

Right Coronary

Artery (RCA)AcuteMarginal

BypassGrat

SuperiorVena Cava

Coronary

Vasculature


5/40

Coronary Artery Disease (CAD)

Causes

Coronary Artery Disease (CAD) is a condition that occurs when the

coronary arteries that supply oxygen-rich blood and nutrients to the

heart muscle become narrowed or bloced by a gradual build-up

o plaque. Plaque is made up o cholesterol (atty deposits), white

blood cells, calcium, and other substances that collect under the

inner lining o the coronary artery. As the plaque narrows the lumen

o a coronary artery, it maes it difcult or adequate quantities o

blood to ow to the heart muscle. Over time, the coronary artery

becomes less elastic (i.e., it hardens) due to plaque deposit. This

process is called atherosclerosis. Gradually, blood ow to the heart

muscle is reduced, which can cause chest pain (angina). A heart

attac is the result o a completely bloced artery, usually by a blood

clot orming over a plaque that has broen open (ruptured).


6/40

Symptoms o CAD

Gradually, blood ow to the heart muscle is reduced, which can

cause chest pain (angina) and shortness o breath. These are oten

the frst signs o coronary artery disease. I the plaque build-up

reduces ow only mildly, there may be no noticeable symptoms

at rest, but symptoms such as heaviness in the chest may occur

with increased activity or stress. Other symptoms that may be

experienced are pain in the jaw or pain radiating to the arms,

heartburn, nausea, vomiting and heavy sweating.

When ow is signifcantly reduced and the heart muscle does not

receive enough blood ow to meet its needs, severe symptoms

such as chest pain (angina pectoris), heart attac (myocardial

inarction), or rhythm disturbances (arrhythmias) may occur.

There are some patients who report no symptoms o CAD. It is

possible to have a heart attac without experiencing any symptoms.


7/40


CAD is the most common orm o heart disease. Recent research

has shown that women experience symptoms dierent rom men.

Chest pain, heaviness in the chest or chest discomort are the

typical symptoms that men report during a heart attac, but more

than one third o women having a heart attac do not report any o

these. Women may have symptoms earlier, such as unusual atigue

or sleep disturbances up to one month prior to having a heart

attac. These symptoms are very important because in the past

these dierences have caused women to delay seeing help

or treatment. This delay may lead to more severe disease.

Additional warning signs or women are eeling breathless,

oten without chest pain o any ind, u-lie symptoms, nausea,

clamminess or cold sweats, unexplained weaness or dizziness,

pain in the upper bac, shoulders, nec or jaw and eelings o

anxiety. Unortunately, according to the large, 50-year Framingham

Heart Study, over 50% o men and 63% o women who died

suddenly o CAD (mostly rom heart attac) had no previous

symptoms o this disease.


8/40

Recent improvements in treatment options, combined with earlier

diagnosis, and increased public awareness o the symptoms and

ris actors that contribute to this disease are helping to decrease

the death rate rom coronary artery disease.

Risk Factors o CAD

Two main ris actors or CAD are:

Increasing age Being male or menopausal emale1

Other ris actors that may increase your chances o developing

CAD are:

Family history o heart disease (close relatives

with heart disease at a young age)

Diabetes

High blood cholesterol levels

Smoing

High blood pressure

Stress

Obesity (being overweight)

High at diet Lac o exercise

1. Menopausal women begin to develop and die o heart disease at a rate equal to men. Menopause

is the transition in a womans lie when production o the hormone estrogen in the body alls

permanently to very low levels, the ovaries stop producing eggs, and menstrual periods stop.


9/40


Diagnosis o CAD

I your doctor suspects that you have CAD or i you have symptoms

o the disease, he/she will as you about your ris actors and your

symptoms. A complete physical examination and blood tests to

identiy injury to your heart muscle will also be completed.

In addition, some o the tests used to mae the diagnosis are:

Electrocardiogram (ECG/EKG) is a commonly used test that

records your hearts electrical activity and can show certain

problems such as abnormal heartbeats or damage to the heart

muscle. ECG can be done at rest or while you are waling or

running on a treadmill or pedaling a stationary bicycle (Stress ECG).

