Drug-eluting stents (or coated stents,
or medicated stents) have been touted as solving
one
of the
biggest
problems
of interventional
coronary
treatment:
restenosis -- or reclosure of the
artery. And the "Stent
Wars" among the various manufacturers continue.
Boston Scientific's TAXUS paclitaxel drug-eluting stent and
the Johnson & Johnson/Cordis
CYPHER sirolimus drug-eluting stent continue to vie for market
share, while Medtronic's Endeavor is looking for 2007 U.S.
approval. Abbott's Xience stent is next in line. For more
information, features
and interviews, visit our Drug-Eluting
Stent Center.
If you wish a different date range,
select from the following menu:
(Disclaimer: the
following links to news, press releases and other
timely information
sources about drug-eluting stents are provided as
a service by Angioplasty.Org, which is not responsible
for the content found on any external sites. Items
marked with a ($$) indicate that the external
site normally restricts viewing to paid subscribers.
Other sites may require free registration.)
April 22, 2008 Study
in JAMA Shows Patients Treated With Abbott's XIENCE™ V Drug Eluting
Stent Experience Better Outcomes
Than Patients Treated With Market-Leading Drug Eluting Stent
A study published in today's Journal of the American Medical Association (JAMA)
demonstrated that use of Abbott's XIENCE™ V Everolimus Eluting Coronary
Stent System in patients with coronary artery disease resulted in a significant
50
percent reduction in vessel renarrowing (in-segment late loss) at eight months,
non-inferior rates of target vessel failure (TVF) at nine months, and an observed
42 percent reduction in major adverse cardiac events (MACE) at one year compared
to the TAXUS® Paclitaxel-Eluting Coronary Stent System. (Read
more...)
March 26, 2008 FDA Makes Recommendations on
Medical Devices That Treat Blocked Heart Arteries
16 months after the FDA held hearings about safety issues with drug-eluting
stents, the Agency has issued draft guidelines for future approvals. The guidelines
include 12 months of initial data, with five years of follow-up. Today's draft
guidance has a public comment period of 120 days. (Read
more...)
March 19, 2008 Cook
Medical Announces the Launch and First Patient Enrollment of the REFORM Clinical
Trial
The FDA has approved initiation of the REFORM clinical trial, officials of
Cook Medical announced today. The REFORM trial is designed to evaluate the
Formula™ Balloon Expandable Stent for the treatment of renal artery stenosis,
a narrowing of the renal artery that can result in hypertension, renal atrophy,
and kidney failure if left untreated. (Read
more...)
March 11, 2008 Abbott
Receives CE Mark for Smaller-Size XIENCE™ V Drug Eluting Stent Abbott announced today that it has received CE Mark (Conformité Européene) approval for a 2.25 mm version of its XIENCE™ V Everolimus Eluting Coronary Stent System, offering physicians a smaller stent based upon the proven efficacy, positive safety results and excellent deliverability of XIENCE V. (Read more...)
February 27, 2008 New "Y"-Shaped
Stent Studied by Medtronic
Today Medtronic, Inc. announced the first human use of its new investigational
bifurcation stent. The new stent employs an innovative Y-shaped design to match
the anatomy of lesions that form at the junctions of coronary arteries. Dr.
Robert Whitbourn, associate professor and director of the Cardiovascular Research
Centre at St Vincent's Hospital in Melbourne, performed the first clinical
implant of the new device on Feb. 25 as an investigator in the trial, dubbed
the BRANCH study. (Read
more...)
February 15, 2008 US judge increases damages against
Boston Scientific in stent patent case; award totals $501M (Mark Jewell, Associated Press)
A patent judgment against Boston Scientific Corp. has jumped to $501 million
after a judge tacked on an additional $69 million in interest. U.S. District
Judge John Ward ruled Thursday to expand the damages award -- decided by a
federal jury in Marshall, Texas -- to cover interest on royalties dating to
the medical device maker's 2004 U.S. launch of drug-coated heart stents. (Read
more...)
February 13, 2008 Paclitaxel-Coated
Balloon Keeps Leg Arteries Open (Gene Emery,
Reuters)
Balloons coated with a common cancer drug can help keep blood flowing
in clogged leg arteries better than plain angioplasty balloons, German researchers
reported
Wednesday. These so-called drug eluting balloons have been seen as an alternative
to drug-coated stents -- little mesh tubes often used to hold an artery open
after angioplasty. (Read
more...)
February 5, 2008 Stopping
Plavix Doubles Risk of Heart Attack or Death for 90 Days, With or
Without Stents
A study appearing in tomorrow's Journal of the American Medical Association (JAMA)
reports a two-fold increase in death and heart attack in the 90 days after heart
patients completed their prescribed course of medical therapy with clopidogrel
(Plavix). The study suggests there may be a rebound effect with clopidogrel that
may have major implications for acute coronary syndrome and stent patients.
A study author also makes recommendations for what patients should do. (Read
more...)
February 5, 2008 Boston Scientific posts $458M 4Q loss
Costs from Boston Scientific Corp.'s $27 billion acquisition of Guidant Corp.
continue to erode the company's bottom line, but Boston Scientific sees signs
of turnarounds in drug-eluting stent and pacemaker / defibrillator markets. (Read
more...)
February 1, 2008 FDA
Approves Medtronic's Drug-Eluting Stent
Following the unanimous recommendation of its advisory panel in October,
the FDA today approved Medtronic's Endeavo® Zotarolimus Drug-Eluting
Stent System, making it the third DES available in the U.S. and the
first approval
in almost four
years (Read
more...)
February 1, 2008 NICE
Issues Final Guidance on Drug-Eluting Stents for the Treatment
of Coronary
Artery Disease
The draft guidance recommends the use of drug-eluting stents (DES) for those
patients who are at higher risk of needing further stents if a conventional
bare-metal stent (BMS) were used instead. These patients have a coronary artery
less than 3mm in diameter, or the segment of the artery to be treated is longer
than 15mm. The draft guidance also states that drug eluting stents should only
be used if the price difference between it and a bare metal stent is no more
than £300. (Read more...)
January 16, 2008 Terumo Receives CE Certificate for Nobori™ Drug-Eluting Stent
The Nobori™ stent system is a truly new generation drug eluting stent (DES)
with a bioresorbable polymer, offering best in class clinical results, excellent
deliverability and strong patient safety profile. The company intends to launch
the product shortly and to expand to more than 20 countries during the first
quarter of fiscal year 08. (Read more...)
November 29, 2007 Boston
Scientific Welcomes FDA Panel Recommendation to Approve PROMUS™ /
XIENCE™ V Everolimus-eluting Coronary Stent System
"Today's recommendation is a significant step toward making Boston Scientific's
two-drug program a reality in the United States," said Hank Kucheman, Senior
Vice President and President of Boston Scientific's Cardiovascular business. "Once
approved in the United States, the PROMUS stent system -- together with our
proven and market-leading TAXUS stent technology -- will enable Boston Scientific
to offer physicians and their patients a choice of two distinct drugs, each
on a highly deliverable stent platform." (Read more...)
November 29, 2007 FDA
Advisory Panel Recommends Approval for Abbott's XIENCE™ V Drug Eluting
Heart Stent
The FDA Circulatory System Devices Advisory Panel, which met today to hear data
and opinions from the manufacturer, as well as outside experts, on the safety
and efficacy of Abbott's XIENCE V Drug-Eluting Stent, has voted 9-to-1 to recommend
approval. The FDA is not required to follow the Panel's recommendation, but usually
does. This vote augurs the possibility of four drug-eluting stents on the U.S.
market next year. (Read
more...)
