Two-year clinical outcomes with drug-eluting stents for diabetic patients with de novo coronary lesions: results from a real-world multicenter registry.
BACKGROUND
The long-term effectiveness of drug-eluting stents (DES) in unselected diabetics in routine practice is currently unclear.


RESULTS
To evaluate the long-term effectiveness of bare metal stents and DES in a real-world setting of diabetic patients, we analyzed 2-year follow-up data from all diabetic patients with de novo lesions enrolled in a prospective Web-based multicenter registry (Registro Regionale Angioplastiche dell'Emilia-Romagna; study period, 2002 to 2004) comprising all 13 hospitals performing percutaneous coronary interventions in the Emilia-Romagna region of Italy. Among the 1648 eligible patients treated with either bare metal stents alone (n=1089) or DES alone (n=559), 27% were insulin dependent and 83% had multivessel coronary disease. At 2 years, use of DES was associated with lower crude incidence of major adverse cardiac advents (all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization) compared with bare metal stents (22.5% versus 28.1%; P=0.01). After propensity score adjustment, only target vessel revascularization appeared significantly lower in the DES group (11.6% versus 15.0%; hazard ratio, 0.66; 95% confidence interval, 0.46 to 0.96; P=0.041). Two-year angiographic stent thrombosis occurred in 1.5% DES patients and 0.7% of the bare-metal-stents patients (P=0.18). At Cox regression analysis, predictors of 2-year major adverse cardiac advents were left ventricular ejection fraction <35%, Charlson comorbidity index, insulin-dependent diabetes, and total lesion length.


CONCLUSIONS
In this large, real-world, diabetic population, the use of DES was associated with a moderate reduction in the 2-year risk of target vessel revascularization, a benefit that was limited to non-insulin-dependent diabetic patients. Larger long-term studies are needed to clarify the long-term effectiveness and safety of such devices in diabetic patients.
Ortolani
Paolo
P
Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola-Malpighi, Via Massarenti 9, 40138, Bologna, Italy. paortol@tin.it
Balducelli
Marco
M
Marzaroli
Paolo
P
Piovaccari
Giancarlo
G
Menozzi
Alberto
A
Guiducci
Vincenzo
V
Sangiorgio
Pietro
P
Tarantino
Fabio
F
Geraci
Giuseppe
G
Castriota
Fausto
F
Tondi
Stefano
S
Saia
Francesco
F
Cooke
Robin M T
RM
Guastaroba
Paolo
P
Grilli
Roberto
R
Marzocchi
Antonio
A
Maresta
Aleardo
A
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D003131:Combined Modality Therapy; D015897:Comorbidity; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000188:drug therapy* / Q000628:therapy; D003328:Coronary Thrombosis / Q000453:epidemiology; D003920:Diabetes Mellitus / Q000188:drug therapy; D003925:Diabetic Angiopathies / Q000188:drug therapy* / Q000628:therapy; D005260:Female; D006801:Humans; D007328:Insulin / Q000627:therapeutic use; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D015607:Stents / Q000706:statistics & numerical data; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D007328:Insulin; D020123:Sirolimus; D016559:Tacrolimus