Everolimus Eluting

Coronary Stent System

Patient Information Guide

 Table of Contents

Coronary Artery Disease (CAD).........................5 Your Drug-Eluting Stent Procedure.................19

Your Heart.........................................................5 How Do I Prepare for My Procedure?............19
What is CAD?...................................................5 Your Drug-Eluting Stent Placement
What are the Symptoms of CAD?....................5 Procedure.......................................................19
What are the Risk Factors of CAD?.................6 Immediately after Procedure..........................22
How Can My Doctor Tell if I Have CAD?..........7 Take All Medications as Instructed.................22
Follow-up Care...............................................23
Your Treatment Options......................................8
Keep Your ID Card Handy..............................23
Surgery..............................................................9
Angioplasty.......................................................9 Preventing CAD.................................................24
Coronary Artery Stents...................................10 Frequently Asked Questions............................25
Drug-Eluting Stents (DES)................................11 Definition of Medical Terms.............................26
XIENCE Family of Coronary Stents.................12
Contraindications............................................13

Potential Adverse Events Associated with

the XIENCE Family of Coronary Stents...........13

The SPIRIT Family of Clinical Trials................16

Other Key Clinical Trials and Studies .............18

3
Coronary Vasculature

Aortic Arch
Plaque

Bypass Graft Left Main

Left Anterior Descending
(LAD)

Circumflex (CX)

Obtuse Marginal
Right Coronary
(OM)
Artery (RCA)

Acute Diagonal
Marginal

Posterior
Descending

4
 Coronary Artery Disease
(CAD)

Your Heart (angina), shortness of breath, sweating, and pain

Your heart is a muscle that pumps blood down the arms (most commonly the left arm).
throughout your body. The blood carries oxygen Narrowing of a heart blood vessel that results in
and nutrients that your body needs to work a complete blockage can progress gradually or
correctly. For the heart to be able to function can occur suddenly resulting in a heart attack,
properly, it also needs a constant supply of known as a myocardial infarction. Heart attacks
oxygen-filled blood. The vessels that supply this cause irreversible damage to the heart muscle.
blood to the heart are called coronary arteries. If Unfortunately, the first symptom of CAD may be
these arteries become blocked or narrowed, an sudden death without any other “warning” signs.
adequate supply of nutrients and oxygen are not Advancements in medical understanding and
available to be delivered. Therefore, treatment treatment, earlier recognition of disease, and
may be required to restore blood flow and the vital improved testing, combined with earlier diagnosis,
supply of oxygen to the heart. and increased public awareness of the heart
disease symptoms and risk factors have helped to
What is CAD?
reduce the death rates associated with CAD.
Coronary artery disease, or CAD, is the most
common form of heart disease. It is a condition What are the Symptoms of CAD?
that occurs when the coronary arteries that supply Two common symptoms of CAD are chest pain
oxygen-rich blood and nutrients to the heart (also known as angina) and shortness of breath,
muscle become narrowed or blocked by a gradual which are both associated with the reduction of
build-up of “plaque.” Plaque is made up of fatty blood flow to the heart muscle due to narrowing
deposits (cholesterol), white blood cells, calcium, of heart blood vessels. If plaque build-up does
and other substances that collect over time in the not reduce blood flow excessively, there may be
wall of a coronary artery. As the plaque narrows no noticeable symptoms at rest, but symptoms
the opening (lumen) of a coronary artery, it makes such as heaviness in the chest and difficulty with
it difficult for adequate quantities of blood to breathing may occur with increased activity or
flow to the heart muscle. This process of plaque stress.
formation and narrowing of the vessel diameter
is called “atherosclerosis.” Reduction of blood
flow to the heart muscle can cause chest pain
5
Coronary Artery Disease (CAD)
(continued)

Other symptoms that may be experienced are: realize they are suffering a heart attack and seek
• Pain in the jaw or neck treatment.
• Pain radiating to the arms or back What are the Risk Factors of CAD?
• Heartburn Two main risk factors for CAD are:
• Nausea • Increasing age (over age 65)
• Vomiting • Being male or a menopausal female1
• Heavy sweating
Other risk factors that may increase your chances
• Dizziness
of developing CAD are:
When blood flow is significantly reduced and the
heart muscle does not receive enough blood to • Family history of heart disease (close relatives
meet its needs, severe symptoms such as chest with heart disease at a young age)
pain (angina pectoris), heart attack (myocardial • Diabetes
infarction), or heart rhythm disturbances • High blood cholesterol levels
(arrhythmias) may occur. These symptoms occur • Smoking
intermittently or, as the narrowing worsens, at • High blood pressure
more frequent intervals. • Stress
There are some patients who report no symptoms • Obesity (being overweight)
of CAD. It is possible to have a heart attack
• High fat diet
without experiencing any symptoms.
• Lack of exercise
Recent research has shown that women may
experience different CAD symptoms from men,
and therefore, may be less likely than men to
report chest pain, heaviness in the chest, or chest
discomfort during a heart attack. Women may
notice other early symptoms, such as unusual
tiredness or sleep disturbances up to one month
prior to a heart attack. Given a lack of awareness
that these differences in symptoms could be due 1
Menopausal women begin to develop and die of heart disease at a rate equal to
men. Menopause is the transition in a woman’s life when production of the hormone
to CAD, women may be less likely than men to estrogen in the body falls permanently to very low levels, the ovaries stop producing
eggs, and menstrual periods stop.
6
Coronary Artery Disease (CAD)
(continued)

