Coronary Artery Disease UNDERSTANDING YOUR DRUG

14-3-11UNDERSTANDING YOUR DRUG-ELUTING STENT PROCEDUREToday, there are options regarding thesurgical approaches for CABG surgery withrespect to the type and location of chestincisions. The heart surgeon may discussthese options with you. Following successfulCABG surgery, patients typically stay in thehospital for less than one week and continuetheir recovery at home.Balloon AngioplastyBalloon angioplasty is one type of a group ofheart procedures known as percutaneouscoronary intervention (PCI) and is performedin the catheterization laboratory — the sameroom where you may have had a coronaryangiogram. Balloon angioplasty does notrequire open surgery. A local anestheticwill be used to numb the puncture site,and you may be given a sedative to helpyou relax. Your doctor will determine thebest entry point for evaluating your heartarteries — leg, wrist, or arm. That area willbe cleaned, shaved, and numbed before theartery puncture is made. After the arterypuncture is made, a short tube known as asheath will be placed in the artery to providea temporary passageway for the necessarymedical devices to reach your heart. Duringthe coronary angiogram, your doctor willinject a contrast dye through a catheter intoyour bloodstream, which allows your doctorto view your arteries on the X-ray monitor.A catheter with a small balloon on its tip isinserted through the sheath and threadedthrough your arteries until it reaches yourblocked coronary artery. Then the balloon7is inflated to flatten the plaque against thewall of the artery. It is normal to have somechest pain when the balloon is inflated. Tellyour doctor or nurse if you feel any painor discomfort during the procedure. Theballoon is then deflated and the catheter isremoved from your artery. This procedureopens the narrowing in your coronary artery,and increases blood flow through the artery(see Figure 7).PlaqueAn artery is narrowed by plaque buildup.BalloonArtery wallA special balloon is inflated to reopen the artery byflattening the plaque against the artery wall.The balloon is deflated and withdrawn fromthe body, restoring blood flow.Figure 7. Balloon angioplasty inside an artery

14-3-128Stent TherapyRestenosisIn many cases, balloon angioplasty alone maynot be successful in effectively opening yourblocked artery. Therefore, your doctor mayrecommend placing a coronary stent at thesite of the artery blockage. Stent implantationin a heart artery is another type of PCIprocedure. Implanting a stent does not requireopen surgery.Restenosis is the renarrowing of the arterydue to the overgrowth of tissue within thestent during the healing process. Althoughstenting is a less invasive way to openclogged arteries compared with CABGsurgery, restenosis may occur in somepatients who receive stents.A stent is a tiny, metallic, expandable meshlike tube that supports the artery and helpsto keep it open (see Figure 8). You will likelyalready have a short tube known as a sheath inan artery in your leg, wrist, or arm. Your doctorwill insert a specially designed balloon catheterthrough the sheath and deliver the stent tothe blocked area of the coronary artery. Theballoon is inflated to expand the stent. Asthe stent expands, it helps flatten the plaqueagainst the artery wall, increasing bloodflow. Once the stent is properly expanded,the balloon is deflated and the catheter isremoved from your body. The stent stays inyour artery permanently to help keep it opento maintain blood flow.Drug-Eluting Stents for CoronaryArtery DiseaseTo help prevent restenosis from occurring,scientists developed drug-eluting stents.Drug-eluting stents reduce the risk ofrestenosis and reduce the potential needfor future treatment. They provide the samesupport to the artery wall as uncoated stents,except they have a coating on the stentthat includes a drug that is released overtime. The drug helps limit the overgrowth oftissue within the stent as the artery heals,preventing renarrowing (see Figure 9).Artery wallDrugStentFigure 8. A coronary stentFigure 9. Drug releasing from the coated stent

14-3-13UNDERSTANDING YOUR DRUG-ELUTING STENT PROCEDUREDid you know?nnSince the introduction of stents, millions ofpeople around the world have been treatedwith this therapy.Stents come in a variety of sizes so thatdoctors can best match the size of thediseased artery.Source: American Heart AssociationDiabetes and heart diseaseIf you have diabetes, you are at an increasedrisk for having a heart attack. Therefore, inaddition to all the measures aimed at loweringthe risk of CAD, diabetic individuals should payattention to the following measures to lowerthe chances of CAD:nnAdopt a heart-healthy diet rich in fiber, fruitsand vegetablesAim for at least 30 minutes of physicalactivity dailynTake your medications as directednKeep your blood glucose under controlnCheck your feet daily for cuts, blisters, sores,swelling, redness or sore toenailsnBrush and floss your teeth dailynManage your blood pressure and cholesterolnMaintain a healthy weightnDo not smokeSource: National Diabetes Information Clearinghouse9

