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Swedish Registry Reverses Conclusions:
"Drug
Eluting Stents Are Not Dangerous"
Latest DES Analysis
Stresses Importance of Physicians Well-Trained in
Implantation
Technique and Patient Follow-Up
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September 2, 2007 -- Washington -- New data about the safety of drug- eluting stents (DES) translates
into excellent news for thousands of
patients with cardiovascular disease, according to The Society for
Cardiovascular Angiography and Interventions (SCAI). These new findings
also underscore the crucial importance of training physicians in the proper
selection of patients, proper implantation technique, and in prescribing a
strict regimen of medications that prevent blood clots in the first one to
two years after DES implantation.
Findings announced this morning from the European Society of Cardiology
Congress indicate that patients treated with DES benefit from a 50 percent
reduction in restenosis, the re-clogging of arteries that has plagued bare
metal stents, with no increased long-term risk. This is in direct contrast
to last year's findings based on shorter-term observation of patients from
the same registry, which led to widespread concern about whether the
devices cause dangerous blood clots and may have dissuaded some patients
and their doctors from treatment with DES.
Describing the findings as "reassuring news for patients with
cardiovascular disease," SCAI President Bonnie H. Weiner, M.D., FSCAI,
Professor of Medicine and Interim Chair of Cardiovascular Medicine at St.
Vincent Hospital at Worcester Medical Center in Worcester, MA said,
"Patients and physicians have been confused about stents, and we have been
concerned that last year's headlines may have prevented some patients from
getting the best therapy. This report is consistent with all other data on
the benefits of DES and reaffirms the value of drug-eluting stents as a
highly effective tool to open blocked arteries and stop regrowth of plaque
and scar tissue in those vessels."
After tracking over 13,000 patients for up to 4 years after
implantation of stents, Swedish Coronary Angiography and Angiolasty
Registry (SCAAR) lead investigator Dr. Stefan James stated that
"drug-eluting stents are not dangerous," but he pointed out that in a very
small percentage of patients (0.5 percent per year) blood clots may form in
these stents. This is in stark contrast to the 50 percent decrease in
repeat artery narrowing in DES compared to in that in bare metal stents.
"The SCAAR data represent 'real-world' outcomes that show how Swedish
doctors' technique improved over time because of more experience implanting
drug-eluting stents resulting in improved outcomes for patients," says SCAI
Secretary Steven R. Bailey, M.D., FSCAI, Interim Chief of the Division of
Cardiology, Professor of Medicine and Radiology, and Janey Briscoe
Distinguished Chair at the University of Texas Health Sciences Center at
San Antonio. "Our patients can be reassured by these findings. If their
interventional cardiologist chooses to implant a drug-eluting stent, they
are receiving a safe and effective treatment."
To explain the new findings, Dr. Weiner points to indications that
physicians' technique with the stents has improved and stent patients are
now more likely to be on strict regimens of anti-clotting medications for a
longer period. SCAI reemphasizes the need for high-quality education and
training that will guide physicians in evaluating the benefits and risks of
DES for each patient, depending on his or her age, gender, co-morbid
conditions, and complexity of disease.
In addition, both physicians and patients need further education on the
importance of a strict regimen of both clopidogrel and aspirin, two drugs
that help prevent the formation of blood clots. SCAI, a leader in physician
education, urges doctors to review the Clinical Alert
the Society issued in
early 2007,
which stresses that physicians must take care to use DES in the right
patients and the right blood vessels, and only if the patient is willing
and able to comply to a long-term regimen of clopidogrel and aspirin.
"SCAI is committed to education and training that helps physicians
assess which patients will benefit from drug-eluting stents, use the best
implantation technique, and prescribe the right drugs after stent," says
Dr. Weiner. "The new SCAAR data re-affirm all the other available results
concerning DES, particularly from the clinical trials, showing significant
patient benefit and no additional long-term risk."
Headquartered in Washington, DC, the Society for Cardiovascular
Angiography and Interventions is a 3,700-member professional organization
representing invasive and interventional cardiologists in 70 nations.
SCAI's mission is to promote excellence in invasive and interventional
cardiovascular medicine through physician education and representation, and
advancement of quality standards to enhance patient care. SCAI's annual
meeting has become the leading venue for education, discussion, and debate
about the latest developments in this dynamic medical specialty.
Source: Society for Cardiovascular
Angiography and Interventions
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