November 27, 2007 Abbott to Present
Comprehensive Safety and Efficacy Data on XIENCE™ V Drug Eluting
Stent to FDA Advisory Committee on November 29
"The data we have submitted to the FDA to support the approval of XIENCE V
is robust, consistent across several independent randomized trials and shows
sustained positive results over time," said John M. Capek, Ph.D., executive
vice president, Medical Products, Abbott. "XIENCE V is the only drug eluting
stent that has demonstrated clinical superiority over another drug eluting
stent in a randomized clinical trial, and we look forward to sharing our data
with the FDA Advisory Panel as they review this important new technology for
physicians and patients." (Read
more...)
November 12, 2007 About Those Stents:
Tiny Time Bombs in Your Heart...or Not? (The Editor's Blog)
Recent studies have reversed the conclusions of a year ago, regarding
the safety of drug-eluting stents, according to an article in this
morning's New York Times. So what has changed? (Read
more...)
November 5, 2007 FDA
Panel to Review Abbott's XIENCE™ V Drug-Eluting Stent (Angioplasty.Org Feature)
Such a review for Abbott's stent has been a topic of
speculation
in
the interventional cardiology community for some time, especially on the heels
of
the same Panel's
review and unanimous recommendation last month of Medtronic's Endeavor® drug-eluting
stent. (Read
more...)
November 5, 2007 Abbott
Confirms FDA Advisory Panel to Review XIENCE™ V Drug Eluting Stent
on November 29 (Abbott Laboratories)
Abbott announced today that the U.S. Food and Drug Administration (FDA) has
confirmed a Circulatory Systems Devices Advisory Panel meeting on November 29,
2007, to review the company's Premarket Approval (PMA) submission for the XIENCE™ V
Everolimus Eluting Coronary Stent System. (Read
more...)
November 2, 2007 Market
For Drug-Eluting Stents Grows Crowded (Peter Benesh, Investor's Business Daily)
The race is on among medical device makers to grab bigger pieces of
a shrinking market for cardiovascular stents. The latest entrant is
Medtronic, with Abbott
Labs coming up fast on incumbents Boston Scientific and the Cordis unit
of Johnson & Johnson. (Read
more...)
October 10, 2007 FDA Advisory Committee
Recommends Medtronic's Endeavor® Drug-Eluting Stent for Approval
The long-awaited review of Medtronic's entry into the U.S. drug-eluting stent
market happened today and the Endeavor stent has received unanimous approval
from the FDA Circulatory Devices Panel -- an approval usually followed by the
FDA.
This development
augurs
well for Medtronic to be the third drug-eluting stent, possibly by the end
of the year. (Read
more...)
September 4, 2007 International study
shows risks from drug-coated stents in some heart attack patients (source: Associated Press)
Some heart attack patients, those with elevated ST segments, would be better
off if their doctors avoided using drug-coated stents to open their clogged
arteries,
an
international
study
found, raising new concerns about the devices.
The study, presented Tuesday, showed that heart attack patients who received
drug-coated stents in an emergency situation were five times more likely to
die after two years than those who received bare metal stents. (Read
more...)
September 2, 2007 New research shows drug-coated
stents may not significantly increase risk of blood clots (source: AP)
Last year, research suggested that the devices were responsible
for an increased number of fatal blood clots. But on Sunday, Dr. Stefan James
of
the
Uppsala
Clinical Research Centre in Sweden presented follow-up results from last year's
study to the European Society of Cardiology conference, which runs until Wednesday
in Vienna. (Read
more...)
September 2, 2007 Swedish Registry States: Drug
Eluting Stents Are Not Dangerous
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. (Read
more...)
September 2, 2007 Safety Profile of TAXUS®
Liberte™ Stent System Highlighted in World's Largest
Stent Registry
The one-year results demonstrated a low overall 3.9 percent rate of TAXUS Liberte
stent related cardiac events, including cardiac death (1.1 percent), myocardial
infarction (0.9 percent), and TAXUS Liberte stent related re-intervention of
the target vessel (2.5 percent). The one-year stent thrombosis rate was 0.8
percent, which is consistent with safety data from other DES registries. (Read
more...)
August 27, 2007 British doctors protest new heart stent proposal (source: Associated Press)
British heart doctors are trying to defeat a proposal to end government coverage
of drug-coated heart stents, tiny metal-mesh tubes that prop open clogged arteries.
The proposal was made by Britain's National Institute for Health and Clinical
Excellence, which has the lead role in deciding what the country's health system
pays for. (Read
more...)
July 19, 2007 Boston
Scientific Announces First Implant of TAXUS® Element™
Platinum Chromium Stent
The TAXUS Element Stent features the proprietary Platinum Chromium Alloy, designed
specifically for stents. This alloy, coupled with an innovative new stent design,
is designed to enable thinner struts, increased flexibility, and a lower profile
while improving radial strength, recoil, and radiopacity. (Read
more...)
July 2, 2007 Medtronic ENDEAVOR IV Drug-Eluting
Stent Clinical Trial Meets Primary Endpoint
Medtronic announced today that results from its Endeavor IV clinical trial
showed that its new drug-eluting stent achieved its endpoint of non-inferiority
with Boston Scientific's Taxus stent. The study of over 1,500 patients will
become part of the data on over 4,100 patients worldwide that will be submitted
to the FDA in the fall as the basis for approval of the Endeavor in the U.S. (Read
more...)
June 15, 2007 Cordis Resolves FDA CYPHER Stent
Warning Letter
The lifting of the warning letter means that Cordis is now free to seek expanded
indications for the CYPHER stent, and to submit next generation devices for
approval. Currently, the company markets a "more deliverable"
version of the CYPHER in Europe. (Read
more...)
June 8, 2007 Consumer
Reports Gives Incorrect Information About Angioplasty and CT Angiograms
Last week Consumer Reports posted their recommendations on angioplasty and CT
angiograms, as part of their CR Medical Guide web site. The article is riddled
with incorrect information and assumptions and leaves one with the impression
that coronary artery disease is best treated with medications alone, or bypass
surgery. (Read
more...)
June 1, 2007 Abbott XIENCE™ Drug-Eluting
Stent Submitted for FDA Approval
Abbott has completed its FDA application and is hoping for a first quarter
2008 approval for the drug-eluting stent it acquired from Guidant. The application
also includes a request for approval of a private-label version, called PROMUS,
to be marketed by Boston Scientific. (Read
more...)
Advertisement
:
May 30, 2007 Most Heart Stents Are Placed
Imperfectly, Increasing Risk of Heart Attack or Reclosure
Results of a new study show that stent placement involves a "geographic
miss" two-thirds of the time, resulting in a three-fold increased
risk of heart attack and a two-fold increase in reintervention. The article
includes interviews with Dr. Marco Costa of the University of Florida College
of Medicine in Jacksonville, chief investigator for the S.T.L.L.R. study, and
Dr. Antonio Colombo of Columbus and San Raffaele Hospitals in Milan, Italy (Read
more...)
May 22, 2007 No
Late Stent Thrombosis for Medtronic Endeavor Drug-Eluting Stent
Medtronic presented new three and four year data from the ENDEAVOR clinical
trial program reinforcing the existing safety and efficacy profile of the Endeavor®
drug-eluting coronary stent system, showing sustained safety, significant reductions
in repeat procedures and no late stent thrombosis in either trial using the pre-specified
trial protocol definitions adjudicated by the Harvard Clinical Research Institute.
Using the broader Academic Research Consortium (ARC) definitions for definite
and probable stent thrombosis, Endeavor's cumulative rate in the ENDEAVOR I-III
trials was still very low: 0.5% at three years while the Driver bare metal stent
had a rate of 1.5%. (Read
more...)
