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«Table of Contents Coronary Artery Disease (CAD) Your Heart What is CAD? What are the Symptoms of CAD? What are the Risk Factors of CAD? How Can My Doctor Tell if I Have CAD? .8 Your Treatment Options ...»

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20 XIENCE Family of Coronary Stents (continued) Contraindications • If you have a known hypersensitivity (allergy) or contraindication to everolimus or structurallyrelated compounds cobalt, chromium, nickel, tungsten, acrylic, and fluoropolymers • If you cannot take aspirin or blood-thinning medications (also called antiplatelet or anticoagulant therapy) • If your physician decides that the coronary artery blockage will not allow complete inflation of the angioplasty balloon or proper placement of the stent 21 Potential Adverse Events Associated with the XIENCE Family of Coronary Stents The risk of using the XIENCE Family of Coronary Stents is similar to those that are associated with standard stent procedures. If the stent clots, you may need another angioplasty procedure. It may also lead to a heart attack, the need for urgent bypass surgery, or death. Even with successful stent implants, there is a chance of re-narrowing of your coronary artery. This may require further treatments, such as repeat angioplasty and / or bypass surgery, to reopen the artery and to increase blood flow to the heart. The risks from using balloon catheters after stent implants are similar to the risks that may occur during the initial stent implant. These may be serious enough to require surgery or cause death.

Other risks from these devices are the same as treatment procedures for a narrowed coronary artery.

Some problems associated with standard balloon

angioplasty and stenting include, but are not limited to:

Common Risks • Bruise or bleeding at the catheter insertion 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 22 Potential Adverse Events Associated with the XIENCE Family of Coronary Stents (continued) • Decreased or increased blood pressure Rare Risks • Tearing, puncture, or rupture of the coronary artery • Air, pieces of devices, or fragments of clots blocking the coronary or peripheral arteries • Complete blockage of the coronary artery, which may require a repeat procedure to reopen the coronary artery • Compression of the heart due to accumulation of blood around the heart • Re-narrowing of the coronary artery • Heart attack • Damage to the stent or injury to the coronary artery, requiring emergency heart surgery • Bleeding, requiring transfusion or surgery • Allergic reaction (may include X-ray dye, cobalt, chromium, nickel, tungsten, everolimus, acrylic, and fluoropolymer) • Infection • Nerve injury • Kidneys fail to function normally • Aneurysm (weakening of a portion of the wall of a blood vessel) • Shock • Stroke • Death 23 Potential Adverse Events Associated with the XIENCE Family of Coronary Stents (continued) Zortress, the oral formulation of everolimus developed by Novartis Pharmaceuticals Corporation, has been evaluated in clinical trials and is approved in the United States for the prevention of organ rejection in adult kidney transplant recipients at the dose of 1.5 mg/day. Outside the U.S., Zortress is sold under the brand name Certican in more than 70 countries. Everolimus is also approved in the United States under the name of Afinitor for patients with advanced renal cell carcinoma (cancer) at doses of 5 to 20 mg/day when taken by mouth. The amount of drug in your blood from the XIENCE V stent is several fold lower than that obtained with oral doses (1.5 mg to 20 mg/day). Potential adverse events related to taking everolimus daily by mouth (based on long-term everolimus drug studies in organ transplant patients and in patients with advanced

renal cell carcinoma) may include:

