News | October 13, 2008

Data on Medtronic’s Endeavor Stent Shows Strong Performance in Complex Patients

October 14, 2008 – Medtronic released, at TCT 2008, new data from the ENDEAVOR clinical program that reinforces the consistently strong performance of the company’s Endeavor drug-eluting stent (DES) across diverse patient populations affected by coronary artery disease.

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,” said professor 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.

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, said Medtronic.

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.

For more information:

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
Onyx DES 2.0 mm stent meets primary endpoints in small vessels
News | June 12, 2017
June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failur
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
Biosensors, BioFreedom drug-coated stent, LEADERS FREE II IDE trial, first patient, U.S. pivotal study
News | Stents Drug Eluting| March 03, 2017
Biosensors International Group Ltd. announced in February enrollment of the first patient in LEADERS FREE II, its new...
CeloNova Cobra Pzf stent
Technology | Stents| March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents| January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
Overlay Init