Key result
In patients treated with a biodegradable polymer drug-eluting stent, those with diabetes mellitus had a significantly higher rate of target lesion failure at 5 years compared to non-diabetic patients (12.39% vs 7.34%, p<0.0001).
Why the study?
Does the Nobori biodegradable polymer drug-eluting stent provide safe and effective long-term outcomes in patients with diabetes mellitus compared to non-diabetic patients?
Observational (n=3,067)
Open-label
Yes
Does the Nobori biodegradable polymer drug-eluting stent provide safe and effective long-term outcomes in patients with diabetes mellitus compared to non-diabetic patients?
Absolute Event Rate: 12.39% vs 7.34%
p-value: p=<0.0001
The Nobori biodegradable polymer drug-eluting stent demonstrated acceptable long-term safety and efficacy in diabetic patients over 5 years, with very low rates of very late stent thrombosis, though diabetic patients still had higher rates of target lesion failure compared to non-diabetics.
Biodegradable polymer DES shows acceptable 5-year performance in diabetes; leaves open whether very low very late stent thrombosis rates confer meaningful clinical benefit in insulin-dependent patients.
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. RESULTS: At 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. 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. Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10.
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Wiemer et al. (2017) conducted an observational in Coronary artery disease requiring percutaneous coronary intervention (n=3,067). Diabetes Mellitus vs. Non-diabetic patients was evaluated on Target lesion failure (composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 5 years (p=<0.0001). In patients treated with a biodegradable polymer drug-eluting stent, those with diabetes mellitus had a significantly higher rate of target lesion failure at 5 years compared to non-diabetic patients (12.39% vs 7.34%, p<0.0001).
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