Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

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

28.08.2012
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 New England Journal of Medicine that was designed to evaluate the benefits of using a diagnostic tool called fractional flow reserve, or FFR, to help determine the best course of treatment for fixing a narrowed artery.

"We believe there is a significant proportion of patients who benefit from stenting early on as opposed to receiving only medical therapy," said William Fearon, MD, associate professor of cardiovascular medicine 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 heart muscle] 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 heart bypass surgery.

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 coronary artery 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 coronary artery disease. Its findings demonstrated that FFR-guided stenting decreased a patient's chance of dying, having a heart attack or needing a repeat coronary revascularization, 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.

The study was funded by St. Jude Medical, which owns Radi Medical Systems Inc. based in Sweden, one of two companies that make the pressure wires used in the study. Fearon reports receiving an institutional research grant from St. Jude Medical.

Information about Stanford's Department of Medicine, which also supported the study, is available at http://medicine.stanford.edu/.

The Stanford University School of Medicine consistently ranks among the nation's top medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children's Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

PRINT MEDIA CONTACT: Tracie White at (650) 723-7628 (traciew@stanford.edu)
BROADCAST MEDIA CONTACT: M.A. Malone at (650) 723-6912 (mamalone@stanford.edu)

Tracie White | EurekAlert!
Further information:
http://www.stanford.edu

More articles from Health and Medicine:

nachricht Norovirus evades immune system by hiding out in rare gut cells
12.10.2017 | University of Pennsylvania School of Medicine

nachricht Flexible sensors can detect movement in GI tract
11.10.2017 | Massachusetts Institute of Technology

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Smart sensors for efficient processes

Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).

When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...

Im Focus: Cold molecules on collision course

Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.

How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...

Im Focus: Shrinking the proton again!

Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.

It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...

Im Focus: New nanomaterial can extract hydrogen fuel from seawater

Hybrid material converts more sunlight and can weather seawater's harsh conditions

It's possible to produce hydrogen to power fuel cells by extracting the gas from seawater, but the electricity required to do it makes the process costly. UCF...

Im Focus: Small collisions make big impact on Mercury's thin atmosphere

Mercury, our smallest planetary neighbor, has very little to call an atmosphere, but it does have a strange weather pattern: morning micro-meteor showers.

Recent modeling along with previously published results from NASA's MESSENGER spacecraft -- short for Mercury Surface, Space Environment, Geochemistry and...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

World Health Summit 2017: International experts set the course for the future of Global Health

10.10.2017 | Event News

Climate Engineering Conference 2017 Opens in Berlin

10.10.2017 | Event News

Conference Week RRR2017 on Renewable Resources from Wet and Rewetted Peatlands

28.09.2017 | Event News

 
Latest News

A single photon reveals quantum entanglement of 16 million atoms

16.10.2017 | Physics and Astronomy

The melting ice makes the sea around Greenland less saline

16.10.2017 | Earth Sciences

On the generation of solar spicules and Alfvenic waves

16.10.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>