Compared with a strategy of initial medical therapy alone, coronary stent implantation plus medical therapy for stable CAD is not associated with improved outcomes. The data come from a meta-analysis of eight previously published clinical trials. While PCI reduces death and nonfatal MI in acute coronary syndrome settings, its role may be limited in treating stable coronary artery disease (CAD), according to the analysis published in Archives of Internal Medicine.1

Kathleen Stergiopoulos, M.D., Ph.D, and David L. Brown, M.D., of Stony Brook University Medical Center, New York, analyzed data encompassing 7,229 patients between 1997 and 2005.. Of those patients, 3,617 were randomized to stent placement and medication therapy and 3,612 were randomized to receive medication therapy alone.
 
The authors noted that their work differs from previous studies. "By limiting the analysis to studies in which stent implantation was the predominant form of PCI, this meta-analysis, for the first time that we know of, compares contemporary versions of PCI and medical therapy. The exclusion of studies using balloon angioplasty as the primary form of PCI shifted the years of enrollment forward by almost a decade during which time optimal medical therapy evolved to the current regimen that includes aspirin, β-blockers, ACE-inhibitors (or angiotensin receptor blockers) and statins," they note.

Of the total 649 deaths among the 7,229 patients in the trials, 322 occurred among 3,617 patients in the stent groups (8.9%) and 327 occurred among 3,612 patients in the medical therapy groups (9.1%). Similar rates for both groups were found for other outcomes: nonfatal MI (8.9% vs. 8.1%, respectively), unplanned revascularization (21.4% vs. 30.7%), and even persistent angina (29% vs. 33%).

"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.

Take-Away
In an accompanying editorial, William E. Boden, M.D., Samuel S. Stratton VA Medical Center, Albany, NY, wrote: "What is the practicing clinician to take away from the present study in the context of other published meta-analyses?2 First, the totality of evidence does not support any demonstrable clinical benefit for PCI in patients with stable CAD in terms of reducing death, nonfatal MI, hospitalization for ACS (acute coronary syndrome), need for unplanned revascularization and a durable, sustained effect on angina relief."

Also, he noted, "…given the spiraling health care costs that we have witnessed in the United States over the past decade, and the financial burden this places on our existing health care system, businesses and health care consumers, we certainly have abundant scientific evidence to support a more selective, measured and balanced approach to the initial management of SIHD (stable ischemic heart disease) and one that promotes and embraces optimal medical therapy for the majority of patients as a proven alternative to revascularization."

So, Who Does Need PCI?
Recently updated ACC guidelines for managing PCI offer recommendations on how to determine optimal care for patients with stable ischemic CAD.3  For example, the writing committee advocates using a SYNTAX score in decision making regarding treatment of patients with multivessel disease. 

Introduced in the SYNTAX study, published in the New England Journal of Medicine in 2009, this scoring system estimates the extent and complexity of CAD by entering the patient’s angiography results into a computer-based “SYNTAX score calculator.” While this calculation is complex, using the score to classify extent of disease more objectively may help guide decisions regarding CABG or PCI.

The revised PCI guidelines further help eliminate ambiguity by providing specific recommendations for the first time for every anatomic subgroup of patients with stable CAD. Recommendations on revascularizing patients are provided based on improving both survival and symptoms. While it has historically been hard to obtain data for each subgroup, leading to their exclusion from previous guidelines, the 2011 committee conducted an extensive effort to find information so that each group could be included, whether at a level of evidence A (multiple randomized, controlled trials) or a level of evidence C (expert recommendations or case studies).

References

1. Stergiopoulos K, Brown DL. Initial Coronary Stent Implantation With Medical Therapy vs Medical Therapy Alone for Stable Coronary Artery Disease: Meta-analysis of Randomized Controlled Trials. Arch Intern Med 2012;172:312-9.
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;172:319-21.
3. Levine GN, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol 2011;58:e44-122.  http://content.onlinejacc.org/cgi/content/full/58/24/e44

 

Keywords: Acute Coronary Syndrome, Health Care Costs, Angioplasty, Balloon, Coronary, Hospitalization, Stents

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