How Can My Doctor Tell if I Have CAD? Echocardiography is a heart exam using
If your doctor suspects that you have CAD or if sound waves. It can be performed with a probe
you have symptoms of the disease, he or she placed on the chest, or the probe is placed in
will ask you about your risk factors and your the food pipe (esophagus) while the patient is
symptoms. A complete physical exam and blood under anesthesia.
tests to identify injury to your heart muscle will Troponin, CK-MB, and CK are enzymes
also be completed. In addition, some of the tests that are released into the bloodstream when
used to make the diagnosis are: cardiac muscle cells are injured due to reduced
Electrocardiogram (ECG / EKG) is a blood flow. Blood tests for these enzymes are
commonly used test that records your heart’s performed to help determine if a patient is
electrical activity and can show certain suffering a heart attack.
problems such as abnormal heartbeats or Coronary Angiogram or Heart
damage to the heart muscle. An ECG can Catheterization is a procedure carried out in
be done at rest or while you are walking or the cardiac catheterization laboratory (cath lab)
running on a treadmill or pedaling a stationary by a cardiologist. Angiography is a procedure
bicycle (Stress ECG). An ECG is noninvasive in which coronary arteries are visualized using
and requires pads to be placed on your chest X-rays. A catheter (long, thin, hollow tube) is
to measure the heart’s electrical activity. inserted into an artery in the groin or arm. The
Stress Tests are used to evaluate your heart tip of this tube is positioned at the beginning
rate, heart rhythm, and ECG while you are of the arteries supplying blood to the heart.
exercising. The results of a stress test can A special fluid called contrast dye is injected
help your doctor determine the areas of heart through the tube to visualize the blood vessels
muscle that are affected by lack of blood flow on X-rays so that pictures called angiograms
due to CAD. The test is performed by having can be taken. These angiograms allow the
the patient exercise on a treadmill or, if he / she doctor to see any blockage and / or narrowing
is unable to walk, medication to mimic exercise in your coronary arteries and determine their
to “stress” the heart. severity and the affected areas of the heart
muscle.

7
Coronary Artery Disease (CAD) Your Treatment Options
(continued)

Using the information gathered from one or Once a diagnosis has been made, your doctor
more of these tests, your doctor is better able to will recommend the most appropriate form of
decide the best treatment plan for you. treatment, depending on the condition and
severity of your CAD.
If the severity of CAD is mild, it can usually
be managed by a combination of changes in
lifestyle (eating a healthy diet low in saturated
fat, regular exercise, and quitting smoking)
and medical treatment. Your treatment may
include medications to lower cholesterol, reduce
blood pressure, and relieve your chest pain by
increasing blood flow to your heart.
In some patients with more advanced CAD, diet,
exercise, and medicine may not provide adequate
treatment. In this case, you may need more
advanced therapy, including surgery, angioplasty,
Cardiac Catheterization Laboratory and / or stenting to treat your symptoms.
Your doctor will explain the risks and benefits
of your treatment options and answer any
questions you or your family may have. You
are encouraged to discuss your treatment
options with your doctor.

8
Your Treatment Options
(continued)

Surgery the artery. In balloon angioplasty, no permanent

Coronary artery bypass graft (CABG) surgery is device remains in the artery after the balloon
a common surgical procedure that removes a catheter is removed. Balloon angioplasty can be
section of artery or vein from another part of your performed with a balloon alone or can involve
body. This vessel is then connected (grafted) to placement of a permanent device called a stent,
the coronary artery at the blockage site. This within the coronary artery.
creates a new path for blood to flow around Although balloon angioplasty enlarges the lumen
(bypass) the blocked artery and to your heart. of coronary arteries, some patients may develop
Often, several blocked arteries are bypassed re-narrowing of the vessel in the months following
during the same operation. Most coronary bypass the procedure. This process is called restenosis,
patients remain in the hospital for about a week, and it is caused by the growth of scar tissue
followed by a recovery period at home. within the coronary artery.

Angioplasty
Angioplasty is a minimally invasive, or
nonsurgical, procedure used to open blocked
arteries. You may also hear it referred to as
Percutaneous Transluminal Coronary Angioplasty
(PTCA). This procedure is performed under local,
and at times, monitored sedation in a cardiac
catheterization laboratory. A catheter with a small
balloon mounted on the end is passed into the
coronary artery after it is inserted through the
femoral (leg) or radial (wrist) artery. The catheter
is then positioned at the narrowed portion of the
artery and the balloon is inflated. As the balloon
inflates, it stretches the wall of the coronary
artery and compresses the plaque, creating a
wider opening for blood flow. The balloon is
then deflated, and the catheter is removed from
9
Your Treatment Options
(continued)

