Medtronic says RESOLUTE enrollment complete
Medtronic (Minneapolis) said that enrollment in the 2,300-patient RESOLUTE All-Comers (R-AC) clinical study was completed in just six months, two months ahead of schedule. The randomized trial compares the safety and efficacy of Medtronic's Endeavor Resolute drug-eluting stent (DES) with Abbott Laboratories' (Abbott Park, Illinois) Xience DES.
The Endeavor Resolute DES features the biocompatible BioLinx polymer, the first polymer designed specifically for use on a DES. The BioLinx polymer is designed to extend the duration of drug exposure in the vessel – an elution profile of potential relevance to patients that physicians consider to be at high risk of needing a repeat procedure – without trading off polymer biocompatibility.
R-AC symmetrically randomized 2,300 unselected patients to the Endeavor Resolute DES or the Xience DES stent at 17 prominent medical centers in Europe and Israel. The primary endpoint for R-AC is target lesion failure (TLF), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), within 12 months.