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Multicenter Study
. 2017 Feb 10;16(1):23.
doi: 10.1186/s12933-017-0500-3.

Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up

Marcus Wiemer  1 , Sinisa Stoikovic  2 , Alexander Samol  3 , Zisis Dimitriadis  4 , Juan M Ruiz-Nodar  5 , Ralf Birkemeyer  6 , Jacques Monsegu  7 , Gérard Finet  8 , David Hildick-Smith  9 , Damras Tresukosol  10 , Enrique Garcia Novo  11 , Jacques J Koolen  12 , Emanuele Barbato  13   14 , Gian Battista Danzi  15 ; NOBORI 2 investigators
Affiliations
Multicenter Study

Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up

Marcus Wiemer et al. Cardiovasc Diabetol. .

Erratum in

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.

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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Figures

Fig. 1
Fig. 1
Primary endpoint: TLF incidence. TLF target lesion failure
Fig. 2
Fig. 2
Secondary endpoint: survival from cardiac death
Fig. 3
Fig. 3
Secondary endpoint: survival from TLR. TLR target lesion revascularization
Fig. 4
Fig. 4
Survival from patient oriented composite endpoints. POCE patient oriented composite endpoints
Fig. 5
Fig. 5
Survival from TLF in non-IDDM versus IDDM. TLR target lesion failure
Fig. 6
Fig. 6
Survival from cardiac death in IDDM versus non-IDDM
Fig. 7
Fig. 7
Survival from myocardial infarction in IDDM versus non-IDDM
Fig. 8
Fig. 8
Survival from POCE in IDDM versus non-IDDM
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