What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?: a meta-analysis

J Am Coll Cardiol. 2005 Mar 15;45(6):941-6. doi: 10.1016/j.jacc.2004.11.064.

Abstract

Objectives: This study investigated the risk of stent thrombosis associated with the use of paclitaxel-eluting stents (PES) compared to bare-metal stents (BMS).

Background: Clinical experience with coronary drug-eluting stents (DES) is relatively limited. There is concern that DES used for percutaneous coronary intervention may result in subsequent thrombosis.

Methods: We conducted a meta-analysis on eight trials (total of 13 study arms) in 3,817 patients with coronary artery disease who were randomized to either PES or BMS.

Results: As compared with BMS, PES do not increase the hazard for thrombosis up to 12 months (risk ratio [RR] = 1.06, 95% confidence interval [CI] 0.55 to 2.04, p = 0.86]). There was no evidence of heterogeneity among the studies (chi-square value for Q-statistic = 5.90 [10 degrees of freedom], p = 0.82). Similar results were obtained when the analysis was restricted to trials with a polymeric stent platform (Treatment of de novo coronary disease using a single pAclitaXel elUting Stent [TAXUS]-I, -II, -IV, and -VI) (RR = 1.01, 95% CI 0.40 to 2.53, p = 0.99), trials with longer lesions (TAXUS-IV and -VI) (RR = 0.62, 95% CI 0.2 to 1.91, p = 0.41), and trials that used a higher dose of paclitaxel (ASian Paclitaxel-Eluting Stent Clinical trial [ASPECT], European evaLUaTion of paclitaxel Eluting Stents [ELUTES], and DELIVER-I) (RR = 1.87, 95% CI 0.52 to 6.81, p = 0.34).

Conclusions: Current evidence suggests that standard dose PES do not increase the hazard of stent thrombosis compared to BMS.

Publication types

  • Clinical Trial
  • Comparative Study
  • Meta-Analysis
  • Multicenter Study
  • Randomized Controlled Trial
  • Review

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary*
  • Antineoplastic Agents, Phytogenic / therapeutic use*
  • Aspirin / therapeutic use
  • Blood Vessel Prosthesis Implantation
  • Clopidogrel
  • Coated Materials, Biocompatible / therapeutic use*
  • Coronary Artery Disease / epidemiology
  • Coronary Artery Disease / therapy
  • Coronary Thrombosis / epidemiology*
  • Coronary Thrombosis / etiology*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects*
  • Platelet Aggregation Inhibitors / therapeutic use
  • Postoperative Complications / epidemiology*
  • Postoperative Complications / etiology*
  • Risk Factors
  • Stents / adverse effects*
  • Ticlopidine / analogs & derivatives*
  • Ticlopidine / therapeutic use
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Phytogenic
  • Coated Materials, Biocompatible
  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticlopidine
  • Paclitaxel
  • Aspirin