E-Five Shows 2-Year Benefits of Medtronic's Endeavor Stent

March 28, 2009—Medtronic, Inc. (Minneapolis, MN) announced the presentation of data demonstrating the long-term safety and effectiveness results for the company's Endeavor drug-eluting coronary stent in a large multicenter, real-world study, in which no defined patient selection criteria were specified, and angioplasty was used at medical discretion. Two-year results for more than 2,000 patients in the international, E-Five study show that the Endeavor stent was associated with a low rate of both overall (0.7%) and very late stent thrombosis (VLAST) at 0.1%.

According to the company, long-term controlled clinical studies of other approved drug eluting stents (DES) reveal a small but consistent (0.3% per year) increase in the frequently fatal VLAST complication. The E-Five findings run counter to expectations based upon these prior studies of other DES that have also reported an approximate doubling (0.6% per year) in the rate of VLAST when these devices are used in real-world patient populations. The long-term safety results for the Endeavor stent are distinct in that the overall rate of stent thrombosis and the rate of VLAST were found to be low and similar to those rates observed in pooled data from controlled, clinical trials in the ENDEAVOR program.

On other safety endpoints, the 2-year results for this prespecified subset of E-Five patients were similarly favorable, with low and stable rates of cardiac death (1.2% vs 1.5%) and myocardial infarction (1.2% vs 1.5%) at 1 and 2 years, respectively. Duration of dual-antiplatelet therapy (DAPT) for these E-Five patients underscores the safety benefits of the Endeavor stent: 52.6% of the patients were on DAPT at 1 year and 22.1% at 2 years. These safety and efficacy results from E-Five closely resemble those from a pooled analysis of the ENDEAVOR clinical program and they compare favorably to the results of similarly designed registries for other DES, the company stated.

E-Five enrolled more than 8,000 patients at more than 200 sites in Europe, Asia Pacific, the Middle East, and South America. Extended 2-year follow-up was planned for a prespecified subset of approximately 2,000 patients at 26 centers in 14 countries to determine the durability of the Endeavor stent's safety and efficacy in a "real-world" population, which reflects the variability of patient types and lesion characteristics in standard clinical practice.

Medtronic stated that the E-Five (n = 8,314) primary endpoint of major adverse cardiac events (MACE) was 7.5% at 1 year (n = 7,832). For the prespecified subset (n = 2,116), the MACE rate was 6.7 % at 1 year and 8.5% at 2 years. Patient demographics were similar for the entire cohort and the prespecified subset, with slightly more complexity in the demographics of the entire cohort.