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Our Pioneering Role In Creating The Coated Stent
The problem of restenosis (the reblockage of arteries after stenting) presented a challenge to cardiac care experts at Prairie Heart Institute. Working closely with America's leading drug manufactures, medical researchers and our own world class research team, we set about finding a solution to the condition that affects about 25% of all stent recipients. The results are remarkable coated stent technology that promises to virtually eliminate restenosis. It may be the greatest giant leap forward for cardiac care we'll experience in our lifetime. Here are the trials Prairie Heart Institute has participated in:
SIRIUS TRIAL
The Sirius Trial, sponsored by Cordis, a Johnson and Johnson Company, is a clinical research study that enrolled subjects who experienced symptoms due to a narrowing of their coronary arteries and needed to undergo the placement of a metal stent in their heart to correct the lack of blood flow. The purpose of this study was to evaluate a new kind of stent coated with a medication and to assess if the coated stent improves the re-occurrence of narrowings in the artery(s) that supply blood flow to the heart as compared to the uncoated stent. The Bx Velocity stent is currently FDA approved, as is the Sirolimus medication that was used to coat the stent. Sirolimus is a drug commonly used in renal transplant patients to decrease the rate of kidney rejection after a kidney transplant. The investigational device for this study was the coated Sirolimus Bx Velocity stent. Volunteers were randomly assigned (like flipping a coin) to either the uncoated Bx Velocity stent or the Sirolimus-coated Bx Velocity stent. Approximately 1,058 patients participated with 533 receiving the Bx Velocity Sirolimus-coated stent and 525 receiving the uncoated Bx Velocity stent. To help evaluate the coated stent's ability to decrease the incidence of re-narrowing in the artery, 850 patients were assigned to undergo a repeat heart catherization 8 months after the initial placement of the stent. Additionally, the patients are contacted by telephone for the 5-year duration of the study. The trial completed enrollment in the fall of 2001 and the final results were presented in Washington, D.C. on September 24, 2002. The findings support the continued excellent performance in significantly reducing re-narrowing of arteries that supply blood flow to the heart in patients with coronary artery disease.
DELIVER TRIAL
The Deliver Clinical Trial, sponsored by Guidant Corporation, is another investigational study testing a coated stent for the treatment of the narrowing of arteries that supply blood to the heart. Approximately 1043 subjects were enrolled at 80 hospitals in the United States. The investigational stent utilized in this study was the Achieve Drug Coated Coronary Stent System. The stent itself is previously FDA approved, as is the Paclitaxel medicated coating. Paclitaxel is commonly used as a chemotherapy agent to treat various cancers. Since one of the common complications in procedures used to open a blocked artery is the re-narrowing of the artery due to overgrowth of cells, it is hoped that the low dose of paclitaxel (500 times less than the dose a cancer patient receives) used to coat the stent may prevent this overgrowth. Volunteers were randomly assigned (like flipping a coin) to either the Achieve Drug Coated Stent System or the Uncoated Multi-link RX Penta. Additionally, a subset of 500 patients agreed to undergo an 8-month repeat heart catherization in order to evaluate the performance of the stent. These procedures are presently in progress as is the collection of data evaluating the effectiveness of the stent's ability to assist in the reduction of re-narrowing in the arteries that supply blood to the heart.
TAXUS IV
Taxus IV is the third coated stent trial that patients at Prairie Heart could participate in. Boston Scientific, another stent manufacturer, also used the drug Paclitaxel to coat an Express stent. Paclitaxel, as stated above, is a drug used to treat cancer patients, but in much higher doses. However, unlike the stents used in the first two studies, the Express stent utilized in this study is still under investigation by the FDA. The amount of medicine on the Taxus stent is 1000-1400 times less than the dose given to cancer patients. The intended outcome for this study is that these coated stents will also have a decreased incidence of re-narrowing than the uncoated stents. Volunteers were randomly assigned (like flipping a coin) to a Paclitaxel coated stent or an uncoated Express stent. The stent was placed in patients that had blockage in one of their heart vessels. A total of 1,326 patients participated in this study at 80 different sites in the United States. The first 534 patients will return 8 months after their initial procedure for a follow-up angiogram to evaluate the stented arteries. The patients in this study will also be followed for 5 years. Since data is still being collected, no preliminary results are available at this time.
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