12-Month ELUTES Data Confirm Positive Results of Higher Dosage Paclitaxel-Eluting Coronary Stents In Inhibiting Restenosis
May 23, 2002
PARIS, France – Data from the 192-patient ELUTES dose-ranging study of drug-eluting coronary stents confirmed the positive results of cytostatic, higher dosages of paclitaxel in inhibiting restenosis after twelve months, researchers announced today at the Paris Course on Revascularization.
Presented by principal investigator Anthony Gershlick, M.D., the ELUTES study’s 12-month safety data showed paclitaxel’s sustained ability to dramatically inhibit restenosis, together with an excellent safety profile for the drug-coated coronary stent. Cook’s data also indicated no late thrombosis, deaths or myocardial infarctions (MI). Target lesion revascularization (TLR) in the highest dose treatment arm of the study was just five percent compared to a 16 percent TLR rate in the control arm, a result that indicates positive clinical impact for patients receiving stents coated with the highest dose of paclitaxel.
“These data released by Dr. Gershlick today indicate convincingly that the clinical benefits of Cook’s paclitaxel-coated stents are durable over the period of one year and that Cook’s polymer-free paclitaxel coating does not contribute to major adverse coronary event (MACE) rates over 12 months,” reported Phyllis McCullough, chairman, Cook Incorporated. “The clinical trends we measured at 12 months are nearly identical to the positive results seen in these patients at six months.”
“We are encouraged to see paclitaxel’s consistent safety and effectiveness over a 12-month period,” added William L. Hunter, M.D., chairman and chief executive officer of Angiotech Pharmaceuticals, which has licensed to Cook co-exclusive rights to coat its coronary stents and other devices with paclitaxel. “Since long-term data will yield more realistic outcomes, today’s results provide further evidence that paclitaxel-eluting stents will continue to benefit patients well after the initial stenting procedure.”
The ELUTES (European EvaLUation of pacliTaxel-Eluting Stent) trial evaluated the safety and efficacy of four different doses of paclitaxel compared to an uncoated Cook V-Flex Plus stent. This randomized, prospective dose-ranging study included dosages of 0.2 mcg/mm2; 0.7 mcg/mm2; 1.4 mcg/mm2 and 2.7 mcg/mm2. Patients were evaluated clinically at twelve months to determine the effectiveness of each dose of paclitaxel in reducing the rate of restenosis in patients with de novo lesions undergoing coronary artery angioplasty and stenting.
The ELUTES study data was used by Cook in its submission in January for CE Mark approval to market its V-Flex Plus PTX stent system in the European Community. Approval is anticipated in the second quarter of 2002. The V-Flex Plus PTX Coronary Stent from Cook Incorporated is an investigational device not available for sale in Europe or the United States at this time.
Today, Guidant Corporation also announced excellent preliminary results from the DELIVER Clinical Trial, a single-blinded, randomized study comparing the paclitaxel-coated ACHIEVE Drug Eluting Coronary Stent to an uncoated bare-metal control stent. The DELIVER Clinical Trial is designed to serve as the basis for Guidant’s submission for U.S. Food and Drug Administration (FDA) approval of the ACHIEVE Stent System on behalf of Cook. The ACHIEVE Stent System, an investigational device not yet approved for sale in the United States or Europe, is manufactured by Cook and will be distributed worldwide exclusively by Guidant.
With international headquarters in Bloomington, Ind., privately held COOK® (www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, tissue-engineered medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.
Other News Articles
- Cook Incorporated To Consolidate Its U.S. Paclitaxel-Eluting Stent Program to Support the ACHIEVE Stent
- Two Paclitaxel-Eluting Coronary Stents From Cook Incorporated Enter New Advanced Trials In Europe
- Cook Incorporated Receives FDA Clearance For Investigational Use Of Zilver® Vascular Stent
- Cook Incorporated's ACHIEVE Paclitaxel-Eluting Coronary Stent Receives First CE Mark Approval For Sale In Europe
- Cook Wins Approval To Sell Second Paclitaxel-Eluting Stent In Europe
- Cook Incorporated To Begin First U.S. Clinical Trial Of A Drug-Eluting Non-Coronary Stent
- Cook and Angiotech Restructure License Agreement: Cook to Focus on Developing Paclitaxel-Eluting Medical Devices
for Peripheral (Non-Coronary) Market
- First U.S. Drug-Eluting Stent Trial To Treat Peripheral Arterial Disease Enrolls First Patient At Stanford University Medical Center: New treatment could benefit millions who suffer from seriously under-diagnosed disease
- Cook To Begin First International Trial of a Paclitaxel-Eluting Stent for Peripheral Artery Disease: new treatment could benefit millions who suffer from seriously under-diagnosed disease
- Two Patients Treated in First International Case Testing Drug-Eluting Stents To Treat Peripheral Arterial Disease
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