Market Overview

Medtronic Resolute Drug-Eluting Stent Shows Superiority to Taxus® DES in Study of Patients with Coronary Artery Disease

The Resolute® drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT), showed superiority to Boston Scientific Corp.'s Taxus® DES on the primary endpoint of the RESOLUTE Japan clinical study: in-stent late lumen loss at eight months.

The primary endpoint of RESOLUTE Japan compared 100 patients treated with the Resolute DES to a historical control – specifically, eight-month in-stent late lumen loss for 135 patients in the ENDEAVOR IV clinical trial who received a Taxus DES. Assessed at 12 months, 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.

RESOLUTE Japan was designed to evaluate the non-inferiority of the primary endpoint; if the non-inferiority threshold was met, then superiority was to be tested. With an in-stent late lumen loss at eight months of 0.13 mm ± 0.22 mm for RESOLUTE Japan patients (compared to 0.42 mm ± 0.50 mm for patients in the Taxus arm of ENDEAVOR IV), both non-inferiority and superiority were demonstrated (p<0.0001).

In addition, RESOLUTE Japan featured an exceptionally low rate of TLF (4.0%) and no instances of stent thrombosis.

Posted-In: News FDA

 

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