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The findings come from ENDEAVOR IV, a randomized trial involving nearly 1,550 patients with coronary artery disease that compared the two drug-eluting stents head-to-head. A separate analysis released at the same meeting of interventional cardiovascular specialists also affirmed the strong, long-term safety profile of Medtronic's Endeavor DES, which elutes the drug zotarolimus from a highly biocompatible polymer that mimics the surface of a red blood cell.
The final five-year results of ENDEAVOR IV, presented today by co-principal investigator Dr. David Kandzari of Piedmont Heart Institute in Atlanta during the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, show statistically significant differences favoring the Endeavor DES on cardiac death/myocardial infarction (CD/MI) and very late stent thrombosis (VLST). The data also show a trend toward lower rates of target vessel failure (TVF) with the Endeavor DES in long-term follow-up. "The five-year results from ENDEAVOR IV confirm that long-term clinical outcomes should be an essential consideration when making decisions related to stent selection," said Dr. Kandzari. "Interventionalists treating patients with coronary artery disease now have ample data to distinguish the important differences between the performance of these two drug-eluting stents." 5-YEAR RESULTS
* Endpoint Key ENDEAVOR Pooled Safety Dr. Kandzari also presented a five-year update to a pooled analysis of safety data from the Endeavor clinical program at TCT 2011. The analysis, called ENDEAVOR Pooled Safety, involved 2,132 patients who received an Endeavor DES as participants in one of six studies, including ENDEAVOR IV. ENDEAVOR Pooled Safety shows that at five years of follow-up, treatment with the Endeavor DES resulted in a significant reduction in TLR and CD/MI, and was associated with no increased risk of stent thrombosis in comparison to a bare-metal stent (BMS) control group including 596 patients from ENDEAVOR II. 5-YEAR RESULTS
note: Data in this table are from post-hoc analysis; event rates are unadjusted. "These findings are even more relevant because most patients in both groups were off dual-antiplatelet therapy by one year after stent implantation," explained Dr. Kandzari, whose paper titled "Dual antiplatelet therapy duration and clinical outcomes following treatment with zotarolimus-eluting stents" appeared in the October 2011 edition of JACC: Cardiovascular Intervention. "The Endeavor DES exhibits a safety profile that not only is durable through late-term follow-up but that also distinguishes it from comparative devices." In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. About Medtronic Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Source: Medtronic, Inc. |
