A Medical Device Daily

Medtronic (Minneapolis) presented new long-term data from the ENDEAVOR clinical trial program at the EuroPCR meeting last week in Barcelona, reinforcing, it said, the existing safety and efficacy profile of the Endeavor drug-eluting coronary stent (DES) system.

Four-year results from the 100-patient first-in-man ENDEAVOR I trial and three-year results from the nearly 1,200 patient ENDEAVOR II trial demonstrate that Endeavor is associated with sustained safety, significant reductions in repeat procedures and no late stent thrombosis in either trial using the pre-specified trial protocol definitions. The ENDEAVOR II study also showed that the Medtronic Driver bare metal stent offers consistent and durable long-term clinical results.

The data was presented by Andreas Zeiher, MD, J.W. Goethe-University (Frankfurt, Germany), during a late-breaking clinical trial session.

The Endeavor is approved in more than 100 countries and is under review by the FDA. The company said it anticipates approval this quarter.

The company said that ENDEAVOR I data continue to show excellent long-term results, with only one clinical event between years three and four, a non-cardiac death from cancer. Target Lesion Revascularization (TLR) at four years was 3.1% and Target Vessel Revascularization (TVR) was 5.2%. The major adverse cardiac events (MACE) rate, one of the trial's primary endpoints, was 7.2%, with no late stent thrombosis events in this patient cohort.

Through three years of follow-up in the ENDEAVOR II trial, the TLR rate was 7.3%, compared to 14.7% for the Driver bare metal control arm, representing a 50% reduction in the need for repeat procedures. Target Vessel Failure, the trial's primary endpoint, was 12.8% for Endeavor and 21.4% for Driver, a 40% reduction. Endeavor showed a MACE rate of 12% at three years, compared to 20.7% for Driver, while the combined cardiac death/myocardial infarction (MI) rate for Endeavor was 4.5% and 6.7% for Driver. When compared to Driver, Endeavor has fewer total deaths, fewer cardiac deaths and fewer MIs at three years.

Under the definitions for definite and probable stent thrombosis, Endeavor's cumulative rate in the ENDEAVOR I-III trials is 0.5% at three years and the Driver bare metal stent has a rate of 1.5%. Additionally, composite analysis of myocardial infarction and cardiac mortality showed three-year freedom from death or MI of 96.0% for Endeavor and 93.4% for the Driver bare metal stent.

In other news from EuroPCR:

• The efficacy of OrbusNeich's (Hong Kong) Genous Bio-engineered R stent compares favorably to that of drug-eluting stents, while the risk of late thrombosis is minimized with the Genous stent, according to an interim analysis of post-marketing data presented by Robbert de Winter, MD, PhD, co-principal investigator of the study and director of the catheterization laboratory at the Academic Medical Center (Amsterdam, the Netherlands).

Unlike DES devices, Genous is coated with an antibody, capturing a patient's endothelial progenitor cells (EPCs) to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis.

Collected from more than 120 sites in 29 countries, follow-up data for patients who received at least one Genous Bio-engineered R stent showed that for 2,175 patients at 30 days, the target lesion revascularization (TLR) rate was 0.05%, the major adverse cardiac events (MACE) rate was 1.61%, and the sub-acute thrombosis (SAT) rate was 0.37%. For 1,039 patients at six months, the TLR rate was 2.89%, the MACE rate was 5.87%, and the thrombosis rate was 0.88%.

OrbusNeich's e-HEALING is a multi-center, worldwide prospective registry of patients treated with the Genous Bio-engineered R stent in accordance with the instructions for use. The protocol recommends that patients receive two weeks of statin treatment prior to the procedure and one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary outcome of the registry is target vessel failure at 12 months

• XTENT (Menlo Park, California) reported positive six-month follow-up data from the CUSTOM II clinical trial, which assessed the safety/efficacy of the company's investigational Custom NX DES system for the treatment of long and multiple lesions in patients with coronary artery disease.

The single-arm prospective study evaluated the use of CUSTOM NX in patients with long lesions, defined as greater than 20 mm, and patients with two lesions. Of the 100 patients enrolled, 69 patients were enrolled in the long lesion arm, and 31 patients were enrolled in the two lesion arm of the study. Up to two customizable stent deployments of up to 60 mm total length were evaluated in the study. The primary endpoint was MACE at six months, with clinical follow-up at one, six and 12 months, then annually for five years. Angiographic and intravascular ultrasound (IVUS) follow-up was conducted at six months. The anticoagulation regimen was clopidogrel for a minimum of three months plus aspirin.