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Two hospitals get new stent to help treat heart patients
Drug-coated device may result in fewer heart attacks
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Published: July 8, 2008
Two local hospitals have gained another option for treating coronary disease that could result in fewer heart attacks and repeated procedures.
Forsyth Medical Center and Wake Forest University Baptist Medical Center began using the Xience V stent on patients for the first time yesterday, hospital officials said.
The U.S. Food and Drug Administration recently approved the Xience stent. The FDA approved the Endeavor stent in February -- the first new drug-coated stent to gain approval in five years.
The medical centers' participation in long clinical trials for the stents led to their first use of the product.
Stents are tiny, mesh-wire tubes that prop open arteries after they have been surgically cleared of fatty plaque. They work by releasing medication at the right dosage directly into the arterial wall over several weeks. The stent helps prevent the re-closing of the arterial walls, which can require additional procedures. It also helps limit the scar-tissue growth that occurs around a stent after it is implanted.
"Since the introduction of the first generation of drug-eluting stents, thinner stents have been designed that are much easier to place in the coronary arteries, and are gentler on the artery," said Dr. Robert Applegate, an interventional cardiologist at Baptist. "The newest version not only incorporates a thinner stent, but also uses less overall medication and employs a gentler coating.
"The combination of all of these newer features in a single stent will likely result in better outcomes for the patients who receive them, including fewer repeat procedures, heart attacks and deaths, compared to the currently used drug-eluting stents," he said.
Stents became one of the most lucrative medical devices in modern history after companies began adding drug coatings to them in 2003 to prevent blood clotting. It's estimated that 6 million people worldwide have had one implanted.
But the drug-coated stent lost some of its popularity in the past two years amid safety concerns about a higher risk of blood clots compared with bare metal stents. The percentage of stent patients receiving drug-coated versions versus the bare-metal models has fallen to 65 percent, compared with more than 80 percent before 2006.
Medical societies are urging patients to continue taking anti-clotting drugs for at least a year after implantation.
An European study reported in May found that use of the Xience stent resulted in a 43 percent reduction in the risk of major cardiac events, a 32 percent reduction in the risk of vessel failure, and lower rates of stent thrombosis.
A separate study, published in the June 25 edition of the Journal of the American Medical Association, found similar results.
"We have found that for the Medicare population undergoing non-emergent coronary stenting, the availability of drug-eluting stents has decreased the incidence of repeated revascularization and resulted in no increase in the risk of death over two years of follow-up," the JAMA report stated.
"Although other data may suggest some incremental risk of stent thrombosis with the use of drug-eluting stents, we can detect no adverse consequence to the health of the population."
Baptist reported that its Heart Center, which has participated in nine clinical trials since 2001, did its own evaluation of patient outcomes. It reported that the benefit found with the use of drug-eluting stents at nine months was still present at two years.
Dr. John Patterson, an interventional cardiologist at Forsyth, said that the Endeavor and Xience stents will be viable options depending on the needs of the patient.
"The Endeavor tends to have more scar-tissue development than the Xience, which can lead to procedures needing to be repeated," Patterson said. "But the Endeavor tends to be more flexible in getting the stent into a difficult place.
"As with any competition, the more of these drug-coated stents that become available, the more potential there is for the price to come down over time."
■ Richard Craver can be reached at 727-7376 or at rcraver@wsjournal.com.
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