Of the 5,130 patients in the RESOLUTE clinical program who have been followed for at least one year, 878 (57.2%) were considered ‘on-label.’
Insulin-dependence characterized 250 (28.5%) of the on-label diabetic patients.
Heart Catheterization Centre in Munich, Germany, professor Sigmund Silber said diabetic patients whose co-morbid heart disease is treated with percutaneous coronary intervention have an increased risk of repeat procedures and other major adverse cardiovascular events.
"And yet our analysis of the ‘on-label’ diabetic patient cohort from the RESOLUTE clinical program suggests a homogeneous treatment effect across diabetic and non-diabetic patients that we find intriguing," Silber said.
"Not surprisingly, a notable exception to this effect was seen in the insulin-dependent diabetic patient subset, which serves to underscore the challenges that persist in determining the ideal interventional treatment for these patients.
"While the outcomes in the on-label diabetic patient population are encouragingly low, it is of interest to determine how these event rates compare with those seen in non-diabetic patients as well as between insulin-dependent and non-insulin-dependent diabetics."
Another independent research, conducted by a network of Italian physicians, examined a total of 896 ‘all-comer’ (in contrast to ‘on-label’) patients: 293 (32.7%) with diabetes, 603 (67.3%) without diabetes.
The results showed low rates of adverse events at 15 months of follow-up.
The Resolute DES is commercially available in more than 100 countries outside the US, where its use is limited by US law to clinical trials approved by the US Food and Drug Administration (FDA).
The RESOLUTE clinical program will ultimately enroll more than 6,000 patients worldwide and involves a collaborative effort involving hundreds of medical centers in more than 25 countries across Europe, Asia, the Pacific Rim, the Middle East, Africa, Latin America and North America.