May 21, 2007 Medtronic Announces Start of 8,800-Patient
Clinical Trial Evaluating Drug-Eluting Stent Safety
The 8,800-patient trial, called PROTECT (Patient Related OuTcomes
with Endeavor versus Cypher stenting Trial), will compare the Medtronic
Endeavor(R) zotarolimus-eluting
coronary stent system and the Johnson & Johnson Cypher(R) sirolimus-eluting
stent, using key safety endpoints and other clinically relevant outcomes. (Read
more...)
Advertisement
:
May 7, 2007 Conor Medsystems, LLC Reports
COSTAR II Pivotal Drug-Eluting Stent Trial Conclusions
The Conor COSTAR II trial has failed to prove non-inferiority of the CoStar
stent to Boston Scientific's Taxus. Johnson & Johnson, which acquired
Conor in January for $1.4 billion, will terminate existing clinical trials
and work with its marketing partners to cease sales in the countries where
the Conor stent is currently approved for sale. (Read
more...)
April 7, 2007 Don't
Cancel Your Angioplasty or Heart Stent Yet, Say Patient Advocates
The real take away from the COURAGE trial, is not just that medication is useful,
which we know, but that patients benefit from substantial compliance education
and lifestyle support. Patients need to participate in treatment decisions, so
that they understand their treatment options and can commit to a course of action. (Read
more...)
March 27, 2007 The
Goal of Therapy in Patients With Chronic Stable Angina Is the Relief
of Symptoms
Results of the COURAGE trial, presented today at the American College of Cardiology
Annual Scientific Session, are unlikely to alter the approach that interventional
cardiologists take in treating most patients with chronic stable angina, say
leaders from the Society for Cardiovascular Angiography and Interventions (SCAI),
the leading professional society for interventional cardiologists in the United
States. (Read
more...)
March 23, 2007 Boston
Scientific Announces Industry-Leading Program to Improve Anti-Platelet
Compliance for DES Patients
The company today announced a program designed to improve patient compliance
with physician-prescribed anti-platelet therapy following implantation of a drug-eluting
stent (DES). This program is the first of its kind in the medical device industry
and is expected to launch in the United States later this year. It will be made
available to all patients who receive a DES, regardless of brand, through their
prescribing physician. (Read
more...)
January 31, 2007 Johnson & Johnson
Completes Acquisition of Conor Medsystems
Johnson & Johnson announced it completed its acquisition of Conor
Medsystems, Inc. and Conor's second generation drug-eluting stent technology
on the same
day that rival Boston Scientific announced a significant drop in sales of its
Taxus drug-eluting stent. Johnson & Johnson had reported a similar drop in
sales
for
its
Cypher stent last
month. (Read
more...)
January 31, 2007 Conor
Medsystems Stockholders Approve Merger Agreement with Johnson & Johnson (source: Conor Medsystems)
Conor Medsystems, Inc. today announced that its stockholders approved
the merger
agreement between Conor Medsystems, Johnson & Johnson
and a wholly owned subsidiary of Johnson & Johnson. The proposed
transaction is expected to close within the next few days, subject to the satisfaction
of the remaining closing conditions. (Read
more...)
January 31, 2007 Encouraging
Results for First International Trial of Drug-Eluting Stent in
Legs (source: Cook Medical)
Cook Medical's Zilver PTX Paclitaxel-Eluting Stent (DES) trial
results demonstrated no stent fractures. The major adverse event
(MAE) rate was equivalent to conventional
balloon angioplasty treatment at its six-month follow-up point, as reported
by the trial's national principal investigator today.
Michael Dake, M.D., national principal investigator for Cook's Zilver® PTX Drug-Eluting
Stent Trial, presented important nine-month data on the first 60 patients in
the randomized trial examining the safety of using Cook's Zilver PTX stent to
treat blockages of the superficial femoral artery (SFA) above the knee. (Read
more...)
January 29, 2007 New Advisory:
Will Stent Patients and Their Doctors Get the Message?
Burt Cohen, patient advocate and Editor-in-Chief of Angioplasty.Org, applauds
the groups for publicizing these issues. However, he adds: "It's
admirable and important for these societies to band together and put out this
Advisory.
But there's a disconnect between what these advisories recommend and what patients
experience." (Read
more...)
January 18, 2007 FDA
Approves 18-Month Shelf Life for TAXUS® Stent System (source: Boston Scientific Corporation)
The U.S. Food and Drug Administration (FDA) has approved extending
the shelf
life
of
Boston Scientific's TAXUS® Express(2)™ paclitaxel-eluting coronary stent system
in the United States to 18 months from the current shelf life of 12 months.
The
decision
was based on data submitted by Boston Scientific to the FDA that demonstrated
the performance of the TAXUS Stent -- in particular the drug content, drug
degradation profile and drug-release -- was maintained within FDA-approved
specifications at 18 months. The newly approved TAXUS Stent U.S. shelf life
is longer than any competing drug-eluting stent product.
January 11, 2007 SCAI Issues
Clinical Alert on Drug-Eluting Stents and Late Thrombosis (source: Society for Cardiovascular Angiography and Interventions)
Following the FDA Panel held on December 7-8, the SCAI has issued what it terms
"Practical Advice to Physicians on the Use of Drug-Eluting Coronary Artery
Stents".
January 11, 2007 Private-Label
Version of Abbott's XIENCE™V Drug-Eluting Coronary Stent System
Launches in Europe (source: Abbott)
A private-label version of Abbott's XIENCE™ V Everolimus Eluting Coronary Stent
System has launched in Europe, Boston Scientific Corporation announced today.
The PROMUS™ Everolimus-Eluting Coronary Stent System is designed, studied and
manufactured by Abbott and supplied to Boston Scientific as part of a distribution
agreement between the two companies announced last year.
December 11, 2006 Angioplasty.Org
Forum Member's Moving Testimony to FDA Stent Safety Panel
On the second day of FDA hearings regarding
the safety of drug-eluting stents, Rick Dulin, a member of Angioplasty.Org's
Patient Forum eloquently presented the case for patient education. His moving
speech, given shortly before the Panel went into its final deliberations, provided
a powerful closing argument on behalf of patients and elicited a "thank you for
your most eloquent presentation" from the panel's chairman, Dr. William Maisel.
A transcript of Rick's speech is provided. (Read
more...)
December 8, 2006 Patient
Advocate Tells FDA Stent Safety Panel: Public Deserves Better
On the first day of the FDA's advisory panel hearings on drug-eluting stent
safety, product manufacturers vigorously defended their devices. In the succession
of PowerPoint presentations and research reports, Burt Cohen of Angioplasty.Org,
a popular website for heart patients, was the lone voice on behalf of thousands
of concerned patients. The focus of the meeting is on the risk of potentially fatal blood clots, or
late stent thrombosis, with drug-eluting stents. Cohen believes regulators have
not paid enough attention to patient complaints, and that patients need more
information when choosing to have heart stents implanted. (Read
more...)
December 7, 2006 Cordis Corporation
Announces Clinical And Educational Programs For The CYPHER® Sirolimus-Eluting
Coronary Stent (source: Cordis Corporation)
Cordis Corporation stated to an advisory panel to the U.S. Food and Drug Administration
(FDA) that analysis of its research on the CYPHER® Sirolimus-eluting Coronary
Stent suggests a need for additional education on anti-platelet therapy regimens
for bare-metal and drug-eluting stent patients and further research to understand
safety factors.
