Impact of renal insufficiency on safety and efficacy of drug-eluting stents compared to bare-metal stents at 6 years

Catheter Cardiovasc Interv. 2012 Jul 1;80(1):18-26. doi: 10.1002/ccd.23199. Epub 2012 Apr 17.

Abstract

Background: There is few information on the long-term efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared to bare metal stents (BMS) in all-comer percutaneous coronary intervention (PCI)-patients complicated by renal insufficiency (RI).

Objective: Our aim was to assess the 6-year clinical outcome of PCI-patients with RI treated exclusively with BMS, SES, or PES in our academic hospital.

Methods: A total of 1382 patients, included in three cohorts of consecutive PCI-patients (BMS = 392; SES = 498; PES = 492), were categorized by creatinine clearance calculated by the Cockroft-Gault formula (normal kidney function ≥ 90; mild RI = 60-89; moderate RI < 60) and systematically followed for the occurrence of major adverse cardiac events (MACE).

Results: Mortality rates were significantly higher for patients with moderate RI compared to mild RI and normal kidney function at 6 years (Kaplan-Meier estimate: moderate RI (34%) vs. mild RI (12%), P < 0.001; moderate RI (34%) vs. normal kidney function (8%), P < 0.001). After multivariate Cox-regression analysis, SES and PES decreased the occurrence of target-vessel revascularization (TVR) and MACE at 6 years in patients with a normal creatinine clearance compared to BMS [adjusted hazard ratio (aHR) = 0.48, 95% CI: 0.28-0.84; aHR = 0.75, 95% CI: 0.57-0.97, respectively] with no significant effect on mortality. Safety- and efficacy end points were comparable for the three stent types in patients with mild- and moderate renal function.

Conclusion: Patients with a normal creatinine clearance had significant improvement in TVR and MACE rates after SES- or PES implantation compared to BMS at 6 years. However, there was no superiority of both drug-eluting stents over BMS in safety and efficacy end points for patients with impaired renal function.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Biomarkers / blood
  • Cardiovascular Agents / administration & dosage
  • Chi-Square Distribution
  • Coronary Artery Disease / complications
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Creatinine / blood
  • Drug-Eluting Stents*
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Kaplan-Meier Estimate
  • Kidney / metabolism
  • Kidney / physiopathology*
  • Male
  • Metals*
  • Middle Aged
  • Multivariate Analysis
  • Netherlands
  • Paclitaxel / administration & dosage
  • Patient Safety
  • Proportional Hazards Models
  • Prosthesis Design
  • Registries
  • Renal Insufficiency / blood
  • Renal Insufficiency / complications*
  • Renal Insufficiency / mortality
  • Renal Insufficiency / physiopathology
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Sirolimus / administration & dosage
  • Stents*
  • Time Factors
  • Treatment Outcome

Substances

  • Biomarkers
  • Cardiovascular Agents
  • Metals
  • Creatinine
  • Paclitaxel
  • Sirolimus