INTERVENTIONAL CARDIOLOGY AND SURGERY

Drug eluting stents: an updated meta-analysis of randomised controlled trials

C Roiron¹, P Sanchez², A Bouzamondo², P Lechat², G Montalescot¹

¹ Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France
² Service de Pharmacologie Clinique, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France

Correspondence to:
Dr Gilles Montalescot
Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtrière, 47 Bd de l’Hôpital, 75013 Paris, France; gilles.montalescot{at}psl.ap-hop-paris.fr

Objective: To confirm the overall benefit of drug eluting stents (DES), to evaluate the effect of different DES, and to assess the global safety of DES compared with bare stents through a meta-analysis of randomised controlled trials.

Methods: Randomised controlled trials comparing sirolimus and derivates or paclitaxel and derivates eluting stents versus bare stents. Binary restenosis and major adverse cardiac events (MACE) were chosen as primary end points. Death, Q wave myocardial infarction (MI), and stent thrombosis up to 12 months’ follow up were also analysed.

Results: MACE overall occurrence was highly reduced with DES from 19.9% to 10.1% (odds ratio (OR) 0.46, 95% confidence interval (CI) 0.41 to 0.52, p < 0.001). A significant heterogeneity (p < 0.001) was found between subgroups according to the drug: MACE OR was 0.28 (95% CI 0.22 to 0.35) in the sirolimus subgroup and 0.62 (95% CI 0.53 to 0.73) in the paclitaxel subgroup. Restenosis was also highly reduced from 31.7% with bare stents to 10.5% with DES (OR 0.25, 95% CI 0.22 to 0.29, p < 0.001) with a similar heterogeneity between subgroups. Mortality, Q wave MI, and stent thrombosis were not significantly different between DES and control group, whereas Q wave MI and stent thrombosis tended to be more frequent with paclitaxel.

Conclusion: This meta-analysis confirms the overall benefit of DES on restenosis and MACE with significant heterogeneity between drugs, suggesting higher efficacy of sirolimus eluting stents. Additional data with longer follow up and in high risk populations are needed to clarify issues on stent thrombosis.

Abbreviations: CI, confidence interval; DES, drug eluting stents; ENDEAVOR, randomised, controlled trial of the Medtronic Endeavor drug (ABT-578) eluting coronary stent system versus the Taxus paclitaxel eluting coronary stent system in de novo native coronary artery lesions; FDA, Food and Drug Administration; MACE, major adverse cardiac events; MI, myocardial infarction; OR, odds ratio; SCORE, study to compare restenosis rate between quest and quads-QP2; SIRIUS, sirolimus eluting balloon expandable stent in the treatment of patients with de novo native coronary artery lesions

Keywords: drug eluting stents; meta-analysis; coronary stenting; sirolimus; paclitaxel

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