COURAGE Had Little Impact on Drug Tx in PCI

Publication of the results of the COURAGE trial appears to have had little effect on real-world use of optimal medical therapy before percutaneous coronary intervention (PCI) and at discharge in patients with stable coronary artery disease, researchers found.

COURAGE, presented at the American College of Cardiology meeting in March 2007, showed that adding PCI to optimal medical therapy did not reduce the rate of death or MI compared with optimal medical therapy alone in patients with stable coronary artery disease.

In this current study of more than 460,000 patients, the percentage who received optimal medical therapy with an antiplatelet agent, a beta-blocker, and a statin before PCI actually increased slightly -- from 43.5% to 44.7% -- after COURAGE was reported (P<0.001), according to William Borden, MD, of Weill Cornell Medical College in New York City, and colleagues.

The proportion who received optimal medical therapy at discharge after PCI also rose slightly, from 63.5% to 66% (P<0.001), the researchers reported in the May 11 issue of the Journal of the American Medical Association.

Although the changes were statistically significant, both had marginal clinical significance, the authors noted.

"Collectively, these findings suggest a significant opportunity for improvement and a limited effect of an expensive, highly publicized clinical trial on routine clinical practice," they wrote.

In addition, they wrote, the findings "support a call for innovations in how optimal medical therapy is incorporated into interventional strategies and for improving the translation of clinical evidence into practice."

Borden and his colleagues looked at data from the CathPCI Registry, which is part of the National Cardiovascular Data Registry. They included information on 467,211 patients from 1,012 hospitals who presented without an acute coronary syndrome for elective PCI from Sept. 1, 2005, to June 30, 2009.

Optimal medical therapy before PCI was defined as having a prescription for or a documented contraindication to aspirin, a beta-blocker, and a statin. The definition was similar at discharge, although the antiplatelet drug could be either aspirin or a thienopyridine.

Overall, optimal medical therapy was used in 44.2% of patients before PCI and in 65% at discharge; both rates were higher in patients with known cardiovascular disease and increased slightly from before to after the COURAGE results were reported in March 2007.

"Our study demonstrated that less than half of patients undergoing PCI are taking optimal medical therapy before their procedure, despite the guideline-based recommendations to maximize [such therapy] and the clinical logic of doing so before PCI so that the need for additional symptom relief from revascularization can be appreciated," the authors wrote.

Although a recent study published in Circulation: Cardiovascular Quality and Outcomes found that publication of the COURAGE results was associated with a decline in the use of PCI for patients with stable coronary artery disease in New England, Borden and his colleagues wrote that "our findings demonstrate a continued opportunity to improve care among those patients who do receive PCI."

That responsibility, they added, should fall to both the interventional cardiologist and the patient's primary care physician.

"The findings ... demonstrate the need for continuous research in the medical field, specifically for the improvement of medical therapy before and after PCI," commented David Holmes, MD, of the Mayo Clinic in Rochester, Minn., in a statement.

"The study also shows us there is a need to improve how the results of comparative effectiveness research are distributed and become features of care, and how research is translated to practice," said Holmes, who is president of the American College of Cardiology.

The authors acknowledged some limitations of the study, including the use of data from centers that chose to participate in the registry, the possibility that medication contraindications were underdocumented, and the inability of the registry to capture cases in which clinicians recommended optimal medical therapy to referring physicians but did not implement the guidance themselves.