Since COURAGE, Little Change in Optimal Medical Therapy for Stable PCI Patients

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When the COURAGE trial was published in April 2007, its results bolstered the case for optimal medical therapy (OMT) in patients with stable coronary artery disease (CAD) who might be considered for percutaneous coronary intervention (PCI). But a new paper published in the May 11, 2011, issue of the Journal of the American Medical Association shows that the study had surprisingly little effect on practice patterns: In the 2 years after its release, fewer than half of such patients were receiving antiplatelet drugs, beta-blockers, and statins prior to PCI and two-thirds were given appropriate drugs at discharge.

William B. Borden, MD, of Weill Cornell Medical College (New York, NY), and colleagues conducted a retrospective, observational study of patients in the National Cardiovascular Data Registry (NCDR) who had stable angina and underwent PCI from September 2005 to June 2009. Their analysis compared the use of OMT before and after publication of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, which showed that PCI offered no advantage over OMT alone in such patients. Inclusion and exclusion criteria largely mirrored those of COURAGE.

To allow for dissemination of the COURAGE results following publication, the researchers excluded the 3-month period from April through June 2007. Patients were counted as receiving OMT if they were either prescribed or had a documented contraindication to all drugs considered appropriate: antiplatelet agents (aspirin before PCI and thienopyridine after PCI), beta-blockers, statins, and post-PCI ACE inhibitors and angiotensin receptor blockers (ARBs).

In all, 467,211 patients met study criteria, of whom 37.1% received PCI before and 62.9% after COURAGE’s publication date. Although the proportion of patients receiving OMT both before PCI and at discharge rose following COURAGE, the change was slight (table 1).

Table 1. OMT Use Before and After the COURAGE trial


Before Publication
(n = 173,416)

After Publication
(n = 293,795)

P Value

Prior to PCI



< 0.001

At Discharge



< 0.001


In an e-mail communication, Dr. Borden stressed that the study serves as a reminder that “there remains an important opportunity to improve the medical therapy of patients receiving PCI for stable angina. This is a shared responsibility amongst both primary cardiologists and interventional cardiologists to collaborate and assure that patients are receiving optimal medical therapy, both before and after stenting.

“Moreover,” he continued, “the finding that the COURAGE results did little to change the practice of applying medical therapy suggests that more work needs to be done to aid the translation of comparative effectiveness results into clinical practice.”

From Clinical Trial to Clinical Practice

Although the current study did not examine why patients may not have received OMT, Dr. Borden suggested several possible reasons: “physician lack of knowledge or questioning of the COURAGE results, a false impression that PCI obviates the need for medical therapy, and health system financial incentives that favor interventions over medical therapy.” Currently, the investigators are looking at how OMT rates vary across different geographic regions and hospital settings.

Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), told TCTMD in an e-mail communication that in addition to suboptimal care, there may be other explanations for why OMT may be less used in practice than in a randomized trial. For example, medications were typically free of cost to COURAGE patients and follow-up visits were frequent.

Looking at individual medications also is informative, he added. Before PCI, antiplatelet agents were given to 88.3% of patients, and statins and beta-blockers were each prescribed to approximately 63%. After PCI, the numbers rose to 99.2%, 75.9%, and 84.7%, respectively. ACE inhibitors or ARBs were given to 60.7%.

“Overall, these utilization rates are not as bad as the authors insinuate, especially given the likely under-capture of contraindications,” Dr. Stone emphasized.

In a telephone interview with TCTMD, Christopher J. White, MD, of the Ochsner Clinic Foundation (New Orleans, LA), expressed “serious concerns,” however, that the findings are inaccurate.

For one, COURAGE has been widely recognized as influencing interventional practice, reducing the number of patients treated with stents for stable disease, he said. Also, because the NCDR is an administrative database and did not directly contact patients, it may not account for all contraindications, Dr. White explained. “Many patients can’t take a beta-blocker, for example. They call you and say ‘I’m having a side effect,’ and you stop the medicine. You may write in their chart that you had a problem, but for this to work, you had to also put it into the NCDR database.”

Yet the investigators are “very qualified,” he said, so the study is at least “hypothesis generating. It doesn’t prove anything, but it does raise the question. And I think it needs to be taken seriously. We do need to do [additional studies] to see if this is in fact the case. And if it is true, we need to really work on education of providers, interventionalists as well as primary care [physicians].”

How to Improve Care

Dr. Stone offered a number of patient-centered strategies that could encourage OMT, including more time spent with physicians and allied health care providers, more frequent visits, and free medications. “All of this requires greater expenditures for preventative care, which would be great—but it should not come at the expense of procedures that also improve quality of life in selected patients,” he added.

Asked how interventional cardiologists can help improve the situation, Dr. Borden commented that appropriate care requires collaboration with referring cardiologists.

“[A]fter a diagnostic angiogram for stable angina, if the patient is not on optimal medical therapy, it is reasonable to stop the procedure at that point and work with the primary cardiologist to maximize the medical therapy to see if symptoms can be alleviated, thus either delaying or avoiding the need for PCI. While an interventional cardiologist may be concerned that the referring cardiologist expects a stent to be placed when they send their patient for a catheterization, the primary cardiologist should also recognize the ability of optimal medical therapy alone to improve symptoms and reduce myocardial infarctions and mortality,” he wrote, noting that a team approach during hospitalization after PCI also can help optimize OMT.

Dr. White, who is president of the Society for Cardiovascular Angiography and Interventions (SCAI), highlighted a quality-improvement tool that the organization released last week at its 2011 meeting. The tool, called SCAI-QIT, includes a checklist to help clinicians prescribe appropriate post-PCI medications at discharge, he reported.

“You’ve got to walk before you run. All of these issues are local,” he said. When physicians are asked about why they do not comply with recommended care, “the barrier is typically just the difficulty of doing things the same way every time. That’s why checklisting is so important for medicine. Doctors hate it, but the truth is a checklist is the way to get it right every time.”

In terms of the current study showing COURAGE’s lack of influence, “the argument is not whether this is real or not real, terrible or good. It is what it is,” Dr. White concluded. “All we can reasonably do is try to be better tomorrow than we were yesterday. As long as we’re working that way, I think we’ll be in good shape.”


Borden WB, Redberg RF, Mushlin AI, et al. Patterns and intensity of medical therapy in patients undergoing percutaneous coronary intervention. JAMA. 2011;305:1882-1889.



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  • The study was supported by the National Cardiovascular Data Registry.
  • Dr. Borden reports participating in a one-time advisory board meeting for Kowa Company.
  • Dr. Stone reports serving as a consultant to Abbott Vascular, Boston Scientific, Bristol-Myers Squibb-Sanofi, Eli Lilly, Medtronic, and Merck.
  • Dr. White reports no relevant conflicts of interest.