The rate of the primary efficacy endpoint – clinically driven target lesion revascularization at 1 year – was 6.1% with the drug-coated stent and 9.3% with the bare-metal stent, for an absolute risk difference of –3.2% (hazard ratio, 0.63; P for superiority = .0111). Findings again were consistently in favor of the drug-coated stent across most patient subgroups, with the exception of patients having renal failure at the time of admission. Secondary efficacy endpoints all significantly favored that stent as well.
The 1-year rates of bleeding overall and by severity were statistically indistinguishable, Dr. Krucoff reported. The rate of severe bleeding – Bleeding Academic Research Consortium (BARC) type 3-5 – was 7.0% with the drug-coated stent and 7.3% with the bare metal stent.
Dr. Krucoff disclosed that he has various affiliations and financial relationships with Abbott Vascular, Biosensors, Boston Scientific, CSI, Medtronic, OrbusNeich, and Terumo. The trial was sponsored by Biosensors.