Restenosis and Drug-Eluting Stents
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Restenosis is the process by which renarrowing occurs in an artery that has been treated with balloon angioplasty or stent implantation. The process involves the response to injury at the treated site with the production of smooth muscle tissue (like scar tissue) during the subsequent 3-6 months following the procedure. With balloon angioplasty alone the restenosis approaches 40- 50 percent and 20-30 percent with bare metal stents. New technology allows coating a bare metal stent with medication like rapamycin or paclitaxel which is slowly released into the surrounding tissue after implantation. This process is designed to slow the rate of smooth muscle growth during healing of the arterial wall to the extent that renarrowing (restenosis) is inhibited. Sirolumus eluting stents (Cypher) were approved by the FDA following review of a major clinical trial in the United States and known as SIRIUS. The results from that trial were presented in September of 2002 and showed a reduction in restenosis from 36.3 percent to 8.9 percent. Paclitaxel eluting stents (Taxus) were approved by the FDA following a major clinical trial in United States known as Taxus IV. The restenosis rate with this study was determined to be 6.9 percent.
Following approval from the FDA a total of 2722 drug eluting stents were implanted in patients with coronary artery disease at Hartford Hospital from a 2003 through November of 2004. The overall restenosis rate was 1.1 percent which contrasts with the restenosis rate for bare metal stents (nondrug eluting stents) of 8.9 percent. Generally patients are admitted the day of the procedure for angiographic evaluation and implantation of a drug eluting stent, if necessary, is performed during the same procedure. Most patients are hospitalized overnight and discharged the following day with rapid return to normal activities. In addition to pre-stent medications, patients are required to continue aspirin on a daily basis and clopidogrel (Plavix) for six months.
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