Lessons from major heart trial need implementation

A NewYork-Presbyterian Hospital/Weill Cornell Medical Center review of almost 500,000 cardiac cases nationally shows that the clinically indicated medical therapy reported in a widely publicized study was lost in translation to real-world heart care after its publication.

The researchers report in the May 11 issue of JAMA, the Journal of the American Medical Association, that medical therapy given to patients who received a heart stent improved less than 3 percent as a result of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial. Overall, fewer than half of all patients received appropriate treatment with the combination of common cardiac drugs used in the COURAGE trial, such as aspirin, before their stenting procedure, and almost one-third didn't receive these drugs afterward.

As we all think about health care for the future, this study provides actionable information for both physicians and policymakers about quality of care and how comparative effectiveness research findings are being implemented, the researchers say.

"We find that an expensive and highly publicized clinical trial had a very limited effect on the clinical practice of providing optimal medical therapy, and this snapshot of what is happening in the real world should be a call for physicians, as well as policymakers, to look at how patient care can be improved," says the study's lead author, Dr. William Borden, assistant professor of medicine and of public health and the Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College, and a cardiologist at the Ronald O. Perelman Heart Institute of NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

"These findings also should encourage patients to be aware of the need for optimal medical therapy if they are slated to receive a heart stent - a consideration they should discuss with the physicians who treat them," says co-author Dr. Alvin I. Mushlin, chairman of the Department of Public Health at Weill Cornell Medical College and public health physician-in-chief at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

In this study, the research team, which includes investigators from the University of California at San Francisco, Duke Clinical Research Institute, and the University of Missouri, sought to see if heart care changed after publication of the $33.5 million COURAGE clinical trial in the New England Journal of Medicine in 2007.

In COURAGE, 2,287 patients with stable coronary artery disease (CAD) were randomized to receive either "optimal medical therapy" alone or the same therapy along with a stent - a device that presses artery-clogging plaque back against a vessel wall. Optimal medical therapy was sought with all patients, even those having stents placed, assigning them to receive common cardiac agents - a statin drug, a beta blocker, and aspirin or thienopyridine.

COURAGE investigators found there was no difference in the outcomes of the two groups, except for angina symptoms, which demonstrated that adding stenting to optimal medical therapy is not better than the ability of optimal medical therapy alone to prevent heart attacks and death in patients with stable CAD. Even before COURAGE was published, other studies had shown that medical therapy was beneficial in these patients and its use was encouraged by established cardiac care guidelines.