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Don't Cancel Your Angioplasty or Heart Stent Yet, Say Patient Advocates

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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

April 7, 2007 -- After headlines around the country recently declared that drugs are as good as angioplasty and stents for heart disease sufferers with chest pain, patients have reportedly begun questioning their cardiologists, even canceling appointments.

"While it's encouraging that two-thirds of the low-risk heart disease patients in the recent COURAGE trial did well without receiving stents, these patients got much more than prescriptions," says patient advocate Burt Cohen.

According to Cohen, who testified on behalf of patients at a December 2006 FDA Panel on stent safety, the study offered a level of on-going care not available to the majority of Americans.

"This was a study of hand-picked patients at low risk for heart attack who were receiving subsidized healthcare through the Canadian health system and the Veterans Administration. These patients got what is known as 'optimal medical therapy,' including free medications and continual free support services for five years from healthcare personnel who made sure they took their drugs, changed their diets, stopped smoking, exercised and reduced stress."

"Optimal Miracle Therapy"
At a recent panel of 10 leading cardiologists, convened by, several physicians referred to the care offered to COURAGE trial participants as "optimal miracle therapy".

"There would be less angioplasty, stenting and bypass surgeries if patients in this country received optimal preventative medical care, but it will take a change in healthcare delivery and reimbursement to make that happen," says Deborah Shaw, patient education editor of Angioplasty.Org, a popular website for cardiologists and patients.

"The real take away from the COURAGE trial, is not just that medication is useful, which we know, but that patients benefit from substantial compliance education and lifestyle support. Patients need to participate in treatment decisions, so that they understand their treatment options and can commit to a course of action," says Shaw.

"Patients have to change their lives in order to lower their heart attack risk factors, and to reduce angina without intervention. But managed care allows doctors only 10-15 minutes with patients in a typical appointment. A lot of people have trouble complying with prescriptions -- 1 in 7 heart attack victims stops taking medication after leaving the hospital, and what's more motivational than a heart attack?"

Nothing New: Most Angina Patients Don't Get Stents
"COURAGE really does not present anything new...there are no surprises in this trial," says leading cardiologist Dr. Eric Topol, whose efforts contributed to the Vioxx recall. Indeed, the conclusions of the COURAGE study read: "Our findings reinforce existing guidelines."

All current treatment guidelines recommend that stable angina patients begin with "optimal medical therapy" and only receive stents if their chest pain continues. And, in fact, one third of the patients in the COURAGE Trial had to cross over from medication to stents in an effort to get relief from chest pain.

According to the American Heart Association 9 million Americans suffer from stable angina; only a minority of these angina sufferers is among the one million individuals receiving interventions with angioplasty and stents each year.

Stents Can Save Lives
"It's unfortunate, potentially harmful, that the COURAGE study resulted in the public getting a misleading, negative message that this study proves stents are not helpful," says Cohen.

15% of all stents go into people who are having heart attacks, a proven life-saving intervention. According to the December FDA stent safety panel, 60% of all stents are used "off-label," to improve quality of life in patients whose disease is generally more complex than in the group of patients looked at in the COURAGE Trial.

The COURAGE trial included "a very modest subgroup of patients and excluded the majority of patients with cardiovascular disease that we (implant stents for) now," Ralph Brindis, head of cardiology for Northern California at Kaiser Permanente, told Reuters.

A Call To Action
"Some low risk patients who could reduce their pain with medication and lifestyle changes do indeed get stents. But the COURAGE Trial will only help these heart patients," says Shaw, "if it inspires a widespread call for an investment of time and money in the on-going patient support, lifestyle and compliance programs that are needed to make 'optimal medical therapy' work in the real world."