1. TUXEDO–India
Trial design: Patients with type 2 diabetes mellitus (DM2) and coronary artery disease undergoing PCI were randomized to receive Taxus Element PES and Xience Prime EES. They were followed for 12 months.
Results
pnoninferiority = 0.38 psuperiority = 0.005
Primary endpoint: Target vessel failure for PES vs. EES: 5.6% vs. 2.9%, pnoninferiority = 0.38; psuperiority = 0.005
All-cause mortality: 2.5% vs. 2.3%, p = 0.75
Target vessel MI: 2.8% vs. 0.5%, p < 0.001
Stent thrombosis: 2.1% vs. 0.4%, p = 0.002
Target lesion revasc.: 3.4% vs. 1.2%, p = 0.002 %
Conclusions
EES is superior to PES for clinical endpoints at 1 year in patients with DM2 undergoing DES-PCI
Consistent with other reports, rates of stent thrombosis with PES were also higher
Primary endpoint
PES
(n = 914)
EES
(n = 916)
Kaul U, et al. N Engl J Med 2015; Oct 14:[Epub]