COURAGE Sub-study: PCI Outperforms Drugs-Only

PCI Provides Patients With Clogged Arteries Significant Added Benefits Over Drugs, According to Nuclear Imaging Scans

WASHINGTON, November 06, 2007 /PRNewswire/ -- Patients with ischemia, or clogged arteries, benefit significantly from percutaneous coronary intervention (PCI) when compared with optimal medical therapy, according to a nuclear sub-study of the COURAGE trial presented this week at the American Heart Association (AHA) in Orlando.

This sub-study is especially significant given that the COURAGE trial had previously called into question the relative effectiveness of PCI (which uses a combination of angioplasty, stents, and medications) compared to medications alone in the prevention of death and heart attack in patients with stable heart disease.

The Society for Cardiovascular Angiography and Interventions (SCAI), the world's leading society of interventional cardiologists, questioned those findings from the beginning. SCAI noted that the COURAGE study excluded all but the most stable patients, including only those who were able to adhere to very strict medication and lifestyle-change requirements. COURAGE also enrolled patients only after their anatomy was determined, another significant study design limitation. Furthermore, the existing data had never suggested that angioplasty or stenting reduced the risk of death or heart attack in this population of stable patients.

"This new analysis confirms what interventional cardiologists have said all along -- when compared to using only drugs, PCI improves overall heart health and reduces debilitating chest pain by opening up blocked arteries," said Dr. Bonnie Weiner, President of The Society for Cardiovascular Angiography and Interventions.

Patients with stable coronary artery disease, especially those with a moderate to severe case, gained significant long-term health benefits from PCI when compared with a drugs-only approach, according to Dr. Leslee J. Shaw, the principal investigator and a professor of medicine at Emory University, who presented the late-breaking clinical trial at the AHA Scientific Sessions.

Using a nuclear imaging technique called "single photon emission computed tomography" (SPECT), the study showed that patients with moderate to severe ischemia benefited most from PCI when compared with those who received only optimal medical therapy. In fact, when ischemia was reduced, the risk of death was also reduced. This finding confirms cardiologists' general understanding of heart disease -- that significant ischemia is not in a patient's best long- term interests.

The SPECT images, which enable physicians to assess the blood flow to the heart, showed that some patients had a very significant reduction in ischemia (more than 5 percent). Of patients who underwent PCI and took medications, 33 percent showed a reduction in ischemia of 5 percent or more, compared with only 19 percent of patients who took only medications.

"This study also confirms the importance of identifying patients who are at most risk and who can therefore most benefit from PCI," Dr. Weiner said.

Among the patients who had reduced ischemia, nearly 80 percent of both treatment groups were free of angina, which is characterized by chest pain that can be debilitating. PCI in addition to medications is clearly more effective than a medications-only approach in patients with high-risk ischemia (those with greater than 5 percent of their heart muscle compromised), according to the study.

The COURAGE trial received widespread attention earlier this year when some concluded that PCI offered no reduction in the risk of death or heart attack in patients with stable coronary artery disease compared with using only drugs.

The overall COURAGE trial looked at a narrow group of relatively healthy, stable patients who represented only about 30 percent of patients treated by interventional cardiologists. The nuclear sub-study demonstrates that even in these patients, the continued presence of ischemia increases the risks of death or heart attack. These risks can be reduced with revascularization.

For almost all other patients seen by interventional cardiologists, PCI is the preferred treatment, especially in heart attack patients, because it stops the heart attack immediately, saves lives, and improves health.

The COURAGE trial did not consider that many patients are not suitable for a medications-only approach because, although that approach may be desirable and recommended, such patients may not be able to tolerate side effects of the drugs or adhere to the strict regimen required due to multiple factors.

The COURAGE trial also did not address significant quality-of-life factors for the stable angina population. In consultation with their physicians, many patients choose PCI because it offers almost immediate relief from pain and discomfort, and they are much more likely to be able to resume normal lifestyle activities sooner with far fewer symptoms than many patients who choose the medications-only route.

Posted: November 2007

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