Three-Year RESOLUTE Data Presented for Medtronic's Zotarolimus-Eluting Stent

September 21, 2009—Medtronic, Inc. (Minneapolis, MN) announced that new clinical data show strong and sustained efficacy and safety of the company's Resolute zotarolimus-eluting coronary stent in long-term patient follow-up. Principal Investigator Ian T. Meredith, MD, presented the 3-year RESOLUTE trial data at the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco.

The single-arm RESOLUTE trial (N = 129) demonstrated a low, 1.6% cumulative rate of target lesion revascularization (TLR) with no new TLRs between 2 and 3 years of follow-up. Cumulative rates of other clinical events remained low as well, with no new myocardial infarctions or cardiac deaths after 2 years. In addition, the rate of stent thrombosis remained at zero, despite only 36.6% of patients being maintained on dual-antiplatelet therapy (aspirin and clopidogrel) at 3 years.

The average lesion length of RESOLUTE patients was 15.5 mm, and 82% of the subjects had challenging B2/C lesions. In addition, 46% had a previous myocardial infarction, 18% had a previous percutaneous coronary intervention, 18% had diabetes, 30% had unstable angina, and 70% had a history of smoking.

"RESOLUTE included patients with a high degree of complexity for an initial clinical trial of a new drug-eluting stent," commented Dr. Meredith. "Their remarkable outcomes at 3 years suggest that the Resolute drug-eluting stent offers a durable combination of long-term safety and efficacy that bodes well for the broad range of patients we see in the challenging environment of standard clinical practice."