The Resolute drug-eluting stent (Medtronic) showed superiority to Taxus drug-eluting stent (Boston Scientific) on the primary endpoint of the RESOLUTE Japan clinical study: in-stent late lumen loss at eight months. Results were presented by Shigeru Saito, director of Cardiology and Catheterisation Laboratories at Shonan Kamakura General Hospital, Japan, at the 20th Annual Meeting of the Japanese Association of Cardiovascular Interventions in Therapeutics (CVIT).
The primary endpoint of the Japanese study compared 100 patients treated with the Resolute drug-eluting stent 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 drug-eluting stent. Assessed at 12 months, clinical endpoints for RESOLUTE Japan included target lesion failure a composite endpoint of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization 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 a low rate of target lesion failure (4.0%) and no instances of stent thrombosis.
These results will be used to support Medtronic’s submission to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for regulatory approval of the Resolute drug-eluting stent in Japan.
“Results from RESOLUTE Japan show that the Resolute drug-eluting stent will be a welcome addition to the treatment options already available to Japanese patients with coronary artery disease,” Saito said. “They will be evaluated with interest by my fellow interventional cardiologists while we await the Japan launch of this next-generation drug-eluting stent.”
The Resolute drug-eluting stent received CE mark in October 2007 and is currently available in approximately 100 countries worldwide.