December 4, 2006 FDA
Policy on Plavix and Stents: Catch-22
Most cardiologists know that antiplatelet therapy of aspirin
and clopidogrel (Plavix) is essential after the placement of
a drug-eluting stent. This week
an FDA Panel will be examining the duration of that therapy. But something
few know
is that the use of clopidogrel in most stent cases is technically off-label
and an unapproved use by the FDA. (Read
more...)
November 29, 2006 Cleveland
Clinic Analysis Shows Greater Risk of Late Stent Thrombosis in
Drug-Eluting Stents
A Cleveland Clinic study, published in the December issue of the American Journal
of Medicine (AJM), concludes that drug-eluting stents are four to five times
more likely than bare metal stents to induce a blood clot months or years after
implantation. But, according to one of the article's authors, the conclusions
of the study do not warrant an abandonment of drug-eluting stents, because
other studies have shown that bare metal stents have their own problems, which "are
not benign". (Read
more...)
November 27, 2006 Intravascular
Ultrasound (IVUS) Imaging Technology May Help Lower Rates of Late
Stent Thrombosis
While there are a number of causes of late stent thrombosis that have been identified,
one of the factors most associated is poor apposition (incomplete expansion or
suboptimal positioning) of the drug-eluting stent. A recent presentation by Dr.
William Wijns of Aalst, Belgium at last month's TCT meeting showed that in 77%
of the late stent thrombosis cases (clotting one year after implantation) the
stent showed incomplete apposition (mal-apposition was seen in only 12% of cases
where there was no stent thrombosis). (Read
more...)
November 16, 2006 Johnson & Johnson
Announces Definitive Agreement to Acquire Conor Medsystems, Inc. (source: Johnson & Johnson)
Expanding its portfolio of interventional devices, Johnson & Johnson
announced it has reached agreement with Conor Medsystems for
acquisition of the company
and its innovative second generation stent technology. The Conor CoStar is
currently available outside the United States and is a uniquely designed stent
which utilizes a biodegradable polymer. While the CoStar is implanted as a
drug-eluting stent, within a few months it in effect becomes a bare metal stent
and may avoid the problems of late stent thrombosis that have been getting
much publicity in recent weeks.
November 16, 2006 New Treatment
for In-Stent Restenosis: A Balloon Coated with Paclitaxel
A small German study of 52 patients was published in the
New England Journal of Medicine today that has the potential
for significantly improving the treatment of in-stent restenosis.
When stents are placed in the coronary arteries, they sometimes
restenose -- tissue starts growing inside of the stent and the
artery begins to close up again. Drug eluting stents have reduced
this restenosis rate, but the problem, called "in-stent restenosis",
still occurs. (Read
more...)
October
27, 2006 Stent Wars
Across the Atlantic: USA vs. Europe (source: The Stent Blog: "Voice in the Ear")
Angioplasty.Org coined the term "Stent Wars" back in 2002, referring to the
combat waged among the various device manufacturers. But at this year's TCT
meeting,
the
specially-assembled "Stent Thrombosis Hot Line Session" revealed a new face
of the stent wars: intercontinental cardiologists mano a mano! (Read
more...)
October 25, 2006 Abbott Reports
Positive Subset Results for XIENCE™ V in Tough-to-Treat
Diabetic Patients (source: Abbott)
A subset analysis of diabetic patients in the SPIRIT II Clinical trial of the
XIENCE™ V Everolimus Eluting Stent System showed nearly identical rates of
in-stent late loss at six months in diabetic patients as those observed in
the overall study patient population, according to new results presented today.
Abbott also presented new positive nine-month safety data from the SPIRIT II
trial, which showed no additional occurrences of MACE (Major Adverse Cardiac
Event) or stent thrombosis between six and nine months. Overall six-month data
from SPIRIT II, which demonstrated that the XIENCE V system is statistically
superior to Boston Scientific's TAXUS® Paclitaxel- Eluting Coronary Stent System
as measured by its primary endpoint of in-stent late loss, was presented last
month at the World Congress of Cardiology in Barcelona.
October 25, 2006 Medtronic
Announces Positive Results for Endeavor RESOLUTE Drug-Eluting
Coronary Stent System (source: Medtronic Inc.)
The company's press release states: Current drug-eluting stents (DES) do not
meet
all
the
requirements
of
physicians who deal with the most challenging clinical cases, such as patients
with diabetes.
This newest DES innovation from Medtronic leverages the strengths
of the Endeavor stent and introduces a proprietary, new biocompatible polymer
called BioLinx. This new polymer is designed to help match the duration of drug
delivery with the longer healing duration often experienced by patients with
complex medical conditions. BioLinx is different than other polymers in that
its outer surface is hydrophilic (water friendly), which leads to high biocompatibility
with the body, while the interior of the polymer is hydrophobic, which helps
to precisely control the drug release.
October 24, 2006 Abbott Reports
Initial Results from World's First Clinical Trial Featuring a
Fully Bioabsorbable Drug-eluting Coronary Stent (source: Abbott)
Early clinical results from Abbott's ongoing ABSORB clinical trial, the world's
first study to evaluate the safety and performance of a fully bioabsorbable
drug-eluting stent platform for the treatment of coronary artery disease in
humans, were presented today during the 18th annual Transcatheter Cardiovascular
Therapeutics (TCT) scientific symposium in Washington, D.C. Initial results
for the first 30 patients in the trial demonstrated no MACE (Major Adverse
Cardiac Events, such as heart attack) and no stent thrombosis at 30 days for
patients who received a bioabsorbable everolimus-eluting stent.
October
24, 2006 Data
Presented by Independent Physician Panel Confirms Low Rate of Thrombosis
with Medtronic Endeavor Drug-Eluting Stent (source: Medtronic Inc.)
Ever since the European Society of Cardiology congress in Barcelona, the words
"safety" and "stent thrombosis" have been in the forefront of the interventional
community's consciousness. Medtronic's new study, released at TCT, touts its
safety profile, showing less stent thrombosis than its bare metal stent equivalent,
the Driver. The study reports no late stent thrombosis, with patients out to
three years.
October
19,
2006 Medtronic
Announces Largest Clinical Study Evaluating Drug-Eluting Stent
Safety (source: Medtronic, Inc.)
The PROTECT (Patient Related OuTcomes with Endeavor versus Cypher stenting
Trial) study will enroll approximately 8,000 “real world” patients at
200 clinical centers in Europe and other international markets. Real world
patients
refers
to the general population typically seen by physicians in their everyday clinical
practice, including many patients with complex medical conditions. Medtronic
feels that their zotarolimus drug, imbedded in a non-inflammatory
phosphorylcholine (PC) polymer, is a less thrombogenic device. The company
also hopes to provide more definitive data about the safety of drug-eluting
stents for clinicians. One of the co-principal investigators is Dr. Edoardo
Camenzind, Division of Cardiology, University Hospital Geneva, whose presentation
at the World Congress of Cardiology in September ignited the concern over late
stent thrombosis in drug-eluting stents.
October 18, 2006 Patients
Worried About Safety of Heart Stents Turn To The Web (source: Angioplasty.Org)
Angioplasty.Org, an authoritative website for heart patients and physicians,
has seen a surge in readership following news reports of possible blood clot
risk with drug-eluting stents. The site, which receives 70,000 monthly visits,
is advising patients with stents to talk to their cardiologist about anti-clotting
medications. (Read
more...)
October 12, 2006 Drug-Eluting
Stents: More Dangerous Than Spinach?
Reinforcing the controversy over the potential dangers of drug-eluting stents
and late stent thrombosis, Drs. Sanjay Kaul and George Diamond of Cedars-Sinai
Medical Center in Los Angeles published an editorial in yesterday's Cardiosource,
an online publication of the American College of Cardiology.
