One-year results from the ENDEAVOR-Five registry – including those for subsets of diabetics and patients with acute myocardial infarction (AMI) – demonstrate that the Endeavor DES performs comparably in a real-world population of patients with complex disease and in specific patient subsets.
“Registries generally enroll more challenging ‘real-world’ patients than randomized trials,” explained Prof. Martin Rothman of the U.K.’s London Chest Hospital and one of ENDEAVOR-Five’s principal investigators. “Approximately 70 percent of the 8,314 patients enrolled in E-Five had complex cardiovascular disease, including diabetes, small vessels and long lesions, and a significant number were acute coronary syndrome or AMI. Despite the higher complexity of the patients enrolled in this registry, the outcomes at 12 months were excellent; the rates of MACE, TLR, cardiac death, MI and stent thrombosis were remarkably low and consistent with findings from the ENDEAVOR clinical trial program overall.”
The 12-month target lesion revascularization (TLR) rate for all patients in E-Five (n=8,314) was 4.5 percent; for the subset of diabetics (n=2,563), 5.3 percent; for the AMI patients (n=1,077), 3.2 percent; and for the high-risk patients (n=5,824), 5.0 percent.
ENDEAVOR-I Results Square with Overall Clinical Program
Five-year results from the ENDEAVOR-I trial complement and corroborate a vast array of consistently compelling data which supports the durable efficacy of the Endeavor DES over the long term.
Unprecedented in clinical DES efficacy trials, Medtronic’s Endeavor stent is associated with TLR rates which stop increasing at three years. Randomized controlled trials of other drug-eluting stents show a continued increase in TLR, reducing the durability of benefit. More compelling is how the ENDEAVOR-I TLR plateau is replicated on a larger scale in ENDEAVOR-II, the device’s pivotal study. With data out to four years, exactly the same curve is apparent, and TLR stops increasing at 36 months.
Results of ongoing head-to-head trials will be required to these time points for confirmation, but the Endeavor TLR plateau appears to be a unique observation among available drug-eluting stents and has the potential to redefine the standard by which efficacy is measured.
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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 25, 2008. Actual results may differ materially from anticipated results.
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Source: Medtronic, Inc.
