Healthcare Industry News: drug-eluting stent
News Release - October 19, 2006
Medtronic Announces Largest Clinical Study Evaluating Drug-Eluting Stent SafetyPROTECT Trial Will Compare Frequency of Stent Thrombosis Associated with Medtronic's Endeavor Stent and Johnson & Johnson's Cypher Stent in Large Randomized Trial
MINNEAPOLIS--(HSMN NewsFeed)--Reflecting its commitment to patient safety and ongoing medical research, Medtronic, Inc. (NYSE:MDT ) has announced that it will begin a new, large-scale clinical trial focusing on the safety of drug-eluting stents (DES). The PROTECT study will be the largest randomized stent trial ever conducted to assess and compare key safety measures of two drug-eluting stents. The trial will compare the Medtronic Endeavor® zotarolimus-eluting coronary stent system and the Johnson & Johnson Cypher® sirolimus-eluting stent.
The primary endpoint for the PROTECT study will be overall stent thrombosis, with secondary endpoints that include death and non-fatal myocardial infarction as well as customary clinical efficacy end points. The 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.
"Until the PROTECT trial, there have been no large, randomized clinical trials that have focused primarily on the safety of drug-eluting stents or that have provided head-to-head analysis with a specific safety outcome as a primary endpoint," said Dr. William Wijns, Co-Director of the Cardiovascular Center, OLV Ziekenhuis, Aalst, Belgium and co-principal investigator of the PROTECT trial. "Safety has become a growing concern among physicians, and this trial is carefully designed and powered to provide an extremely thorough, long-term assessment of Endeavor and Cypher safety in real world practice. This safety data will serve as a complement to the extensive clinical data already available on these two devices and will provide physicians with a clearer picture on the balance between safety and efficacy of drug-eluting stents."
The Endeavor stent has demonstrated a favorable safety profile throughout its multi-phased clinical program, with approximately 1,000 Endeavor patients studied beyond two years. Data published recently in CIRCULATION magazine from the ENDEAVOR II Clinical Trial showed no documented stent thrombosis beyond 30 days up to two years after implantation. Endeavor's overall stent thrombosis rate in all clinical trials is just 0.3 percent. Endeavor's efficacy data also has been excellent, with a Target Lesion Revascularization (TLR) rate at two years of 6.5 percent in the ENDEAVOR II trial - meaning that approximately 94 percent of the patients receiving Endeavor did not require a repeat procedure. In a pooled analysis of all Endeavor data, the TLR rate was consistent across various patient subgroups, including those with diabetes, small blood vessels and long lesions.
"The safety and efficacy data on Endeavor is extensive, consistent, and very favorable, and we expect that this record will be confirmed yet again in the PROTECT Trial," said Scott Ward, president of the Vascular business unit at Medtronic. "We believe it is important to undertake this trial to provide even more long-term safety data on these devices and compare the differences between the Cypher and Endeavor drug eluting stent platforms. We are extremely pleased to bring together such a distinguished group of clinical experts to serve as our principal investigators for this study and look forward to beginning this study in the coming months."
In addition to Dr. Wijns, other co-principal investigators for PROTECT include: Dr. Patrick Serruys, Thoraxcenter, Erasmus University, Rotterdam, Netherlands; Prof. Philippe Gabriel Steg, M.D., Hopital Bichat-Claude Bernad, Paris; Dr. Edoardo Camenzind, Division of Cardiology, University Hospital Geneva; and Dr. William O'Neill, Executive Dean of Clinical Affairs at the University of Miami Miller School of Medicine. An independent Clinical Events Committee (CEC) will be engaged for adjudication of events related to the primary endpoint and an independent statistical organization used for data analysis.
The Endeavor drug-eluting stent is built on a modular, cobalt chromium stent platform that provides outstanding deliverability and side branch access. In addition to the non-cytotoxic drug compound zotarolimus, which is fully eluted into the vessel wall at 28 days, the Endeavor stent also uses a proven, non-inflammatory phosphorylcholine (PC) polymer. PC Polymer is designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, allowing for full endothelialization, or healing of the tissue following stent implant.
drug-eluting stents are tiny mesh devices that help prop open clogged arteries during angioplasty procedures. They were introduced in 2002 in Europe and have been considered a breakthrough in interventional cardiology because of their effectiveness in reducing restenosis, or the re-clogging of an artery following a stent implant. Large randomized studies have established that drug-eluting stents are much more effective at preventing restenosis than their bare metal predecessors, which have no drug coating. Bare metal stents remain a valuable tool for physicians in the treatment of cardiovascular disease, especially for patients with specific medical conditions or for whom drug-eluting stents are not ideal due to medical procedures that require patients to discontinue anti-platelet therapy.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Editors: PROTECT = Patient Related OuTcomes with Endeavor versus Cypher stenting Trial.
Caution: In the United States, the Endeavor drug-eluting Coronary Stent is an investigational device with an investigational drug (zotarolimus) and is exclusively used for clinical investigation.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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