Step 1: Coronary Artery Stents

The doctor guides a Coronary artery stents are devices (small metallic
catheter with a small mesh tubes) that are placed over a balloon
balloon through the blood catheter and delivered to the narrowed portion
vessel to the narrowed
of the coronary artery. The balloon is used to
section of the artery. By
expand the stent. The stent presses against
watching the progress
of this catheter on the the narrowed vessel wall, holding the vessel
Step 1 open. This results in a wider artery channel to
fluoroscope (an X-ray
device that creates real-time images of the improve blood flow to the heart muscle. This may
internal structures of the body that can be viewed be followed by repeat balloon inflations within
on a TV monitor), the doctor is able to maneuver the stent to achieve the result desired by your
it into the blocked coronary artery. doctor. Once the balloon has been deflated and
withdrawn, the stent stays in place permanently,
Step 2: holding the coronary artery open. The inner lining
The balloon is inflated, of the artery grows over the surface of the stent,
pushing out against the making the stent a permanent part of your artery.
wall of the artery and
compressing the plaque. Step 1:
The balloon is deflated The doctor maneuvers
and the catheter is the catheter into the
removed. blocked artery and
Step 2
inflates the balloon.
Step 3:
The inside of the blood
vessel is now larger Step 1
and the blood flow is
improved.

Step 3

10
Your Treatment Options Drug-Eluting Stents (DES)
(continued)

Step 2: To help prevent restenosis, “drug-eluting” stents

The stent expands against have been developed. These stents are coated
the vessel wall as the with a drug and provide the same structural
balloon is inflated. support as uncoated stents. The drug is released
over time, helping to prevent restenosis by
limiting the overgrowth of normal tissue within the
stent.
Step 2

Step 3:
Once the balloon has
been deflated and the
catheter is withdrawn,
the stent stays in place
permanently, holding the
blood vessel open, and
improving blood flow.
Step 3

Coronary artery stents are less invasive than

bypass surgery. Stenting involves a shorter
hospital stay – usually one to three days – and
faster recovery than surgery. However, restenosis
can also occur in some patients who receive
stents (in-stent restenosis), due to the build-up of
scar tissue within the stent, leading to narrowing
of the stent lumen.

11
 XIENCE Family of Coronary
Stents

The illustration shown is an artist’s XIENCE Xpedition SV, XIENCE Xpedition,

rendition of one of Abbott’s XIENCE
Family of drug-eluting stents. XIENCE Xpedition LL, and XIENCE Alpine
systems will be referred to as the “XIENCE Family
of Coronary Stents” or as “XIENCE stents.” The
XIENCE Family of Coronary Stents is designed
to prevent re-narrowing within the stent (in-stent
restenosis). These stents consist of a medical
grade cobalt chromium stent with a thin coating
of a drug called everolimus on its surface. This
stent provides mechanical support to the artery
while everolimus is slowly released into the artery
wall around the stent from a thin polymer (a type
Magnified photo of plastic) coating. The polymer coating helps
of actual stent
control the release of everolimus into the arterial
wall. The polymer used on XIENCE stents has a
long history of being used in medical products
The XIENCE Family of Coronary Stents is
in contact with blood. The release of everolimus
intended for use by or under the direction of a
is intended to limit the overgrowth of tissue
physician.
within the coronary stent. The XIENCE Family of
The XIENCE Family of Coronary Stents includes Coronary Stents is available in various diameters
the following: Everolimus Eluting Coronary Stent and lengths (reference Table 1 below).
Systems – XIENCE V, XIENCE nano, XIENCE
PRIME, XIENCE PRIME LL, XIENCE Xpedition Table 1: XIENCE Family Size Matrix
Available Stent Available Stent
SV, XIENCE Xpedition, XIENCE Xpedition LL, Diameters Lengths
and XIENCE Alpine. The differences between the XIENCE V 2.5, 2.75, 3.0, 3.5, 8, 12, 15, 18, 23,
4.0 mm 28 mm
various XIENCE systems involve differences in
8, 12, 15, 18, 23,
sizes (diameter and length) as well as differences XIENCE nano 2.25 mm 28 mm
in the stent design and delivery system. Going XIENCE PRIME 2.25, 2.5, 2.75, 3.0, 8, 12, 15,18,
3.5, 4.0 mm 23 mm
forward in this document, the XIENCE V, 2.25*, 2.5, 2.75, 3.0,
XIENCE PRIME LL 28, 33, 38 mm
XIENCE nano, XIENCE PRIME, XIENCE PRIME LL, 3.5, 4.0 mm

12
XIENCE Family of Coronary Potential Adverse Events
Stents (continued) Associated with the XIENCE
Family of Coronary Stents

Available Stent Available Stent The risk of using the XIENCE Stent is similar to
Diameters Lengths
those that are associated with standard stent
8, 12, 15, 18, 23,
XIENCE Xpedition SV 2.25 mm procedures. If the stent clots, you may need
28 mm

