1. Primary safety endpoint
LEADERS FREE
Trial design: Patients with high bleeding risk undergoing PCI were randomized to either BioFreedom drug-coated stent (DCS) or Gazelle bare-metal stent (BMS). They were followed for 12 months.
Results
pnoninferiority < psuperiority = 0.005
Primary safety endpoint: Cardiac death, MI, stent thrombosis for DCS vs. BMS: 9.4% vs. 12.9%, pnon-inferiority < 0.001; psuperiority = 0.005
Primary efficacy endpoint: Target lesion revascularization (TLR): 5.1% vs. 9.8%, p <
Stent thrombosis: 2.0% vs. 2.2%, p = 0.7
BARC bleeding 3-5: 7.2% vs. 7.3%, p = 0.96 %
Conclusions
Clinical outcomes following biolimus A9 DCS implantation are superior to BMS in patients with high bleeding risk and able to take only 1 month of DAPT. There was a significant reduction in MI, TLR, with similar rates of stent thrombosis
Very interesting study in a novel stent conducted in patients typically excluded from stent trials
Primary safety endpoint
DCS
(n = 1,221)
BMS
(n = 1,211)
Urban P, et al. N Engl J Med 2015;Oct 14:[Epub]