title: Sirolimus-eluting stent versus bare metal stent in diabetic patients: the final five-year follow-up of the DIABETES trial.
abstract: OBJECTIVE
  The DIABETES (DIABETes and sirolimus-Eluting Stent) trial is a prospective, multicentre, randomised, controlled trial aimed at demonstrating the efficacy of sirolimus-eluting stent (SES) as compared to bare metal stent (BMS) implantation in diabetic patients. The aim of the present analysis was to assess the five-year clinical follow-up of the patients included in this trial.
  
  
  RESULTS
  One hundred and sixty patients (222 lesions) were included: 80 patients were randomised to SES and 80 patients to BMS. Patients were eligible for the study if they were identified as non-insulin-dependent diabetics (NIDDM) or insulin-dependent diabetics (IDDM), with significant native coronary stenoses in ≥1 vessel. There was a sub-randomisation according to diabetes status. Clinical follow-up was extended up to five years. Five-year clinical follow-up was obtained in 96.2%. Overall, MACE at five years was significantly lower in the SES group as compared with the BMS arm, mainly due to a significant reduction in TLR. There were no significant differences in cardiac death or myocardial infarction (MI). This was also observed in both prespecified subgroups IDDM and NIDDM. In the SES group, the incidence density of definite/probable stent thrombosis was 0.53 per 100 person-years, whereas in the BMS group it was 0.8 per 100 person-years. Independent predictors of MACE were: SES implantation (p<0.001), multivessel stent implantation (p=0.04), and creatinine levels (p=0.001).
  
  
  CONCLUSIONS
  Five-year follow-up of the DIABETES trial suggests the effect of SES in reducing TLR is similar in both IDDM and NIDDM. No major safety concerns in terms of ST, MI or mortality were observed.
authors.affiliation: Servicio de Cardiología, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Jiménez-Quevedo
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Hernando
authors.forename: Joan Antoni
authors.initials: JA
authors.lastname: Gómez-Hospital
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.forename: Alberto
authors.initials: A
authors.lastname: SanRoman
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.forename: Rosana
authors.initials: R
authors.lastname: Hernández-Antolín
authors.forename: Dominick J
authors.initials: DJ
authors.lastname: Angiolillo
authors.forename: Camino
authors.initials: C
authors.lastname: Bañuelos
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.forename: Nieves
authors.initials: N
authors.lastname: Gonzalo
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D003922:Diabetes Mellitus, Type 1 / Q000150:complications* / Q000401:mortality; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000401:mortality; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage*; D013030:Spain; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D020123:Sirolimus