Stress Tests are several types o tests used to evaluate your heart

rate and rhythm while you are exercising. The results o these tests

help your doctor to determine the areas o heart muscle which are

aected by lac o blood ow due to CAD.


10/40

0

Echocardiographyis an examination o the heart using sound

waves.

Coronary Angiogram or Heart Catheterization is a procedure

carried out in the cardiac catheterization laboratory (cath lab) by a

cardiologist. Angiography is a procedure in which coronary arteries

are visualized using X-rays. A catheter (long, thin, hollow tube) is

inserted into an artery in the groin or arm. The tip o this tube is

positioned at the beginning o the arteries supplying blood to the

heart and a special uid called the contrast dye is injected through

the tube to visualize the blood vessels on X-rays so that pictures,

called angiograms, can be taen. These angiograms allow the

doctor to see any blocage and/or narrowings in your coronary

arteries and determine their severity.


11/40

Using the inormation gathered rom one or more o these tests,

your doctor is better able to decide the best treatment plan or you.

Your doctor will explain the riss and benefts o your treatment

options and answer any questions you or your amily may have.

Once a diagnosis has been reached, your doctor will recommend

the most appropriate orm o treatment depending on the condition

and severity o your CAD. CAD can be managed by a combination

o changes in liestyle (eating a healthy, low-saturated at diet,

regular exercise, and quitting smoing) and medical treatment.

Medical treatment o CAD may include medications, angioplasty

with or without stent placement, or Coronary Artery Bypass Grat

surgery (CABG or open heart surgery).

Your Treatment Options


12/40

Angioplasty

Angioplasty is a procedure used to open bloced arteries. You

may also hear it reerred to as PTCA (Percutaneous Transluminal

Coronary Angioplasty). This procedure is perormed under local

anesthetic in a cardiac catheterization laboratory. A catheter with a

small balloon mounted on the end is passed into the coronary artery.

The catheter is then positioned at the narrowed portion o the artery

and the balloon is inated.

As the balloon inates, it pushes out against the wall o the coronary

artery and compresses the plaque. This opens the narrowing and

improves the blood ow to the heart muscle. The balloon is then

deated and the catheter is removed rom the artery. In balloon

angioplasty, no permanent device remains in the artery ater the

balloon catheter is removed. A PTCA can be perormed with a

balloon alone or can involve placement o a permanent device called

a stent, within the coronary artery.


13/40


Step 1: The doctor guides a catheter with

a small balloon through the blood vessel

to the narrowed section o the artery. By

watching the progress o this catheter on the

uoroscope, the doctor is able to maneuver

it into the bloced coronary artery.

Step 2: The balloon is inated, pushing

out against the wall o the artery and

compressing the plaque.

Step 3: The inside o the blood vessel is now

larger and the blood ow is improved.


14/40

Coronary Artery Stents

Coronary artery stents are devices (small metallic mesh tubes) that

are placed over a balloon catheter and delivered to the narrowed

portion o the coronary artery. The balloon is used to expand

the stent. The stent presses against the narrowed vessel wall

holding the vessel open. This maes a wider channel to improve

blood ow to the heart muscle. This may be ollowed by repeat

balloon inations with the stent delivery system or with a dierent

angioplasty balloon to achieve the result desired by your doctor.

Once the balloon has been deated and withdrawn, the stent stays

in place permanently, holding the coronary artery open. The inner

lining o the artery grows over the surace o the stent maing the

stent a permanent part o your artery.


15/40


Step 1: The doctor maneuvers the

catheter into the bloced artery and inates

the balloon.

Step 2: The stent expands against the

vessel wall as the balloon is inated.

Step 3: Once the balloon has been deated

and withdrawn, the stent stays in place

permanently, holding the blood vessel open

and improving blood ow.


16/40

Restenosis

Unortunately, 30-50% o patients undergoing balloon angioplasty

will experience narrowing o the artery within the treated area

(restenosis) within the frst 6 months. This narrowing can be caused

by many actors including vessel shrinage and ormation o tissue

in-growth in the treated area.

