Medtronic Resolute® Stent Shows Strong Performance in Heart Disease Patients With and Without Diabetes

In short

According to study results presented at the American Association of Clinical Endocrinologists (AACE) 21st Annual Scientific and Clinical Congress in Philadelphia, Medtronic’s Resolute® drug-eluting stent (DES) from Medtronic, Inc. yields strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up.

Background 

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’s 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 have commonly undergone open heart surgery, which is more invasive and requires longer hospital stays and recovery time compared with stent procedures.

Just last week we were reporting on Biotronik’s drug eluting balloon data which similarly drew attention to its performance in diabetic as well as non diabetic patients.

Within the RESOLUTE clinical program, roughly 30 percent of the patients had diabetes, a proportion that mirrors current clinical practice. This 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.

The analysis showed consistently low event rates out to two years for both groups, despite the higher-risk nature of the diabetes patient population. At two years of follow-up, rates of target lesion failure (TLF) –– 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) –– are 7.1 percent for the patients without diabetes and 9.6 percent for patients with diabetes.

The Resolute Integrity DES was approved by the U.S. Food and Drug Administration (FDA) in February 2012 with a first-of-its-kind indication for CAD patients who also have diabetes.

Clinician comments

“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 Dr. Scott W. Lee, M.D., clinical professor of medicine at Loma Linda University Medical Center near Los Angeles and medical director of global clinical research for Medtronic Diabetes in Northridge, Calif., who will present the results of the diabetes analysis. “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.”

Source: Medtronic Inc.