XIENCE Xpedition 2.5, 2.75, 3.0, 3.25, 8, 12, 15, 18, 23, another angioplasty procedure. It may also lead
3.5, 4.0 mm 28 mm
2.5, 2.75, 3.0, 3.25, to a heart attack, the need for urgent bypass
XIENCE Xpedition LL 33 and 38 mm
3.5, 4.0 mm surgery, or death. Even with successful stent
2.25**, 2.5, 2.75, 3.0, 8, 12, 15, 18, 23,
XIENCE Alpine 3.25, 3.5, 4.0 mm 28, 33, 38 mm implants, there is a chance of re-narrowing of
* The 2.25 mm stent diameter for XIENCE PRIME LL is only available in the 28 mm your coronary artery. This may require further
stent length.
** The 2.25 mm stent diameter for XIENCE Alpine is not available in the 33 and 38 mm treatments, such as repeat angioplasty and /
stent lengths.
or bypass surgery, to reopen the artery and to
increase blood flow to the heart. The risks from
Contraindications
using balloon catheters after stent implants
• If you have a known hypersensitivity
are similar to the risks that may occur during
(allergy) or contraindication to everolimus
the initial stent implant. These may be serious
or structurally related compounds cobalt,
enough to require surgery or cause death.
chromium, nickel, tungsten, acrylic, and
fluoropolymers Other risks from these devices are the same as
treatment procedures for a narrowed coronary
• If you cannot take aspirin or blood-thinning
artery. Some problems associated with standard
medications (also called antiplatelet or
balloon angioplasty and stenting include, but are
anticoagulant therapy)
not limited to:
• If your physician decides that the coronary
artery blockage will not allow complete Common Risks
inflation of the angioplasty balloon or proper • Bruise or bleeding at the catheter insertion
placement of the stent site in the groin or arm
• Pain at the catheter insertion site
• Irregular heartbeats
• Chest pains during and after the procedure
• Spasm of the coronary artery
• Decreased or increased blood pressure

13
Potential Adverse Events Associated
with the XIENCE Family of Coronary
Stents (continued)

Rare Risks Zortress, the oral formulation of everolimus

• Tearing, puncture, or rupture of the coronary developed by Novartis Pharmaceuticals
artery Corporation, has been evaluated in clinical trials
• Air, pieces of devices, or fragments of clots and is approved in the United States for the
blocking the coronary or peripheral arteries prevention of organ rejection in adult kidney
• Complete blockage of the coronary artery, transplant recipients at the dose of 1.5 mg/day.
which may require a repeat procedure to Outside the U.S., Zortress is sold under the
reopen the coronary artery brand name Certican in more than 70 countries.
• Compression of the heart due to accumulation Everolimus is also approved in the United States
of blood around the heart under the name of Afinitor for patients with
advanced renal cell carcinoma (cancer) at doses
• Re-narrowing of the coronary artery
of 5 to 20 mg/day when taken by mouth. The
• Heart attack
amount of drug in your blood from the XIENCE V
• Damage to the stent or injury to the coronary
stent is several-fold lower than that obtained
artery, requiring emergency heart surgery
with oral doses (1.5 mg to 20 mg/day). Potential
• Bleeding, requiring transfusion or surgery adverse events related to taking everolimus
• Allergic reaction (may include X-ray daily by mouth (based on long-term everolimus
dye, cobalt, chromium, nickel, tungsten, drug studies in organ transplant patients and in
everolimus, acrylic, and fluoropolymer) patients with advanced renal cell carcinoma) may
• Infection include:
• Nerve injury • Abdominal pain
• Kidneys fail to function normally • Abnormal collection of a clear fluid containing
• Aneurysm (weakening of a portion of the wall white blood cells
of a blood vessel) • Acne
• Shock • Blood clot in the vein
• Stroke • Constipation
• Death • Cough
• Decreased functioning of sexual organs in
men
14
Potential Adverse Events Associated
with the XIENCE Family of Coronary
Stents (continued)
• Decreased platelet cell count • Muscle pain
• Decreased red or white blood cells • Nausea
• Decreased sense of taste • Nose bleeds
• Destruction of red blood cells • Pain in the arms and legs
• Destruction of the kidney tubules • Painful urination
• Diarrhea • Presence of red blood cells in the urine
• Dry or itchy skin • Rash
• Fatigue • Shortness of breath and lung or breathing
• Fever problems
• Headache • Surgical wound complication
• Higher levels of potassium and lower levels of • Tremor
magnesium and phosphorus in the blood • Vomiting
• Increased blood cholesterol • Water retention in the body
• Increased blood pressure Exposure to drug and polymer on the XIENCE
• Increased blood sugar Family of Coronary Stents is directly related to
• Increased fat and triglyceride fats in the blood the number and lengths of the stents implanted.
• Infection of the lungs The use of multiple XIENCE stents will result
• Infections in you receiving larger amounts of drug and
• Inflammation of the lining of the digestive polymer. It should be noted that a kidney
system transplant patient usually receives a daily dose of
• Insomnia the drug everolimus by mouth that is about seven
times more than the maximum dose of the drug
• Kidney function test abnormality
contained on one XIENCE stent.
• Lack or loss of strength
Everolimus, when given by mouth daily to organ
• Liver function test abnormality
transplant patients, may interact with other drugs
• Loss of appetite
or substances. Please tell your physician about
• Loss of blood supply to the bone
any medications you are taking.
• Mouth ulcers or sores

15
 The SPIRIT Family of
Clinical Trials

There have been five clinical trials that together SPIRIT II

show the safety and effectiveness of the XIENCE The SPIRIT II clinical trial was the second study
Family of Coronary Stents in patients with of the XIENCE V stent. The purpose of the
coronary artery disease. A short description of study was to compare the XIENCE V stent to
some of these trials is detailed below: an approved drug-eluting stent, called TAXUS
Express stent or TAXUS Liberté stent (TAXUS
SPIRIT FIRST
stent). The SPIRIT II study was conducted outside
SPIRIT FIRST was the first clinical trial. This study
of the United States.
had 60 patients and was performed outside the
United States. The purpose of the study was to After six months, the XIENCE V stent was
compare the XIENCE V stent that is coated with significantly better than the TAXUS stent at
a drug to that of an approved metallic stent that reducing the re-narrowing of the artery where the
is not coated with a drug. There were 28 patients stent was placed. At five years, patients who had
who received the XIENCE V stent and 32 patients received the XIENCE V stent had a rate of major
who received the metallic stent (patients who adverse cardiac events of 8.9% compared to a
received the metallic stent are also known as the rate of 20.3% for those patients receiving the
“control” group). TAXUS stent.

