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Why Stents? Coating Overflow Removal Tool Team Vimage (aka Team #3) Mario H. Gonzalez November 1, 2004 EXECUTIVE SUMMARY The intent of this report is to depict the stent in a larger context. Since stents are used to treat medical conditions, a mechanical description of a stent is not suffice for this report. After a remedial description on how blood circulates through the body, the report will focus on a specific disease for which stents are implemented in the treatment for it. Initially, the report will focus more on medical subjects laying a foundation in order to talk about the evolution of the stent right up to the Drug Eluting Stents (DES) which are said to revolutionize the cardiovascular medical industry. Depending on a person’s lifestyle, plaque composed of fatty particles, can build up on the inner diameter of the artery which slows the blood flow, which is called Coronary Artery Disease (CAD). Bare-metal stents are becoming obsolete with the introduction of DESs because of many advantages that the DES has over the bare-metal stent. The drug that coats the stent is released overtime and it basically fools the body into thinking that the stent is not a foreign object. I Table of Contents INTRODUCTION ................................................................................................................... 1 REMEDIAL DESCRIPTION OF BLOOD CIRCULATION ......................................................... 1 CORONARY ARTERY DISEASE ........................................................................................... 2 STENTS ................................................................................................................................ 2 BARE METAL STENTS..................................................................................................... 3 DRUG ELUTING STENTS ................................................................................................. 3 REFERENCES....................................................................................................................... 5 i INTRODUCTION For people who suffer from heart disease a stent can save their lives. The intent of this report is to depict the stent in a larger context. Since stents are used to treat medical conditions, a mechanical description of a stent is not suffice for this report. After a remedial description on how blood circulates through the body, the report will focus on a specific disease for which stents are implemented in the treatment for it. Initially, the report will focus more on medical subjects laying a foundation in order to talk about the evolution of the stent right up to the Drug Eluting Stents (DES) which are said to revolutionize the cardiovascular medical industry. REMEDIAL DESCRIPTION OF BLOOD CIRCULATION Our bodies need oxygen to survive. Every breath we take our lungs introduce oxygen into our bloodstream. Arteries carry oxygen enriched blood to all parts of the body while veins carry carbon dioxide waste back to the lungs where we breathe it out. People who are diabetic or who have bad eating habits tend to have restrictions in their blood circulation. If there is poor circulation in a coronary artery it can cause a heart attack, which can be fatal. Restrictions to circulation to an extremity can cause that extremity to slowly die, which will cause infection and eventually the extremity will have to be amputated. 1 CORONARY ARTERY DISEASE There are many types of arteries in the body and they range in size and importance, the larger arteries carry more blood. Coronary arteries carry O2 enriched blood to the heart. Depending on a person’s lifestyle, plaque composed of fatty particles, can build up on the inner diameter of the artery which slows the blood flow, which is called Coronary Artery Disease (CAD). Untreated this will eventually lead to a heart, 2 out of 3 diabetics die from CAD [1]. Current treatments for CAD range from diet and exercise, medications, to very intrusive surgeries, such as angioplasty (removal or compression of the plaque) or bypass grafting (detouring around the blockages) [2]. STENTS Stents were not the first treatment method for coronary disease. It was not until 1987 that the first coronary stent was reportedly used, but physicians had been trying to unblock arteries far before then. The technology that preceded stents is called angioplasty balloons. The procedure called, balloon dilation, consisted of a small balloon that would be fed through a main artery, such as the femoral artery, with a catheter to the problem area. Once the balloon is in place, it is inflated which compresses the plague against the wall of the artery. This treatment directly led to stents because without a way to hold the artery open restenosis, the blockage an artery after corrective surgery, would occur. Stents were designed to act as a scaffold and hold the artery open. Stents are categorized into two distinct groups, bare-metal stents and the more advanced DES. DES’s have shown in clinical studies that they further reduce the occurrence of restenosis 2 when compared to bare-metal stents. For this reason about 95% of stents being used to treat patients are DESs [3]. Bare Metal Stents Bare-metal stents are becoming obsolete with the introduction of DESs. As the name implies this type of stent comes into direct contact with the arterial wall tissue. Although some physicians believe that there should be a test to distinguish patients who may not need a DES to save money. Bare-metal stents on average cost $2000 dollars less than there drug coated counterpart [4]. In stent restenosis, blockage that recurred inside the stent, occurred about 24.4 % of the time during clinical studies of bare-metal stents [4]. I believe patients that do not have sensitive immune systems, such as AIDS patients, would be prime candidates for bare-metal stents because there bodies may not have the resources to attack the stent. Drug Eluting Stents On the other hand there are DESs, which are basically bare-metal stents covered in a immunosuppressant, that may cost more, but have more of a guarantee that restenosis will not occur. The drug that coats the stent is released overtime and it basically fools the body into thinking that the stent is not a foreign object. In a study of 1300 patients comparing bare-metal stents to DESs, a major adverse cardiac event was reduced from 3 15%, for bare-metal stents to 8.5% for DESs. Diabetics, a subgroup in this study, a group that is at high risk for restenosis have even a larger gap in occurrence of restenosis between bare-metal stents and DESs, 42.9% and 7.7% respectively for those diabetics on insulin and 29.7% and 5.8% respectively for diabetics taking oral medications [3]. With results like these one can understand why DESs are gaining popularity with doctors despite the higher cost. 4 REFERENCES [1] www.diabetes.org [2] www.angioplasty.org/articles/taxus [3] Interview of Greg W. Stone, MD, Director of Cardiovascular Research and Education, Cardiovascular Research Foundation, Lenox Hill Hospital, New York City [4] Real-World Bare Metal Stenting: Identification of Patients at Low or Very Low Risk, Stephen G. Ellis, MD, Wiley-Liss Inc. 5