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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Clinical Efficacy of Drug-Eluting Stents in Diabetic Patients

A Meta-Analysis

Division of Cardiovascular Medicine, University of California–San Diego Medical Center, San Diego, California.

Manuscript received April 2, 2007; revised manuscript received February 21, 2008, accepted March 7, 2008.

^_* Reprint requests and correspondence: Dr. Ehtisham Mahmud, Director, Cardiovascular Catheterization Laboratories, University of California, San Diego Medical Center, 200 West Arbor Drive, San Diego, California 92103-8784. (Email: emahmud{at}ucsd.edu).

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.

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   DES = drug-eluting stent(s)   MACE = major adverse cardiac event   OR = odds ratio   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   RCT = randomized controlled trial   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

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