After six months, the XIENCE V stent was SPIRIT III

significantly better than the metallic stent at SPIRIT III was the third clinical study of the
reducing the re-narrowing of the artery where the XIENCE V stent. This was a much bigger study
stent was placed. After five years, patients who than either the SPIRIT FIRST or SPIRIT II studies,
had received the XIENCE V stent had fewer major and was conducted in the United States. In one
adverse cardiac events (16.7%) compared to part of this study, 1002 patients were given either
patients who received the metallic stent (28.0%). the XIENCE V stent or the TAXUS stent. There were
(Major adverse cardiac events included death 669 patients who received the XIENCE V stent and
due to cardiac causes, heart attack, or the need 333 patients who received the TAXUS Express
for coronary artery bypass surgery or repeat stent (TAXUS stent).
angioplasty at the site of the lesion.) After eight months, the XIENCE V stent was
significantly better than the TAXUS stent at
reducing the re-narrowing of the artery where the
stent was placed. At five years, patients who had
16
The SPIRIT Family of
Clinical Trials (continued)

received the XIENCE V stent had a rate of major stent (XIENCE nano) in small coronary arteries.
adverse cardiac events of 14.4% compared to There were 144 patients who received the
a rate of 22.0% for those patients receiving the XIENCE nano stent.
TAXUS stent. After three years, the rate of target lesion failure
SPIRIT IV (which is comprised of cardiac death, heart
attacks, bypass surgery, or repeat angioplasty
SPIRIT IV was the fourth clinical study of the
at the site of the lesion), was 12.1% with the
XIENCE V stent. This is the largest study of the
XIENCE nano stent.
four randomized SPIRIT clinical trials and was
conducted in the United States. A total of 3,687 SPIRIT PRIME
patients were given either the XIENCE V stent or The SPIRIT PRIME clinical study was conducted
the TAXUS Express stent (TAXUS stent). There globally to evaluate the performance of the
were 2,458 patients who received the XIENCE V XIENCE PRIME family of stent systems. There
stent and 1,229 patients who received the TAXUS were 415 patients enrolled in the Core Size
stent. Registry (stent diameters 2.25, 2.5, 3.0, 3.5,
After one year, the XIENCE V stent was 4.0 mm with stent lengths 8, 18, and 28 mm) and
significantly better than the TAXUS stent at 110 patients enrolled in the Long Lesion Registry
reducing the need for bypass surgery or repeat (stent diameters 2.5, 3.0, 3.5, 4.0 mm, with stent
angioplasty at the site of the lesion where the lengths 33 and 38 mm) at up to 75 global sites.
stent was placed. The occurrence of target lesion After three years, the rate of target lesion failure
failure (which is comprised of cardiac death, heart (which is comprised of cardiac death, heart
attacks, bypass surgery or repeat angioplasty at attacks, bypass surgery, or repeat angioplasty
the site of the treated lesion) was significantly at the site of the treated lesion) was 8.5% in the
lower in patients treated with XIENCE V stents Core Size Registry patients and 9.6% in the
(9.5%) compared to TAXUS stents (11.9%) at Long Lesion Registry patients.
three years. For patients treated with the XIENCE Family of
SPIRIT Small Vessel Coronary Stents in ways not studied in these
The SPIRIT Small Vessel clinical study was clinical trials, clinical results may vary.
conducted in the United States to evaluate the
performance of the 2.25 mm diameter XIENCE

17
 Other Key Clinical Trials and
Studies

XIENCE V USA EXPERT CTO

After the XIENCE V stent was approved for use The EXPERT CTO clinical study was designed
in the United States, the XIENCE V USA clinical to evaluate the safety and performance of the
study was conducted to evaluate the continued XIENCE stent systems in completely blocked
safety and effectiveness of the XIENCE V stent in coronary arteries. There were 250 patients
a wide range of patients. A total of 8,040 patients enrolled in the study at 20 sites across the
were enrolled from 191 sites in the United States. United States. At one year, the rate of major
At four years, 1.56% of patients experienced adverse cardiac events (which is comprised of
a stent-associated blood clot. In addition, the death, heart attacks, bypass surgery, or repeat
occurrence of cardiac deaths or heart attacks angioplasty at the site of the lesion) was 18.5% in
was 14.9% at four years with the XIENCE V stent. patients treated with the XIENCE stent.

DIABETES MELLITUS STUDY

The safety and effectiveness of treatment with
XIENCE stents in patients with diabetes was
evaluated using one-year data from diabetic
patients enrolled in selected Abbott Vascular
studies (SPIRIT IV, SPIRIT PRIME and XIENCE V
USA) plus data from diabetic patients followed
in hospital registry studies maintained at the
Cleveland Clinic and Wake Forest University. A
total of 1239 diabetic patients treated with at
least one XIENCE stent were evaluated (949 from
Abbott Vascular trials and 290 from the hospital
databases). The rate of target vessel failure
(which is comprised of cardiac death, target-
vessel myocardial infarction or ischemia driven
target vessel revascularization) was 8.0%.

