Medical Device Daily Executive Editor
ORLANDO — Earlier this year, the man and woman on the street were told that for treating angina and other early symptoms of heart disease, drugs are better than stenting.
Or at least that was probably the most common take-home as a result of the national coverage of the COURAGE (Clinical Outcomes Utilizing Percutaneous Coronary Revascularization and Aggressive Guideline-Driven Drug Evaluation) trial.
No matter that this conclusion wasn’t exactly what COURAGE said — that it actually referred only to initial treatment, and that many of those in the drug (optimal medical therapy [OMT]) arm were then crossed over to the percutaneous cardiovascular intervention (PCI)/stenting arm; that the study looked at stenting at a time of only 3% of drug-eluting stent use; a fairly restricted population of U.S. and Canadian army veterans; and that there were many other variables not reported (Medical Device Daily, March 28, 2007).
The broad effect of COURAGE was to cast further doubt on stenting and continue the stagnation of an already stagnated — and, in some regions, declining — med-tech sector.
Now we begin to have the analysis of key subsets and drill-down looks at COURAGE. This brings with it the possibility that DES patients and providers may be even more confused concerning what COURAGE said and should be used for direction of treatment. And it most certainly will continue the debates surrounding this trial and the drugs vs. stenting debate.
Two of these studies were presented at this year’s annual scientific sessions of the American Heart Association (Dallas), ongoing here this week.
In one analysis, researchers reported that PCI/stenting is significantly superior to medical therapy in terms of dealing with a critical level of ischemia — but with the proviso that determining this level of ischemia and follow-on ischemia relief requires a specific form of imaging and imaging follow-up.
The other report said that, whatever the clinical differences between the two types of therapy, PCI/stenting is not just more expensive, it is significantly more expensive.
Leslee Shaw, PhD, professor of medicine at Emory University School of Medicine (Atlanta), reported that in a “nuclear analysis” sub-study of 314 patients from the 2,287-patient COURAGE trial, patients with 5% or more of Ischemia received more benefit from PCI/stenting than from medical therapy.
She said that the results of the study offered a sort of “back to the future” approach because “ischemia is the clarifier” in determining the best therapeutic alternative. By contrast, she said the more recent trend has been to find a blockage/treat a blockage, of whatever type, without assessing the impact of the ischemia and its associated symptoms.
The assessment of ischemia was made with myocardial perfusion SPECT (MPS) imaging before treatment and then after. The imaging studies found that PCI/stenting-treated patients a 30% reduction in ischemia vs. 20% for the OMT group, and so PCI/stenting was a 50% improvement over OMT, an assessment made via MPS upon 18-month follow-up.
However, Shaw told Medical Device Daily that she did not see these findings as greatly altering the use of stenting in current practice. Rather, she said that the study helps to better use the results of COURAGE.
“It won’t tip the balance,” she said. “It says COURAGE I should be followed by COURAGE II and other trials.”
Questioned as to the availability of the scans necessary to determine ischemia for the average person, Shaw told MDD that there are about 8 million perfusion scans each year in the U.S., with about half of cardiology centers offering this type of imaging for assessment.
Overall, she said that this imaging modality is becoming more and more a “standard of care” and thus more broadly available. Thus, she said that the sub-study of COURAGE confirmed the value of MPS in identifying the rate of ischemia putting a patient most at risk at the benefit of PCI/stenting was greatest for these patients thus identified.
William Weintraub, MD, professor of medicine at Christiana Care Health Services (Newark, Delaware), followed Shaw, presenting a cost/benefit analysis of COURAGE and concluding that in this trial PCI/stenting “costs significantly more without offering a survival advantage.”
Weintraub’s data showed that PCI/stenting initially adds about $10,000 per procedure. And he further said that the data showed from “$150,000 to $300,000 per year of life or quality of life” in what he called “an incremental cost-effectiveness ratio.”
He emphasized that the economic evaluation he was presenting was “different than accounting” in that it puts the focus on quality of life, not just dollars and “ties together the economic and the clinical.”
A similar conclusion was reached in a later presentation by Daniel Mark, MD, professor of medicine at Duke University Medical Center (Durham, North Carolina), subtitled “lots of bucks, not much bang.”
Mark said that the “punch line on the cost side of things” from the OAT trial was that the results of the two therapies were equivalent across a range of measures —from physiological to psychological — but the cost of treatment with PCI/stenting was about 40% higher.
Treatment by medical therapy averaged $12,683 while treatment with PCI/stenting was nearly $10,000 higher, on average, at $22.859.