Coronary artery angioplasty with stent placement has proven to

reduce restenosis compared to balloon angioplasty alone. Still,

in about one third o the patients who are treated with coronary

angioplasty and stent placement narrowings can reoccur within

6 months o the procedure. This is primarily due to increased tissue

in-growth within the stented area.


17/40

Drug Eluting Stents (DES)

A drug eluting stent is a coronary artery stent that has been coated

with a drug and a polymer to deliver the drug locally to the diseased

area. The drug is designed to reduce tissue in-growth and thereore

reduce the need or re-intervention due to restenosis in the stented

area over time (in-stent restenosis).


18/40

Stent Strut

Drug/Polymer


19/40

The XIENCE V stent is designed to prevent re-narrowing rom

occurring within the stent (in-stent restenosis).

It consists o a medical grade cobalt chromium stent with a thin

coating o drug on its surace. This stent is based on the design

o the MULTI-LINk VISION stent and provides mechanical support

to the artery while everolimus is slowly released into the artery

wall around the stent rom a thin uoropolymer coating. The

uoropolymer coating helps control the release o everolimus into

the arterial wall. Fluoropolymers are a class o polymers that have

a long history in blood contacting applications. Underneath the

uoropolymer, another layer o polymer is also coated on the stent

to help hold the drug layer to the stent surace. The release o

everolimus is intended to limit the overgrowth o normal tissue as

the healing process occurs ater coronary stent implantation. Over-

growth o normal tissue is believed to be a signifcant actor

in re-narrowing o the artery ater stenting.

XIENCE V Everolimus Eluting Coronary

Stent System (XIENCE V Stent System)


20/40

0

When XIENCE V Stent System

Should Not be Used (Contraindicated)

I you have a nown hypersensitivity (allergy) or

contraindication to everolimus, cobalt, chromium,

nicel, tungsten, acrylic and uoropolymers and/or

cannot be adequately pre-medicated.

I you cannot tae aspirin or blood thinning medications

(also called antiplatelet or anticoagulant therapy).

I the physician decides that the blocage will not allow

complete ination o the angioplasty balloon or proper

placement o the stent.


21/40

Know the Risks and Potential Benefts o

Treatment with the XIENCE V Stent System

Potential adverse events associated with the implantation o

a coronary stent in native coronary arteries are:

Abrupt closure (sudden blocage o the artery)

Acute myocardial inarction (heart attac)

Allergic reaction or hypersensitivity to contrast dye and drug

reactions to antiplatelet drugs or contrast dye

Aneurysm (a sac-lie protrusion rom a blood vessel, resulting

rom a weaening o the vessel wall)

Arterial peroration (puncture o the coronary artery) and injury to

the coronary artery

Arterial rupture (rupture o the coronary artery)

Arteriovenous fstula (connection between an artery and an

adjacent vein)

Atrial and ventricular arrhythmias (irregular heart beats in the

upper and lower chambers o the heart), including bradycardia

(slowing o heart rate), tachycardia (increased heart rate) and

fbrillation (rapid irregular contraction o the heart muscle)

Bleeding complications, which may require transusion

Cardiogenic shoc (shoc rom heart ailure)

Cardiac tamponade (compression o the heart due to

accumulation o blood around the heart)


22/40

Coronary artery spasm (spasm o the coronary artery causing the

artery to narrow)

Coronary artery or stent embolism (air, atty deposits, ragments

o blood clots, or parts o the stent going downstream and

blocing the arteries or the stent)

Coronary artery or stent thrombosis (at or ragments o blood

clots blocing the arteries or the stent)

Death

Distal emboli (air, tissue or thrombotic)

Emergency or non-emergency coronary artery bypass grat surgery

Heart, lung and idney ailure

Hypotension (decreased blood pressure) / Hypertension (increased

blood pressure)

Inection and pain at insertion site

Injury to the coronary artery

Ischemia, myocardial (decreased blood supply to a part o the

heart muscle) and peripheral (decrease in blood ow in the blood

vessels outside the heart / nerve injury leading to a decrease in

blood ow to the blood vessels outside the heart)

