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There's a powerful logic to the argument that people will live longer and have fewer heart attacks if their clogged arteries are repaired with a procedure called angioplasty. Most commonly, the arteries are widened with a tiny balloon threaded through their blood vessels, then kept open with slender mesh tubes called stents. The logic has turned this medical procedure into a huge—and profitable—business. Each year in the U.S., more than 1.2 million angioplasties are performed, at a cost of more than $25 billion. The cardiologists who open arteries love the sense that they are warding off death, and patients "think the angioplasty saved their lives," says Floyd J. Fowler Jr., president of the Foundation for Informed Medical Decision Making.
But the data show that doctors and patients are wrong. Several recent studies have found that angioplasty doesn't save lives or prevent heart attacks in patients with stable heart disease compared to treatment with drugs. And now, in a study presented at the American Diabetes Assn. meeting on June 7 (and published in the June 11 issue of The New England Journal of Medicine), the limitations of angioplasty are evident even when the procedures were performed on diabetics with heart disease. For those patients, "medical therapy [the use of drugs] rather than any intervention is an excellent first-line strategy," conclude Dr. William E. Boden of the State University of New York at Buffalo and Oxford University's Dr. David P. Taggart in an NEJM editorial.
The new study, which is certain to be pulled into the national debate about how to reduce health-care costs, offers important new insights about which cardiovascular therapies are most effective. In contrast with some previous clinical trials, a large number of the patients undergoing angioplasty received high-tech drug-eluting stents of the sort sold by Johnson & Johnson (JNJ), Medtronic (MDT), and others, which doctors had hoped would offer better outcomes than the older, plain-metal variety. And the study focused on diabetics, many of whom also have heart disease. "We began the study because we don't know how best to treat this deadly duo that is affecting more and more people," explains Sheryl F. Kelsey, a professor of epidemiology at the University of Pittsburgh Graduate School of Public Health and principal investigator of the study. "We were thinking that maybe for this group, revascularization [angioplasty] would be better than medical therapy."
It wasn't. There were no differences in deaths or events like heart attacks between the 798 diabetics who got drugs only and the 807 patients who had their arteries opened in addition to getting the same drugs.
This growing evidence that angioplasty brings few benefits has yet to make a dent in the number of procedures performed. "There are people in the cardiology community who don't believe the results. They don't believe it applies to the patients they see," says Dr. Judith S. Hochman, director of the Cardiovascular Clinical Research Center at New York University School of Medicine. "So we still see a lot of angioplasty being done without patients really understanding that it will not reduce their chances of heart attack or death."
In addition, Dr. Albert G. Mulley, an associate professor of medicine and health-care policy at Massachusetts General Hospital, sees angioplasty as "the poster child for supply-induced demand." Once hospitals have made big investments in the catheterization laboratories, where the procedures are done, they have every incentive to use them as much as possible. Plus, patients also have bought into the argument that clogged arteries should be propped open. "There is a huge demand from patients for quick dramatic fixes," says Mulley.
At the same time, the new results are having an effect on the scientific understanding of heart disease, helping to revive a neglected theory. Years ago, before angioplasty, one prominent idea was that heart attacks were not caused by gradually clogging arteries. Instead, the theory went, heart attacks occurred when unstable plaque in the artery suddenly ruptured, leading to dangerous or fatal clots. This idea lost favor once physicians had the ability to prop open or bypass those clogged arteries. Now the theory is coming back. And if unstable plaque is the real culprit, then drugs that reduce inflammation and clotting, including everything from ordinary aspirin to cholesterol-lowering statins from the likes of Pfizer (PFE), Merck (MRK), and AstraZeneca (AZN) make more medical sense than angioplasty does.
As many as 40% of the angioplasties performed today are unnecessary, says Dr. Elliott S. Fisher, a professor of medicine and director of the Center for Health Policy Research at Dartmouth Medical School. So limiting the procedure to those who really need it—such as those having a heart attack or with severe angina—could save billions of dollars in health-care costs. But the real reason to reduce the number of angioplasties and other unnecessary procedures is to provide better care, Fisher says: "This is not about cost. This is about effectiveness."
Carey is a senior correspondent for BusinessWeek in Washington.