The two cardiologists start with a comparison between the recent public health
uproar over e-coli infected spinach and the potential increase in deaths due
to late stent thrombosis with drug-eluting stents.... (Read
more...)
October 6, 2006 Abbott Drops
Zomaxx; Immediately Starts Marketing of Xience Drug Eluting Stent
Abbott, which acquired the Guidant-developed Xience stent as part of its deal
with Boston Scientific, announced on Tuesday that it will immediately begin
marketing the stent in Europe. Moreover, in a surprise to many observers, Abbott
has cancelled its own drug-eluting stent, the Zomaxx, which was in clinical
trials but not yet approved. (Read
more...)
October
5,
2006 Conor Medsystems
Receives Approval for One-Year Shelf Life for CoStar®
Stent in the European Union (source: Conor Medsystems, Inc.)
The company announced that its CoStar Stent has now been approved for double
the shelf-life: it previously was six months; it is now good for a year. This
is a plus for any stent, so that hospital can stock the various lengths and
sizes without worrying about a short expiration date.
October 4, 2006 Conor
CoStar: New Stents May Be Solution to New Stent Problems
Today's Wall Street Journal is running a story about Conor Medsystems
and how the company may benefit from the current controversy over
late stent thrombosis in drug-eluting stents. The Conor Medsystems
CoStar, and other emerging technologies in this field, take a different approach
to
drug-eluting stents than the current generation of Cypher and Taxus
permanent polymer-coated devices. (Read
more...)
October 3, 2006 Abbott
Begins Early International Launch of XIENCE™ Everolimus
Eluting Coronary Stent System (source: Abbott) Abbott, which got the Xience drug eluting stent as part of
its deal with Boston Scientific during the Guidant acquisition,
has decided to immediately begin marketing the Xience and, to some
observers' surprise, has decided to abandon its Zomaxx stent completely.
September 14, 2006 FDA
Chimes In On Drug-Eluting Stents
Responding to the studies presented at the annual World Congress of Cardiology
meeting in Barcelona last week, showing potential long term problems with drug-eluting
stents, the U.S. Food and Drug Administration has announced that it "will convene
a public meeting of the Circulatory System Devices Advisory Panel" by the end
of the year to discuss these data. (Read
more...)
September 14, 2006 Conor Medsystems
to Present at the A.G. Edwards Emerging Growth Conference (source: Conor Medsystems, Inc.)
The company is scheduled to present at the
A.G. Edwards Emerging Growth Conference on Wednesday, September 20, 2006 in
New York. Frank Litvack, M.D., Chairman and CEO, will provide a corporate update
at 2:15 p.m. ET.
September 9, 2006 (updated from September
4) Problems
Resurface with Drug-Eluting Stents
Several presentations made yesterday at The World Congress
of Cardiology in Barcelona are once again highlighting some
physicians' concerns about the long-term
safety of drug-eluting stents (DES). Dr. Edoardo Camenzind of University
Hospital in Geneva, Switzerland gave a presented a meta-analysis
of all the data gathered
in the various clinical trials, and up to three years of followup, for both
the CYPHER (J&J/Cordis) and TAXUS (Boston Scientific) drug-eluting stents.
The results were dramatic: the incidence of death and heart attack was higher
in patients who got drug-eluting stents -- 30-40% higher in the Cypher studies;
about 5% higher in the Taxus group. Dr. Camenzind concluded that these increases
were "the clinical presentation of stent thrombosis" -- a concern
that has been expressed since drug-eluting stents were first introduced. (Read
more...)
September
7,
2006 Boston Scientific
Confirms Long-Term Clotting Risk of Drug-Eluting Stents On the heels of several presentations from European
hospital centers and amidst heated controversy about late stent
thrombosis occurring with drug-eluting stents at this week's World
Congress
of
Cardiology meeting in Barcelona, stent manufacturer Boston Scientific
confirmed this morning that it too had found a slightly higher
risk of blood clotting in patients who received the Taxus drug-eluting
stent, when compared to those
with
bare
metal
stents. (Read
more...)
September
5,
2006 Conor Medsystems
Announces Two-Year Follow-Up Data from EuroSTAR Pivotal Study (source: Conor Medsystems, Inc.) After 24 months, the Conor CoStar stent seems to be fulfilling
its promise as a new generation drug-eluting stent that may eliminate
several of the problems hotly discussed over the past few days
at the World Congress of Cardiology in Barcelona. (Read
more...)
September 1, 2006 PROMUS™ Everolimus-Eluting
Stent Added to Boston Scientific Coronary Stent Portfolio (source: Boston Scientific Corporation) In this press release, Boston Scientific announces its plans
to pursue the approval and subsequent marketing of a new drug-eluting
stent, the PROMUS. Actually the PROMUS is another name for the
Xience stent, originally developed by Guidant, which now,
according to the terms of the Boston Scientific/Guidant/Abbott
agreement, will be jointly marketed by Abbott (as the Xience) and
Boston Scientific (as the PROMUS).
August 28, 2006 Abbott
Announces Conference Call and Key Activities at World Congress
of Cardiology 2006 (source: Abbott)
The company states in its press release that it "will present results
of its SPIRIT II clinical trial of the XIENCE™ V Everolimus Eluting Coronary
Stent System at the World Congress of Cardiology (WCC) meeting in Barcelona,
Spain, on Sept. 5." Abbott also will host a conference call with the investment
community and the media to discuss the findings. (Read
more...)
August 14, 2006 Abbott Enrolls
First Patient in New Clinical Trial Utilizing XIENCE™ V
Drug Eluting Stent (source: Abbott)
Abbott has made its first announcement of news about the XIENCE drug-eluting
stent since it acquired the product from Guidant in the Boston Scientific/Guidant/Abbott
three-way
acquisition
and trade. A clinical trial, with Gregg Stone, MD as principal investigator,
has been launched and will enroll 1,125 patients at 40 sites in the U.S. The
trial will compare the XIENCE to Boston Scientific's TAXUS -- interestingly
enough, Dr. Stone has also served as principal investigator for many TAXUS
studies. Abbott now has two drug-eluting stent technologies in clinical trials:
the XIENCE, which has already received
approval in Europe and
the ZoMaxx, as well as research into bioabsorbable stent technology.
June 22, 2006 Cordis Corporation's
Third-Generation Coronary Stent Approved For Use In Europe (source: Cordis Corporation)
Cordis has announced European approval for its CYPHER SELECT™ PLUS, a new version
of the CYPHER that has a special hydrophilic coating, making it more lubricious
(slippery) and therefore more "deliverable". The company states that now that
the approval has been secured, the company is "aggressively" building its manufacturing
capacity as it approaches the product launch. The company will be tracking
the product's performance in a special registry.
June 22, 2006 Use
of Drug-Eluting Stents Declines at Some Hospitals The stock prices for Boston Scientific
and Johnson & Johnson dropped today, as the Wall Street Journal
published an article reporting that some hospitals, including
Washington Hospital Center (Washington, DC) and Cedars-Sinai
(Los Angeles) are using less drug-eluting stents in
favor of the older bare metal stents. (Read
more...)
June
12,
2006 1
in 7 Heart Attack Patients Stops Meds Within 30 Days Today's online rapid access
edition of Circulation, the AHA's journal, contains a very important
message for heart attack patients who have gotten drug-eluting
stents: Be sure to keep taking the
antiplatelet medications prescribed, such as clopidogrel (Plavix),
ticlopidine (Ticlid) and aspirin, for the full length of time prescribed. This
study found that 1 in 7 patients stopped their meds within 30 days
-- a far higher rate of non-compliance than had been previously
thought. And those that stopped had a death rate more than 10 times
higher than those that kept taking their medications. (Read
more...)