18
 Your Drug-Eluting Stent
Procedure

How Do I Prepare for My Procedure? Your Drug-Eluting Stent Placement Procedure

In the days prior to your treatment, make sure you: Your procedure will be performed in a cardiac
• Take all of your prescribed medicines catheterization laboratory (cath lab). You will
• Tell your doctor if you are taking any other lie on the X-ray table, and an X-ray camera will
medication move over your chest during the procedure. The
staff will monitor your heart by attaching several
• Tell your doctor if, for any reason, you
small sticky patches to your chest and using a
cannot take aspirin and / or thienopyridine
specialized ECG recorder and monitor.
medications such as Plavix or Effient
The groin is the most common site for catheter
• Make sure your doctor knows about any
introduction and requires a very small skin
allergies you have
incision to be made on the inside of your upper
• Refrain from eating and drinking after midnight
thigh. The area will be shaved and cleaned
on the night before your treatment
with an antiseptic, and you will be given a local
• Follow all instructions given to you by your
anesthetic to numb the area. This incision will
doctor or nurse
allow an introducer sheath (short tube) to be
You may be given a mild sedative to help you inserted into your femoral artery (the main artery
relax, but you will not be put to sleep. There are of the thigh, supplying blood to the leg). Your
two reasons for this. Firstly, most people find doctor will then insert a guiding catheter (long,
they experience little to no discomfort from the flexible tube) into the introducer sheath and
procedure. Secondly, your doctor may need advance it to where the coronary arteries branch
to ask you to take a deep breath while X-rays off to the heart. A guide wire is then advanced
are being taken, to improve the quality of the through the guiding catheter to the narrowing
pictures. in the coronary artery. This helps carry all the
The procedure usually lasts about 90 minutes, necessary devices required during the stenting
during which time your doctor will ask you to procedure.
remain very still. For the most part, you will be Additional options for catheter introduction are
comfortable, but you may feel some pressure or the arm / brachial approach (incision is made on
chest pain when the balloon is inflated. This is the inside of your elbow) and the wrist / radial
normal and will quickly fade when the balloon is approach (incision is made on the inside of your
deflated. wrist).
19
Your Drug-Eluting Stent Procedure
(continued)

June, 2012. Used with

permission of Elsevier.
All rights reserved.

Blood vessel access for heart catheterization

through the femoral, radial or brachial artery

20
Your Drug-Eluting Stent Procedure
(continued)

After the catheters are inserted, your doctor Step 1:

will inject a contrast dye through the guiding The stent mounted on
catheter into your artery to view the narrowing. a balloon catheter is
Your doctor will watch the injection on an X-ray delivered to the narrowing
monitor, much like a TV screen. While these in the coronary artery by a
delivery catheter.
X-rays are being taken, your doctor may ask
you to take a deep breath and hold it for a few
seconds. You may also be asked to cough after Step 1
the X-ray picture is completed, to help speed the
removal of the contrast dye from the arteries. Step 2:
Using the guiding catheter, a balloon catheter is The balloon is then
positioned in the narrowing in the coronary artery inflated and this expands
and the balloon is then inflated. This compresses the stent, pressing it
against the coronary
the plaque and widens the coronary artery. This
artery wall. Your doctor
procedure is called pre-dilatation. may choose to expand
the stent further, by using
Step 2
another balloon so that
the stent can make better contact with the artery
wall. This is known as post-dilatation.

Step 3:
Once in place, the XIENCE
stent will remain as a
permanent implant in your
coronary artery.

Step 3

21
Your Drug-Eluting Stent Procedure
(continued)

Immediately after Procedure Take All Medications as Instructed

You will be asked to lie flat for four to six hours After you leave the hospital, your cardiologist will
following the procedure and to not bend your leg instruct you to take a daily dose of aspirin and
or arm, depending on which area your doctor another antiplatelet drug such as Plavix, Effient,
used to insert the catheters. Pressure will also be or Brilinta. Your doctor will tell you how long you
placed on the area. should continue taking the antiplatelet drugs. It is
A vascular closure device may be used to seal very important that you take these medications
the incision site in your groin or arm. You will be exactly as your doctor instructs you:
allowed to get up and walk around sooner if this • Follow your medication schedule exactly to
type of device is used. Your hospital stay may avoid possible complications after you receive
range from one to three days. your stent. Do not miss any doses.
• Call your doctor if you cannot keep taking
Medications will be prescribed for you before and your medications because of side effects such
after stent placement. Antiplatelet medications as rash, bleeding, or upset stomach.
such as aspirin and other blood thinning • CAUTION: Do not stop taking your
medications (such as Plavix, Effient, or Brilinta) prescribed medications unless you are
are the most commonly prescribed. They help instructed to do so by the doctor who
prevent a blood clot (thrombus) from forming and performed your stent procedure.
• CAUTION: Notify your cardiologist or family
blocking the stent lumen. Your doctor or nurse
doctor if you are scheduled to see the
will give you instructions about your medications dentist while on antiplatelet medication.
before you leave the hospital. Your doctor may prescribe antibiotics
CAUTION: If you have any chest pain, or to avoid the potential of an infection.
discomfort or bleeding from your incision site, You should review with your doctor any
recommendations from your dentist to
call your doctor immediately. If your doctor is
stop your prescribed medications.
unavailable, call for an ambulance to take you • CAUTION: Before undergoing implantation
to the nearest hospital emergency room. of a drug-eluting stent, if you plan to have
any type of surgery that may require you
to stop taking antiplatelet medications,
you and your cardiologist should discuss
whether or not placement of a drug-eluting
stent is the right treatment choice for you.
22
Your Drug-Eluting Stent Procedure
(continued)