• Abdominal pain • Abnormal collection of a clear fluid containing white blood cells • Acne • Blood clot in the vein • Constipation • Cough 24 Potential Adverse Events Associated with the XIENCE Family of Coronary Stents (continued) • Decreased functioning of sexual organs in men • Decreased platelet cell count • Decreased red or white blood cells • Decreased sense of taste • Destruction of red blood cells • Destruction of the kidney tubules • Diarrhea • Dry or itchy skin • Fatigue • Fever • Headache • Higher levels of potassium and lower levels of magnesium and phosphorus in the blood • Increased blood cholesterol • Increased blood pressure • Increased blood sugar • Increased fat and triglyceride fats in the blood • Infection of the lungs • Infections • Inflammation of the lining of the digestive system • Insomnia • Kidney function test abnormality • Lack or loss of strength • Liver function test abnormality • Loss of appetite • Loss of blood supply to the bone 25 Potential Adverse Events Associated with the XIENCE Family of Coronary Stents (continued) • Mouth ulcers or sores • Muscle pain • Nausea • Nose bleeds • Pain in the arms and legs • Painful urination • Presence of red blood cells in the urine • Rash • Shortness of breath and lung or breathing problems • Surgical wound complication • Tremor • Vomiting • Water retention in the body Exposure to drug and polymer on the XIENCE Family of Coronary Stents is directly related to the number and lengths of the stents implanted. The use of multiple XIENCE stents will result in you receiving larger amounts of drug and polymer. It should be noted that a kidney transplant patient usually receives a daily dose of the drug everolimus by mouth that is about seven times more than the maximum dose of the drug contained on one XIENCE stent.





26 Potential Adverse Events Associated with the XIENCE Family of Coronary Stents (continued) Everolimus, when given by mouth daily to organ transplant patients, may interact with other drugs or substances. Please tell your physician about any medications you are taking.

–  –  –

There have been five clinical trials thus far that together have shown the safety and effectiveness of the XIENCE Family of Coronary Stents in patients with coronary artery disease. A short description of these trials, known as the SPIRIT Family of Trials, is

detailed below:

SPIRIT FIRST

SPIRIT FIRST was the first clinical trial. This study had 60 patients and was performed outside the United States. The purpose of the study was to compare the XIENCE V stent that is coated with a drug to that of an approved metallic stent that is not coated with a drug. There were 28 patients who received the XIENCE V stent and 32 patients who received the metallic stent (patients who received the metallic stent are also known as the “control” group).

After six months, the XIENCE V stent was significantly better than the metallic stent at reducing the re-narrowing of the artery where the stent was placed. After five years, patients who had received the XIENCE V stent had fewer major adverse cardiac events (16.7%) compared to patients who received the metallic stent (28.0%). (Patients were considered to have major adverse cardiac events if they died 28 The SPIRIT Family of Clinical Trials (continued) due to cardiac causes, or had heart attacks, or underwent bypass surgery or repeat angioplasty at the site of the lesion.) SPIRIT II The SPIRIT II clinical trial was the second study of the XIENCE V stent. The purpose of the study was to compare the XIENCE V stent to an approved drugeluting stent, called TAXUS Express stent or TAXUS Liberté stent (TAXUS stent). The SPIRIT II study was conducted outside of the United States.

After six 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 received the XIENCE V stent had a rate of major adverse cardiac events of 8.9% compared to a rate of 20.3% for those patients receiving the TAXUS stent.

SPIRIT III SPIRIT III was the third clinical study of the XIENCE V stent. This was a much bigger study than either the SPIRIT FIRST or SPIRIT II studies, and was conducted in the United States. In one part of this study, 1002 patients were given either the XIENCE V stent or the

–  –  –

TAXUS stent. There were 669 patients who received the XIENCE V stent and 333 patients who received the TAXUS Express stent (TAXUS stent).

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 received the XIENCE V stent had a rate of major adverse cardiac events of 14.4% compared to a rate of 22.0% for those patients receiving the TAXUS stent.

SPIRIT IV SPIRIT IV was the fourth clinical study of the XIENCE V stent. This is the largest study of the four randomized SPIRIT clinical trials and was conducted in the United States. A total of 3,687 patients were given either the XIENCE V stent or the TAXUS Express stent (TAXUS stent). There were 2,458 patients who received the XIENCE V stent and 1,229 patients who received the TAXUS stent.

After one year, the XIENCE V stent was significantly better than the TAXUS stent at reducing the necessity for bypass surgery or repeat angioplasty at the site of the lesion where the stent was placed.

