MONDAY, Feb. 21, 2005 (HealthDay News) -- Stents coated with a protective drug work better after three years than the older, uncoated devices in keeping arteries open and preventing heart problems and death, claims the latest report from a pivotal European study.
A stent is a flexible metal tube implanted to keep blood vessels from closing again after the artery-opening procedure called angioplasty. Bare-metal stents were the first to be used, but they have largely been supplanted by the coated kind, which made their appearance a few years ago. Drug-coated stents slowly release medication designed to keep the blood vessel from reclosing.
The new report comes from cardiologists at the Clinique Pasteur in Toulouse, France, who have overseen the trial, called RAVEL, since its inception. The study enrolled 238 men and women averaging 60 years of age at the start of the trial. All had experienced blockage of a single coronary artery.
The advantage of the coated stent showed up almost immediately, with better than 99 percent of the 113 patients who got one surviving a year without the need for a second angioplasty. This compared to 75.9 percent of the 114 patients who got bare-metal stents.
After three years, only 15.8 percent of those who got the coated stent had a "major adverse event" -- death, heart attack or another artery-opening procedure -- compared to 33.1 percent of those getting a bare-metal stent, the cardiologists reported.
The researchers report their findings in the Feb. 22 issue of Circulation.
Dr. Alexandra Lansky, an associate professor of medicine at Columbia University Medical Center in New York City, said, "Now it has been confirmed that you have therapy that is extremely effective both in the short term and the three-year term."
One reason why the longer-term results are important is that "historically, with any therapy that shows benefit in the short term you might see an erosion of its effect over time," Lansky said. "It was important to show that these results are durable."
But there also are "far-reaching implications," she added, notably a possible reduction in the need for bypass operations, which require major surgery.
"We have been looking at alternatives to surgery," Lansky said. "Now that we have results that are durable, this could provide an alternative to bypass surgery."
But a slight note of caution came from Dr. Warren K. Laskey, chief of cardiology at the University of New Mexico, who wrote an accompanying editorial in the journal.
"The patients who are put in these trials are the best cases, ideal cases, not always typical of what is happening in the real world, where people are older and sicker for a lot of reasons," Laskey said. "We need to keep in mind that these are ideal senior patients, and that there might not be as rosy a situation for real-world patients."
Laskey said he still uses bare-metal stents in some cases, although only for a small percentage of patients. These are patients who might have a problem with Plavix, a blood-thinning drug prescribed for patients getting coated stents but not for those getting the bare-metal kind, he said.
When he uses a bare-metal stent, Laskey said, "I tell people the reason is that this artery is likely to respond well no matter what we do. I may not want a patient on Plavix for six months or a year."
Drug-coated stents "are wonderful and have conferred many benefits," Laskey added. "But all of us are anxious to see how they work in the real world with patients who are not ideal."
More information
To learn more about stents, visit the American Heart Association.
