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Since the 2007 publication of the COURAGE trial, which showed no advantage for percutaneous coronary intervention (PCI) over optimal medical therapy in patients with stable ischemic heart disease, both the utilization and geographic variability of the intervention for this population has declined substantially, according to a study published online December 17, 2013, ahead of print in Circulation: Cardiovascular Quality and Outcomes. However, geographic variation in the use of PCI for stable disease remained relatively high compared with that for acute coronary syndromes (ACS).
Arun V. Mohan, MD, MBA, of the Emory University School of Medicine (Atlanta, GA), and colleagues reviewed records from the State Inpatient Database for 7 states and the Dartmouth Atlas for Healthcare from 2006 through 2008. Overall, data from PCIs performed for stable disease (n = 272,659) and ACS (n = 333,196) in 67 health referral regions at 526 hospitals were included.
Marked Fall-off in Stable PCI
Age- and sex-adjusted rates of PCI for stable disease significantly decreased after publication of COURAGE compared with ACS, with the most prominent decline in referral regions with the highest use of PCI before COURAGE. Over the course of the study, PCI use declined in all referral region tertiles by one quarter, although the drop was most noticeable in the highest tertile. Rates of PCI decline in ACS tertiles were considerably smaller than those for stable disease (table 1).
Table 1. Age- and Sex-Adjusted Rates of PCI by Utilization Tertile Over Time
Rate Per 1,000 Residents > 40 Years
Geographic variation in PCI use for stable disease fell by 24.9% between 2006 and 2008 (0.53 vs. 0.10) but was still high compared with use for ACS, which remained virtually unchanged over the same period (0.17 vs. 0.17).
A ‘Substantial Impact’
The COURAGE trial appears to have had a substantial impact on PCI use for stable disease, Dr. Mohan told TCTMD in a telephone interview. “Our findings are pretty consistent with 2 studies published before ours that demonstrated a 16% to 20% reduction,” he said.
Additionally, “our study is the first to look at what happened with geographic variation,” Dr. Mohan continued. “We found a 25% decrease in variation that coincides with [a 25%] reduction in use and we saw no change in geographic variation for ACS,” he said.
Effort to Downplay COURAGE?
COURAGE lead author William E. Boden, MD, of the Albany Stratton VA Medical Center (Albany, NY), told TCTMD in a telephone interview that the current findings are “rather interesting because . . . [COURAGE] engendered significant criticism from many within the interventional cardiology community” in the first few years after its publication. Many of the initial reports on changes in PCI rates in this patient population before and after the publication of COURAGE were “played down by the interventional community,” he observed, “perhaps because they were trying to minimize the impact of the study.”
Other Factors at Play
While the COURAGE trial appears to have had some impact on PCI use, many other forces are at play, Jeffrey W. Moses, MD, of NewYork-Presbyterian Hospital/Columbia University Medical Center (New York, NY), told TCTMD in a telephone interview. For example, greater public and professional scrutiny of the procedure and appropriate use criteria, widespread publicity of prosecutions surrounding alleged overuse of DES, and guidelines changes may all have played a role, he noted.
Additionally, studies of PCI specifically in diabetic patients showed the same outcomes as COURAGE and indicated that the procedure is largely for ACS and not stable disease, Dr. Boden said.
“We can’t say with certainty that COURAGE is responsible for decreased use [of PCI for stable disease], but the timing and magnitude of the changes are suggestive,” noted Dr. Mohan.
Reasons for Geographic Variation
Reasons for regional variation of PCI use are difficult to explain with precision, Dr. Boden commented. Social and cultural factors, as well as fundamental differences in clinical practice philosophy, may play a role, and “fee-for-service reimbursement is also a big driver,” he said.
Geographic variation may also reflect underlying uncertainty about the best option for treating stable disease, Dr. Mohan said. Even after a well-regarded study such as COURAGE, many questions remain unanswered, such as how generalizable the results are considering the study’s exclusion of high-risk patients. Moreover, bare metal stents were used predominantly and medical therapy was very aggressive, he noted, adding that it is difficult to know what variation in use is inappropriate.
While in the vast majority of intermediate-to-high-risk ACS patients, intervention saves lives and reduces MI, which specific patients may benefit from PCI is unclear, Dr. Moses commented. “When you start stratifying patients into different risk groups, people differ about what’s appropriate treatment,” he said. For example, some recent meta-analyses indicate that stenting reduces spontaneous MI and has an impact on mortality in so-called stable disease, he observed. “You could argue to some extent that there’s underutilization now in patients in whom PCI has been deemed appropriate and that it could have an impact on mortality.”
Moreover, when utilization of an inappropriate procedure goes down, “it doesn’t mean that appropriate utilization goes up,” Dr. Moses added.