Mortality in Randomized Controlled Trials Comparing Drug-Eluting vs. Bare Metal Stents in Coronary Artery Disease: A Meta-Analysis

Eur Heart J. 2006 Dec;27(23):2784-814. doi: 10.1093/eurheartj/ehl282. Epub 2006 Oct 4.

Abstract

Aims: To evaluate the effect of drug-eluting vs. bare metal stents for the treatment of coronary artery disease on overall, cardiac, and non-cardiac mortalities.

Methods and results: We conducted a systematic literature search to identify all randomized controlled trials comparing sirolimus or paclitaxel-eluting stents with bare metal stents and reporting mortality data after at least 1 year of follow-up. Trial data were reviewed and extracted independently by two investigators in an unblinded standardized manner. Seventeen trials including a total of 8221 patients were analysed. Peto's odds ratios (ORs) for total mortality after 1 (n=8221), 2 (n=4631), 3 (n=4105), and 4 (n=1293) years of follow-up were 0.94 [95% confidence interval (CI) 0.66-1.34], 1.11 (95% CI 0.76-1.61), 1.25 (95% CI 0.91-1.73), and 1.46 (95% CI 0.92-2.31), respectively. Corresponding ORs for non-cardiac mortality were 1.07 (95% CI 0.64-1.80), 1.72 (95% CI 1.01-2.94), 1.45 (95% CI 0.93-2.25), and 1.65 (95% CI 0.89-3.10). There was no difference in OR for cardiac mortality among all trials. In sensitivity analyses, sirolimus- but not paclitaxel-eluting stents were associated with an increase in non-cardiac mortality at 2 and 3 years of follow-up.

Conclusion: Drug-eluting stents for the treatment of coronary artery disease do not reduce total mortality when compared with bare metal stents. Preliminary evidence suggests that sirolimus- but not paclitaxel-eluting stents may lead to increased non-cardiac mortality. Long-term follow-up and assessment of cause-specific deaths in patients receiving drug-eluting stents is mandatory to determine the long-term safety of these devices.

Publication types

  • Comparative Study
  • Evaluation Study
  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Aged
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Drug Implants
  • Follow-Up Studies
  • Graft Occlusion, Vascular / etiology
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Randomized Controlled Trials as Topic
  • Sensitivity and Specificity
  • Sirolimus / administration & dosage*
  • Stents*
  • Tubulin Modulators / administration & dosage*

Substances

  • Drug Implants
  • Immunosuppressive Agents
  • Tubulin Modulators
  • Paclitaxel
  • Sirolimus