Strong Physicians Scrutinize Treatment for Heart Disease
January 31, 2001
Charles Francis, M.D.
Medical advances in the past 30 years have led many Americans to believe that when it comes to treating heart disease, invasive therapy with an angioplasty or stent is the way to go. Hospitals nationwide are accustomed to doing these procedures as a matter of course. But Strong Memorial Hospital physicians and researchers have just begun participating in a $30 million North American study that questions the conventional wisdom and attempts to measure the value of a more conservative approach. The study seeks to better evaluate low, moderate and high-risk coronary disease patients and then determine if medications and lifestyle changes will treat their problems as well as the invasive techniques. "In the past decade, many large clinical trials have shown that for patients with coronary artery disease, medications and a healthful lifestyle greatly reduce the risk of having a fatal or non-fatal heart attack. However, the additional value of using angioplasty and stents remains controversial," said Ronald Schwartz, M.D., director of Nuclear Cardiology at Strong Memorial Hospital, a unit he describes as a "gatekeeper" for heart disease intervention. "The point of the study is to take a fresh look in 2001 at whether we are matching the level of intervention with the level of risk in our intermediate and high-risk patients," said Schwartz, who is the principal investigator for the study at Strong. "The idea is to fine-tune our definition of the risk point at which we recommend invasive therapy." A lot of lives and dollars are at stake. Coronary artery disease remains the No. 1 cause of death for women and men in our society. Although death rates due to heart disease have declined substantially since their peak in the 1950s and 1960s, evidence now shows those rate reductions are beginning to level off, Schwartz said. And as the baby boomer generation ages, the number of patients with heart disease is expected to increase, along with the costs of treating them. Already, $100 billion is spent annually on managing coronary artery disease. The study, called the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation, (COURAGE), was prompted by previous research comparing the methods of diagnosing and treating heart disease in the U.S. and Canada. Findings suggested that long-term survival rates are about the same, although invasive therapy is more prevalent in the U.S. Dr. Fred Ling, associate professor of medicine at the University of Rochester Medical Center and director of the Cardiac Catheterization Laboratory at Strong, said that invasive therapy is necessary in many cases to open blocked vessels, improve the symptoms of angina and prolong life. But he agrees there is value in demonstrating which type of therapy is better for some high-risk patients. "The rapid advances in both medical therapy and in angioplasty warrant a new trial such as COURAGE," Ling said. "For example, the common use of stents and new anti-clogging medications not routinely available several years ago has dramatically decreased the risk and increased the efficacy of angioplasty." All but the very highest risk coronary artery patients could be enrolled in the COURAGE study. Participants would be provided free heart medications recommended by the American Heart Association, and then selected at random to receive additional therapy. Currently, there are 884 patients enrolled in Canada and the U.S. A total of 3,240 patients are needed. The URMC is one of 13 non-Veterans Administration sites in the U.S. participating in the study. Funding is provided by the Canadian Government Medical Research Council, the U.S. Department of Veterans Affairs and several industrial companies that produce coronary catheters, radionuclide tracers, and medications used to treat high cholesterol, high blood pressure, angina and other coronary conditions. The chief investigator is Dr. William Boden, head of the cardiology unit at Hartford Hospital in Connecticut. Patients or physicians seeking more information about the COURAGE trial can call the trial coordinator, Darlene Bedard, R.N., at (716) 273-1300 or Dr. Ronald Schwartz at (716) 275-2316.