Drug-eluting stents: a meta-analysis of randomised controlled trials

Cécile Roiron ¹, Paola Sanchez ^1*, Anissa Bouzamondo ¹, Philippe Lechat ¹ and Gilles Montalescot ¹

¹ Universitaire Pitié-Salpêtrière, Paris, France

^* To whom correspondence should be addressed. E-mail: gilles.montalescot{at}psl.ap-hop-paris.fr.

Accepted 21 September 2005

Abstract

Background: Several trials have demonstrated a strong reduction of Major Adverse Cardiac Events (MACE) and restenosis with drug-eluting stents (DES). We performed a meta-analysis of randomised controlled trials to confirm the overall benefit of DES, to evaluate the effect of different DES, and to assess the global safety of DES compared to bare stents.

Methods and results: We identified randomised controlled trials comparing sirolimus or paclitaxel eluting stents to bare stents. We chose binary restenosis and MACE as primary end- points. Death, Q-wave myocardial infarction (Q-MI) and stent thrombosis up to 12 months follow-up were also analysed. MACE overall occurrence was highly reduced with DES from 18,2% to 10,1%, (Odds Ratio OR 0.49 ,95% Confidence Interval CI [0.42-0.58], p<0.001). We found a significant heterogeneity (p<0.001) between subgroups according to the drug: MACE OR was 0.27 (95% CI[0.21- 0.36]) in the sirolimus sub-group and 0.72 (95% CI[0.59- 0.88]) in the paclitaxel sub-group. Restenosis was also highly reduced from 30.6% with bare stents to 8.7% with DES (OR 0.21, 95% CI[0.17-0.25] p<0.001) with a similar heterogeneity between sub-groups. Mortality was not significantly different between DES and control group: OR 1.23 (95% CI[0.71-2.13]). Both stent thrombosis and Q- MI tended to be more frequent with DES than with bare stents (OR 1.6, 95% CI[0.91-2.79] and 2.11, 95% CI[0.95- 4.68] respectively).

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. Unfavourable but non-significant trends were found with DES on both stent thrombosis and Q-MI during follow-up. Additional data with longer follow-up and in high-risk populations are urgently needed to clarify these findings.

Keywords: drug-eluting stents, meta analysis

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