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Study By Cardiologists At Northwestern Memorial Reveals A High Percentage Of Heart Patients Receive Off-Label And Untested Drug-Coated Stents
A one-year study of roughly 5,500
patients who underwent angioplasty for the insertion of drug-eluting stents
(DES) found that nearly half of those patients -- some 47 percent -- did
not fit the standard, approved indications for use set by the Food & Drug
Administration. The study, which appears in the May 9 issue of JAMA,
observed that at the one-year mark, absolute event rates for the
occurrences of complications associated with DES implantation, such as
clotting and even death, were virtually no different from patients who
received DES under the FDA's indications for approved use. Furthermore, the
study also demonstrated durable efficacy in preventing re-narrowing of the
artery.
"We set out to systematically evaluate and compare the frequency of
use, the safety and the effectiveness of drug-eluting stents in off-label
and untested use versus standard use," said Nirat Beohar, MD, department of
cardiology at Northwestern Memorial Hospital and assistant professor of
medicine at Northwestern University's Feinberg School of Medicine. "Our
results showed that patients are receiving stents that are either off-label
or untested nearly half of the time. And, we were pleasantly surprised to
learn that these patients fared just as well as those who received the
stents under standard use."
DES represents the newest generation of stents in that they are coated
with drugs that are meant to prevent the instance of blood clots. As Beohar
explains, current FDA indications for DES use are narrowly defined and
therefore many heart patients' symptoms will not fit the criteria. However,
as the study concludes, use of DES outside of the FDA's approved guidelines
has proliferated. This is largely due to the emergence of clinical trials
that deem "off-label" and "untested" DES use as being safe and effective.
For the purposes of this study, off-label use meant that patients
received the DES although they did not meet approved indications, and
untested stents were those where the safety and effectiveness of the DES
had not been established for the applied use or treatment.
The study reviewed records for 7,752 percutaneous coronary intervention
treated patients from 140 hospitals and medical centers. Roughly 90 percent
of those patients received DES. Of that lot, 84 percent received DES and no
other devices. It was then determined that roughly 95 percent, or 5,541, of
those patients either received standard, off-label and untested use for
DES, and it was this subgroup that was examined and followed for the
purpose of this study. The research measured in-hospital, 30-day and
one-year outcomes in an observational, prospective and multicenter
registry.
About Northwestern Memorial Hospital
Northwestern Memorial Hospital is one of the country's premier academic
medical centers and the primary teaching hospital for Northwestern
University's Feinberg School of Medicine. Northwestern Memorial and its
Prentice Women's Hospital and the Stone Institute of Psychiatry have 744
inpatient beds, 6,625 employees and 1,464 physicians on the medical staff.
Northwestern Memorial is recognized for outstanding clinical and surgical
advancements in women's health, cardiovascular care, oncology, neurology
and neurosurgery, solid organ and bone marrow transplantation and
orthopaedics.
Northwestern Memorial has consistently been ranked by healthcare
consumers as the "most preferred" hospital in the Chicago region for more
than a decade and several of its clinical specialties continue to be listed
in U.S. News & World Report's annual issue of "America's Best Hospitals".
In addition, the hospital has been named as one of the "100 Best Companies
for Working Mothers" by Working Mother magazine for seven consecutive
years.
In 2005 Northwestern Memorial was the sole recipient of the prestigious
National Quality Healthcare Award and is recognized as a national leader
for efforts to improve quality and patient safety. And in 2006, the
hospital achieved Magnet recognition, the gold standard for nursing
excellence.
Northwestern Memorial Hospital
http://www.nmh.org
Studiul de Cardiologists Memorialul de la nord-vest, aratã un procent ridicat de pacienþi inima primi off-etichetã ºi netestat de droguri cu înveliº de Stents - Study By Cardiologists At Northwestern Memorial Reveals A High Percentage Of Heart Patients Receive Off-Label And Untested Drug-Coated Stents - articole medicale engleza - startsanatate