A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease

Sebastian Kufner, Antoinette De Waha, Fabrizio Tomai, Seong Wook Park, Seung Whan Lee, Do Sun Lim, Moo Hyun Kim, Anders M. Galloe, Michael Maeng, Carlo Briguori, Alban Dibra, Albert Schömig, Adnan Kastrati

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Abstract

Background: There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients. Methods: Individual patient data were analyzed from 6 randomized trials specifically designed to compare SES with PES in diabetic patients. In total, 1183 patients were followed up for a median of 3.9 years (25th, 75th percentiles 3.4-4.5 years). The primary efficacy end point was target lesion revascularization (TLR). The composite of death and myocardial infarction (MI) was the primary safety end point. Stent thrombosis was a secondary end point. Overall hazard ratios (HRs) with 95% CIs were calculated as summary estimates. Results: No significant heterogeneity was seen across the 6 randomized trials for all analyzed events. Sirolimus-eluting stent was associated with a significant reduction in the risk of TLR (HR 0.65 [0.47-0.91], P =.01). No significant differences were observed regarding the risk of death or MI (HR 1.04 [0.74-1.45], P =.83) and stent thrombosis (HR 1.00 [0.31-3.30], P =.67). Mortality was also not affected by the type of DES (HR 0.95 [0.65-1.39], P =.79). Conclusions: In diabetic patients with coronary artery disease, SES leads to a sustained reduction in the risk of TLR compared with PES. Both these DES types are, however, comparable with respect to the risk of stent thrombosis, MI, or death over long-term follow-up.

Original languageEnglish
Pages (from-to)740-747
Number of pages8
JournalAmerican Heart Journal
Volume162
Issue number4
DOIs
Publication statusPublished - 2011 Oct

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Kufner, S., De Waha, A., Tomai, F., Park, S. W., Lee, S. W., Lim, D. S., Kim, M. H., Galloe, A. M., Maeng, M., Briguori, C., Dibra, A., Schömig, A., & Kastrati, A. (2011). A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease. American Heart Journal, 162(4), 740-747. https://doi.org/10.1016/j.ahj.2011.07.003