June
2, 2006 St.
Jude CEO: Medicare Reimbursement Plan Is 'Flawed' (source: Jon Kamp, Dow Jones Newswires $$)
Daniel J. Starks, president and CEO of St. Jude Medical comments on
the Medicare changes that were proposed
in April which, if left unchanged, will significantly reduce reimbursement
payments to hospitals for implantable defibrillators, drug-eluting stents and
other
medical
devices
used
in the treatment of heart disease. According to this article appearing in the
Wall Street Journal, he
says the plan is "ambitious" and "well-intentioned", but "flawed" and that the
June 12 deadline for comments is too soon for such a complex issue. He expresses
doubt that the reimbursement cuts will remain at the low levels in the draft
proposal.
May
26,
2006 Court of
Appeals Rules Boston Scientific's Products Do Not Infringe Medtronic
Stent Patents (source: Boston Scientific Corporation)
Upholding an earlier ruling, the Court of Appeals for the Federal
Circuit has reaffirmed that Boston Scientific' s devices, namely
the TAXUS® Express®, Express®,
and NIR® stents, do not infringe on patents owned by Medtronic.
May 25, 2006 Cordis Corporation
To Establish New Innovative Research Center In Silicon Valley (source: Cordis Corporation)
Cordis has been busy doing a retooling of sorts this past week. First Cordis
announced that highly-respected cardiologist Dr. Campbell Rogers was leaving
Brigham
and Women's in Boston to become their Chief Technology Officer; then today
Cordis has announced plans to start a research center in the Bay Area, home
to a number of significant innovations in interventional cardiology (the first
intraoperative angioplasties were
performed in San Francisco by Drs.
Andreas Gruentzig and Richard Myler). Cordis, a division of Johnson & Johnson,
was the first company to offer a coronary stent back in the 80's. Then it made
available the Cypher Sirolimus-Eluting stent in Fall 2003, the first drug-eluting
stent on the market. But the perception has been that Cordis has not kept up
its innovation since that time. It will be most interesting to see what comes
out of this new initiative.
May
18, 2006 Conor
Medsystems Announces First Patient Treated with Dual-Drug Coronary
Stent (source: Conor Medsystems, Inc.)
Conor's unique reservoir
design allows a combination of drugs to be used to reduce the reblocking
of the coronary artery that has been stented. In this trial, and
stent with paclitaxel only will be compared to another that uses
a combination of paclitaxel and pimecrolimus.States lead investigator
Dr. Keith D. Dawkins of Southampton University Hospital, Southampton,
UK, "The
SymBio stent capitalizes on the advantages of Conor's reservoir-based
stent
design to deliver more than one drug. In addition, the use of bioresorbable
polymers ensures that no permanent polymer residue or drug remains
at the target site, which may confer a long-term advantage with
respect to reduced rates of late stent thrombosis."
May 15, 2006 Abbott Announces
First Patients Enrolled in ZOMAXX™ Europe Clinical Trial (source: Abbott)
The ZOMAXX EUROPE study is a single-arm trial that will evaluate the safety
and performance of the ZoMaxx zotarolimus-eluting stent in patients with single-
or two-vessel coronary artery disease, representing an important step toward
broadening the complexity of patients treated with ZoMaxx. The study will include
approximately 900 patients at up to 60 sites throughout Europe with a primary
endpoint of target lesion revascularization (TLR) at nine months.
May 11,
2006 Desensitization
Protocol Overcomes Allergy
to Clopidogrel (source: Society for Cardiovascular Angiography and Interventions -- SCAI)
A careful desensitization
protocol can help patients
overcome allergic reactions
to anti-clotting medication critical to preventing new blockages inside coronary
stents, according to a new study being presented at SCAI's annual meeting. Nicholas
E. Walker, MD, a cardiology fellow at the University of Iowa, Iowa City, states,“We
showed we could successfully and safely desensitize patients who had just recently
had a drug-eluting stent placed. That’s a critical population to manage.” (Read
more...)
May 11, 2006 Conor Medsystems
Initiates RAPID Clinical Study for First Pimecrolimus Drug-Eluting
Stent (source: Conor Medsystems, Inc.)
Using pimecrolimus, a drug licensed from Novartis, Conor has begun a clinical
trial to evaluate the safety and efficacy of its new Corio drug-eluting
stent. The trial will also test the feasibility of reducing dual antiplatelet
therapy to two months post-stent. The company believes this is possible because
the polymer on the Corio (like the CoStar) is bioabsorbable and may not require
the long-term clopidogrel therapy of the Taxus and Cypher stents.
May
4,
2006 Boston Scientific
Sues Conor Medsystems Ireland Ltd. (source: Boston Scientific Corporation)
The stent wars have momentarily shifted from the titans of
drug-eluting stents, Boston Scientific and J&J/Cordis, to some
smaller, but significant, skirmishes. Boston is
suing Conor, a small company with an innovative drug-eluting bioabsorbable
polymer coated stent. Conor is, based in California but has a
manufacturing arm in Ireland. At issue
is a
balloon
catheter patent,
one
that
Boston successfully
leveraged against Cordis in The Netherlands back in October
2005. If Boston prevails, Conor could be fined and could be prevented
from manufacturing its CoStar stent in Ireland. Conor's stent
is currently approved for sale in the European Union.
May 4, 2006 J&J's
Cordis Calls Off Stent Promotion Deal With Guidant (source: Jon Kamp, Dow Jones Newswires $$)
Not a terrific surprise -- Cordis/J&J, maker of the Cypher drug-eluting
stent, has terminated its co-marketing deal with Guidant, a company which
technically no longer exists. Back when Guidant did exist, Cordis, a company
with a coated stent but in need of an enhanced sales force, partnered with
Guidant,
a company with a failed coated stent, but a crack sales force, to sell the
Cypher. Together they worked and the Cypher slowly regained almost 20 points
in market share from Boston Scientific. For almost a year, it looked like their
partnership
would
be formalized
by J&J buying Guidant. Then Boston Scientific stepped in and with Abbott's
cash assistance, spoiled the deal and took Guidant away. Abbott said it wanted
to keep the deal with Cordis, but Cordis doesn't exactly think that a future
competitor in drug-eluting stents (Abbott has two in the pipeline) would be
such a good partner.
May
3,
2006 Boston Scientific
and Angiotech Win Patent Infringement Case Against Sahajanand
in the Netherlands (source: Boston Scientific Corporation)
Angiotech and Boston Scientific report that a Dutch court has granted them
a favorable patent ruling and an injunction against Sahajanand Medical Technologies
Pvt. Ltd. of India regarding its Infinnium paclitaxel-eluting stent. The Indian
company has been ordered to pay damages as well.
April
26,
2006 Two Million
Patients Treated With The CYPHER® Sirolimus-Eluting Coronary
Stent (source: Cordis Corporation)
The company announced a milestone: two million patients have now been treated
with the CYPHER drug-eluting stent since it first went on the market in Europe
four years ago. Cordis Vice-President Dennis Donohoe, M.D. stated, "The
increasing body of clinical evidence supporting the use of the CYPHER® Stent,
even in complex and difficult-to-treat patients, is unprecedented and has helped
establish the CYPHER® Stent as the leading drug-eluting stent
used by interventional cardiologists globally." The company has also submitted
for FDA approval a narrower version of the stent for use in smaller arteries
(2.25mm diameter) -- narrower vessels are more prone
to restenosis (reblockage).
