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



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). Five years follow-up has been completed in this study.



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.



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.
Department of Cardiology and Intensive Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, Hans-Nolte-Str. 1, 32429, Minden, Germany. marcus.wiemer@muehlenkreiskliniken.de.
Marcus
M
Wiemer
Clinic for Cardiology, Clinical Center of Serbia, School of Medicine, University of Belgrade, Belgrade, Serbia.
Sinisa
S
Stoikovic
Department of Cardiology and Intensive Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, Hans-Nolte-Str. 1, 32429, Minden, Germany.
Alexander
A
Samol
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.
Zisis
Z
Dimitriadis
Hospital General Universitario de Alicante, Universidad Miguel Hernández, Alicante, Spain.
Juan M
JM
Ruiz-Nodar
Herzklinik Ulm, Ulm, Germany.
Ralf
R
Birkemeyer
Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France.
Jacques
J
Monsegu
Hospital Cardiovasculaire Louis Pradel, Bron, France.
Gérard
G
Finet
Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK.
David
D
Hildick-Smith
Siriraj Hospital, Bangkok, Thailand.
Damras
D
Tresukosol
Hospital Guadalajara, Guadalajara, Spain.
Enrique Garcia
EG
Novo
St. Catharina Eindhoven, Eindhoven, The Netherlands.
Jacques J
JJ
Koolen
Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium.|Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
Emanuele
E
Barbato
Ospedale Santa Corona, Pietra Ligure, Italy.
Gian Battista
GB
Danzi
D020341:Absorbable Implants; D000368:Aged; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D003920:Diabetes Mellitus / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011108:Polymers / Q000737:chemistry*; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
D007004:Hypoglycemic Agents; D007328:Insulin; D010975:Platelet Aggregation Inhibitors; D011108:Polymers