Study examines stent implantation compared to initial medical therapy for stable coronary disease

February 27, 2012

A meta-analysis of eight previously published clinical trials suggests that initial stent implantation for patients with stable coronary artery disease is not associated with improved outcomes compared with initial medical therapy for prevention of death, nonfatal heart attacks, unplanned revascularization or angina, according to a study published in the Feb. 27 Archives of Internal Medicine. The article is part of the journal's Less is More series.

While percutaneous (PCI) reduces death and nonfatal (MI, ) in settings, its role in treating stable (CAD) "remains controversial," the authors write in their study background.

Kathleen Stergiopoulos, M.D., Ph.D, and David L. Brown, M.D., of Stony Brook University Medical Center, New York, conducted a meta-analysis of previous randomized clinical trials that compared initial coronary and medical therapy with initial medical therapy alone. Eight trials that enrolled 7,229 patients between 1997 and 2005 were included. Of those patients, 3,617 were randomized to receive stent placement and medication therapy and 3,612 were randomized to receive alone.

"The significant finding of this analysis is that compared with a strategy of initial medical therapy alone, implantation in combination with medical therapy for stable CAD is not associated with a significant reduction in mortality, nonfatal MI, unplanned revascularization or angina after a mean (average) follow-up of 4.3 years," the researchers comment.

They explain their results are in contrast to two recent meta-analyses that found reductions in mortality and angina (discomfort, tightness or heaviness in the chest) in patients assigned to initial PCI. They suggest that an aspect of the current study may explain the difference.

"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 percent) and 327 occurred among 3,612 patients in the medical therapy groups (9.1 percent). Nonfatal MI was reported in 323 of 3,617 patients in the stent groups (8.9 percent) compared with 291 of 3,612 patients in the medical therapy groups (8.1 percent.) Unplanned revascularization was performed in 774 of 3,617 stent patients (21.4 percent) and 1,049 of 3,420 medical therapy patients (30.7 percent).

Data on angina were available for 4,122 patients. Among the initial stent implantation patients, 597 of 2,070 experienced persistent angina (29 percent) compared with 669 of 2,052 medical therapy patients (33 percent).

"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.

In an invited commentary, William E. Boden, M.D., of the Samuel S. Stratton VA Medical Center, Albany, N.Y., writes: "What is the practicing clinician to take away from the present study in the context of other published meta-analyses? 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 relief."

He continues: "Finally, 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 for the majority of patients as a proven alternative to ."

Explore further: Coronary artery stenting viable palliative option for infants and toddlers

More information: Arch Intern Med. 2012;172[4]:312-319; 172[4]:319-321.

Related Stories

Coronary artery stenting viable palliative option for infants and toddlers

August 22, 2011
Percutaneous coronary intervention (PCI) is not a generally accepted option for infants or toddlers with acute coronary syndrome. However, a new report published in the August issue of Catheterization and Cardiovascular Interventions, ...

Lessons from major heart trial need implementation

May 10, 2011
A NewYork-Presbyterian Hospital/Weill Cornell Medical Center review of almost 500,000 cardiac cases nationally shows that the clinically indicated medical therapy reported in a widely publicized study was lost in translation ...

Most PCIs (such as balloon angioplasty) performed in US for acute indications appear warranted

July 5, 2011
In an examination of the appropriateness of the widespread use of percutaneous coronary interventions (PCIs), researchers found that of more than 500,000 PCIs included in the study, nearly all for acute indications were classified ...

Recommended for you

How Gata4 helps mend a broken heart

August 15, 2017
During a heart attack, blood stops flowing into the heart; starved for oxygen, part of the heart muscle dies. The heart muscle does not regenerate; instead it replaces dead tissue with scars made of cells called fibroblasts ...

Injectable tissue patch could help repair damaged organs

August 14, 2017
A team of U of T Engineering researchers is mending broken hearts with an expanding tissue bandage a little smaller than a postage stamp.

Air pollution linked to cardiovascular disease; air purifiers may lessen impact

August 14, 2017
Exposure to high levels of air pollution increased stress hormone levels and negative metabolic changes in otherwise healthy, young adults in a recent study conducted in China. Air purifiers appeared to lessen the negative ...

Study hints at experimental therapy for heart fibrosis

August 14, 2017
Researchers report encouraging preclinical results as they pursue elusive therapeutic strategies to repair scarred and poorly functioning heart tissues after cardiac injury—describing an experimental molecular treatment ...

Scientists identify mutations in venous valve disease

August 14, 2017
A team of scientists has discovered that mutations in the genes FOXC2 and GJC2 are associated with defects in venous valves, flaps within veins that help maintain proper blood flow.

Mechanism behind sudden cardiac deaths in sports uncovered

August 10, 2017
Researchers have worked out the mechanism behind sudden cardiac deaths that follow a hard blow to the chest.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.