Former President George W. Bush's decision to allow doctors to use a stent to clear a blocked heart artery, performed absent symptoms, is reopening a national debate on the best way to treat early cardiac concerns.
The discussions have been ongoing since 2007, when the trial known as Courage first found that less costly drug therapy averted heart attacks, hospitalizations and deaths just as well as stents in patients with chest pain. The results were confirmed two years later in a second trial.
The debate has centered on both the cost of stenting, which can run as high as $50,000 at some hospitals, and its side effects, which can include excess bleeding, blood clots and, rarely, death. Opponents say the overuse of procedures like stenting for unproven benefit has helped keep U.S. medical care on pace to surpass $3.1 trillion next year, according to the U.S. Centers for Medicare and Medicaid Services.
"This is really American medicine at its worst," said Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio, in a telephone interview. "It's one of the reasons we spend so much on health care and we don't get a lot for it. In this circumstance, the stent doesn't prolong life, it doesn't prevent heart attacks and it's hard to make a patient who has no symptoms feel better."
Each year more than a half million Americans get stents - tiny metal and mesh tubes made by Abbott Laboratories, Boston Scientific and Medtronic - inserted to hold open clogged arteries after angioplasty.
Stents are lifesaving when patients are in the midst of a heart attack, said Chet Rihal, an interventional cardiologist at the Mayo Clinic in Rochester, Minn., who has studied use of the devices. They allow immediate and sustained blood flow that help a patient recover.
For those who aren't suffering a heart attack, the benefits are less clear, according to Rihal. While stents may be used in patients with clear chest pain, there's no evidence that they prevent future heart attacks, he said.
Two large-scale clinical trials completed within the last seven years have shown that drug therapy works just as well as stents in preventing cardiac complications. The three major U.S. heart associations changed their guidelines in 2011 in an effort to reduce excess treatment. A review of eight studies published last year in JAMA Internal Medicine also found no differences.
In the Courage trial, all 2,287 patients were given medicine to lower their cholesterol, cut their blood pressure and prevent clots. Half also received stents to treat blockages that cut off at least 70 percent of at least one artery. After five years, there was no difference in deaths, heart attacks, or hospitalizations for chest pain between the two groups.
Two years later, the results were confirmed in a second trial involving more than 2,300 patients with diabetes and heart disease. In that study, called Bari 2D, patients treated with stents had the same rates of death, heart attack and stroke after five years as those who were given medicines.
In Bush's case, he underwent the procedure without any symptoms after a stress test during his annual physical turned up signs of an electrical abnormality on an EKG, according to Freddy Ford, the former president's spokesman. A subsequent CT angiogram found a blockage that doctors and Bush determined needed to be treated, he said.
Paul Chan, an associate professor at the Mid-America Heart Institute in Kansas City, Mo., questioned why Bush would have undergone a stress test at all if he didn't have symptoms. While it's fairly common practice for doctors to put older patients through such tests even without chest pain, Chan said, there's no evidence showing it's beneficial.
"The reality is that we don't know if we can change the trajectory of disease in people who don't have symptoms, are doing fine and are physically active," he said in a telephone interview. "There's no evidence treatment will help them live longer, feel better, or have fewer heart attacks."
While it's not common to go directly from a physical exam into a CT angiogram, it does occur, said John Harold, president of the American College of Cardiology and an attending physician at Cedars-Sinai Heart Institute in Los Angeles.
While most doctors now use drug therapy before considering use of a stent in such cases, the decision on Bush may have come as the result of unusual circumstance that haven't been made public, said Harold, who wasn't involved in Bush's cases.
"It's not always a simple calculus," Harold said in a telephone interview. "While we use medical therapy first, the need to pursue other interventions depends on high-risk markers. It depends on what the team discovered and whether it was appropriate to intervene sooner than later."