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5/20/2003
“People are calling it the single most important development in heart care since bypass surgery”, says Gerry Phillips, M.D. interventional cardiologist with Cardiology Associates. Johnson & Johnson’s drug-eluting stent, the newest device for treating heart disease, approved by the FDA at the end of April, will likely be available to patients in the Mobile, Baldwin and south Alabama area within the next two weeks. This new device has been shown to reduce the rate of restenosis (re-occlusion of a blocked blood vessel) by two-thirds, according to the manufacturer.
“Somewhere between 600,000 and 800,000 stents are placed each year in the United States to treat patients with Coronary Artery Disease,” according to a recent article written by Erik Eways, M.D., another interventional cardiologist and partner of Dr. Phillips’. In the article, Eways cautions that “in the past, the downside of stenting patients has been that 20 to 30% of patients who receive stents may require a repeat procedure within one year due to a process called restenosis.” A subset of them, 10 to 20%, may develop a recurrent blockage requiring a repeat procedure within 4 to 6 months.
Dr. Phillips elaborates on why the medical technology community has such high praise for this new stent by quoting results from an FDA trial dubbed SIRIUS. “In the SIRIUS trial, which followed patients through one year post-treatment, 1,058 patients received, at random, either a traditional uncoated stent or a CYPHER stent coated with an anti-inflammatory drug called Sirolimus.” He continues that, “patients who received the CYPHER stent experienced an 8.9% restenosis rate, while patients who received an uncoated stent experienced a significantly higher restenosis rate of 36.3%. More importantly, the trial revealed that the combined occurrence of death, heart attack, bypass surgery and repeat angioplasty was only 8.3% for CYPHER stent patients, but a much higher 22.3% for patients receiving the traditional uncoated stent.”
How CYPHER Stent Works
To understand how the drug-eluting stent works, it is helpful to understand how restenosis occurs. When a blockage is discovered in a patient’s blood vessel, it can often be treated by inserting a catheter wire and advancing a stent mounted on a balloon to the site of the blockage. The balloon is blown up and the stent expands to press the plaque and fatty material of the blockage against the vessel wall. The stent itself helps to hold the vessel open and allow proper blood flow to the heart.
When these stents are placed, scar tissue can form that causes a “re-narrowing” of the vessel and blood flow can once again become a problem. This process is known as restenosis. Patients may begin to feel “heart disease symptoms” again such as pain, pressure or tightness in the chest.
A drug eluting stent contains a medicine within a plastic coating on the stent that is released into the artery wall over time to prevent the formation of this scar tissue.
The drug used in the CYPHER stent, Sirolimus, is an anti-inflammatory that is currently used in transplant and kidney patients. The medicine is released slowly over a 30 day period. So far, trial results show that 30 days of slow release is enough to gain the tremendous benefits.
For Which Patients Will CYPHER Stent Work ?
To date, no patients in this area have received this new stent, but area hospitals are all anticipating the arrival of their first shipment of the devices within the coming weeks. Any cardiologist who is interventionally trained is qualified to place the new device.
The procedure for placing the CYPHER stent is no different than the uncoated stents. Michael W. Monson, M.D., who is currently completing a specialized interventional cardiology fellowship at Mid-America Heart Institute in Kansas, MO and is joining Cardiology Associates in July 2003, has been placing the stents in patients at his educational institution and reports that the maneuverability of<
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