Doctors who treat patients for angina shouldn't rush into angioplasty, according to a new report on the subject, because a combination of medicine and lifestyle changes may be just as effective.
The report, published last week in the New England Journal of Medicine, suggests that for patients with stable angina, the benefits of percutaneous coronary intervention (PCI) such as angioplasty over drug therapy alone disappear within three years.
The data expands on the previously published Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, which showed that in 2,287 patients from the U.S. and Canada optimal medical therapy (drugs and prescribed lifestyle changes) were as effective as optimal medical therapy and PCI in reducing the risk of subsequent heart attacks or death in patients with anginal chest pain and stable coronary disease.
"These results are certainly good for patients," William Weintraub, MD, chief of cardiology at Christiana Care Health System (Wilmington, Delaware), the lead author of the quality-of-life findings from the COURAGE study, told Medical Device Daily. "Everything in COURAGE was good for patients. Most of them got better, whether they were treated with PCI or medical therapy alone."
The study compares the quality of life for patients who received catheter-based treatment combined with medications to those patients treated only by medications and lifestyle changes.
Among patients with stable angina, both those treated with PCI and those treated with medical therapy alone had marked improvements in health status during follow-up, the study concluded. The PCI group had small, but significant, incremental benefits that disappeared by threes, the study noted. In other words, by three years there was no difference between the two patient groups, Weintraub said.
The results mean that physicians can work with patients to decide what treatment is best, Weintraub said, instead of feeling like they have to do angioplasty or the patient will die. "It is safe to wait; a third of the patients in COURAGE crossed over," he said.
Three months after treatment, 53% of patients who had angioplasties and drug treatment and 42% of the drugs-alone patients were free of chest pain, according to the study results. Both groups continued to improve, and the gap started to narrow within six months. After three years, there was no difference in their scores on chest pain, quality of life and treatment.
The lone exception is that those patients who started out with more severe chest pain fared better with angioplasty. And not everyone did well on drugs alone about a third ultimately needed angioplasty or heart bypass surgery.
"The data show three things: first, patients' health improved with either treatment; second, for about the first two years following treatment with catheter-based treatment and medication, there is a small, but statistically significant, quality-of-life advantage for those patients compared to those COURAGE patients receiving medication alone; and, third, those patients suffering from more severe angina receive greater benefit from catheter-based treatment and medication than patients suffering from milder angina," Weintraub said.
The U.S. Department of Veterans Affairs, the Medical Research Council of Canada and several drug companies funded the study. The patients in the study received a mix of drugs, including asprin, cholesterol-lowering statins, nitrates, ACE inhibitors, beta-blockers and calcium channel blockers.
"The COURAGE trial is a particularly important cardiovascular trial since it examines optimal treatment for patients with stable angina, a very common problem. The COURAGE Trial is what some researchers call a 'strategy trial,' indicating that its results will directly affect how heart specialists treat patients with coronary artery disease," said Timothy Gardner, MD, medical director of Christiana Care's Center for Heart & Vascular Health and president of the American Heart Association (AHA; Dallas).
Last November at the AHA's scientific sessions, Weintraub, who also is director of Christiana Care's Center for Outcomes Research, presented an economic evaluation that showed that the addition of catheter-based treatment to medical therapy in the initial management strategy for patients with coronary artery disease cost significantly more without offering a survival advantage (Medical Device Daily, Nov. 6, 2007).
"By expanding the ways we look at clinical trials, we can fully capture the impact of a treatment or therapy," he said. "Economic and health outcomes are important to other stakeholders and parties in our society, such as government agencies, payers and health policy groups."
In assembling the new data, researchers used an angina-specific health status questionnaire called the Seattle Angina Questionnaire that measures physical limitation, angina stability, angina frequency, treatment satisfaction and quality of life, plus an overall questionnaire that measures physical functioning, physical limitation, emotional limitation, vitality, emotional well-being, social functioning, pain and general health.
The number of angioplasties has been falling since the first results from this big study came out last year, according to an Associated Press report citing new figures from an American College of Cardiology (ACC; Washington) database.
According to the AP report, angioplasty remains the top treatment for people having a heart attack or hospitalization with worsening symptoms. However, at least a third of angioplasties are done on people not in imminent danger, to relieve chest pain. The report also noted that about 1 million angioplasties are done in the U.S. each year.