Study Finds Little Effect of COURAGE On Adoption of Optimal Medical Therapy Reply

Optimal medical therapy (OMT) for patients with coronary artery disease (CAD) was not significantly boosted by the publication of the COURAGE trial, despite the clear message from that trial showing the benefits of OMT, according to a new study published in JAMA.

William Borden and colleagues used data from 467,211 patients in the National Cardiovascular Data Registry to analyze the use of OMT in CAD patients prior to PCI and at the time of discharge, both before and after COURAGE was published.

  • Before PCI, OMT was used in 43.5% of patients before COURAGE  and 44.7% after COURAGE
  • At discharge after PCI, OMT was used in 63.5% of patients before COURAGE and 66.0% after COURAGE

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

In an interview with Harlan Krumholz on CardioExchange, Borden and co-author John Spertus said that patients with a high risk stress test not receiving OMT may be appropriately considered for PCI.

However, I would want to be sure that the patient clearly understood that the procedure is not likely to make them live longer or prevent a heart attack.  Furthermore, the patient would still be encouraged to take aspirin, thienopyridines, statins and beta-blockers. The PCI does not obviate the benefit of these medications. The primary benefit of revascularization would be the alleviation of symptoms, which might also be accomplished with aggressive OMT alone.

Borden and Spertus speculated on possible reasons why OMT has not been more widely adopted following COURAGE:

…there are a number of potential explanations, including possible clinicians’ disbelief of the COURAGE results, economic incentives to preferentially treat with revascularization, referral patterns and concerns of interventionalists that if they don’t perform the PCI for a referring doctor that the doctor will not refer future patients.  More work is clearly needed to illuminate the opportunities to further improve the use of OMT prior to, and after, PCI.

Here is the press release from JAMA:

Patients Often Do Not Receive Optimal Medical Therapy Before and After Percutaneous Coronary Intervention

CHICAGO – Despite guideline-based recommendations that underscore the importance of optimal medical therapy (OMT) for patients with stable coronary heart disease undergoing percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries), data from a cardiovascular registry indicate that less than half of these patients are receiving OMT before PCI and approximately one-third are not receiving OMT at discharge following PCI, according to a study in the May 11 issue of JAMA.

Although PCI may improve outcomes for patients with acute coronary syndrome, OMT results in similar rates of cardiovascular events when compared with PCI in patients with stable coronary artery disease (CAD). Findings of a meta-analysis of 11 trials concluded that there was no benefit of PCI in preventing heart attack or death in patients with stable CAD. In addition, the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, which provided OMT to all patients, demonstrated no incremental advantage of PCI on outcomes other than angina-related quality of life in stable CAD, suggesting that a trial of OMT is warranted before PCI. “It is unknown to what degree OMT is applied before PCI in routine practice or whether its use increased after the COURAGE trial,” according to background information in the article.

William B. Borden, M.D., of Weill Cornell Medical College, Cornell University, New York, and colleagues conducted a study to examine use of OMT before and after PCI and to evaluate whether the use of OMT changed after the publication of the COURAGE trial (March 2007). The study included data from the National Cardiovascular Data Registry of patients with stable CAD undergoing PCI between September 2005 and June 2009. Analysis compared use of OMT, both before PCI and at the time of discharge, and before and after the publication of the COURAGE trial. Optimal medical therapy was defined as either being prescribed or having a documented contraindication to all medicines (antiplatelet agent, beta-blocker, and statin).

A total of 467,211 patients receiving PCI procedures were included in the analysis, with 173,416 patients (37.1 percent) and 293,795 patients (62.9 percent) in the before and after COURAGE periods, respectively. The researchers found that 206,569 patients (44.2 percent) received OMT before PCI and 303,864 patients (65 percent) received OMT at the time of discharge. “Before the COURAGE trial, the rate of OMT at the time of PCI was 43.5 percent. Although the increase in the proportion of patients receiving OMT before PCI after the COURAGE trial was statistically significantly higher, it was of little clinical significance (131,188 patients [44.7 percent]). The rates of OMT before PCI in each study period month showed a small increase during the 46 months of observation, with an OMT rate before PCI of 43.4 percent in September 2005 and an OMT rate after PCI of 45.0 percent in June 2009,” the authors write.

The overall rate of OMT after PCI, a time at which the diagnosis of significant obstructive CAD had been confirmed, was 63.5 percent before the COURAGE trial and 66 percent after the COURAGE trial.

“Our study demonstrated that less than half of patients undergoing PCI are taking OMT before their procedure, despite the guideline-based recommendations to maximize OMT and the clinical logic of doing so before PCI so that the need for additional symptom relief from revascularization can be appreciated. Even after publication of the COURAGE trial, little change in this practice pattern was observed. Although clinicians did increase the use of OMT before discharge, with antiplatelet agents being almost universally applied, almost a third of patients were not treated with OMT, a pattern that also did not change after the COURAGE trial was published. Collectively, these findings suggest a significant opportunity for improvement and a limited effect of an expensive, highly publicized clinical trial on routine clinical practice,” the authors write.
(JAMA. 2011;305[18]1882-1889.

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