Appropriate utilization of percutaneous coronary interventions (PCI) has been a hot topic among cardiovascular leaders over the past few years (and a common topic on this blog). A recent meta-analysis of eight trials published in the Archives of Internal Medicine promises to add more fuel to the debate by suggesting that patients with stable coronary artery disease (CAD) fare no better with PCI than medical management. Rather than sending patients directly to the cath lab, study authors suggest medical therapy as a first line of defense given the lack of benefit found in treating stable CAD with costly interventions.
Overall, the study found no significant difference in the risk of death, nonfatal MI, unplanned coronary revascularization or angina when the two treatments were compared. The meta-analysis combined data from eight contemporary trials such as the COURAGE, OAT, and BARI 2D studies. All told, 7,229 patients were evaluated, half of whom were randomized to receive both PCI and medical therapy, and half of whom were randomly chosen to receive medical therapy alone. Three of the five studies enrolled patients with stable CAD following an MI while the rest enrolled patients with stable angina and/ or ischemia following a stress test.
The average follow-up time across the eight trials was 4.3 yearsand outcomes from each therapy were shockingly similar, with a mortality rate of 8.9% for stented patients and 9.1% of those who received medical therapy. Furthermore, 8.9% of stented patients experienced nonfatal MI, as opposed to 8.1% of medical therapy patients, and unplanned revascularizations occurred in 21.4% for stented patients and 30.7% for medically managed patients. The study’s authors found none of these results to be statistically significant.
With increased pressure on providers to select the most effective and cost-effective treatments, this study offers data to support physicians in choosing the more cost-effective therapy. In an editorial published alongside the meta-analysis, the author notes that diverting stable CAD patients to medical therapy instead of PCI could save the healthcare system billions of dollars in unnecessary expenses.
Ensuring appropriate, cost-effective treatment selection
Today, more than half of stable CAD patients are treated with PCI without first attempting medical therapy a reality which the study’s authors attribute more to financial motivations than clinical data. Given the profitability of the cardiovascular interventions and the service line’s role as a hospital revenue engine, there are few, if any, stakeholders with an incentive to recommend against stenting. As one of the study authors put it: “when you put in a stent, everyone is happy—the hospital is making more money, the doctor is making more money—everybody is happier except the health care system as a whole, which is paying more money for no better results.”
It is of note that the use of PCI for CAD patients is not without some clinical support; other meta-analyses on this topic have notably shown that PCI does carry some advantage over medical management. However, these studies evaluated patients treated in the 1980s and 1990s when balloon angioplasty was the predominant form of interventional therapy, and medical management did not include today’s regimen of aspirin, statins, ACE inhibitors and beta blockers. The study authors note that theirs is a more up-to-date comparison between optimal medical therapy and coronary intervention than those which have tended to favor PCI over medical management.
With the recent publication of the focused update to the American College of Cardiology’s 2009 appropriate use criteria (AUC) for PCI and CABG, programs are facing significant pressure to ensure appropriateness of coronary interventions. This study compounds those pressures, suggesting that PCI in stable CAD patients, while not inappropriate, may not be the optimal therapy for this specific patient population in an era increasingly defined by heavy cost scrutiny.
That said, with the complexity of CAD and the broad demographic makeup of those affected, PCI may indeed be the optimal therapy for certain patients (such as older individuals or those for whom medical management has not reduced symptoms). No singular treatment pathway is guaranteed to be successful in all patients, so the emphasis should instead focus on ensuring accurate diagnoses and even risk stratifying patients to ensure that any ensuing therapy is ultimately both cost-efficient and effective for each patient.
Recent Roundtable research supporting efforts
Our recent study, The New Economics of Quality, takes a deeper look at addressing the increasing scrutiny over appropriate use, as well as integrating evidence-based practice into clinical pathways through the use of tools such as risk stratification, and multidisciplinary decision making teams.
For additional information on the growing appropriate use mandate, please register for our ongoing 2011-2012 national meeting series, where we take a deeper look at the increasing scrutiny over utilization of CV services, including the increasing pressure on administrators to ensure appropriate use of PCI.