Medtronic Presents Data from Drug-Eluting Stent Clinical Trial

Minneapolis, Minn.-based Medtronic Inc.’s Resolute drug-eluting stent (DES) has been shown to yield strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up, according to data from a study released on May 27.

The Resolute Integrity DES was approved by the U.S. Food and Drug Administration in February 2012 with an indication for CAD patients who also have diabetes, which has never before been indicated.

Research shows that people with diabetes have a two- to three-fold increased risk for CAD and two- to four-fold higher CAD morbidity and mortality rates. Historically it has been difficult to treat CAD patients with diabetes because they tend to have smaller coronary arteries and persistently elevated blood-sugar levels, which can increase the rate of procedural complications and long-term safety risks. As a result, CAD patients with diabetes usually have undergone open-heart surgery, which is more invasive and requires longer hospital stays and recovery time when compared to stent procedures.

Within the study, known as the Medtronic Resolute U.S. Clinical Trial, roughly 30 percent of patients had diabetes––a percentage that mirrors current clinical practice. The diabetes analysis compared the clinical outcomes associated with the Resolute DES in 878 standard risk diabetes patients to 1,903 patients without diabetes enrolled in the clinical program.

Despite the CAD patients with diabetes being at a significantly higher risk, the trial data showed consistently low event rates over two years for both groups equally. After two years of follow-up, rates of target lesion failure––defined as cardiac death, target vessel myocardial infarction (heart attack due to a blockage in the stented vessel) and target lesion revascularization (a repeat procedure)––were 7.1 percent for the patients without diabetes and 9.6 percent for patients with diabetes.

“Clinically-validated and minimally-invasive treatment options for patients with both coronary artery disease and diabetes has represented a significant unmet clinical need for the diabetes community for quite some time,” said Scott W. Lee, M.D., clinical professor of medicine at Loma Linda University Medical Center near Los Angeles, Calif., and medical director of global clinical research for Medtronic Diabetes in Northridge, Calif. “Considering the challenges that are presented when treating diabetes patients with CAD, physicians can have confidence in the consistently low event rates in both patients with and without diabetes when using this device.”

Lee presented the trial data at the American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress in Philadelphia, Pa.