Drug-eluting stents with biodegradable polymer for the treatment of patients with diabetes mellitus: clinical outcome at 2 years in a large population of patients.
OBJECTIVE
This study investigates the safety and efficacy of a third-generation drug-eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus (DM).


BACKGROUND
ISRCTN81649913.


BACKGROUND
Percutaneous coronary interventions in patients with DM are associated with a higher incidence of death, restenosis, and stent thrombosis as compared to non-diabetic patients. The use of a DES has been shown to improve outcomes in diabetic patients.


METHODS
Out of 3,067 patients, enrolled in 126 centers worldwide in the NOBORI 2 registry, 888 patients suffered from DM, 213 of them (14%) being insulin-dependent DM (IDDM). Two years' follow-up has been completed in this study.


RESULTS
At 1- and 2-year follow-up, 97% and 95% of the patients, respectively, were available. The reported target lesion failure (TLF) rates at 1- and 2-year follow-up were 6.0% and 7.2% in the DM group, respectively, and 3.0% and 4.2% in the non-DM group, respectively (P<0.001 for both years). Inside the DM group, the TLF rates of 9.9% and 11.7% at the 1- and 2-year follow-ups, respectively, in patients with IDDM were significantly higher than the TLF rates of 4.7% and 5.8%, respectively, in the non-IDDM subgroup (P<0.01 for both years). The rate of stent thrombosis at the 2-year follow-up was 1.0% in the DM group and 0.7% in non-DM patients. There were no cases of late, or very late stent thrombosis in IDDM patients.


CONCLUSIONS
The Nobori DES performed well in patients with DM. As expected, patients with DM, particularly those with IDDM, had worse outcomes. However, the absence of late, and very late stent thrombosis in IDDM patients merits further investigation, as this finding might have significant clinical value.
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.
Marcus
M
Wiemer
Ospedale Maggiore Policlinico, Milan, Italy.
Gian Battista
GB
Danzi
Papworth Hospital, Cambridge, UK.
Nick
N
West
Onassis Cardiac Surgery Center, Athens, Greece.
Vassilios
V
Voudris
Clinique Saint Hilaire, Rouen, France.
René
R
Koning
Vivantes Netzwerk für Gesundheit GmbH, Berlin, Germany.
Stefan
S
Hoffmann
Azienda Ospedaliera Villa Sofia, Palermo, Italy.
Mario
M
Lombardi
Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Josepa
J
Mauri
Institute for Cardiovascular Diseases Dedinje, Belgrade, Serbia.
Rade
R
Babic
Dorset County Hospital, Dorchester, UK.
Fraser
F
Witherow
biodegradable polymer; diabetes mellitus; drug-eluting stents; percutaneous coronary intervention