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April 19, 2007 – Complications and three-year survival rates are similar for heart patients treated with drug-coated stents and those treated with bypass surgery, a new study shows.
But experts tell WebMD it's still too soon to tell whether study patients treated with drug-coated stents will get the same long-term benefits as those who undergo surgery. A trend toward the more frequent use of drug-coated stents -- in patients with more complex heart disease -- already has reversed direction.
Even so, the finding offers hope that some patients with seriously blocked arteries may be able to avoid open-chest surgery.
The study compared outcomes for 799 patients treated with drug-coated stents to outcomes for 799 matched patients treated with coronary artery bypass grafts. The study, sponsored by stent maker Cordis J&J, included researcher James M. Wilson, MD, cardiology program director at St. Luke's Episcopal Hospital and Texas Heart Institute in Houston.
"When we look at an important outcome measure -- whether you live or die -- at three years the procedures look pretty similar," Wilson tells WebMD. "But we are still in the early days on this endpoint of survival."
Wilson notes that his team did an earlier study comparing bare-metal stents with bypass surgery.
"In the first year of that study, it looked like you were better off with a stent than with a bypass," he says. "But at three years, it was a dead heat. And now, after nine years, it's clear that surgery was better for long-term survival. So here we are at three years for drug-coated stents vs. bypass -- now they look equal, but we reserve judgment."
Nine percent of the drug-coated stent recipients died vs. 6.6% of those who had bypass surgery. Statistically speaking, these death rates are not significantly different. But it's an ominous trend, suggests Prediman K. Shah, MD, who is director of cardiology at the Atherosclerosis Research Center at Cedars-Sinai Medical Center and professor of medicine at UCLA.
"The three-year outcome is 9% of patients died -- almost 50% more than bypass patients who died," Shah tells WebMD. "So the trend is not in favor of drug-coated stents. ... I am not reassured by any of this."
Another study finding surprised Wilson. Because they don't require surgery, stent procedures are supposed to be much safer than bypass surgery. But the study showed that patients who got drug-coated stents had at least as many complications as bypass patients.
"When we tried to tackle the tougher patients -- those with greater risk, like the typical patient sent to bypass surgery -- our complication rate went up," Wilson says. "We can no longer say we are safer with stents than with bypass at the time of procedure."
Shah and Wilson agree that early stent complications are much more likely in patients with more advanced, more complicated disease. Shah says such complications are unlikely when doctors use stents as approved by the FDA.
Researchers presented the study today at the American Heart Association's Arteriosclerosis, Thrombosis, and Vascular Biology Annual Conference in Chicago.