Twelve-month outcomes in patients with diabetes implanted with a zotarolimus-eluting stent: results from the E-Five Registry.
OBJECTIVE
To retrospectively evaluate the 12-month effectiveness of the Endeavor zotarolimus-eluting stent (ZES) in diabetic versus non-diabetic patients enrolled in the E-Five Registry.


METHODS
The E-Five Registry is a prospective, multicentre registry of 8314 patients presenting with symptomatic coronary artery disease treated with the Endeavor (ZES). Patients were treated at 188 centres located in 37 countries across Europe, Latin America and Asia Pacific.


METHODS
There were 2721 (32.7%) patients with diabetes (DM) and among these patients 682 were insulin-treated (ITDM) and 2039 were non-insulin-treated diabetic patients (NITDM). Interventions All enrolled patients received an Endeavor ZES and were followed for 12 months.


METHODS
The primary outcome measure was major adverse cardiac event (MACE) at 12 months. Secondary endpoints included target lesion revascularisation (TLR), target vessel revascularisation (TVR), target vessel failure (TVF) and stent thrombosis.


RESULTS
Compared with non-DM patients, DM patients had higher rates of MACE (9.7% vs 6.4%, p<0.001), TLR (5.3% vs 4.0%, p=0.028) and Academic Research Consortium (ARC) definite and probable stent thrombosis (1.5% vs 0.9%, p=0.041). Compared with non-DM patients, ITDM patients had higher rates of MACE (12.6% vs 6.4%, p<0.001). ITDM patients had higher rates of death (6.7% vs 1.7%, p<0.001), cardiac death (4.5% vs 1.2%, p<0.001) and TLR (6.5% vs 4.0%, p=0.011) than non-DM patients.


CONCLUSIONS
The Endeavor ZES performed well in DM patients; however, DM patients experienced higher rates of adverse clinical events compared with non-DM patients. TRIAL REG NO:


BACKGROUND
http://www.clinicaltrials.gov; Unique identifier: NTC00623441.
Jain
Ajay K
AK
Barts and The London National Health Service Trust, London, UK.
Lotan
Chaim
C
Meredith
Ian T
IT
Feres
Faustos
F
Zambahari
Robaayah
R
Sinha
Nakul
N
Rothman
Martin T
MT
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D003920:Diabetes Mellitus / Q000188:drug therapy / Q000401:mortality; D054855:Drug-Eluting Stents; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D012042:Registries / Q000706:statistics & numerical data; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; C489443:zotarolimus; D020123:Sirolimus