Healthcare Industry News: stent thrombosis
News Release - August 21, 2006
Circulation Article Reports That Medtronic's Endeavor(R) Drug-Eluting Stent Provides Further Evidence of Effective, Safe and Sustained Clinical OutcomesENDEAVOR II Shows Impressive Reduction in Repeat Procedures and Vessel
Re-Narrowing for Patients with Coronary Artery Disease
MINNEAPOLIS--(HSMN NewsFeed)--Aug. 21, 2006--Medtronic, Inc. (NYSE:MDT ): Clinical results from the ENDEAVOR II study published in this week's American Heart Association journal CIRCULATION provide further evidence of the safety and effectiveness of the Medtronic EndeavorŪ drug-eluting coronary stent system for patients with coronary artery disease, with a clinically significant treatment effect that is being sustained over time.
"Since the presentation of the initial ENDEAVOR II data at the American College of Cardiology in 2005, we have learned that the clinical results achieved with the Endeavor stent system are extremely durable over time and remain quite consistent across a wide variety of patients," said William Wijns M.D., the Co-Principal Investigator of the ENDEAVOR II Pivotal Clinical Trial and Co-Director of the Cardiovascular Center, OLV Ziekenhuis, Aalst, Belgium. "These excellent clinical outcomes have been maintained at 9 months, 12 months and 24 months. Compared to bare metal stents, Endeavor is safe and effective in reducing the rates of clinical and angiographic restenosis, and is a highly deliverable stent that has significant anti-restenosis properties and a favorable safety record with dual anti-platelet therapy."
The CIRCULATION article describes the ENDEAVOR II clinical trial, which was a randomized, double-blind pivotal trial designed to evaluate the safety and efficacy of the Endeavor stent compared to Medtronic's popular DriverŪ cobalt alloy bare metal stent. Sponsored by Medtronic (NYSE:MDT ), the trial enrolled 1,197 patients at 72 facilities in 17 countries and was the first and largest drug eluting stent trial outside the U.S. comparing a drug eluting stent to a bare metal stent. The primary endpoint of the trial was Target Vessel Failure (TVF) at nine months. TVF is a composite endpoint, which includes death, myocardial infarction and Target Vessel Revascularization (TVR).
The study met all of its endpoints, including a 48 percent reduction in TVF, and a 61 percent reduction in Target Lesion Revascularization (TLR) between the Endeavor arm and the control group. TLR is the rate of re-treatment of patients after coronary stenting and is widely viewed by physicians as an important clinical marker of drug eluting stent effectiveness. Angiographic results of the study demonstrated a significant reduction in restenosis rates at eight months. The study showed a 72 percent reduction in in-stent angiographic binary restenosis (ABR) in the Endeavor arm versus the Driver arm, and the in-segment ABR rate was reduced by 62 percent.
Additionally, the rate of stent thrombosis was just 0.5 percent for the 598 patients in the trial who received the Endeavor stent, not statistically different from the 1.2 percent rate among those who received a bare metal stent. Between 30 days and 9 months, there were no observations of late stent thrombosis, which is the formation of dangerous blood clots after 30 days that can potentially lead to heart attacks or death.
"Given the recent concerns with the long-term safety of some drug-eluting stents, the results of Endeavor have been extremely encouraging," said co-principal investigator Jean Fajadet, M.D., Clinique Pasteur Unite de Cardiologie Interventionnelle, Toulouse, France. "Endeavor's combination of a phosphorylcholine coating polymer and the drug Zotarolimus has provided excellent clinical results and a favorable safety profile."
Among the questions the trial attempted to address was whether or not the Endeavor stent would prove effective in patients with a moderate tendency for restenosis, such as patients with diabetes, or with challenging lesion structures. Also, with early angiographic results somewhat higher in ENDEAVOR II than in other drug-eluting stent trials, questions arose about whether the Endeavor data would retain its robustness over time. Both questions have now been answered.
"In this trial, the Endeavor stent reduced the risk of restenosis for patients both with and without diabetes, as well as across subgroups in terms of vessel size and lesion length," Dr. Wijns said. "This subgroup analysis suggests that the Endeavor stent is effective in each of these clinical settings, as included in the trial."
In May, positive two-year clinical results from ENDEAVOR II were presented at the Paris Course on Revascularization, along with three-year data from the ENDEAVOR I trial. Both studies provided evidence that the Endeavor stent was, in fact, sustaining its clinical effectiveness.
"The Endeavor stent offers a combination of clinical effectiveness and safety that is withstanding the test of time," said Scott Ward, president of Medtronic's vascular business. "Combined with its acknowledged deliverability, Endeavor's overall performance has provided physicians with excellent clinical outcomes for their patients. We look forward to submitting our final PMA module to the FDA this fall and anticipate approval in the U.S. in 2007."
In addition to the modular, cobalt alloy architecture developed to enhance deliverability, the Endeavor stent uses the drug compound Zotarolimus (ABT-578) and is coated with phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell. This helps mimic the structure of the natural cell membrane, leading to a healthy healing response and lower inflammation following implant. The Endeavor drug-eluting stent received CE Mark approval in Europe in July 2005 and is available in approximately 100 countries worldwide.
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: In the United States, the Endeavor drug-eluting Coronary Stent is an investigational device with an investigational drug (zotarolimus, 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 28, 2006. Actual results may differ materially from anticipated results.
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