Healthcare Industry News: Bare-Metal
News Release - May 15, 2008
International Endeavor Registry Reports Safety and Performance of Medtronic Drug-Eluting Stent in Diverse Patient PopulationE-Five Results on 8,300 Patients at One Year Reported at EuroPCR; Update on Pooled Safety Analysis of Endeavor DES Also Presented at European Meeting of Interventional Cardiologists
MINNEAPOLIS & BARCELONA, Spain--(HSMN NewsFeed)--New data presented today at EuroPCR reports extensive experience on the safety and performance of Medtronic’s (NYSE: MDT ) Endeavor Zotarolimus-Eluting Coronary Stent in routine clinical practice with a diverse patient population, providing in-practice alignment with results from the ENDEAVOR clinical trials.
“Registries generally enroll more challenging ‘real-world’ patients than randomized trials,” explained Prof. Martin Rothman of the United Kingdom’s London Chest Hospital when presenting the results. “In fact, nearly 70 percent of the more than 8,300 patients enrolled in Medtronic’s E-Five registry had complex cardiovascular disease, including diabetes, small vessels and long lesions, and a significant number were acute coronary syndrome or suffering acute myocardial infarction. Despite the higher complexity of the patients enrolled in this registry, the outcomes at 12 months were excellent, with a low MACE rate of 7.5 percent.”
MACE, the primary endpoint for E-Five assessed at one year, comprises death, cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR).
E-Five enrolled 8,314 patients at 200 medical centers in Europe, Latin and South America, Asia Pacific, Australia, New Zealand, and Israel. Of those, 33 percent had diabetes; 39 percent had a reference vessel diameter of 2.75 mm or smaller; and 39 percent had lesions of 20 mm or longer.
In addition to MACE, Prof. Rothman reported additional clinical outcomes for patients in E-Five at 12 months of follow-up:
- TLR - 4.5%
- Target Vessel Revascularization (TVR) - 4.9%
- Target Vessel Failure (TVF) - 7.2%
- Death - 2.4%
- Cardiac Death - 1.7%
- MI - 1.6%
- Stent Thrombosis (ARC definite/probable) - 1.1%
0-30 days - 0.8%
31-365 days - 0.3%
“The Endeavor drug-eluting stent was associated with a consistently low TLR rate in E-Five, regardless of lesion complexity,” Prof. Rothman concluded. “In this complex patient and lesion cohort, rates of cardiac death, MI and stent thrombosis were remarkably low and consistent with the safety findings from the ENDEAVOR clinical trial program overall.”
Long-Term Safety Affirmed in Separate Analysis
The Medtronic-sponsored symposium where the E-Five results were reported also featured an update of the ENDEAVOR pooled safety analysis (E-Safety). The latest update of E-Safety, which now includes four-year data on 678 patients and 2,132 overall, shows that the Endeavor drug-eluting stent has a remarkable long-term safety profile, as evidenced by a paucity of late adverse safety events.
E-Safety is a post-hoc analysis of Endeavor patients from ENDEAVOR I, II, II continued access, III, IV and pharmacokinetics comparing the safety outcomes with 596 patients who received the Driver Bare-Metal stent as part of ENDEAVOR II’s control group. (ENDEAVOR II is a randomized trial that compared the Endeavor stent to the Driver stent across a variety of safety and efficacy metrics, with a primary endpoint of TVF at nine months. Four-year data from ENDEAVOR II was presented Tuesday during EuroPCR’s late-breaking clinical trials session.)
Cumulative incidence of adverse safety events to four years follow:
Stent Thrombosis (ARC definite/probable) - 0.7% Endeavor; 1.5% Driver
-Total Year 1 - 0.6% Endeavor; 1.4% Driver -Total Years 2, 3 and 4 - 0.1% Endeavor; 0.2% Driver
MI - 2.7% Endeavor; 4.4% Driver
Cardiac Death - 1.8% Endeavor; 2.6% Driver
Cardiac Death plus MI - 4.3% Endeavor; 7.0% Driver
Death - 4.6% Endeavor; 5.2% Driver
“Compared to patients treated with the Driver stent, those treated with the Endeavor stent had no increased rate of death, cardiac death or MI,” said Prof. Ian Meredith of Monash Medical Centre in Australia, who presented the updated safety analysis. “In fact, these rates trend lower with Endeavor. Likewise, there was no evidence of an increased risk of stent thrombosis within one year or between one and four years among the Endeavor patients. In short, the results remain compelling through four years of follow-up.”
Prof. Meredith stressed the importance of considering the Endeavor stent’s excellent long-term safety profile in relation to the density of clinical follow-up and the concomitant rates of compliance with dual-antiplatelet therapy. Fewer than 10 percent of the patients were on DAPT at three and four years, fewer than 15 percent at two years, and fewer than 30 percent at one year. He also pointed out that patients at high-risk of complications – those with diabetes, small vessels or long lesions, for example – had similarly positive safety outcomes as average-risk patients.
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.
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 27, 2007. Actual results may differ materially from anticipated results.
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