April
20, 2006 Conor Medsystems
Completes Enrollment of COSTAR II Pivotal Randomized Drug-Eluting
Stent Trial (source: Conor Medsystems, Inc.)
The company announced it has now completed enrollment of 1,700 patients in its
U.S. trial. Principal investigator of the trial, Dr. Mitchell Krucoff of Duke,
said he thought that the quick enrollment refected a "widespread interest
in Conor's CoStar stent...[which]...may offer
several potential advantages as compared to conventional drug-eluting stents,
including no surface coating, a low profile
for ease of delivery and the use of a polymer that is absorbed by the body, leaving
a bare metal stent. I look forward to analyzing the comparative data."
April
18, 2006 J&J slices
deep into Boston's stent share (source: Financial Times)
Both companies have released sales figures for the first quarter of 2006, and
Cordis / Johnson & Johnson now claims 47% of the U.S. drug-eluting stent
market. Boston claims that its market share has "stabilized" at 53.5%.
(Just after its introduction, Boston's Taxus stent accounted for around
2/3
of the U.S.
market.) Johnson
& Johnson's sales were weaker in certain areas, but its device sales were strong
-- and its bottom line was definitely helped by the large "kill" fee paid
by Guidant when decided to be acquired by Boston Scientific instead --
the Wall Street Journal reports that the after tax profit on that was $368
million. related stories: Boston
Scientific 1Q profit dips 7% -- Mark
Jewell, Associated Press Boston
Scientific profit off, device sales slump -- Susan
Kelly, Reuters J&J,
Boston Scientific Report
Mixed Earnings and Weak Sales -- Scott Hensley
& Suzanne Sataline, Wall Street Journal
($$)
March
29,
2006 Guidant
Stops Selling Xience V Drug-Coated Stents (source: Associated Press)
Having discovered a manufacturing defect in approximately 1% of the Xience
stents manufactured, Guidant is freezing its inventory and rebuilding the product.
Kim Boetsch of Guidant said the problem was not a design flaw and that the
company has corrected the problem and is back manufacturing the Xience. Meanwhile
a hold has been put on part of its SPIRIT III clinical trial in progress.
The company has also delayed the introduction of the stent to the European
market until the third quarter of this year (it was approved in January). Boston
Scientific, which is buying Guidant, stated that this will have no effect on
the closing
of the purchase. Stockholders vote on Friday. related stories: Guidant
to Temporarily Suspend XIENCE V Supply -- Guidant
Corporation
March 29, 2006 ACC Data
Show Numerical Trend Favoring TAXUS® Coronary Stent System (source: Boston Scientific Corporation)
Boston Scientific issued this release to wrap up all the various studies presented
at the American College of Cardiology meeting two weeks ago. Most of these
studies were already covered in Angioplasty.Org's summary on
this page and, as Angioplasty.Org has reported, there
were no statistically significant differences in the two stents. There is
one exception that the company added
to this press
release: the
six-month results
of Washington Hospital
Center's
REWARD
Registry,
which
compares
the
Taxus
and
Cypher stents
that were placed
at the hospital. Dr. Ron Waksman concluded that patients with either stent
had similar outcomes. However the press release points out that the overall
stent thrombosis rate was higher with the Cypher stent (1.5% vs 0.6% in the
Taxus) which was a bit of a surprise. One factor might be that
Plavix, which prevents thrombosis, is indicated for six-months in Taxus stents,
but only three in Cypher -- however, Dr. Waksman noted that his team sees
more cases
of thrombosis from six months to one year, so the one year results will be
interesting. Note: Waksman's group will be following
these
patients for one, two and more years. A second note: Boston Scientific incorrectly
states that the REWARD Registry studied "3,115 consecutive diabetic patients",
but the study includes all patients and the diabetic cohort was a only subset
of those.
So the results reported for REWARD in this press release are not for diabetic
patients, but for the total group.
March 27, 2006 Judge Upholds
Jury Verdicts on Cordis Patents Infringed by Boston Scientific
and Medtronic (source: Cordis Corporation)
A U.S. District Court Judge rejected Boston Scientific's bid to overturn last
year's jury verdict and let stand the decision that upheld the Palmaz-Schatz
patent against several stents no longer sold: Boston's NIR stent and Medtronic's
GFX and Microstent II (does anyone remember AVE??). The judge did not reinstate
a prior damages verdict, however, and deferred to assess those until the appeals
process has concluded. related stories: Federal Judge
Rules on Motions -- Boston Scientific Corporation Boston Sci:Judge
Denies Overturn Of Stent Verdict -- Wall
Street Journal ($$)
March 23, 2006 Medtronic
says patents may crimp Guidant stent (source: Julie Steenhuysen and Debra Sherman, Reuters)
There is disagreement among companies and Wall Street analysts over whether
Medtronic's claim of patent infringment against Guidant's Vision stent will
impact Guidant's purchase by Boston Scientific. The Vision is the basis for
Guidant's new Xience stent, a product which Boston Scientific plans to share
with Abbott.
March
14, 2006 BASKET-LATE
Study Shows Higher Rate of Cardiac Death and Heart Attack
for Drug-Eluting Stents vs. Bare Metal Stents
This small study titled BASKET-LATE (Basel Stent Cost-effectiveness Trial—Late
Thrombotic
Events) was almost overlooked when presented on the final day
of
the American College of Cardiology annual meeting, but the conclusion of the
study
mirrors a concern that we here at Angioplasty.Org have been writing about --
the need for continued long term antiplatelet therapy after drug-eluting stents. (Read
more...)
March
14, 2006 ARRIVE
II Registry Demonstrates Low 2.5 Percent TAXUS-Related
Re-Intervention Rate in Complex Lesions (source: Boston Scientific Corporation)
This registry of over 5,000 patients was completed in
October 2005 and the preliminary results show that at
6 months only 2.5% of patients needed a re-intervention
to open a re-blocked stent. All other adverse event rates were low, showing
safety. These patients will continue to be followed. The patient population
is very diverse with complex lesions and clinical situations (heart attack,
etc.) and, unlike a clinical trial, the registry enrolled patients from a wide
spectrum of hospitals (major
medical centers
to community
hospitals)
with
a
large number of doctors participating, giving a more "real world" view
of the device's performance. It will be very revealing to see how these patients
fare
in 1 or 2 more years, but for now the data confirms the positive results from
earlier studies.
March
14, 2006 Medtronic’s
Endeavor™ Stent Continues to Show Consistent Clinical Efficacy
and Strong Safety Profile (source: Medtronic Inc.)
The Endeavor stent has been approved in Europe and is gaining in sales there.
Medtronic is hoping to become the third drug-eluting stent approved in the U.S.
sometime next year. The data presented at the ACC showed the Endeavor to be rougly
equivalent to Johnson & Johnson's Cypher. At last fall's TCT meeting, the Endeavor
III study narrowly
missed its goal of equivalency with the Cypher, due to "late loss",
a parameter that was not remeasured for the updated results and which Medtronic
feels is not necessarily indicative of the need to do a repeat procedure. Boston
Scientific has also said the same thing about "late loss". (The Cypher's stats
for "late loss" are somewhat better than either the Endeavor or Taxus.) Medtronic's
next
major
clinical trial is pitting the Endeavor against Boston
Scientific's
Taxus
stent in the Endeavor IV Clinical Trial, which needs around 500 patients to complete
enrollment. The trial is being conducted in New York (Columbia Presbyterian)
and
North
Carolina (Duke) and you can enroll here.
