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Endeavor™ drug eluting stent provides significant treatment effect in patients with coronary artery disease, Clinical results show
Final ENDEAVOR II clinical data shows impressive reduction in repeat procedures and vessel renarrowing
(I-Newswire) - William Wijns, MD, Co-Principal Investigator of the ENDEAVOR II Pivotal Clinical Trial and Co-Director of the Cardiovascular Center, OLV Ziekenhuis, Aalst, Belgium, last night presented positive results of the ENDEAVOR II trial at the American College of Cardiology ( ACC ) 54th Annual Scientific Session. The ENDEAVOR II study demonstrated clinically and statistically significant improvement in all of the study's endpoints, including a 47 per cent reduction in the primary endpoint of Target Vessel Failure ( TVF ).
Dr Wijns commented: “Overall the clinical results are impressive and show that more than 95 per cent of the patients who received an Endeavor stent in the trial required no further treatment or revascularisation at the original treatment site at the nine month assessment period. The Endeavor stent's performance in this trial provides substantial evidence that the Endeavor drug eluting stent is safe and that it substantially reduces clinical restenosis compared to a bare metal stent. These clinical results, taken together with the ease of use of the Driver stent platform, establish the Endeavor stent as a valuable treatment option for patients undergoing angioplasty with drug eluting stents”.
The ENDEAVOR II Clinical Trial, sponsored by Medtronic, Inc. ( NYSE: MDT ), was a randomised, double-blind pivotal trial designed to evaluate the safety and efficacy of Medtronic's Endeavor™ Drug Eluting Coronary Stent compared to Medtronic's Driver™ Cobalt Alloy Coronary Stent in patients with coronary artery disease.
The co-principal investigators of the ENDEAVOR II trial are Dr Wijns; Jean Fajadet, MD, Clinique Pasteur Unité de Cardiologie Interventionnelle, Toulouse, France; and Richard M Kuntz, MD, Associate Professor, Harvard Medical School, and Chief, Division of Clinical Biometrics, Brigham and Women's Hospital, Boston.
The trial enrolled 1,197 patients at 72 facilities in 17 countries, making it the first and largest drug eluting stent trial comparing a drug eluting stent to a bare metal stent ever performed outside the US. The primary endpoint of the trial was TVF at nine months. TVF is a composite endpoint, which includes death, myocardial infarction and Target Vessel Revascularisation ( TVR ). The results from the trial will be used to support Endeavor product approvals globally.
“Extremely Solid Clinical and Angiographic Results”
The final results highlight the significant treatment effect the Endeavor stent has in patients with coronary artery disease. The study successfully met its primary and secondary endpoints, including a 47 per cent reduction in TVF in the Endeavor arm ( 8.1% ) in comparison with the control group ( 15.4% ). The study also demonstrated a 62 per cent reduction in Target Lesion Revascularisation ( TLR ) between the Endeavor arm ( 4.6% ) and the control group ( 12.1% ). TLR is the rate of retreatment of patients after coronary stenting and is widely viewed by physicians as a critical clinical marker of drug eluting stent effectiveness.
Angiographic results of the study demonstrated a significant reduction in restenosis rates. The study showed a 71 per cent reduction in in-stent angiographic binary restenosis ( ABR ) in the Endeavor arm ( 9.5% ) versus the control arm ( 32.7% ). The in-segment ABR rate in the study was reduced by 61 per cent in the Endeavor arm ( 13.3% ) versus the control arm ( 34.2% ). The study showed an in-segment late loss of 0.36 mm in the Endeavor arm ( 0.70 mm in the control arm ) and an in-stent late loss of 0.62 mm in the Endeavor arm ( 1.03 mm in the control arm ).
Dr Kuntz commented: “These are extremely solid clinical and angiographic results, supported by a comprehensive base of data compiled through the outstanding work of the ENDEAVOR II investigators around the world. The study had an impressive 88 per cent follow up rate in the assigned angiographic cohort and a 97 per cent follow up rate in the clinical cohort. The result is a strong body of data that provides a clear and compelling case for the outstanding performance of the Endeavor stent”.
“An Impressive Safety Record”
The ENDEAVOR II study revealed impressive data on the Endeavor stent's safety performance. The study indicated a 50 per cent reduction in the Major Adverse Cardiac Event ( MACE ) rate in the Endeavor arm ( 7.4% ) compared to the control arm ( 14.7% ). In addition, the ENDEAVOR II trial showed a 0.5 per cent rate of stent thrombosis at 30 days -- with no late thrombosis beyond 30 days and no late stent malapposition.
Martin B Leon, MD, Co-Principal Investigator of the ENDEAVOR III and ENDEAVOR IV Clinical Trials and Chairman of The Cardiovascular Research Foundation, Columbia University Hospital, New York, commented: “The Endeavor stent has demonstrated an impressive safety record that should not be overlooked. While you get a significant treatment effect with drug eluting stents, we must always remain diligent that long-term safety is not compromised in patients. The ENDEAVOR II clinical experience of zero thrombosis beyond thirty days and no late malapposition places the Endeavor stent among the safest DES systems studied to date”.
Enhanced Deliverability and Excellent Ease of Use
The Endeavor drug eluting stent is based on the Driver Coronary Stent -- the world's leading cobalt alloy stent. The Driver stent is made of a cobalt alloy and a unique modular architecture to provide enhanced deliverability over standard bare metal stents.
Dr Wijns added: “The excellent track record and ease of use of the Driver stent was apparent in the ENDEAVOR II trial results. Device and lesion success rates were all above 99 per cent in both the Endeavor arm and Driver control”.
Commercialisation Outside the US in the Spring
Scott Ward, President of Medtronic Vascular, commented: “We are extremely pleased by the work of the investigators from around the world who participated in this trial as well as the outstanding clinical results observed in ENDEAVOR II. With this compelling and definitive data, we look forward to moving on with our efforts to commercialise the Endeavor stent outside the United States this spring. We are ramping up our manufacturing operations to supply the world with high-quality and readily available product and our distribution network is prepared and ready to bring this product to physicians and patients around the world when approved for use”.
Ward continued: “Based on the data from ENDEAVOR II, we are also confident in our efforts to bring this product to the US and we believe that Endeavor will continue to perform very well in the ENDEAVOR III and ENDEAVOR IV trials. We will present the final results from the ENDEAVOR III trial in October and we intend to begin the ENDEAVOR IV trial in the next few weeks”.
Founded in 1949, Medtronic is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. UK operations, based in Watford since 1987, began in 1972.
CAUTION: The Endeavor Drug Eluting Coronary Stent is an investigational device with an investigational drug ( ABT-578 ) and exclusively 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 30, 2004. Actual results may differ materially from anticipated results.
CONTACTS:
Joe McGrath Medtronic Ltd ( UK ) 01923 205149 ( UK ) 07802 160966 joseph.mcgrath@medtronic.com http://www.medtronic.com
Jacqui Dyson GCI Healthcare ( UK ) 020 7072 4266 ( UK ) 07713 406290 jdyson@gciuk.com http://jwww.gciuk.com
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