Effectiveness and safety of drug-eluting stents in vein grafts: a meta-analysis.

BACKGROUND

The use of drug-eluting stents (DES) in degenerative vein grafts is currently an off-label indication. Recent studies have had conflicting results regarding the effectiveness and safety of this practice. The objective of this meta-analysis was to compare DES to bare-metal stents for the treatment of vein graft stenosis.

METHODS

PubMed and the Cochrane clinical trials database were systematically searched to identify all randomized controlled trials (RCTs) and observational studies examining DES for vein graft stenosis published in English between 2003 and 2009. Inclusion criteria included follow-up duration > or =6 months. Data were stratified by study design and pooled using random effects models.

RESULTS

Twenty studies were found to meet our inclusion criteria. Eighteen studies were observational and 2 were RCTs. In observational studies, DES were associated with a reduction in major adverse cardiac events (MACE) (odds ratio [OR] 0.50, 95% CI 0.35-0.72), death (OR 0.69, 95% CI 0.53-0.91), target vessel revascularization (TVR) (OR 0.54, 95% CI 0.37-0.79), and target lesion revascularization (TLR) (OR 0.54, 95% CI 0.37-0.78). The incidence of myocardial infarction was similar between groups. In the RCTs, pooled results were inconclusive because of small sample sizes.

CONCLUSIONS

Although data from observational studies suggest that the use of DES for vein graft stenosis has favorable effects on MACE, death, TVR, and TLR, these data should be interpreted with caution due to their observational nature. Corresponding RCT data are inconclusive. There remains a need for large multicenter RCTs to address the effectiveness and safety of DES for vein graft stenosis.