Phase III trial shows benefits of Resolute ZES (Medtronic) in CAD patients with Diabetes

New data shows that treatment with the Resolute (zotarolimus-eluting stent), from Medtronic, led to positive outcomes for CAD patients with Diabetes who were not taking insulin and for CAD patients without Diabetes. It presents the results of two analyses from the Phase III RESOLUTE program, which enrolled a total of 5,130 patients. This set a 12-month target vessel failure (TVF) rate of 14.5 percent as a performance goal. The actual rate of TVF at 12 months among standard-risk Diabetes patients was 7.8 percent. It also found comparable rates of target lesion failure (TLF) at 2 years in the patients with non-insulin-treated Diabetes vs patients without Diabetes (8.0% vs. 7.1%).

In addition, it found a higher 2-year TLF rate in the patients with insulin-treated Diabetes (13.7%). Finally it noted comparable 2-year rates of TLF in patients with non-insulin-treated Diabetes vs patients without Diabetes (8.9% vs. 8.4%), and a higher rate of TLF at 2 years in patients with insulin-treated Diabetes (16.7%). See: "Clinical Outcome of Patients With and Without Diabetes Mellitus After Percutaneous Coronary Intervention With the Resolute Zotarolimus-Eluting Stent: 2-Year Results" Sigmund Silber et al. J Am Coll Cardiol Intv. 2013;6(4):357-368.