Long Term Results of a New Generation Drug Eluting Stent in Diabetics

Objective: To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer (BP) in the complex patient population of diabetes mellitus after a follow-up period of five years.
Background: After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to nondiabetic patients.
Methods: In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 pa-tients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study.
Results: At five years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at five years were 12.39% in DM group and 7.34% in non-DM group; (p<0.0001). In the DM group, the TLF rate in patients with IDDM was significantly higher than in the non-IDDM subgroup (17.84 vs. 10.67%; p<0.01). The rate of ST at five years was not different among diabetic vs. non-diabetic patients or IDDM vs. NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred.
Conclusions: The Nobori DES performed well in patients with DM. As expected patients with DM, particularly those with IDDM, had worse outcomes. However, the very low rate of very late stent thrombosis in IDDM patients might have significant clinical value in the treatment of these patients.