Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of randomised controlled trials

Christoph Stettler ¹, Sabin Allemann ², Matthias Egger ^3*, Stephan Windecker ⁴, Bernhard Meier ⁴ and Peter Diem ¹

¹ University Hospital of Bern, Division of Endocrinology and Diabetes, Switzerland
² University of Bern, Institute for Social and Preventive Medicine, Switzerland
³ University of Bern, Department of Social and Preventive Medicine, Switzerland
⁴ University Hospital of Bern, Department of Cardiology, Switzerland

^* To whom correspondence should be addressed. E-mail: egger{at}ispm.unibe.ch.

Accepted 17 October 2005

Abstract

Aims: This study examined whether polymer-based coronary stents eluting sirolimus or paclitaxel are equally effective in patients with and without diabetes.

Methods: A systematic review and meta-analysis was performed using indirect comparisons of randomised controlled trials comparing stents eluting sirolimus or paclitaxel with conventional bare metal stents. Separate analyses were performed for the overall study population and for patients with and without diabetes, respectively, using the ratio of incidence rate ratios (RIRR).

Results: The analysis was based on ten trials (six sirolimus, four paclitaxel), 4,513 patients (1,146 patients with diabetes), 5,755 years of follow-up and 2,464 events. In patients without diabetes sirolimus eluting stents were superior to paclitaxel eluting stents with respect to in-stent (RIRR=0.21, 95% CI 0.10 to 0.48, p<0.001) and in-segment restenosis (0.47, 0.24 to 0.92, p=0.027), target lesion revascularisation (0.54, 0.30 to 0.99, p=0.045), and major adverse cardiac events (0.46, 0.26 to 0.83, p=0.010). In patient with diabetes there were no significant differences between the two drug eluting stents for all of these endpoints. Meta-regression analysis revealed a significant difference between patients with and without diabetes (tests for interaction for in-stent and in-segment restenosis: p=0.036 and p=0.016).

Conclusion: Indirect evidence indicates that stents eluting sirolimus are superior to paclitaxel eluting stents in patients without diabetes but not in patients with diabetes.

Keywords: coronary disease, diabetes mellitus, meta-analysis, revascularisation, stents

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