PHILADELPHIA — The Resolute drug-eluting stent yielded strong performance and low event rates out to 2 years in patients with coronary artery disease both with and without diabetes, according to late-breaking data presented at the American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress Meeting.
The analysis compared clinical outcomes associated with the Resolute drug-eluting stent (Medtronic) in 878 standard-risk patients with diabetes and 1,903 patients without diabetes. All were enrolled in the RESOLUTE clinical program.
Data revealed consistently low event rates at 2 years of follow-up in patients with and without diabetes. Also at 2 years, the rate of target lesion failure (defined as cardiac death, target vessel MI and target lesion revascularization) was 9.6% for patients with diabetes and 7.1% for patients without diabetes, according to a press release.
Researchers also presented data on additional outcomes for safety measures, using a comparison of insulin-dependent and non-insulin-dependent patients with diabetes vs. patients without diabetes. Results showed that 2-year safety rates were similar among non-insulin-dependent diabetes patients and patients without diabetes:
- Target lesion revascularization was 6.5% for insulin-dependent diabetes patients and 4.3% for non-insulin-dependent diabetes patients vs. 3.4% for patients without diabetes.
- Cardiac death/target vessel MI was 8.6% for insulin-dependent diabetes patients and 3.9% for non-insulin-dependent diabetes patients vs. 4.1% for patients without diabetes.
- Definite/probable stent thrombosis was 0.80% for insulin-dependent diabetes patient and 0.16% for non-insulin-dependent diabetes patients vs. 0.43% for patients without diabetes.
“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,” Scott W. Lee, MD, clinical professor of medicine at Loma Linda University Medical Center, Calif., and medical director of global clinical research for Medtronic Diabetes, said in a press release.
In February 2012, the FDA approved the Resolute Integrity drug-eluting stent with an indication for CAD patients who also have diabetes.
Disclosure: Dr. Lee is medical director of global clinical research for Medtronic Diabetes.