A Medical Device Daily

At the EuroPCR conference being held in Paris this week, Medtronic (Minneapolis) reported that preliminary demographic data from its e-Five international registry confirms that the Endeavor drug-eluting coronary stent is being implanted in a broad spectrum of patients during routine clinical practice.

Chaim Lotan, MD, co-principal investigator of the registry and head of the Hadassah University Hospital Heart Institute (Jerusalem), presented the data during a Medtronic-sponsored symposium at the meeting.

The 8,000-patient prospective, multicenter study includes patients with diabetes, tortuous calcified lesions, and small blood vessels.

The registry is designed as an “all comers” trial to assess the safety of the Endeavor stent at more than 200 sites in Europe, Asia, Australia, and other locations outside the U.S., with a primary endpoint of major adverse cardiac events (MACE) at one year. The study has enrolled about 2,500 patients thus far.

Lotan reported that physicians implanting the stent as part of their normal, everyday practice have been successful in delivering the stent to the lesion 99.5% of the time.

The Endeavor stent is made of a cobalt alloy and has a unique modular architecture designed to enhance deliverability, the company said. Lotan also reported that about 35% of these patients are afflicted with diabetes and that small vessel sizes – those 2.25 to 2.75 mm in diameter – account for 42% of the total Endeavor stents implanted in the registry to date.

“These are important findings because it indicates physicians are comfortable using the Endeavor stent in a wide variety of cases on an everyday basis,” he said. “Based on this early look at the data, especially the high delivery success rate, implanting physicians can have confidence that the Endeavor stent will perform well in many types of cases, whether they are routine or in patients with complex medical conditions.”

The average stent length in the registry is 17.6 mm, with 1.4 stents implanted per patient. In addition, more than 35% of the patients had a previous myocardial infarction and 33% had unstable angina at the time of the stent implant. The company said it will present additional results from the registry in the fall.

The Endeavor drug eluting coronary stent received CE mark approval in late July 2005 and is now available in more than 85 countries around the world but has not been approved for use in the U.S.

The company filed its first premarket approval (PMA) module with the FDA in October 2005, and said it remains on track for PMA approval in calendar year 2007.

In other EuroPCR news, Boston Scientific (Natick, Massachusetts) reported that a peer-reviewed medical journal affiliated with the Paris Course on Revascularization called EuroIntervention, has released an integrated analysis that it said further supports the strong performance of the Taxus paclitaxel-eluting coronary stent system for the treatment of coronary artery disease in diabetic patients.

In the analysis, the diabetic patients who received a Taxus stent system had significantly lower rates of restenosis and repeat interventions than those who received a bare-metal stent.

According to the authors of the analysis, a number of mechanistic factors may contribute to the observed Taxus stent benefit. They state that the unique mechanism of action of paclitaxel, the drug used in Taxus stents, supports their conclusion of emerging evidence of the excellent efficiency of Taxus stents in insulin-dependent diabetics.

The study is the first to use an integrated analysis of randomized data to examine aggregate results in a lower frequency but higher-risk diabetic population.

Four TAXUS clinical trials (TAXUS II, TAXUS IV, TAXUS V and TAXUS VI) were included in the analysis, involving a total of 3,445 patients with coronary artery stenosis, 814 of whom had diabetes.

Assessments of lesion characteristics showed that diabetic patients on average had more complex lesions than did non-diabetic patients. While diabetes has been identified as a strong predictor of restenosis after implantation of bare-metal stents, the angiographic and clinical results of this integrated analysis with similar outcomes independent of diabetic status suggest a significant advantage of the Taxus stent system in diabetic patients, including the high-risk insulin-treated subset.

The pooled clinical trial results at nine months reported a target lesion revascularization (TLR) rate of 5.4% in non-diabetic patients in the Taxus group and a TLR rate of 5.8% in diabetic patients (insulin-treated) in the Taxus group.

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