Data Support Use of Medtronic's Resolute DES in Diabetic and Nondiabetic Patients

May 25, 2012—Medtronic, Inc. (Minneapolis, MN) announced study results on the company's Resolute drug-eluting stent (DES) in coronary artery disease (CAD) patients (both diabetics and nondiabetics) through 2 years of follow-up. Scott W. Lee, MD, presented the results of the diabetes analysis in a late-breaking clinical trials session at the American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress held in Philadelphia on May 23–27, 2012. Dr. Lee is Medical Director of Global Clinical Research for Medtronic Diabetes (Northridge, CA) and clinical professor of medicine at Loma Linda University Medical Center in California.

The Resolute Integrity DES was approved by the US Food and Drug Administration in February 2012 with an indication for CAD patients who also have diabetes, the company noted.

As summarized in the company's press release, the late-breaking diabetes analysis compared the clinical outcomes associated with the Resolute DES in 878 standard-risk diabetes patients to 1,903 patients without diabetes. The analysis showed consistently low event rates out to 2 years for both groups, despite the higher-risk nature of the diabetes patient population. At 2 years of follow-up, rates of target lesion failure (defined as cardiac death, target vessel myocardial infarction, and target lesion revascularization) were 7.1% for patients without diabetes and 9.6% for patients with diabetes.

Dr. Lee commented in Medtronic's press release, “Clinically validated and minimally invasive treatment options for patients with both coronary artery disease and diabetes have represented a significant unmet clinical need for the diabetes community for quite some time. 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.”

The company also noted that the analysis featured additional outcomes for important safety measures by comparing insulin-dependent and noninsulin-dependent diabetes patients to patients without diabetes, which showed that the clinical outcomes rates are similar among noninsulin-dependent diabetes patients and nondiabetics patients.