From the April 9, 2007, issue of "The Gray Sheet"
The highly publicized COURAGE trial will cause a roughly 5% reduction in the number of stent procedures in the United States, according to Dartmouth Medical School's Aaron Kaplan, M.D., and Carl Szot, M.D.
Kaplan, director of Dartmouth's cardiac catheterization lab, and Szot, chief of cardiology at the Cheshire Medical Center, Keene, N.H., spoke about the COURAGE results in an April 5 conference call sponsored by Bernstein Research.
The 2,287-patient COURAGE trial compared stenting plus medical management to medical management alone in patients with stable angina. The five-year myocardial infarction and death rates were statistically similar for both groups, according to results released March 26 at the American College of Cardiology meeting in New Orleans.
Szot and Kaplan agreed that the patient population in COURAGE - those with stable angina for at least five months prior to enrollment - represents 10%-20% of the coronary disease patients they see. However, despite the COURAGE results, most of those patients will still get stents in the future, they said.
"If I take my last 20 patients with stable angina, probably 19 opted for catheterization and one more might not now," Szot said. "I don't think it will have that big of an impact, and I think I'm pretty conservative. When you get into more aggressive interventional practice the impact will probably be less [than 5%]."
The findings reinforce clinical practice guidelines for stable coronary disease, which recommend first trying optimal medical therapy alone before resorting to a percutaneous intervention. However, many cardiologists and interventionalists stent patients with stable coronary disease to reduce angina symptoms, even if it is unlikely to prolong their lives or reduce the risk of a heart attack, Kaplan observed.
He also noted that interventionalists rarely have time to precisely assess the severity of a patient's angina, and they cannot be sure if the patient will be compliant with a medication regimen. Therefore, Kaplan's usual approach is "if the patient has angina, then he or she should be revascularized unless there's [another] reason not to."
"The people who are aggressive already, [COURAGE] is not going to impact much, and the conservative people are following the guidelines already," Kaplan said. "I think it's a little less [than 5%]. This is really a small part of the pie."
Szot explained that the impetus for implanting stents comes from patients. "People want an open artery," he said. "You can sit there and get consent from a patient, tell them, 'You know this isn't going to prolong your life - it's just going to relieve your angina,' and they go to the lab and somebody fixes a tight stenosis in there and they come back from the cath lab to their office visit and they thank you for saving their life. I think that's going to be a hard perception to change."
Szot acknowledges that the media coverage surrounding COURAGE may initially cause some patients to opt for medical therapy instead of a stent. However, "the average half life of any medical trial in the national media is about two weeks, so by about six weeks people won't ask me about this anymore."
"There may be a few patients that may opt for medical therapy that wouldn't have previously, but people really like stents. They don't like medications," Szot said.
COURAGE May Not Reflect Reality
Kaplan and Szot also said that the outcomes for the medical therapy only patients in COURAGE are probably not representative of what could be expected in "the real world."
"High levels of compliance with medical therapy are not possible in the real world. Especially in the United States, people are reluctant to follow polypharmacy when there's an alternative," Szot said. "They look at the list of pills that we're talking about and they get very discouraged in a big hurry."
Kaplan observed that patients in COURAGE were followed by research nurses and had more contact with their physicians than patients usually have outside a trial. "What we may be seeing [in COURAGE] is best practice - far more infrastructure supported than what goes on in the ... real world."
- Reed Miller
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