2011 ACC: Slow Release of Stenting Drug Leads to Favorable Results in RESOLUTE Study

Study shows that a long-acting zotarolimus-eluting stent is effective in treating de novo lesions in native coronary arteries.

NEW ORLEANS — April 4, 2011 – A long-acting zotarolimus-eluting stent was effective in treating de novo lesions in native coronary arteries, and met its endpoint of non inferiority to the “historical controls,” investigators report from the RESOLUTE trial, which was presented in today’s late-breaking news conference at the American College of Cardiology’s (ACC) 60th Annual Scientific Session and ACC.i2 Summit.

The study, “One Year Clinical Outcomes from the Pivotal Multicenter RESOLUTE US Study” enrolled 1,402 patients from 116 investigating center between August 2008 and Dec 2009. Patients received Resolute stents that were 2.5-3.5 mm in diameter.

The study was published simultaneously in today’s Journal of the American College of Cardiology.

RESOLUTE was designed to compare the Endeavor zotarolimus-eluting coronary stents (R-ZES) to historical clinical trial data. The R-ZES releases zotarolimus over a six-month period to achieve “optimal clinical effectiveness and safety,” said study author Martin Leon, MD associate director of the Center for Interventional Vascular Therapy and professor of Medicine at Columbia University, New York/Presbyterian Hospital. He reported that the Resolute “met its primary endpoint of non-inferiority to the historical control, the FDA-approved Endeavor stent and is “the first US study to observe the effect of drug elutions characteristics on clinical outcome.”

The Resolute stent “is designed with the same chromium platform and the same drug, but the Resolute uses a new biocompatible polymer that allows for six-week delivery vs. 14 days.

The 12-month endpoint was for this group was 12-month-target lesions failure (the composite of cardiac death, target-vessel heart attack, and clinically driven target revascularization.) After 12 months, the TLF was 3.7% vs 6.5% for the “historical” control group. The Resolute stent had lower rates of target lesion revascularization, cardiac death, and targert-vessel heart attach.

“The Resolute drug eluting stent was shown to have strong efficacy without a trade-off in safety in one year of patient follow up,” said Leon.

The clinical results achieved with this new device show the important role that biocompatible polymers play in the design of drug eluting stents. According to Leon, the study met its primary endpoint of nonnferiority of the RZES main analysis cohort compared to with the E-ZES control group and “significantly lowered TLF by 43%.” This favorable outcome was achieved “despite the higher proportion of diabetic patients” (34%).

The study was funded by Medtronic. Dr. Leon serves on the Medtronic Scientific Review Board.