Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up.
Por:
Wiemer M, Stoikovic S, Samol A, Dimitriadis Z, Ruiz-Nodar JM, Birkemeyer R, Monsegu J, Finet G, Hildick-Smith D, Tresukosol D, Novo EG, Koolen JJ, Barbato E, Danzi GB and NOBORI 2 investigators
Publicada:
10 feb 2017
Ahead of Print:
10 feb 2017
Resumen:
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.
Filiaciones:
Wiemer M:
Department of Cardiology and Intensive Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, Hans-Nolte-Str. 1, 32429, Minden, Germany.
Stoikovic S:
Clinic for Cardiology, Clinical Center of Serbia, School of Medicine, University of Belgrade, Belgrade, Serbia
Samol A:
Department of Cardiology and Intensive Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, Hans-Nolte-Str. 1, 32429, Minden, Germany
Dimitriadis Z:
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany
:
Hospital General Universitario de Alicante, Universidad Miguel Hernández, Alicante, Spain
Birkemeyer R:
Herzklinik Ulm, Ulm, Germany
Monsegu J:
Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France
Finet G:
Hospital Cardiovasculaire Louis Pradel, Bron, France
Hildick-Smith D:
Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK
Tresukosol D:
Siriraj Hospital, Bangkok, Thailand
Novo EG:
Hospital Guadalajara, Guadalajara, Spain
Koolen JJ:
St. Catharina Eindhoven, Eindhoven, The Netherlands
Barbato E:
Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium
Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
Danzi GB:
Ospedale Santa Corona, Pietra Ligure, Italy
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