Abstract
Objective To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years.Background After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients.Methods In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study.ResultsAt 5 years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at 5 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 5 years was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred.ConclusionsThe 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.Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10
Highlights
After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients
In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM)
Through data entry in the electronic case report form, based on prior diagnosis, patients were automatically assigned to predefined analysis group of diabetic patients, and if they were on insulin therapy they were allocated to insulin-dependent DM (IDDM) subgroup
Summary
After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients. Potential biodegradable polymer technology advantages over durable polymer drugeluting stents could be especially valuable in clinically complex patient subgroups, like patients with diabetes mellitus in whom results of percutaneous revascularization are known to be worse compared with non-diabetic population [8, 9]. Nobori Biolimus A9TM eluting stent (Terumo corporation, Tokyo, Japan) with biodegradable polymer technology was associated with relatively low rates of adverse events in diabetic subgroup and no stent thrombosis up to 2 years of follow-up in insulin-dependent diabetes mellitus patients—a finding that demanded additional attention and investigation [12]. The aim of this predefined sub-study was to further investigate long-term outcome up to 5 years of drug-eluting biodegradable polymer technology in high-risk population
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