Healthcare Industry News: STENT Thrombosis
News Release - May 22, 2007
Medtronic Updates Long-Term ENDEAVOR I-II Clinical Data Showing Sustained Safety and Significant Reductions in Repeat Procedures
No STENT Thrombosis Seen in Long-Term Follow-up of Endeavor PatientsBARCELONA, Spain--(HSMN NewsFeed)--Medtronic (NYSE:MDT ) today presented new long-term data from the ENDEAVOR clinical trial program reinforcing the existing safety and efficacy profile of the Endeavor® drug-eluting coronary stent system. Four-year results from the 100-patient first-in-man ENDEAVOR I trial and three-year results from the nearly 1,200 patient ENDEAVOR II trial demonstrate that Endeavor is associated with sustained safety, significant reductions in repeat procedures and no late STENT Thrombosis in either trial using the pre-specified trial protocol definitions. The ENDEAVOR II study also showed that the Medtronic Driver® bare metal stent offers consistent and durable long-term clinical results.
The data was presented by Andreas Zeiher, M.D., J.W. Goethe-University, Frankfurt, Germany, during the EuroPCR's late-breaking clinical trial session. The Endeavor stent is approved in more than 100 countries worldwide and currently is under review by the U.S. Food and Drug Administration. FDA approval is anticipated in the second half of 2007.
The ENDEAVOR I data continue to show excellent long-term results, with only one clinical event between years three and four, a non-cardiac death from cancer. Target Lesion Revascularization (TLR) at four years was 3.1% and Target Vessel Revascularization (TVR) was 5.2%. The Major Adverse Cardiac Event (MACE) rate, one of the trial's primary endpoints, was 7.2%, with no late STENT Thrombosis events in this patient cohort.
Through three years of follow-up in the ENDEAVOR II trial, the TLR rate was 7.3%, compared to 14.7% for the Driver bare metal control arm (p= less than 0.001), representing a 50% reduction in the need for repeat procedures. Target Vessel Failure, the trial's primary endpoint, was 12.8% for Endeavor and 21.4% for Driver, a 40% reduction (p= less than 0.001). Endeavor showed a MACE rate of 12.0% at three years, compared to 20.7% for Driver (p= less than 0.001), while the combined cardiac death/myocardial infarction (MI) rate for Endeavor was 4.5% and 6.7% for Driver (p=0.125). When compared to Driver, Endeavor has fewer total deaths, fewer cardiac deaths and fewer MIs at three years.
"These are well-conceived and well-managed clinical trials. The results are excellent and the clinical investigators have achieved a very admirable level of patient follow-up," said Jean Fajadet, M.D., Clinique Pasteur Unite de Cardiologie Interventionnelle, Toulouse, France, and one of the principal investigators for the ENDEAVOR II trial. "The number of repeat procedures is low, there are few adverse cardiac events and the lack of late STENT Thrombosis is truly extraordinary."
Using pre-specified, protocol-defined data adjudicated by the Harvard Clinical Research Institute, there have been no instances of late or very late STENT Thrombosis among more than 1,300 patients receiving the Endeavor stent. During the late-breaking session, Dr. Zeiher also presented Endeavor data using the broader Academic Research Consortium (ARC) definitions of STENT Thrombosis. Under the definitions for definite and probable STENT Thrombosis, Endeavor's cumulative rate in the ENDEAVOR I-III trials is 0.5% at three years and the Driver bare metal stent has a rate of 1.5%. Additionally, composite analysis of myocardial infarction and cardiac mortality showed three-year freedom from death or MI of 96.0% for Endeavor and 93.4% for the Driver bare metal stent.
"The body of data now available on Endeavor is significant and the results are impressive," said Scott Ward, senior vice president of the CardioVascular business at Medtronic. "We have made several major presentations of Endeavor data during the last year, with consistent and predictable results. Using either the pre-specified protocol definition or the new ARC definitions, these data demonstrate that Endeavor is highly effective at preventing repeat procedures without an increased safety risk, and with a favorably low incidence of death and myocardial infarction."
About Medtronic
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.
Caution: The Endeavor Drug-Eluting Coronary Stent is an investigational device with an investigational drug (Zotarolimus) and exclusively for clinical investigation in the United States.
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.
Source: Medtronic
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