A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents

Lancet. 2004 Aug 14-20;364(9434):583-91. doi: 10.1016/S0140-6736(04)16850-5.

Abstract

Background: Drug-eluting stents (DES) are associated with lower restenosis rates than bare-metal stents (BMS), but the benefits and safety of the new devices have not been systematically quantified across different trials. We undertook a meta-analysis of randomised trials comparing BMS and stents eluting sirolimus or paclitaxel.

Methods: A systematic literature search aimed to identify all randomised clinical trials with 6-12 months of clinical follow-up. Results were pooled by a hierarchical Bayesian random-effects model with prespecified stratification for drug and the presence of carrier polymer. The primary outcomes examined were rates of death, myocardial infarction, target-lesion revascularisation, major adverse cardiac events (death, myocardial infarction, and target-vessel revascularisation), and angiographic restenosis.

Findings: We identified 11 eligible trials involving 5103 patients. The pooled mortality rates were low for both DES and BMS with no evidence of any difference between them (odds ratio 1.11 [95% credible interval 0.61-2.06]). Pooled rates of myocardial infarction showed no between-group difference (0.92 [0.65-1.25]). The rate of major adverse cardiac events was 7.8% with DES and 16.4% with BMS (0.42 [0.32-0.53]), and the angiographic restenosis rates were also lower for DES (8.9% vs 29.3%; 0.18 [0.06-0.40]). The pooled rates of major adverse cardiac events for each DES type and the respective BMS were: for sirolimus, 6.8% versus 21.0% (0.28 [0.17-0.41]); for polymer-based paclitaxel 8.7% versus 16.7% (0.47 [0.25-0.71]); and for non-polymer-based paclitaxel 7.7% versus 9.5% (0.64 [0.42-1.00]). We did not observe higher rates of edge restenosis, stent thrombosis, or late incomplete stent apposition with DES, although the credible intervals were wide.

Interpretation: Sirolimus-eluting and polymeric paclitaxel-eluting stents are effective at decreasing rates of angiographic restenosis and major adverse cardiac events compared with BMS. However, there is no evidence that they affect mortality or myocardial-infarction rates. They also appear to be safe in the short to medium term, although definitive conclusions are not possible. Larger studies with longer follow-up are needed to define better the role of these new devices.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon, Coronary
  • Bayes Theorem
  • Coated Materials, Biocompatible
  • Coronary Disease / therapy*
  • Coronary Restenosis / prevention & control*
  • Drug Carriers
  • Humans
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Polymers
  • Randomized Controlled Trials as Topic
  • Sirolimus / administration & dosage*
  • Sirolimus / adverse effects
  • Stents* / adverse effects

Substances

  • Coated Materials, Biocompatible
  • Drug Carriers
  • Polymers
  • Paclitaxel
  • Sirolimus