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Using data from some of the most well-recognized trials in recent years to compare percutaneous coronary intervention (PCI) with optimal medical therapy, researchers suggest the totality of evidence does not support revascularization as providing any clinical benefit in patients with stable CAD. The meta-analysis, published in the February 27, 2012, issue of Archives of Internal Medicine, yielded no differences in rates of death or other quantitative measures between PCI and medical therapy.
Kathleen Stergiopoulos, MD, PhD, and David L. Brown, MD, both of Stony Brook University Medical Center (Stony Brook, NY), conducted the meta-analysis using 8 recent randomized trials that included a total of 7,229 patients. These trials were:
The study authors excluded trials using balloon angioplasty as the primary form of PCI, choosing instead those in which stents were used in more than half of randomized patients. All trials tested contemporary optimal medical therapy consisting of aspirin, beta-blockers, ACE-inhibitors or angiotensin receptor blockers, and statins. Three trials enrolled stable patients after MI and 5 enrolled those with stable angina and/or ischemia on stress testing.
No Reduction in Hard Outcomes
At a mean follow-up of 4.3 years, PCI was not associated with any reduction in mortality, nonfatal MI, unplanned revascularization, or angina compared with optimal medical therapy (table 1).
Table 1. Outcomes for PCI vs. Optimal Medical Therapy
PCI(n = 3,617)
Optimal Medical Therapy(n = 3,612)
In subgroup analysis, there were no significant differences in rates of death, unplanned revascularization, and freedom from angina between studies that focused only on post-MI patients and those involving patients with either stable angina or ischemia. However, there was a trend toward increased risk of nonfatal MI for stented patients in the post-MI trials (OR 1.49; 95% CI 1.00-2.21; P = 0.05); the same pattern was not seen in trials that assessed stable angina or ischemia patients (OR 1.04; 95% CI 0.84-1.28; P = 0.73).
Moreover, the shift toward DES over BMS in recent years is unlikely to make a difference, the study authors suggest, because any potential benefit accruing from reduced restenosis and subsequent unplanned revascularization in DES patients “would still be greatly offset by the marked reduction in overall procedures in the medical therapy group.” They also cite a recent study (Holmes DR Jr. J Am Coll Cardiol. 2010;56:1357-1365) suggesting that DES use might lead to increases in death and MI from late stent thrombosis.
“In the context of controlling rising health care costs in the United States, this study suggests that up to 76 percent of patients with stable CAD can avoid PCI altogether if treated with optimal medical therapy, resulting in a lifetime savings of approximately $9,450 per patient in health care costs,” the authors conclude. The cost estimate is based on data from the COURAGE trial.
Call to ‘Turn the Tide’
In an editorial accompanying the study, COURAGE lead investigator William E. Boden, MD, of the Samuel S. Stratton VA Medical Center (Albany, NY), writes that “given the notable lack of benefit on improving hard clinical outcomes, the continued practice of a PCI-first strategy compared with an [optimal medical therapy-]first strategy in patients with stable CAD may lead to the performance of many unnecessary PCI procedures.”
Dr. Boden adds that the existing fee-for-service system of physician and hospital reimbursement, “clearly encourages a model that is procedurally driven and one that provides differentially enhanced financial rewards to perform more, not less, revascularization.”
He further questions what more it will take to “turn the tide of treatment” toward a primarily optimal-medical-therapy based strategy for patients with stable CAD and chronic angina.
But in a telephone interview with TCTMD, Ajay Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), strongly disagreed with Dr. Boden’s assessment.
“First of all, there’s no new evidence here,” he said. “These are all old studies that are amalgamated, . . . and in some ways, there is inclusion of older studies that actually take away from the newer studies. It is no accident that this meta-analysis is being published in the Archives.”
According to Dr. Kirtane, OAT, TOAT, and DECOPI included only post-MI patients. Yet in his editorial, Dr. Boden criticizes a previous 2008 meta-analysis that showed benefit of PCI vs. optimal medical therapy in stable patients by saying it was “extremely flawed in that it included trials of patients with acute MI and post-MI patients, which largely contributed to the mortality reduction attributed to PCI.”
“I am surmising that the reason Dr. Boden agrees with this analysis is that the conclusions suit his beliefs,” Dr. Kirtane stated.
He also took issue with the study authors’ assertion that DES use may lead to increased death and MI from late stent thrombosis, and with Archives editor Rita F. Redberg, MD, MSc, of the University of California, San Francisco (San Francisco, CA), who states in an editor’s note, “there is no known benefit and there are definite harms” of PCI.
“Any purported ‘definite harm’ of doing PCI is unsubstantiated,” Dr. Kirtane countered. “The only harm is potentially on the cost side. While that is very important, frankly we ought to give our patients a choice as to the best way to treat their symptoms and there have been multiple studies that have demonstrated that PCI is more beneficial than medical therapy for symptom relief.”
Preferences, Quality of Life Important, Too
In a telephone interview with TCTMD, Theodore A. Bass, MD, of the University of Florida College of Medicine (Jacksonville, FL), commented, “We’ve known for some time that in a patient with chronic stable angina, PCI doesn’t offer a clear benefit when it comes to decreasing mortality or MI. The issues that are unclear are the quality of life issues and there is nothing new [in the meta-analysis] that addresses that question.”
Dr. Bass agreed that patient choice is important, since patients with stable CAD may have issues with optimal medical therapy—such as feeling overmedicated or experiencing complications from multiple drugs—that may make PCI a better choice.
“There are many cases where what is considered optimal medical therapy may not be optimal for the patient,” Dr. Bass said. He cited the case of a 78-year-old female patient with chronic stable angina who was intolerant of beta-blockers and feeling lightheaded from the combination of beta-blockers, nitrates, and ACE inhibitors. After a discussion, the patient decided to undergo PCI, which Dr. Bass said resulted in the patient being angina-free.
As far as appropriateness, Dr. Bass said data show that since 2006 there has been roughly a 20% decrease in the number of PCI cases performed in the Medicare population alone.
“If you drill that down a little it seems that the decrease tends to be in this elective, chronic stable population,” he said, citing a recent study showing that less than 30% of all PCIs occur in this segment (Chan P. JAMA. 2011;306:53-61).
Interventionalists “are listening, and we are reacting to new data and we embrace new data. This meta-analysis isn’t new,” Dr. Bass stressed. “We are being much more prudent than in the past when it comes to the chronic stable population, and I think the numbers reflect this.”
2. Boden WE. Mounting evidence for lack of PCI benefit in stable ischemic heart disease: What more will it take to turn the tide of treatment? Arch Intern Med. 2012;172:319-321.
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