Danish Study Supports Endeavor® Stent Efficacy

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 17 Oct 2008 - 6:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced today the target lesion revascularization (TLR) rate for the company's Endeavor®drug-eluting stent in the real-world Danish trial, SORT OUT III, was 4.0 percent. This result at nine months is consistent with the ENDEAVOR-Five real-world study, which reported an overall TLR of 4.5 percent at 12 months. The rates of myocardial infarction in the SORT OUT III study were very low for both the Endeavor (1.4 percent) and Cypher (0.5 percent) stents. The rate of stent thrombosis in SORT OUT III for Endeavor was 1.2 percent (ARC definite), consistent with typical rates of stent thrombosis for both drug-eluting and bare-metal stents after nine months of patient follow up.

Surprisingly, however, the SORT-OUT III study at nine months reported a 1.0 percent TLR rate for Cypher, considerably less than the 4.5 percent TLR reported in the similar SORT OUT II study, Galloem et al, JAMA 2008, previously conducted in the same five centers by the same group. In addition, the stent thrombosis rate for the Cypher stent was 0.2 percent, compared to 1.7 percent reported in the SORT OUT II study.

Dr. Jens Flensted Lassen, the study investigator stated, "We were very surprised by these results - specifically those for Cypher and especially compared to the SORT OUT II data." It was also noted during the presentation that late stent thrombosis becomes meaningful as a safety signal only after one year. Dr. Lassen commented on the safety outcomes in the study, which reported stent thrombosis for Endeavor of 1.2 percent at nine months, "This is only half the story, as we saw with ENDEAVOR IV, we expect late catch up with Cypher." Dr. Lassen's comments acknowledge that while early events were also seen with Endeavor in the ENDEAVOR IV study at 12 months, there were no instances of late stent thrombosis with Endeavor after 369 days, in follow up to two years.

Medtronic soon will complete enrollment in the PROTECT clinical study. The PROTECT study is the largest randomized trial focusing on the safety of drug-eluting stents. This 8,800-patient trial is being conducted at 200 centers worldwide and will compare Medtronic's Endeavor stent and Cypher, made by Cordis, using key safety endpoints and other clinically relevant outcomes. The primary endpoint for the PROTECT study will be overall stent thrombosis at three years.

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Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world. http://www.medtronic.com

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.