14-3-1410Resolute Onyx ZotarolimusEluting Coronary StentMedtronic Resolute Onyx zotarolimuseluting coronary stents are drug-elutingstents (see Figure 10). They are made ofan alloy containing the following metals:cobalt, chromium, molybdenum, nickel, andplatinum-iridium. They are coated with adrug called zotarolimus, which is containedwithin a polymer (a plastic material designedspecifically to control the drug release). Thedrug helps limit the growth of tissue in theartery where the stent is placed. Each stentis polished for a smooth surface and shapedto allow it to pass through your arteries on aspecially designed balloon catheter. If your doctor decides that your blockagewill not allow complete inflation of anangioplasty balloon or proper placementof the stent or stent delivery systemA drug-eluting stent for peoplewith diabetes:nnContraindicationsYou should not receive the Resolute Onyxstent if you have a known allergy to: Drugs used for suppression of the immunesystem such as zotarolimus, tacrolimus,sirolimus or related drugs Cobalt, nickel, chromium, molybdenum, orplatinum-iridium The polymer or its individual components,including: polybutyl methacrylate, polyhexylmethacrylate, polyvinyl acetate and PVP(polyvinyl pyrrolidone)Coronary artery stenting is contraindicatedfor use in the following: If you are unable to take aspirin orother blood-thinning drugs (also calledantiplatelet or anticoagulation therapy)such as heparin, bivalirudin, clopidogrel,prasugrel, ticagrelor, or ticlopidinenDiabetes affects 25.8 million people in theUnited States* and is on the rise. Peoplewith diabetes are more likely to have highblood pressure, heart disease or suffer astroke. In fact, CAD is the leading cause ofdeath in patients with diabetes.*Resolute stents, including Resolute OnyxDES, have been evaluated in people withdiabetes and have been approved bythe FDA as safe and effective treatmentoptions for this patient population.If you have diabetes, it is important toadopt healthy habits (see Page 5) andtalk with your doctor about ways you canfurther reduce your risk of CAD.*American Diabetes Association

14-3-15UNDERSTANDING YOUR DRUG-ELUTING STENT PROCEDURECatheterStentBalloonFigure 10. Resolute Onyx coronary stentand delivery system(coated with zotarolimus drugand BioLinx polymer)11

14-3-1612Potential Adverse EventsThe risks of using the Resolute Onyxstent are similar to those associated withany stent procedure. Discuss all of youravailable treatment options with yourdoctor, who can advise you as to whetheror not a drug-eluting stent is right for you.If the stent clots, you may need anotherangioplasty procedure. It may also lead toa heart attack, the need for urgent bypasssurgery, or death. Even with successful stentimplants, there is a chance of renarrowing(restenosis). This may require additionaltreatment, such as repeat angioplasty and/or bypass surgery, to reopen the artery andto increase blood flow to the heart. Therisks from using balloon catheters within apreviously implanted stent are similar to therisks that may occur during the initial stentimplant. These may be serious enough torequire additional surgery or cause death.Some risks associated with standard balloonangioplasty and stenting include, but are notlimited to: Bruise or bleeding at the catheter insertionsite in the leg, wrist or arm Pain at the catheter insertion site Irregular heartbeats, possibly life-threatening Chest pains during and after theprocedure Decreased or increased blood pressure Renarrowing of the coronary artery Tearing, puncture or rupture of thecoronary artery

14-3-17UNDERSTANDING YOUR DRUG-ELUTING STENT PROCEDURE Air, pieces of devices or fragments of clotsblocking the coronary artery Complete blockage of the coronary artery,which may require a repeat procedure toreopen the coronary artery Bleeding around the heart Heart attack or death Stent deformation, collapse or fracture Damage to the stent or injury to thecoronary artery requiring emergency heartsurgeryThe risks of the zotarolimus drug are notyet fully known. The risks that might occurinclude but are not limited to: Blood in the urine and/or diarrhea Diarrhea Dry skin Fatigue Headache Infection Pain (abdominal, joint, injection site) Bleeding requiring transfusion or surgery Skin reaction (at injection site) Allergic reaction, which may be due to Tingling feeling around the mouthcontrast dye, antiplatelet therapy, stentmaterial (cobalt, chromium, nickel, andplatinum-iridium), drug or polymer coating Infection or fever Nerve injury Aneurysm (weakening of a portion of thewall of a blood vessel)Exposure to zotarolimus and the ResoluteOnyx polymer coating is directly related tothe number of implanted stents. The use ofmultiple Resolute Onyx stents will result inyour receiving larger amounts of drug andpolymer. Failure to release the stent from thecatheterQuestions to ask your doctor: Stent misplacement in the artery Movement of the stent from where itwas placed The balloon used to expand the stentmay break13nDo I have a blocked or clogged artery?nHow severe is my CAD?n ShockWhat are my treatment options and thebenefits and risks of each? Stroke/transient ischemic attacknWhat happens if I wait to receive treatment? Renal failurenIs stent implantation an option?nWhat kind of stent is best for me?nWhat will I need to do to take care of myselfafter the procedure?

