Published Results Support Medtronic's Resolute Stent in Diabetes Patients

April 15, 2013—Medtronic, Inc. (Minneapolis, MN) announced the publication of outcomes of diabetes patients treated with the company's Resolute zotarolimus-eluting stent (ZES) in Journal of the American College of Cardiology: Cardiovascular Interventions (2013;6:357-368). The article by Prof. Sigmund J. Silber, MD, et al presents the results of two separate analyses of patient-level data from the global RESOLUTE clinical program, which enrolled a total of 5,130 patients who received a Resolute ZES as participants in one of five studies conducted in the United States and internationally.

According to the company, the new data from the Medtronic-sponsored study show that treatment with the Resolute ZES led to similarly positive outcomes for diabetes patients who were not taking insulin and for patients without diabetes. The US Food and Drug Administration (FDA) approved the Resolute ZES with a specific indication for treating coronary artery disease in patients with diabetes mellitus. Diabetes affects approximately one-third of patients who receive coronary stents and historically has been associated with adverse clinical outcomes, noted Medtronic.

In Journal of the American College of Cardiology: Cardiovascular Interventions, the investigators concluded that the Resolute ZES is safe and effective in patients with diabetes. They found that long-term clinical data of patients with non-insulin-treated diabetes are equivalent to patients without diabetes and that patients with insulin-treated diabetes remain a higher risk subset.

As summarized by Medtronic, one analysis reported in the article evaluated the performance of the device in the 878 standard-risk diabetes patients who received it. Prospectively determined in conjunction with the FDA, it set a 12-month target vessel failure rate of 14.5% as a performance goal.

The actual rate of target vessel failure at 12 months among these standard-risk diabetes patients was significantly lower at 7.8% (P < .001), demonstrating superiority of the Resolute drug-eluting stent over first-generation devices in this patient subset. The results of this analysis led to FDA approval of a unique diabetes indication for the Resolute Integrity drug-eluting stent in February 2012, noted Medtronic.

The company stated that this analysis also found low and comparable rates of target lesion failure (TLF) at 2 years in the patients with non-insulin-treated diabetes when compared to the patients without diabetes (8% vs 7.1%). In addition, it found a predictably higher 2-year TLF rate in the patients with insulin-treated diabetes (13.7%).

Another analysis reported in the article evaluated the cumulative incidence of TLF at 2 years for all 5,130 patients, many of whom had complex coronary artery disease. For this analysis, the patients were first divided into two groups: those with diabetes (1,535; 30%) and those without diabetes (3,595; 70%). The diabetes patients were then divided into two groups: those who were taking insulin (455; 30%) and those who were not taking insulin (1,080; 70%).

This second analysis yielded a similar finding. Specifically, it found low and comparable 2-year rates of TLF in patients with non-insulin-treated diabetes and patients without diabetes (8.9% vs 8.4%)—and a predictably higher rate of TLF at 2 years in patients with insulin-treated diabetes (16.7%).

In Medtronic's press release, Prof. Silber, who is director of the Heart Center at the Isar in Munich, Germany, commented, “These two analyses offer interventional cardiologists worldwide increased confidence when making treatment decisions about the coronary artery disease of patients with diabetes mellitus, who have historically experienced worse clinical outcomes following coronary stent procedures.”

The strong performance of the Resolute ZES in patients with diabetes—both in clinical studies and real-world clinical practice—advances the growing body of evidence that warranted the device's unique diabetes indication in the United States, stated Medtronic.