Clinical efficacy of drug-eluting stents in diabetic patients: a meta-analysis.

ABSTRACT

OBJECTIVES: The purpose of this study was to compare estimates for revascularization and major adverse cardiac events (MACE) (death, myocardial infarction, repeat revascularization) in diabetic patients treated with paclitaxel- and sirolimus-eluting stents (PES and SES). BACKGROUND: Outcomes in diabetic patients treated with PES and SES have not been adequately evaluated. METHODS: We searched MEDLINE/EMBASE from January 2002 to February 2007 and identified abstracts/presentations from this period at major cardiology conferences. Randomized controlled trials (RCTs) and registries were included if data for diabetic patients treated with PES or SES were available. Point estimates with 95% confidence intervals (CIs) were computed as summary statistics. RESULTS: In RCTs (13 trials; n = 2,422) similar point estimates for target lesion revascularization (TLR) (PES 8.6%, 95% CI 6.5% to 11.3%; SES 7.6%, 95% CI 5.8% to 9.9%) and MACE (PES 15.4%, 95% CI 12.4% to 19.1%; SES 12.9%, 95% CI 8.5% to 19.2%) were observed. In head-to-head trials (4 RCTs), no difference in the likelihood of TLR (PES vs. SES) was observed (odds ratio [OR] 1.37, 95% CI 0.64 to 2.9, p = 0.42). In registries (16 registries; n = 10,156), point estimates for target vessel revascularization (TVR) (PES 5.8%, 95% CI 3.9% to 8.5%; SES 7.2%, 95% CI 4.6% to 11.2%) and MACE (PES 10.1%, 95% CI 7.3% to 13.8%; SES 11.9%, 95% CI 8.6% to 16.4%) were also similar. In registries reporting outcomes with both stents (8 registries for TVR and 7 registries for MACE), the likelihood of TVR (PES vs. SES) (OR 0.77, 95% CI 0.54 to 1.10, p = 0.15) and MACE (OR 0.83, 95% CI 0.68 to 1.01, p = 0.056) were nonsignificantly lower with PES. CONCLUSIONS: This analysis of over 11,000 diabetic patients treated with drug-eluting stents demonstrates single-digit revascularization rates. Furthermore, revascularization and MACE estimates are similar with both PES and SES.