Background: Observational studies and randomized, controlled trials have yielded uncertain results regarding the benefits of drug-eluting stents (DES) for the treatment of saphenous vein graft (SVG) disease. The objective of this meta-analysis was to assess the cumulative evidence regarding the efficacy and effectiveness of DES to treat SVG compared with bare metal stent (BMS).
Methods and results: We conducted a bayesian hierarchical meta-analysis of all randomized, controlled trials and observational studies that compared clinical outcomes after DES or BMS placement in SVG disease. Our search resulted in 25 studies, cumulating 5755 patients. DES implantation was not associated with an increased risk of death (odds ratio [OR], 0.85; 95% credible intervals (CrI) [CrI], 0.62 to 1.21) or myocardial infarction (OR, 0.83; 95% CrI, 0.56 to 1.32), but wide CrIs preclude definitive conclusions. Target vessel revascularization (OR, 0.55; 95% CrI, 0.39 to 0.76) and target lesion revascularization (OR, 0.58; 95% CrI, 0.37 to 0.87) were both reduced by approximately 45% with DES. When combining these outcomes, the OR for major adverse cardiac events was reduced in patients treated with DES (OR, 0.62; 95% CrI, 0.46 to 0.81). Finally, the relative risk of stent thrombosis appeared lower with DES, although again the CrIs were very wide (OR, 0.54; 95% CrI, 0.13 to 1.39).
Conclusions: In this study-level meta-analysis, the largest ever reported and the first using bayesian methods, the use of DES for the treatment of SVG disease reduces target vessel revascularization and target lesion revascularization procedures compared with BMS. Although there is no evidence to date to suggest increased rates of mortality, myocardial infarction, or stent thrombosis, further data are needed to address this safety issue.