Paclitaxel versus sirolimus eluting stents in diabetic patients: does stent type and/or stent diameter matter?: long-term clinical outcome of 2,429-patient multicenter registry

Catheter Cardiovasc Interv. 2013 Jan 1;81(1):80-9. doi: 10.1002/ccd.24445. Epub 2012 Nov 8.

Abstract

Background: Drug-eluting stents (DES) are more effective in reducing restenosis than bare-metal stents. Less certain is the relative performance of the two widely used DES-sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES)-in diabetic patients undergoing percutaneous coronary intervention (PCI).

Objectives: We studied the long-term effectiveness and safety of SES versus PES in diabetic patients, overall and grouped by the size of the stent placed in the native-stented vessel.

Methods: Data were obtained from an observational, multicenter registry of 2,429 consecutive patients with DM who underwent PCI between August 2003 and August 2009 with SES (n = 1,370) or PES (n = 1,059). Data were analyzed separately for patients with small stents (<3.0 mm, n = 1,274) vs. only large (≥3.0 mm, n = 1,155).

Results: At Cox-adjusted analysis of the overall cohort, there was no significant difference between SES and PES with regard to death/myocardial infarction (D/MI) (P = 0.6) or target lesion revascularization (TLR) (P = 0.3) either in "small-stent" (D/MI, P = 0.8; TLR, P = 0.2) or "large stent" group (D/MI, P = 0.8; TLR, P = 0.4) throughout 1 to 5-year follow-up. These results were confirmed by sensitivity, propensity-score matched analysis (717 matched pairs) that failed to find differences in the safety and efficacy between SES and PES.

Conclusions: In this large observational study, PES and SES were equally safe and efficacious in diabetic patients undergoing PCI in clinical practice, regardless of the stent size.

Publication types

  • Comparative Study
  • Evaluation Study
  • Multicenter Study

MeSH terms

  • Aged
  • Chi-Square Distribution
  • Coronary Angiography / methods
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / mortality
  • Coronary Stenosis / therapy*
  • Diabetes Mellitus / diagnosis*
  • Drug-Eluting Stents*
  • Female
  • Follow-Up Studies
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Patient Safety
  • Proportional Hazards Models
  • Prosthesis Design
  • Prosthesis Failure
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Severity of Illness Index
  • Sirolimus / administration & dosage*
  • Survival Rate
  • Time Factors
  • Treatment Outcome

Substances

  • Paclitaxel
  • Sirolimus