Nausea (urge to vomit) and vomiting


23/40

Pericardial eusion (abnormal collection o uid around the heart)

Pseudoaneurysm (dilatation o an artery with an actual brea in

one or more layers o its wall)

Restenosis o stented segment (repeat closure o the coronary

artery over time)

Stroe / cerebrovascular accident (CVA)

Total occlusion (blocage) o coronary artery

Unstable angina (increase in number, severity and duration o

chest pain) or stable angina pectoris (chest pain beginning in the

heart) and palpitations (eeling o the heart beating rapidly)

Vascular complications, including at entry site, which may require

vessel repair including hematoma

Vessel dissection (tearing)




24/40

Long term eects o the XIENCE V polymer as a part o a permanent

device is unnown at this time. The extent o exposure to drug and

polymer on the XIENCE V stent is directly related to the number and

lengths o the stents implanted. The use o multiple XIENCE V stents

will result in the patients receiving larger amounts o drug and

polymer. A idney transplant patient in clinical trials usually receives

a daily dose by mouth that is about seven times more than the

maximum dose o the drug contained on one XIENCE V stent.

Longer-term eect o the XIENCE V stent as a permanent device is

unnown at this time.


25/40

The saety and efcacy o XIENCE V was initially demonstrated

in the SPIRIT FIRST clinical trial (60 patients). When compared

to a metallic stent with no drug, XIENCE V was more eective at

reducing restenosis. At six months, XIENCE V (7.7%) had a lower

rate o MACE (Major Adverse Cardiac Events) than the metallic stent

with no drug (21.4%). XIENCE V continued to have lower MACE at

two years (15.4% vs. 25.0%). There were no stent thromboses in

the XIENCE V group.

The saety and efcacy o the XIENCE V stent was also shown in the

SPIRIT II clinical study (300 patients). The study results showed that

patients who received a XIENCE V stent had a signifcantly lower

amount o renarrowing o the vessels where the stent was placed,

when compared to the Boston Scientifc TAXUS Paclitaxel-Eluting

Coronary Stent System. The incidence o major adverse cardiac

events was lower in patients receiving a XIENCE V stent (2.7%) than

in patients receiving the TAXUS stent (6.5%) at 6 months ater the

stenting procedure. There was a low incidence o stent thrombosis

with XIENCE V in one patient (0.5%). In this study, one patient who

received the TAXUS stent also had a stent thrombosis (1.3%).




26/40

The saety and eectiveness o the XIENCE V stent in patients with

brachytherapy either beore or ater stent implantation have not

been established. There is no clinical experience on the perormance

o XIENCE V stent with other types o drug eluting stents. Longer

term riss and benefts associated with XIENCE V stent are currently

unnown.


27/40

Your Drug Eluting Stent Procedure

Preparing or Your Procedure

In the days prior to your treatment, mae sure you:

Tae all o your prescribed medicines

Tell your doctor i you are taing any other medication

Tell your doctor i, or any reason, you cannot tae aspirin

and/or Plavix

Mae sure your doctor nows about any allergies you have

Rerain rom eating and drining ater midnight on the night

beore your treatment

Follow all instructions given to you by your doctor or nurse

You may be given a mild sedative to help you relax, but you will

not be put to sleep. There are two reasons or this. First, most

people fnd they can cope quite well with any discomort rom the

procedure. Secondly, your doctor may need to as you to tae a

deep breath while X-rays are being taen to improve the quality o

the pictures.

The procedure usually lasts or about 90 minutes, during which time

your doctor will as you to remain very still. For the most part, you

will be comortable but you may eel some pressure or chest pain

when the balloon is inated. This is normal and will quicly ade

when the balloon is deated again.


28/40

Your Angioplasty and Stent Placement Procedure

Your procedure will be perormed in a cardiac catheterization

laboratory (cath lab). This room may be similar to the one where

you had your diagnostic angiogram. You will lie on the X-ray

table, and an X-ray camera will move over your chest during the

procedure. The sta will monitor your heart by attaching several

small, sticy patches to your chest and using a specialized ECG

recorder and monitor.

