According to study results to be featured in Sunday’s late-breaking clinical trials session at the American Association of Clinical Endocrinologists (AACE) 21
Annual Scientific and Clinical Congress in Philadelphia, the Resolute
drug-eluting stent (DES) from Medtronic, Inc. (NYSE:MDT) yields strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up.
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.
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.
Within the RESOLUTE clinical program, roughly 30 percent of the patients had diabetes –– a proportion that mirrors current clinical practice. The late-breaking diabetes analysis will compare 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 will show 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.