Comparison of three-year clinical outcomes between sirolimus-versus paclitaxel-eluting stents in diabetic patients: prospective randomized multicenter trial

Catheter Cardiovasc Interv. 2010 Dec 1;76(7):924-33. doi: 10.1002/ccd.22369.

Abstract

Background: Three-year follow-up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) implantation have not been reported.

Methods: Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES.

Results: Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three-year follow-up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25-22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07-29.44, P < 0.001) during the three-year follow-up.

Conclusions: The rates of MACEs, TVR, and stent thrombosis during the three-year follow-up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three-year follow-up after either SES or PES implantation.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cardiovascular Agents / administration & dosage*
  • Chi-Square Distribution
  • Coronary Angiography
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / mortality
  • Coronary Stenosis / therapy*
  • Diabetes Complications / diagnostic imaging
  • Diabetes Complications / mortality
  • Diabetes Complications / therapy*
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Hypoglycemic Agents / therapeutic use
  • Insulin / therapeutic use
  • Kaplan-Meier Estimate
  • Logistic Models
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Odds Ratio
  • Paclitaxel / administration & dosage*
  • Prospective Studies
  • Prosthesis Design
  • Republic of Korea
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Sirolimus / administration & dosage*
  • Thrombosis / etiology
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Hypoglycemic Agents
  • Insulin
  • Paclitaxel
  • Sirolimus