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COURAGE Trial Results Breed Public Confusion

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Optimal Medical Therapy with or without PCI for Stable Coronary Disease
-- The COURAGE Study, published in the New England Journal of Medicine

March 28, 2007 --The highly-anticipated results of a study comparing heart stents and angioplasty to drug treatment that were released Tuesday have set off a media firestorm of misinterpretation, causing confusion for patients and physicians. The five-year COURAGE study, presented at the annual meeting of the American College of Cardiology (ACC) in New Orleans, looked at 2,287 heart patients who suffer from chest pain (angina) but who are otherwise considered low-risk for heart attack, and concluded that the addition of angioplasty and stenting to optimal drug therapy resulted in no significant reduction in heart attack or death.

Headlines, such as "Stents' heart value in doubt" (UPI) and "Heart Attack Study Casts Doubt On Routine Use of Angioplasty" (Washington Post) imply that this study demonstrates stents are not an effective heart therapy. One group of leading cardiologists added to this impression with bold public statements: Dr. Steven Nissen, immediate past-president of the ACC called the study a "blockbuster" and AHA president Dr. Raymond Gibbons said the study shows that "hundreds of thousands of Americans with stable angina who received coronary stents did not need them". Others disagreed: leading interventionalist Dr. Martin Leon proclaimed that the study was "rigged to fail". Dr. Eric Topol, a leading cardiologist, whose efforts led to the Vioxx recall, told, "COURAGE really does not present anything new...there is no surprise with this trial."

A balanced interpretation came from Dr. Gregory Dehmer, president of a leading professional organization, the Society for Cardiovascular Angiography and Interventions (SCAI), who told Angioplasty.Org that the study was not "a huge revelation, but more a penetrating glimpse at the obvious." The SCAI itself issued a press release, stating it was unlikely that the study results would alter the approach for treating patients with chronic stable angina.

To cut through this confusion, following are answers to the "Top Ten" key questions from consumers that media reports on the COURAGE Trial have raised:

  1. Can angioplasty and stenting save lives? In the case of a heart attack, angioplasty definitely saves lives -- many studies have proven this; the COURAGE trial does not apply to patients who are having a heart attack;
  2. Do stents have proven value? COURAGE also does not apply to patients with advanced disease who are at risk for heart attack (Acute Coronary Syndrome) -- angioplasty and stenting have been proven to be a significant therapy for these patients;
  3. Will this trial change medical practice? The results of COURAGE are not revolutionary, but instead are consistent with current practice guidelines from all major professional groups (AHA/ACC/SCAI) that recommend using angioplasty and stenting only after medical therapy has proven inadequate;
  4. Were the patients in this trial at risk for heart attack? Patients with chronic stable angina are, in fact, at low risk for death or heart attack -- stents in these patients are not intended to prevent death, but to relieve pain and improve quality of life.
  5. Should people with chronic stable angina get stents? Angioplasty is still a proven treatment option for those whose "quality of life" (angina or activity level) is not improved by medical therapy, or for those patients who do not tolerate the side effects of medical therapy;
  6. Do stents and angioplasty make people feel better? This initial report did show that the scores for physical limitation, angina frequency, and quality of life were significantly better for patients in the angioplasty group; in fact, 1/3 of the patients in the medications-only group switched over to angioplasty during the course of the trial because their angina was not relieved by medication alone;
  7. Are stents safe? In this trial, angioplasty and stenting proved to be as safe as medical therapy;
  8. Do drugs or stents cure heart patients? Coronary artery disease is a chronic condition -- lifestyle changes, medications, stents are ways of managing the disease and relieving symptoms, but they do not "cure" the disease;
  9. Did all the patients in this study experience relief of chest pain? No. In the COURAGE study neither therapy completely eliminated angina for more than a quarter of the patients.
  10. Have patients with stable angina been given stents unnecessarily? Under current practice guidelines, it is recommended that patients with stable angina first be given a trial of medical therapy, along with lifestyle changes and risk factor reduction. They are candidates for stents if they continue to experience problems. What is unknown is how often these guidelines have not been followed, and whether cardiologists have in fact recommended stents as a first treatment option for this patient population. There is significant controversy as to how often this occurs. Estimates of how many angioplasty procedures are done in patients with stable coronary artery disease range from 25% to 85%.

This study comes on the heels of others that have raised concern about rare but life-threatening blood clots (late stent thrombosis) in patients who have received drug-eluting stents (virtually all of the patients in the COURAGE trial received the older bare metal stents). In light of the media coverage of the drug-eluting stent problems, Dr. Lloyd Klein of Rush Heart Institute in Chicago and an editor of the Journal of Invasive Cardiology expressed concern:

"I'm very worried that the same thing will happen with COURAGE -- that in the rush to present something that is new, and which is different...that it will be done in an exaggerated way in which it would appear that therefore having intervention under any circumstance is unnecessary if you have stable angina.... I just don't want to see patients who really could be helped by the procedure walk away from it and say, 'Oh I just heard this study and angioplasty doesn't help.' That would be a bad thing."

"What all of these studies highlight is the importance of careful patient selection and the need to involve patients in deciding among treatment options," says Angioplasty.Org editor Burt Cohen.

"This study will certainly give a heads up to any cardiologists who are not following guidelines and who are intervening with stents before discussing medication options with low risk patients. Also, I think confusion comes because some cardiologists may not make it clear to stable, low risk heart patients that intervention is an option in an effort to make them feel better, not a life-saving necessity," Cohen states. "It seems to be common sense that chest pain must mean you are at risk for a heart attack and that opening up a narrowing in an artery will prevent a heart attack. But the science of heart disease is more complex than this. I'm not sure the profession has done a great job of making this clear to consumers and informing them about the pros and cons of treatment options."