If surgery or dental work that would require Keep Your ID Card Handy
you to stop taking antiplatelet medications CAUTION: Show your identification card if
is recommended after you have received the you report to an emergency room. This card
stent, you and your doctors should carefully identifies you as a patient who has had a stent
consider the risks and benefits of this surgery or implanted.
dental work versus the possible risks from early If you require a magnetic resonance imaging
discontinuation of these medications. (MRI) scan, tell your doctor or MRI technician that
If you do require discontinuation of antiplatelet you have a stent implant. Test results indicate
medications because of significant bleeding, that XIENCE stents are MR conditional. Patients
your cardiologist will carefully monitor you for with single or overlapped XIENCE stents can
possible complications. Once your condition has undergo MRI scans safely under the following
stabilized, your cardiologist may put you back on conditions:
these medications. • Static magnetic field of 1.5 or 3 Tesla
Follow-up Care • Spatial gradient field of 2500 Gauss/cm or
less
You will be discharged to the care of your
cardiologist or family doctor. You should be able • Maximum whole-body-averaged specific
to return to your normal activities soon. absorption rate (SAR) of 2.0 W/kg (normal
operating mode) for 15 minutes of scanning
CAUTION: Notify your doctor immediately if
you experience chest pain (angina), or notice for each sequence.
any changes such as more severe or frequent The stent(s) should not migrate in this MRI
chest discomfort, especially in the first environment, and MRI may be performed
month after a procedure. These symptoms immediately following the implantation of the
may indicate a re-narrowing in your coronary XIENCE stent(s). Prior to undergoing an MRI
arteries. scan, inform your doctor that you have a XIENCE
Your doctor will ask you to return for follow-up stent.
visits. The first visit is usually two to four weeks
after your stent is implanted, with follow-up
visits every six months for the first year. Be sure
to keep all appointments for follow-up care,
including blood tests.
23
 Preventing CAD

Coronary artery disease can be treated effectively, grains, can help you achieve a healthy weight, as
but it has no cure. You can help to prevent your well as help you control your blood pressure and
coronary artery disease from progressing by cholesterol levels.
carefully following your doctor’s advice. Your Manage your stress. Stress is an inescapable
doctor may prescribe medications to help control aspect of modern day living, but you can help
your blood pressure, diabetes, and / or high lessen its negative health effects by practicing the
cholesterol. Your doctor may also recommend “relaxation response.” Research has shown that
some lifestyle changes. Among the healthy relaxation techniques can improve your ability to
choices you can make: cope with stressful events while decreasing your
Stop smoking. If you smoke, quitting is the heart rate, blood pressure, and stress hormone
single most important thing you can do to lower levels.
your risk of coronary artery disease. Chemicals Control your blood pressure and cholesterol.
in cigarette smoke may make it easier for plaque Discuss with your doctor the ways you can
to build up on your artery walls. And smoking control your blood pressure and cholesterol to
increases your heart rate and blood pressure, reduce your risk of cardiac problems.
raising your risk of heart attack and stroke. If you Manage your diabetes. If you have diabetes,
are ready to quit, ask your doctor for advice – he keep your sugar and glucose levels within target
or she can recommend smoking cessation aids to levels to help reduce the risk of coronary artery
help you quit. disease.
Increase your activity and eat a healthy diet. Manage your medications. Continue to take
A sedentary lifestyle increases your risk. Your your medication as prescribed, whether for high
doctor can recommend an activity program blood pressure, elevated cholesterol levels and /
tailored for your situation. Regular exercise can or antiplatelet management post procedure.
help you lower your blood pressure and blood
cholesterol and reach a healthy weight. It can
also help you manage the daily stresses of
modern life more easily. Choose a healthy diet. A
diet low in saturated fats and cholesterol, and rich
in lean protein, fresh fruits, vegetables, and whole

24
 Frequently Asked Questions

How long will the stent stay in my body? those you had with your angina or heart attack,
Stents are designed to stay in your body please notify your physician.
permanently. How can I help prevent a recurrence of
What are the restrictions or cautions after I’ve symptoms?
received a stent? While there is no sure way to prevent a
If you require magnetic resonance imaging (MRI), recurrence of symptoms, you can reduce your
tell your doctor or MRI technician that you have risk through exercise, not smoking, controlling
an implanted stent. your blood pressure and cholesterol, taking
prescribed medications, and eating a healthy
When can I resume my regular activities?
diet. Your doctor can advise you about lifestyle
Your doctor will advise you. Many patients can
changes.
return to work and follow their normal routine
about a week after their stent procedure. Please
confirm with your physician.
Will my stent set off the metal detector at
airport security checkpoints?
No, your stent implant will not trigger alarms at
security checkpoints.

Will I be able to feel the stent inside me?