The occurrence of events related to target lesion 30 The SPIRIT Family of Clinical Trials (continued) failure, which is comprised of cardiac death, heart attacks, bypass surgery or repeat angioplasty at the site of the lesion, was significantly lower for the XIENCE V stent (7.0%) compared to the TAXUS stent (10.0%) at two years.

SPIRIT Small Vessel The SPIRIT Small Vessel clinical study was conducted in the United States to evaluate the performance of the 2.25 mm diameter XIENCE stent (XIENCE nano) in small coronary arteries. There were 144 patients who received the XIENCE nano stent.

After two years, the rate of occurrence of events related to target lesion failure, which is comprised of cardiac death, heart attacks, bypass surgery, or repeat angioplasty at the site of the lesion, was 8.3% with the XIENCE nano stent.

SPIRIT PRIME

The SPIRIT PRIME clinical study was conducted globally to evaluate the performance of the XIENCE PRIME family of stent systems. There were 415 patients enrolled in the Core Size Registry (stent diameters 2.25, 2.5, 3.0, 3.5, 4.0 mm with stent lengths 8, 18, and 28 mm) and 110 patients enrolled

31The SPIRIT Family of Clinical Trials(continued)

in the Long Lesion Registry (stent diameters 2.5, 3.0, 3.5, 4.0 mm, with stent lengths 33 and 38 mm) at up to 75 global sites.

After one year, the occurrence of events related to target lesion failure, which is comprised of cardiac death, heart attacks, bypass surgery, or repeat angioplasty at the site of the lesion, was 4.5% in the Core Size Registry. The occurrence of events for the Long Lesion Registry was 7.7%.

For patients treated with the XIENCE Family of Coronary Stents in ways not studied in these clinical trials, clinical results may vary.

32 The XIENCE V USA Post-approval Trial

XIENCE V USA After the XIENCE V stent was approved for use in the United States, the XIENCE V USA clinical study was conducted to evaluate the continued safety and effectiveness of the XIENCE V stent in a wide range of patients. A total of 8,040 patients were enrolled from 191 sites in the United States.

At 1 year, 0.81% of patients experienced a stentassociated blood clot. In addition, the occurrence of cardiac deaths or heart attacks was 7.2% at 1 year with the XIENCE V stent.

33 Your Drug-Eluting Stent Procedure

How Do I Prepare for My Procedure?

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

• Take all of your prescribed medicines • Tell your doctor if you are taking any other medication • Tell your doctor if, for any reason, you cannot take aspirin and / or thienopyridine medications such as Plavix or Effient • Make sure your doctor knows about any allergies you have • Refrain from eating and drinking after midnight on the night before 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 for this. Firstly, most people find they experience little to no discomfort from the procedure.

Secondly, your doctor may need to ask you to take a deep breath while X-rays are being taken, to improve the quality of the pictures.

The procedure usually lasts about 90 minutes, during which time your doctor will ask you to remain very still. For the most part, you will be comfortable, but 34 Your Drug-Eluting Stent Procedure (continued) you may feel some pressure or chest pain when the balloon is inflated. This is normal and will quickly fade when the balloon is deflated.

Your Drug-Eluting Stent Placement Procedure Your procedure will be performed in a cardiac catheterization laboratory (cath lab). You will lie on the X-ray table, and an X-ray camera will move over your chest during the procedure. The staff will monitor your heart by attaching several small sticky patches to your chest and using a specialized ECG recorder and monitor.

The groin is the most common site for catheter introduction and requires a very small skin incision to be made on the inside of 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 femoral artery (the main artery of the thigh, supplying blood to the leg). Your doctor will then insert a guiding catheter (long, flexible tube) into the introducer sheath and advance it to where the coronary arteries branch off to the heart. A guide wire is then advanced through the guiding catheter to the narrowing in the coronary

35Your Drug-Eluting Stent Procedure(continued)

artery. This helps carry all the necessary devices required during the stenting procedure.

Additional options for catheter introduction are the arm / brachial approach (incision is made on the inside of your elbow) and the wrist / radial approach (incision is made on the inside of your wrist).

36 Your Drug-Eluting Stent Procedure (continued)

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