Medtronic has compared its Resolute drug-eluting stent (DES) with Boston Scientific's Taxus DES which showed superiority in the primary endpoint of the Resolute Japan clinical study with in-stent late lumen loss at eight months.
The Resolute Japan study is an open-label, prospective, single-arm which compared primary endpoint of 100 patients treated with Resolute DES to135 patients receiving Taxus DES in the Endeavor IV clinical trial.
The clinical endpoints for Resolute Japan included target lesion failure (TLF) – a composite endpoint of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) – and stent thrombosis.
The Resolute Japan patients showed non-inferiority and superiority to Endeavor IV patients with in-stent late lumen loss at eight months of 0.13 mm ± 0.22 mm compared to 0.42 mm ± 0.50 mm.
The Resolute DES has received CE mark approval in October 2007.