July 12, 2011 Guideline recommendations for the appropriate use of percutaneous coronary intervention (PCI) for patients who have an occluded coronary artery after having a myocardial infarction (heart attack) appear not to have been fully incorporated in clinical practice, according to a report published Online First by Archives of Internal Medicine, one of the JAMA/Archives journals. The article is part of the journal's Less Is More series.
In 2006, results from the National Heart, Lung, and Blood Institute -- sponsored Occluded Artery Trial (OAT) were published, according to background information in the article. The study examined the effect of PCI, such as using balloon angioplasty and stenting, on completely blocked arteries identified a minimum of 24 hours (on calendar days 3 to 28) after a myocardial infarction (MI) in stable patients. "The OAT results provided objective evidence that the use of PCI did not lead to a reduction in clinical events and that the beneficial effect on angina and quality of life was small and not durable," write the authors. "Percutaneous coronary intervention was more costly than optimal medical therapy alone; hence, these findings should have discouraged routine PCI in this setting." Accordingly, after the trial results were published, the American College of Cardiology and the American Heart Association updated their guidelines.
Marc W. Deyell, M.D., from the University of British Columbia in Vancouver, Canada, and colleagues sought to determine whether clinical practice had changed following the revised guidelines. They examined data from the CathPCI Registry, which collects information from U.S. hospitals that perform cardiac catheterization. The authors compared PCI rates before and after the OAT trial results were published and the guidelines updated, from 2005 to 2008. They studied trends in hospitals in the highest quartile for reporting diagnostic procedures, because institutions are not required to report diagnostic catheterization.
The study included data from 896 hospitals and 28,780 patient visits. Percutaneous coronary intervention was performed in 11,083 patients before the OAT results were published; 7,838 between publication and guideline changes; and 9,859 after guidelines were revised. After adjusting for other variables, the authors report no overall significant decrease in the monthly rate of PCI performed for blockages either after the OAT results were published or after guidelines were changed. Among hospitals that consistently reported procedures done for diagnostic purposes, PCI rates did not diminish after OAT publication, but did appear to trend downward with a small decrease after the guidelines were revised.
"In conclusion, among this large cross-section of hospitals in the United States we found only modest evidence that the results of the OAT and its incorporation into major guideline revisions have influenced cardiology and interventional cardiology practice over the subsequent 1 to 2 years," write the authors. "Percutaneous coronary intervention of total occlusions identified greater than 24 hours after MI remains commonplace despite little evidence to support its use in stable patients and new clinical practice guidelines recommending against it." The researchers point out that this means many patients may be receiving an expensive intervention that does not help them, and that the large amount of time and effort devoted to the research did not appear to have a sizable influence on U.S. clinical practice.
Commentary: The OAT Results, Guideline Revisions and Clinical Practice
Mauro Moscucci, M.D., M.B.A., from the University of Miami's Miller School of Medicine, wrote a commentary which accompanies the paper by Deyell and colleagues. Considering the apparent lack of overall change in PCI usage, he states, "The reason for the observed failure of reversal is multifactorial." Barriers to changing physicians' and patients' beliefs and behaviors may have played a part.
"The study by Deyell et al adds an important chapter to the evaluation of appropriate use of PCI and further focuses our attention on procedures that certainly increase health care expenditures without clear benefit," remarks Moscucci. "While the debate on health care reform is ongoing, health care expenditures in the United States are continuing to escalate. Thus, we must heed the call to professional responsibility aimed at the elimination of tests and treatments that do not result in any benefit for our patients, and for which the net effects will be added costs, waste, and possible harm."
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- M. W. Deyell, C. E. Buller, L. H. Miller, T. Y. Wang, D. Dai, G. A. Lamas, V. S. Srinivas, J. S. Hochman. Impact of National Clinical Guideline Recommendations for Revascularization of Persistently Occluded Infarct-Related Arteries on Clinical Practice in the United States. Archives of Internal Medicine, 2011; DOI: 10.1001/archinternmed.2011.315
- M. Moscucci. Medical Reversal, Clinical Trials, and the "Late" Open Artery Hypothesis in Acute Myocardial Infarction. Archives of Internal Medicine, 2011; DOI: 10.1001/archinternmed.2011.299
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