14-3-1814Clinical StudiesThe safety and effectiveness of the ResoluteOnyx stent was based on data from theRESOLUTE ONYX Study and a series ofclinical studies that evaluated the Resolute stent. The Resolute Onyx and Resolutestents are similar with regard to their metalstent design and identical with respect totheir drug and polymer coating. Given thesimilarities between the two stents, plusadditional laboratory tests, the findingsdescribed below for both the Resolute Onyxand Resolute stent clinical studies apply tothe Resolute Onyx stent.RESOLUTE ONYX Core Clinical StudyIn the RESOLUTE ONYX Core (2.25 mm–4.0 mm) Clinical Study, 75 patients in theUnited States were treated with ResoluteOnyx drug-eluting stents. After eightmonths, angiogram data showed that theResolute Onyx stent was noninferior toanother approved drug-eluting stent atreducing the renarrowing of the artery wherethe stent was placed.The Global RESOLUTE Clinical TrialProgramThere have been five clinical studies thattogether show the safety and effectivenessof Resolute coronary stents in patients withcoronary artery disease. A short descriptionof these studies is provided below:1. RESOLUTE First-In-Man (FIM):RESOLUTE FIM was the first clinical studyconducted with the Resolute stent. Thisstudy had 139 patients and was performedin Australia and New Zealand. After ninemonths, the Resolute stent was noninferiorto another approved drug-eluting stent inreducing the renarrowing of the artery wherethe stent was placed. At four years after theinitial procedure, 2.2% of patients who hadreceived the Resolute stent needed a repeatprocedure at the site of the originally placedstent.2. RESOLUTE US: RESOLUTE US (R-US)was conducted in the United States toevaluate the safety and effectiveness ofthe Resolute stent. There were a total of1516 patients enrolled in the RESOLUTEUS study; 1242 patients in the main study(which included 100 patients towards the150 patients in the 2.25 mm cohort*),100 patients in the Angiographic andIntravascular Ultrasound (IVUS) Substudy,60 patients in the 4.00 mm Substudy and114 patients in the R-US 38 mm Substudy(the 38 mm Substudy included a total of 223patients; 114 from the R-US study and 109from the R-Asia study). 2.50 mm–3.50 mm Substudy: A totalof 1112 patients received at least oneResolute stent to treat blocked heartarteries measuring 2.50 mm to 3.50 mm indiameter. After one year, 3.8% of patientshad a heart-related death, heart attack, orneed for a repeat procedure at the site ofthe originally placed stent Angiographic and IntravascularUltrasound (IVUS) Substudy: A total of100 patients received a Resolute stent.Eight months later, the patients had arepeat angiogram and an ultrasound test*The 2.25 mm cohort included 130 patients who were part of the main study and20 patients who were part of the 2.25–3.50 mm Angio/IVUS substudy.

