Everolimus Eluting Coronary Stent System: Patient Information Guide
Everolimus Eluting Coronary Stent System: Patient Information Guide
Everolimus Eluting Coronary Stent System: Patient Information Guide
3
Coronary Vasculature
Aortic Arch
Plaque
Circumflex (CX)
Obtuse Marginal
Right Coronary
(OM)
Artery (RCA)
Acute Diagonal
Marginal
Posterior
Descending
4
Coronary Artery Disease
(CAD)
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)
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 3
10
Your Treatment Options Drug-Eluting Stents (DES)
(continued)
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
11
XIENCE Family of Coronary
Stents
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)
15
The SPIRIT Family of
Clinical Trials
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
18
Your Drug-Eluting Stent
Procedure
20
Your Drug-Eluting Stent Procedure
(continued)
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)
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.
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
EL2107611 (2015-12-14)