title: A randomized comparison of sirolimus- versus paclitaxel-eluting stent implantation in patients with diabetes mellitus: 4-year clinical outcomes of DES-DIABETES (drug-eluting stent in patients with DIABETES mellitus) trial.
abstract: OBJECTIVE
  We compared 4-year efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).
  
  
  BACKGROUND
  Four-year comparison of SES with PES in diabetic patients has not been evaluated in a randomized manner.
  
  
  METHODS
  This prospective, multicenter, randomized study compared SES (n = 200) and PES (n = 200) implantation in diabetic patients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR).
  
  
  RESULTS
  The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, log-rank, p < 0.01) and MACE (3.5% vs. 12.5%, log-rank, p < 0.01) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p = 0.45) or MI (1.5% vs. 1.0%, p = 0.99) between SES and PES group. The TLR (7.5% vs. 12.0%, log-rank, p = 0.10) and MACE (11.0% vs. 16.0%, log-rank, p = 0.10) were statistically not different between SES and PES group. At multivariate Cox regression, post-procedural minimal lumen diameter (hazard ratio [HR]: 0.44, 95% confidence interval [CI]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% CI: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% CI: 0.26 to 0.99, p = 0.049) were independent predictors of 4-year MACE.
  
  
  CONCLUSIONS
  Superiority of SES over PES during 2 years was attenuated between 2 years and 4 years in diabetic patients. Use of intravascular ultrasound and larger post-procedural minimal lumen diameter were independent predictors of the improved long-term clinical outcomes.
authors: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Seung-Whan
authors: SW
authors: Lee
authors: Seong-Wook
authors: SW
authors: Park
authors: Young-Hak
authors: YH
authors: Kim
authors: Sung-Cheol
authors: SC
authors: Yun
authors: Duk-Woo
authors: DW
authors: Park
authors: Cheol Whan
authors: CW
authors: Lee
authors: Soo-Jin
authors: SJ
authors: Kang
authors: Kyoung-Suk
authors: KS
authors: Rhee
authors: Jei-Keon
authors: JK
authors: Chae
authors: Jae-Ki
authors: JK
authors: Ko
authors: Jae-Hyeong
authors: JH
authors: Park
authors: Jae-Hwan
authors: JH
authors: Lee
authors: Si-Wan
authors: SW
authors: Choi
authors: Jin-Ok
authors: JO
authors: Jeong
authors: In-Whan
authors: IW
authors: Seong
authors: Yoon-Haeng
authors: YH
authors: Cho
authors: Nae-Hee
authors: NH
authors: Lee
authors: June-Hong
authors: JH
authors: Kim
authors: Kook-Jin
authors: KJ
authors: Chun
authors: Hyun-Sook
authors: HS
authors: Kim
authors: Seung-Jung
authors: SJ
authors: Park
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003920:Diabetes Mellitus / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D056910:Republic of Korea; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel; D020123:Sirolimus