The groin is the most common site or catheter introduction and

requires a small incision to be made on the inside o your upper

thigh. The area will be shaved and cleaned with an antiseptic and

you will be given a local anesthetic to numb the area. This incision

will allow an introducer sheath (short tube) to be inserted into your

emoral artery. Your doctor will then insert a guiding catheter (long,

exible tube) into the introducer sheath and advance it to where

the coronary arteries branch o to the heart. A fne guide wire is

then advanced through the guiding catheter to the narrowing in the

coronary artery. This helps carry all the necessary catheters required

during the stenting procedure.


29/40

Additional options or catheter introduction are the arm / brachial

approach (incision is made on the inside o your elbow) and the

transradial approach (incision is made on the inside o your wrist).

Ater the catheters are inserted, your doctor will inject a contrast dye

through the guiding catheter into your artery to view the narrowing.

Your doctor will watch the injection on an X-ray monitor, much lie a

TV screen. While these X-rays are being taen, your doctor may as

you to tae a deep breath and hold it or a ew seconds. You may

also be ased to cough ater the X-ray picture is completed to help

speed the removal o the contrast dye rom the arteries.

Using the guiding catheter, a balloon catheter is positioned in the

narrowing in the coronary artery and the balloon is then inated.

This compresses the plaque and widens the coronary artery. This

procedure is called pre-dilatation.

The stent mounted on a balloon catheter is delivered to the

narrowing in the coronary artery by a delivery catheter. The balloon

is then inated and this expands the stent pressing it against the

coronary artery wall. Your doctor may choose to expand the stent

urther by using another balloon so that the stent can mae better



30/40


31/40

You may need to stay in the hospital or 1 to 2 days and then you

will be discharged into the care o your doctor. Mae sure you

contact your doctor or the hospital immediately i you experience

any discomort, pain or bleeding once you get home.

Taking Your Medications is Essential

Your cardiologist may prescribe a number o medications - including

antiplatelet, anticoagulant medicines such as Plavix, or Ticlid,

and/or aspirin - to thin the blood and prevent blood clots rom

orming and potentially adhering to the surace o the stent. It is very

important that you tae your recommended medication dosage

exactly as prescribed or the entire duration.

It is recommended that you tae antiplatelet medication

ollowing stent implantation or a period o time determined

by your doctor.

It is extremely important to ollow your medication regimen. I

you stop taing these medications earlier than instructed by

your cardiologist, you increase your ris or a serious blood

clot, which oten leads to a heart attac and death.

Be sure not to miss any doses.



32/40

Call your doctor i you eel that you cannot tolerate your

medications, or i you develop any side eects such as

bleeding, upset stomach, rash, or have any questions.

IMPORTANT: I you plan to have any type o dental work or surgery

that may require you to stop taking antiplatelet medications early,

you and your cardiologist should discuss whether or not placement

o a drug eluting stent is the right treatment choice or you. I

surgery or dental work would require you to stop taking antiplatelet

medications earlier than recommended ater youve received the

stent, you and your doctor should careully consider the risks and

benefts o this additional surgery versus possible risks rom early

discontinuation o these medications.

I you do require early discontinuation o antiplatelet medications

because o signifcant bleeding, your cardiologist will be careully

monitoring you or possible complications. Once your condition

has stabilized, your cardiologist will possibly put you bac on these

medications.


33/40

Getting on With Lie

To begin with, you will have to return or periodic chec-ups.

You may be ased to undergo a post-procedure exercise

electrocardiogram or angiogram. Regular periodic chec-ups will

monitor your progress and evaluate your medications, as well as

monitor the clinical status o your CAD and how the stent is woring

or you. Be sure to ollow your doctors instructions careully and

tae all your medications according to what is prescribed by your

doctor. keep all ollow-up appointments, including laboratory blood

tests, ollow-up procedures such as angiograms and/or ultrasound

i required.

Consider maintaining a healthy liestyle by regularly exercising,

maintaining a healthy diet and avoiding tobacco use. Stent

implantation will not limit your activities in any way but you should

consult your doctor beore you do anything physically demanding.