14-3-19UNDERSTANDING YOUR DRUG-ELUTING STENT PROCEDUREto look at whether renarrowing of the arteryhad occurred. The angiogram at eightmonths showed that the Resolute stentwas noninferior to another approved drugeluting stent at reducing the renarrowing ofthe artery where the stent was placed. 2.25 mm Cohort: A total of 150 patientsreceived at least one Resolute stentmeasuring 2.25 mm in diameter to treata blocked artery. After one year, 5.5% ofpatients who received a Resolute stent hada heart-related death, heart attack, or needfor a repeat procedure at the site of theoriginally placed stent. 4.00 mm Substudy: A total of 60 patientsreceived at least one Resolute stentmeasuring 4.00 mm in diameter to treata blocked artery. After eight months,the Resolute stent was noninferior to anapproved bare metal stent in reducing therenarrowing of the artery segment wherethe stent was placed. 38 mm Length Substudy: A total of 223patients, 114 in the USA and 109 in Asia,received at least one stent measuring 38mm in length. After 12 months 4.5% ofpatients had a heart-related death, heartattack or a need for a repeat procedure atthe site of the originally placed stent.3. RESOLUTE All Comers: In RESOLUTE AllComers, 1140 patients received at least oneResolute stent. Many patients had coronaryartery disease that was more complicatedthan in the RESOLUTE FIM, RESOLUTE USand RESOLUTE Japan studies. This studywas conducted in Europe. After one year,8.1% of patients treated with Resolute stents15had a heart-related death, heart attack, orneed for a repeat procedure at the site of anoriginally placed stent. After two years, 11.2%of patients treated with Resolute stentshad a heart-related death, heart attack, orneed for a repeat procedure at the site of anoriginally placed stent.4. RESOLUTE International: In RESOLUTEInternational, a total of 2349 patientsreceived at least one Resolute stent. Manypatients had coronary artery diseasethat was more complicated than in theRESOLUTE FIM, RESOLUTE US andRESOLUTE Japan studies. This study wasconducted in Europe, India, South Africa andArgentina. After one year, 4.3% of patientshad a heart-related death or heart attack.5. RESOLUTE Japan: This study involved100 Japanese patients. After eight months,the Resolute stent was noninferior to anapproved drug-eluting stent at reducing therenarrowing of the artery where the stentwas placed.Resolute Stent in Patients with Diabetes:The safety and effectiveness of the Resolutestent in diabetic patients was evaluatedby combining the results of 878 diabeticpatients from the five studies noted above.After one year, 8.1% of diabetic patients whoreceived a Resolute stent had a heart-relateddeath, heart attack, or need for a repeatprocedure in the same vessel where theoriginal stent was placed.

14-3-2016Your Stent Procedure:What to ExpectPreparing for your procedureIf you know in advance that you will begetting a coronary stent, ask your doctor anyquestions you may still have.Before you receive a Resolute Onyx stentIn the days prior to your treatment, makesure you: Take all of your prescribed medicines. Tell your doctor if you cannot take aspirinand/or blood-thinning medications such asPlavix , also known as clopidogrel, or if youhave a history of bleeding problems. Tell your doctor about any medications youare taking. Tell your doctor about your drug allergies,or if you are allergic to any metalsor plastics. Ask your doctor whichmedications are safe for you to continuetaking. Follow all instructions given to you by yourdoctor or nurse, including limits on whatyou eat and drink before your procedure,arrangements for going home after yourprocedure, what activities are safe to doafter your procedure, and when you shouldsee your physician after you go home.Implanting the stentYour stent procedure will be performed ina cath lab by an interventional cardiologist,a doctor who specializes in this procedure.You will be awake for the procedure and willreceive fluids and drugs to relax you. YourBe sure to tell your doctor if you:nCannot take aspirin or other blood-thinningmedicationsnAre allergic to drugs/metals/plastics/shellfishnHave a history of bleeding problemsnAre or might be pregnant, or are nursingnAre planning other surgeries or dental worksoonprocedure will begin with an angiogram todetermine the number and location of theblockage(s), and will usually include a balloonangioplasty prior to implanting the stent.Using X-ray images to guide the way, yourphysician will insert an unexpanded stentmounted onto a deflated balloon through thesheath placed in an artery in your leg, wrist orarm. You might feel pressure at the sheathsite while this is being done. You won’t beable to feel the catheter as it moves throughyour body. The stent and balloon are carefullyguided to the site of the blockage in theartery. Then the balloon is inflated, expandingthe stent, flattening the plaque against theartery wall. It is common to feel some milddiscomfort as the stent is expanded, but thisshould subside when the balloon is deflated.Once the stent is in place, more X-ray imagesare taken to ensure that the stent is fullyexpanded and that blood flow to your hearthas improved. Your doctor may inflate anddeflate the balloon several times to makesure the stent is firmly pressed against theartery wall. When your doctor sees that

14-3-21UNDERSTANDING YOUR DRUG-ELUTING STENT PROCEDUREblood is flowing properly, the catheter willbe removed from your body. The stent willremain permanently inside the artery tohold it open and maintain blood flow to yourheart (see Figure 11). After the procedure iscompleted, the sheath in the artery in yourleg, wrist or arm will be removed, and thepuncture site will

Mar 14, 2010 · Coronary artery bypass graft Left subclavian artery Circumflex artery Right coronary artery Figure 6. Coronary artery bypass grafting Treatment Options for Coronary Artery Disease CAD can be managed in several ways . Your doctor will recommend a treatment plan based on your symptoms, t