No, you will not be able to feel the stent once it
has been implanted in your artery.

Could I have recurring symptoms?

Yes, it is possible that you will experience
symptoms again, either due to a new blockage
in the region treated with the stent or due to
a blockage at another place in your coronary
arteries. Your doctor will monitor your progress.
If you experience chest pain symptoms similar to
25
 Definition of Medical Terms

Angina: Chest pain caused by inadequate supply Catheter: A thin, hollow, flexible tube used to
of blood to the heart. access the coronary arteries during an angiogram
Angioplasty (also referred to as PTCA): or during an angioplasty procedure. This catheter
A minimally invasive procedure in which a can be used to inject medication, fluids, or
balloon dilatation catheter is passed through contrast dye during your procedure. Catheter
to the blocked area of an artery. Once inflated, is also used to describe the device used to
the catheter compresses the plaque against deliver the balloon or stent during an angioplasty
the blood vessel wall and enlarges the vessel procedure.
opening. An angioplasty can also be performed Coronary Angiography (or Heart
with placement of a stent. Catheterization or Cardiac Cath): A test in
Anticoagulant: A medication to prevent or slow which contrast dye is injected to create images
the clotting of blood by thinning the blood. of the coronary arteries and the chamber of the
heart. This allows the doctor to see the extent of
Antiplatelet: A substance to reduce clumping of
the disease in the coronary arteries and make a
platelets in the blood. An antiplatelet medicine
decision on how to best treat the blockages.
helps thin the blood to prevent clot formation.
Coronary Arteries: The blood vessels that carry
Atherosclerosis: A disease that causes
oxygenated blood from the aorta to the heart
narrowing or blockage of arteries caused by
muscle. There are four major coronary arteries:
a build-up of fat (cholesterol) and scar tissue
the left main, the right coronary artery, the left
within the artery wall. The build-up is sometimes
anterior descending, and the circumflex.
referred to as “plaque.”
Coronary Artery Bypass Graft (CABG)
Brachial Artery: The main artery of the upper
Surgery: Open-heart surgery to treat CAD.
arm, supplying blood to the arm and hand. The
Coronary Artery Disease (CAD): The formation
site at the arm used as an access site to perform
of blockages or atherosclerotic plaques within
coronary angiography and / or angioplasty.
coronary arteries that result in restricted blood
Cardiac Catheterization Laboratory
flow to the heart muscle.
(Cath Lab): A sterile X-ray theater in which heart
catheterization is performed.

26
Definition of Medical Terms
(continued)

Electrocardiogram (ECG / EKG): A test that Percutaneous: Performed through the skin
records changes in the electrical activity of the without requiring a deep incision.
heart. An ECG / EKG may show whether parts of Plaque: An accumulation or build-up of fatty
the heart muscle are damaged due to decreased deposits, calcium, inflammatory cells, and scar
blood flow to the heart muscle. tissue in the artery wall that results in narrowing
Femoral Artery: The main artery of the thigh, of the vessel lumen.
supplying blood to the leg. Often used as an Restenosis: A recurring blockage caused by the
access site to perform coronary angiography and excessive growth of scar tissue inside the artery
angioplasty. or stent, following an interventional procedure
Fluoroscope: An X-ray device that creates an such as angioplasty.
image of the body that can be viewed on a TV Stent: A metallic mesh tube that is implanted
monitor. This permits the doctor to obtain real- into an artery during an angioplasty, providing a
time images of the internal structures of a patient. scaffold to help hold the artery open, ensuring
In-stent Restenosis: Recurrent blockage or blood flow to the heart muscle.
narrowing of a previously stented vessel. Transluminal: Through the inside opening of a
Local Anesthetic: A substance used to numb vessel or artery.
the area to which it is applied.
Lumen: The inner channel or cavity of a vessel or
tube. In a blood vessel, it is the opening through
which blood flows.
Magnetic Resonance Imaging (MRI): A non-
invasive diagnostic procedure used to obtain
images of internal body structures through the
use of magnets and radio waves.
Myocardial Infarction (MI): Also called a heart
attack. Permanent damage of an area of the heart
tissue, due to interruption in the blood flow to the
heart muscle (myocardium).

27
Abbott Vascular Abbott Vascular
3200 Lakeside Drive 26531 Ynez Road
Santa Clara, CA 95054 Temecula, CA 92591
USA USA
TEL: 1.800.227.9902 TEL: 1.800.227.9902
FAX: 1.800.601.8874 FAX: 951.914.2531

This product is intended for use by or under the

direction of a physician. It is important to read
thoroughly the instructions for use, warnings, and
potential complications associated with the use of
this device.

XIENCE V, XIENCE PRIME, XIENCE nano,

XIENCE Xpedition, and XIENCE Alpine are
registered trademarks of the Abbott Group of
Companies.
Taxus, Taxus Express, and Taxus Liberté are
registered trademarks of Boston Scientific
Corporation and its affiliates.
Plavix is a registered trademark of Sanofi-Aventis
Corporation.
Effient is a registered trademark of Eli Lilly and
Company.
Brilinta is a registered trademark of
AstraZeneca AB.
Zortress, Certican, and Afinitor are registered
trademarks of Novartis AG.

For more information, visit our website at

www.AbbottVascular.com

©2015 Abbott. All rights reserved.

EL2107611 (2015-12-14)