Tell your doctor that you have a coronary stent implant, and eep

your stent implant card with you at all times. I anything you have

read has raised urther questions regarding the procedure, discuss

them with your doctor.



34/40

The XIENCE V Everolimus Eluting Coronary Stent has been

shown in non-clinical testing to be MRI sae immediately ollowing

implantation. Your stent should not move during an MRI scan.

It is unnown i an MRI will heat your stent and possibly change

how the drug is released rom the stent. Prior to undergoing

these examinations, inorm your doctor that you have a XIENCE V

Everolimus Eluting Coronary Stent.


35/40

Angina: Chest pain caused by inadequate supply o blood to

the heart.

Angioplasty: (also reerred to as PTCA) A minimally invasive

procedure whereby a balloon dilatation catheter is passed

through to the bloced area o an artery. Once inated the catheter

compresses the plaque against the blood vessel wall.

An angioplasty can also be perormed with a stent.

Anticoagulant: A medication to prevent or slow the clotting

o blood.

Antiplatelet: A substance to reduce clumping o platelets in the

blood. An antiplatelet medicine helps thin the blood to prevent

clot ormation.

Atherosclerosis: A disease that causes narrowing or blocage o

arteries caused by a build-up o at (cholesterol) within the artery

wall. The build-up is sometimes reerred to as plaque.

Brachytherapy: The use o a locally delivered dose o radiation to

control the process o restenosis.

Defnition o Medical Terms


36/40

Cardiac Catheterization Laboratory (Cath Lab): A sterile X-ray

theater in which heart catheterization is perormed.

Catheter: A thin, hollow, exible tube used to access the coronary

arteries during an angiogram or during an angioplasty procedure.

This catheter can be used to inject medication, uids or contrast dye

during your procedure. Catheter is also used to describe the device

used to deliver the balloon or stent during an angioplasty procedure.

Coronary Angiography (or Heart Catheterization):

A test in which contrast dye is injected to create images o the

coronary arteries and the chamber o the heart. This allows the

doctor to see the extent o the disease in the coronary arteries and

mae a decision on how to best treat the blocages.

Coronary Arteries: The blood vessels that carry oxygenated blood

rom the aorta to the heart muscle. There are three major coronary

arteries: the right coronary artery, the let anterior descending, and

the circumex.


37/40

Coronary Artery Bypass Grat Surgery (CABG): Open-heart

surgery to treat CAD

Coronary Artery Disease (CAD): The ormation o blocages

or atherosclerotic plaques within coronary arteries that result in

restricted blood ow to the heart muscle.

Electrocardiogram (ECG/EKG): A test that records changes in

the electrical activity o the heart. An ECG/EkG may show whether

parts o the heart muscle are damaged due to decreased blood ow

to the heart muscle.

In-stent Restenosis: Recurrent blocage or narrowing o a

previously stented vessel.

Local Anesthetic: A substance used to numb the area to which it

is applied.

Lumen: The inner channel or cavity o a vessel or tube.



38/40

Myocardial Inarction (MI): Also called a heart attac.

Permanent damage o an area o the heart tissue, due to

interruption in the blood ow to the heart muscle (myocardium).

Percutaneous: Perormed through the sin.

Plaque: An accumulation or build-up o atty deposits, calcium

and/or cell debris in an artery that results in narrowing o the lumen.

Restenosis: A recurring blocage caused by excessive cell growth

inside the artery or stent, ollowing an interventional procedure such

as angioplasty.

Stent: A metallic mesh tube that is implanted into an artery during

an angioplasty, providing necessary scaolding to hold the artery

open, ensuring blood ow to the heart muscle.

Transluminal: Through the inside opening o a vessel or artery.



39/40

Notes:


40/40

This product is intended for use by or under the direction of a physician. Prior to use, it is important to read the package

insert thoroughly for instructions for use, warnings and potential complications associated with the use of this device.

Information contained herein for distribution outside the USA and Japan only.

Abbott Vascular International BVBA

Park Lane

2B Culliganlaan

1831 Diegem

Belgium

Tel: 32.2.714.14.11

Fax: 32.2.714.14.12

Documents

Xcience Patient Guide Int En