Early use of stents better than medical therapy alone for certain patients

August 28, 2012 in Cardiology

For patients with stable coronary artery disease who have at least one narrowed blood vessel that compromises flow to the heart, medical therapy alone leads to a significantly higher risk of hospitalization and the urgent need for a coronary stent when compared with therapy that also includes initial placement of artery-opening stents.

Those are the findings of a study to be published online Aug. 28 in the that was designed to evaluate the benefits of using a diagnostic tool called fractional , or FFR, to help determine the best course of treatment for fixing a narrowed artery.

"We believe there is a significant proportion of who benefit from stenting early on as opposed to receiving only ," said William Fearon, MD, associate professor of at the Stanford University School of Medicine and co-principal investigator and senior author of the multi-center international trial called FAME 2. "For this group of patients who have significant ischemia [blood vessel narrowing that compromises flow to the ] based on assessment with FFR, the need for hospitalization and urgent revascularization is much higher and the pain relief is much less when only medical therapy is prescribed. People feel better and do better with FFR-guided placement of coronary stents up front in this setting."

The study's principal investigator is Bernard De Bruyne, MD, PhD, of Cardiovascular Center Aalst in Belgium.

The trial was halted early, on Jan. 15, because of the high rates of hospitalization and coronary stenting needed in the patients with significant ischemia who received only medical therapy. Some of those patients had suffered subsequent chest pain and heart attacks requiring urgent revascularization, which entails repairing damaged blood vessels with emergency stenting or .

Narrowing of the arteries caused by buildup of atherosclerotic plaque is common. About 40 percent of Americans over the age of 60 have one or more narrowings in the coronary arteries but no symptoms or stable symptoms, a condition known as stable disease. Many can be treated with medical therapy alone, which may include aspirin or statins.

The idea for this trial grew out of the landmark COURAGE trial, presented in 2007, which found that stenting didn't provide any significant benefits over medical therapy for people with stable coronary artery disease. That trial relied solely on X-rays from coronary angiograms and noninvasive stress tests to determine which patients needed stenting.

The FAME 1 trial, which Fearon also helped coordinate, published in the NEJM in 2009 showed that doctors should go one step beyond the traditional method of relying solely on angiograms and use the additional method of measuring FFR to determine which arteries should or should not be stented for patients with . Its findings demonstrated that FFR-guided stenting decreased a patient's chance of dying, having a heart attack or needing a repeat coronary , and reduced the number of stents necessary, thereby saving money.

The FAME 2 trial also used FFR, which involves inserting a coronary pressure guide wire into the artery to measure blood flow. In this study, it helped doctors pinpoint which patients would benefit from early stenting, as it identifies vessels with blood flow reduced to a dangerous level. As the study documented, these patients need stenting to prevent future adverse events.

"It's hard to know which patients are ischemic and which are not," said Morton Kern, MD, professor of cardiology at the University of California-Irvine. Kern was not directly involved with research on the study, but was a consultant on safety. "FFR is a very simple marker to help identify ischemia."

The cost is low, an additional $700 compared to the average cost of a stent, which is roughly $2,000. And the FFR technology is available to most physicians, he said.

The study included 888 patients with at least one stenosis—one significantly narrowed artery causing ischemia—that was identified with FFR. An artery was considered seriously narrowed if the blood pressure was 80 percent or less past the narrowing than the pressure in front of the narrowing. Patients were enrolled in 28 centers in Europe, the United States and Canada. Fifty patients were enrolled at Stanford University Medical Center and the Veterans Affairs Palo Alto Health Care System in the portion of the trial led by Fearon.

Trial participants were randomly assigned to either medical therapy alone or medical therapy combined with stenting.

Patient enrollment began May 15, 2010. By Jan. 15 of this year, 75 patients in the trial had experienced at least one "cardiac event," such as the need for hospitalization and an urgent stent or a heart attack. The rate of these events was 4.3 percent for patients randomized to stents plus medical therapy compared with 12.7 percent in patients assigned to medical therapy.

Journal reference: New England Journal of Medicine search and more info website

Provided by Stanford University Medical Center search and more info website

not rated yet  

Rank not rated yet
Relevant PhysicsForums posts

More news stories

Heart failure accelerates male 'menopause'

Heart failure accelerates the aging process and brings on early andropausal syndrome (AS), according to research presented today at the Heart Failure Congress 2013. AS, also referred to as male 'menopause', was four times ...

Cardiology created 3 hours ago | popularity not rated yet | comments 1

Death highest in heart failure patients admitted in January, on Friday, and overnight

Mortality and length of stay are highest in heart failure patients admitted in January, on Friday, and overnight, according to research presented today at the Heart Failure Congress 2013. The analysis of nearly 1 million ...

Cardiology created 3 hours ago | popularity not rated yet | comments 0

First drug to improve heart failure mortality in over a decade

Coenzyme Q10 decreases all cause mortality by half, according to the results of a multicentre randomised double blind trial presented today at Heart Failure 2013 congress. It is the first drug to improve heart failure mortality ...

Cardiology created 3 hours ago | popularity not rated yet | comments 4

Registry confirms TAVI efficacy and safety in Asian patients

Transcatheter aortic valve implantation (TAVI) is effective and safe in Asian patients, according to early experience based on first results from a multicentre Asian registry reported at EuroPCR 2013.

Cardiology created 22 hours ago | popularity not rated yet | comments 0

Diagnostic coronary angiography: Functional flow reserve changes decisions in 25 percent of cases

Routinely measuring fractional flow reserve (FFR) using pressure wire assessment during coronary angiography for diagnosis of chest pain leads to significant changes in the management of one in four patients, according to ...

Cardiology created May 24, 2013 | popularity not rated yet | comments 0


Hormone levels may provide key to understanding psychological disorders in women

Women at a particular stage in their monthly menstrual cycle may be more vulnerable to some of the psychological side-effects associated with stressful experiences, according to a study from UCL.

Researchers identify first drug targets in childhood genetic tumor disorder

Two mutations central to the development of infantile myofibromatosis (IM)—a disorder characterized by multiple tumors involving the skin, bone, and soft tissue—may provide new therapeutic targets, according to researchers ...

Feds fight morning-after pill age ruling in NY

(AP)—Department of Justice lawyers have again asked a federal appeals court in New York to delay lifting age restrictions and prescription requirements on an emergency contraceptive popularly known as the morning-after ...

Going live: Immune cell activation in multiple sclerosis

Biological processes are generally based on events at the molecular and cellular level. To understand what happens in the course of infections, diseases or normal bodily functions, scientists would need to ...

Driving and hands-free talking lead to spike in errors, study shows

Talking on a hands-free device while behind the wheel can lead to a sharp increase in errors that could imperil other drivers on the road, according to new research from the University of Alberta.

Comorbidities common with alopecia areata

(HealthDay)—Comorbid conditions often accompany alopecia areata, according to a study published online May 22 in JAMA Dermatology.