March
13, 2006 New
Data Suggest Patients With Bifurcation Lesions Experienced
Very Low Serious Event Rates With The CYPHER® Sirolimus-Eluting
Coronary Stent (source: Cordis Corporation)
A bifurcation lesion is one of the trickier challenges in the coronary
anatomy. It is like the exit on a highway: you have the main road and
and exit ramp, or the main artery and a smaller one branching off. Plaque
tends to collect at the branch or bifurcation and opening up one sometimes
blocks the other. This study used two types of treatment, both using
the CYPHER stent. In one, only the main branch was stented; in the second,
both were. The results were good with both strategies.
March
12, 2006 STENT
Registry Safety Data Favors TAXUS® Over Cypher® in
the Most Complex Diabetic Patients (source: Boston Scientific Corporation)
A few more months data reveals the same basic results for the STENT registry
as were presented last
fall during the TCT meeting. The Cypher and Taxus stents were equally
safe, although as the Company states in this press release, the Taxus
patients with insulin-dependent diabetes fared better than diabetics
with the Cypher. The differences, however, did not reach statistical
significance,
prompting
the study lead investigator, Dr. Charles Simonton of the Carolinas Institute,
to state: "There may be a trend favoring the paclitaxel stent in
patients that are insulin-requiring diabetics, but further study is needed
to confirm the differences." Interestingly, theheart.org, a subscription-based
professional online journal, titled its report on the STENT Registry:
"Taxus
and Cypher comparable in diabetics". At issue is the increased
MACE (Major Adverse Cardiac Events) with the Cypher stent in the insulin-dependent
diabetics subgroup. This increase was not driven by restenosis,
but by mortality -- the death rate in the Cypher group was 2.5 times
that
of
the Taxus group. However, the actual difference in numbers was 10 patients
and, as Dr. Simonton stated in the Q&A, this subgroup (insulin-dependent
diabetics) already has a higher-than-normal mortality rate and that the
study was not powered to show
a statistically
valid difference in mortality of subgroups.
March
12, 2006 CYPHER® Stent
Better Than Radiation (Brachytherapy) for In-Stent
Restenosis (source: Cordis Corporation) Excellent In-Stent Restenosis Clinical Trial Results
Reported for Taxus Stent System (source: Boston Scientific Corporation)
Currently the only FDA approved treatment for a blockage occurring inside
of a bare metal stent (in-stent restenosis) is brachytherapy, or radiation
delivered by a special catheter from within the blocked stent. These
two studies
(parts
of which
were presented last fall at the TCT 2005)
verify what most cardiologists already know --
that brachytherapy
does not work as well as it was originally thought it might. The problem,
seen in previous studies, is one of "late catch-up" -- the radiation
only delays restenosis; it doesn't prevent it. These studies show that
the use of a drug-eluting
stent
expanded
inside
of the
blocked bare
metal
stent
is
a better treatment
--
in this
case
almost
twice as
good, with a lower incidence of major adverse events as well. Both Cypher
and Taxus stents worked well. It is unknown whether, based on these studies,
the FDA may expand the approved treatments for in-stent
restenosis to drug-eluting stents.
March
12, 2006 CYPHER® Stent
Better Than Bare Metal Stent for Heart Attack Treatment (source: Cordis Corporation)
The gold standard for emergency treatment of heart attack (acute myocardial
infarction) is angioplasty. This is normally done with a balloon and
often a bare metal stent. Cardiologists have been cautious about using
drug-eluting stents in this situation, not knowing if the polymer and/or
drug might have a negative effect. However this study of 712 patients
showed equal safety and significant advantages in the in-stent restenosis
rate for the drug-eluting CYPHER stent which was only 3.5%, as opposed
to 20.3% for the bare metal stents.
March
12, 2006 New
Data Suggest Differences In Between The CYPHER® and
Taxus Stent In Long Complex Lesions (source: Cordis Corporation)
The LONG DES-II Study included 500 patients with complex, long lesions > 25
mm and in most measurements, the Cypher showed better outcomes than the
Taxus stent. "Patients with very long lesions are among the most difficult
to treat and tend to be at higher risk of restenosis," said Seung-Jung
Park, M.D., Ph.D., FACC, principal investigator of this study and Chief
of Interventional Cardiology, ASAN Medical Center, Seoul, Korea. "These
findings provide important new information for clinicians to consider
when choosing the best treatment for these types of complex patients."
March
11, 2006 4-Year
CYPHER® Data: Long-Term Efficacy & Safety
Benefits With No "Late Catch-Up" In Restenosis (source: Cordis Corporation)
In the longest period of study yet for a drug-eluting stent, the CYPHER® showed
a 7.9% re-intervention rate, compared to a 23.8% rate for bare metal
stents. "Even after four years, the CYPHER® Stent continues to show impressive,
sustained safety and efficacy benefits for a wide variety of patients
and lesion types, without any evidence of 'late catch-up' in restenosis," said
Martin Leon, M.D., co-principal investigator of the SIRIUS trial. "These
findings add to the extensive body of evidence supporting the use of
the CYPHER® Stent as an excellent, long-term treatment for coronary artery
blockages."
March 10, 2006 J&J
and Boston Scientific continue 'stent wars' (source: Debra Sherman, Reuters)
A wrap up of the current playing field for drug-eluting stents.
(Editor's note: Angioplasty.Org claims
origination of the phrase
"Stent Wars", first used here four years ago.)
February 24, 2006 Conor Medsystems
Announces Decision from U.K. High Court of Justice (source: Conor Medsystems, Inc.)
Conor has announced that the London High Court has ruled against a paclitaxel
patent held by Angiotech, the company that makes the drug-coating for Boston
Scientific's Taxus stent. There are several legal fronts in this patent dispute,
but Boston Scientific and Angiotech have been trying to keep Conor from using
paclitaxel on its new CoStar drug-eluting stent, which was just approved last
week in Europe. This ruling could have significant implications on all three
companies involved. Angiotech states that their patent is still valid in other
European countries and that they plan to appeal the ruling. related stories: Conor says UK court invalidates
Angiotech patent -- Reuters
February
17,
2006 Conor Medsystems
Receives CE Mark for CoStar™ Drug-Eluting Stent (source: Conor Medsystems, Inc.)
A truly 2nd generation drug-eluting stent is now approved for use in Europe.
Manufactured by California-based Conor, the CoStar is a unique new design that,
according to the company, has been designed for drug delivery from the ground
up. The cobalt chromium stent is made with reservoirs, or depressions, in the
stent surface. These hold a bioabsorbable polymer containing a drug which is
then released over time. One of the major differences with thecurrent crop
of drug-eluting stents is that once the drug has been delivered, the polymer
has also been absorbed and the remaining device is, in effect, a bare metal
stent which will then be covered over by the inner lining of the artery. As
chief investigator Dr. Keith Dawkins of Southampton Hospital ,UK, states, ""In
addition to positive clinical results, the CoStar stent has consistently demonstrated
an excellent safety profile, and the use of bioresorbable polymers ensures
that no permanent polymer residue or drug remains at the target site." related stories: Conor
CoStar Stent Gets CE Mark -- Associated Press Conor
gets European approval on drug-eluting stent-- Reuters
February 15, 2006 Boston Scientific
Announces French Reimbursement for TAXUS® Liberte™ Paclitaxel-Eluting
Coronary Stent System (source: Boston Scientific Corporation)
The new second-generation Taxus Liberte stent was approved in Europe in September
2005, but now the French government has decided to reimburse for the Liberte,
opening up the French market, which is relatively small since France has one
of the lowest incidence of coronary artery disease in Europe -- i
October
27, 2006
March
15, 2006