October 13, 2008 - Of those treated with Medtronic’s Endeavor Resolute drug-eluting stent (DES) in the RESOLUTE IDE trial, only two patients required repeat procedures – a 1.5 percent rate of target lesion revascularization (TLR) – at two years following implant, according to data released today at TCT 2008.
There were no instances of stent thrombosis among the 130 study subjects – all of whom received an Endeavor Resolute DES – through 24 months of follow-up.
The patients enrolled in RESOLUTE represented an unusually high degree of complexity for an initial clinical trial of a new DES. Average lesion length was 15.5 mm, and 82 percent of the subjects had challenging B2/C lesions. In addition, 46 percent had a prior myocardial infarction (MI), and 18 percent had a prior percutaneous coronary intervention (PCI); 18 percent had diabetes; 30 percent had unstable angina; and 22 percent were smokers at the time of enrollment.
“Based on the TLR and stent thrombosis rates of most other drug-eluting stents, the performance of Endeavor Resolute in this trial is encouraging,” said professor Ian Meredith of Monash Medical Centre in Australia and principal investigator of RESOLUTE. “That’s a credit to the noninflammatory properties of the drug zotarolimus and the BioLinx polymer’s biocompatibility and elution profile. The clinical and angiographic results are all the more impressive when you consider the complexity and challenging characteristics of the patients in the study.”
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