Resultaten van een 3-jarig onderzoek naar drug eluting stents gepresenteerd

In de cardiologie wordt al enige jaren een discussie gevoerd over de veiligheid en effectiviteit van stents. Deze stents worden ingezet bij de behandeling van coronaire vaatvernauwingen. Het onderstaande engelstalige persbericht van Medtronic geeft verder inzicht in deze materie, met name met betrekking tot de zogenaamde DES, drug eluting stents. Het betreft de resultaten van een 3-jarig klinisch onderzoek, waarbij 2 toonaangevende stents, Endeavor en Taxis, werden vergeleken. Belangrijke verschillen zijn waargenomen bij het optreden van hartinfarcten en ‘very late stent thrombosis’ in deze vergelijking. Deze resultaten zijn gisteren gepresenteerd op het TCT congres, Transcatheter Cardiovascular Therapeutics, gehouden in  San Francisco.

NEWS RELEASE
Contacts:
Joe McGrath Jeff Warren
Public Relations Investor Relations
707‐591‐7367 763‐505‐2696
FOR IMMEDIATE RELEASE
ENDEAVOR® STENT REDUCED RISK OF HEART ATTACK/CARDIAC DEATH BY 48% AT THREE YEARS COMPARED TO TAXUS® STENT IN LARGE STUDY
Latest Findings from ENDEAVOR IV Clinical Trial Also Showed 91 Percent
Reduction in Risk of Very Late Stent‐Related Blood Clots for Endeavor Patients
SAN FRANCISCO – Sept. 21, 2009 – Anticipating a change in the practice of interventional cardiology, Medtronic, Inc. (NYSE: MDT), announced today that the latest findings from the ENDEAVOR IV clinical trial – a large study comparing two drug‐eluting coronary stents head‐to‐head – demonstrate statistically and clinically significant differences in measures of safety between Medtronic’s Endeavor zotarolimus‐eluting stent and Boston Scientific’s Taxus paclitaxel‐eluting stent at three years of patient follow‐up. The new data, which also show no difference in efficacy between the two devices at three years, will be presented at Transcatheter Cardiovascular Therapeutics (TCT) 2009 at approximately 5:28 p.m. Pacific time during The Drug‐Eluting Stent Summit Part 1 in Room 104 at San Francisco’s Moscone Center.
“The three‐year results from ENDEAVOR IV conclusively demonstrate that choice of stent really does matter for patients with coronary artery disease,” said principal investigator Dr. Martin B. Leon of New York‐Presbyterian Hospital/Columbia University Medical Center and the Cardiovascular Research Foundation. “As interventionalists, we now have long‐term outcomes data that should be critically evaluated when making treatment choices for our patients.”

Dr. Leon added: “For several years we have seen a trend toward outstanding safety with the Endeavor stent throughout the clinical program and in pooled analyses. These latest randomized data are the first to show statistically significant differences on hard clinical endpoints that clearly favor one drug‐eluting stent over another at three years. Specifically, they show comparable efficacy between the Endeavor and Taxus stents in long‐term follow‐up, with significant safety advantages for Endeavor patients with regard to a reduction in large myocardial infarctions that are directly attributable to the significantly higher rate of very late stent thrombosis observed with the Taxus stent.”

Concerns about the consequences of the higher observed rate of very late (>1 year) stent clotting in drug eluting versus bare metal stents have loomed since 2006 but have been allayed by large, population‐based registry data that have not shown an increase in death or myocardial infarction . Endeavor IV represents the first long‐term large, head‐to‐head drug eluting vs. drug eluting stent comparison to demonstrate a statistically significant increase in very late stent clotting and a corresponding significant increase in cardiac death and myocardial infarction. The Endeavor IV data definitively show that at three years of follow‐up, patients treated with an Endeavor stent have a statistically and clinically significant 48 percent (p=0.004) lower risk of heart attack or cardiac death than patients treated with a Taxus stent and a 91 percent (p=0.004) reduction in the risk of very late stent thrombosis.

“These are practice‐changing data, demonstrating that we can only truly evaluate the safety and efficacy of drug‐eluting stents over the long term. In clinical trials, as in clinical practice, events may continue to occur, and the story does not end at the timing of a study’s initial endpoint,” said the trial’s other principal investigator, Dr. David Kandzari of the Scripps Clinic in La Jolla, Calif. “At three years of follow‐up, the Endeavor stent demonstrated comparable efficacy and impressive safety in this study
versus the Taxus stent – a finding that was consistent across all patient populations in this study and across the entire Endeavor clinical trial program.”

ENDEAVOR IV enrolled 1,548 patients, equally randomized to receive an Endeavor or Taxus drug‐eluting stent. The primary endpoint in the study was non‐inferiority on the measure of target vessel failure (TVF) – a composite of cardiac death, myocardial infarction and target vessel revascularization – at nine months.
“Medtronic understands that clinical outcomes are what matter to patients, and we are committed to ongoing evidence‐based research to develop products that improve people’s lives,” said interventional cardiologist Dr. Richard Kuntz, senior vice president of strategy, clinical and regulatory affairs at Medtronic. “These new data from ENDEAVOR IV clearly and compellingly demonstrate that the Endeavor stent should play a much larger role in the care of patients with coronary artery disease.”
Medtronic CardioVascular is committed to advancing the treatment of coronary, peripheral, aortic and structural heart disease through collaboration with leading clinicians, researchers and scientists worldwide.

Redactie Medicalfacts/ Janine Budding

https://www.medicalfacts.nl

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