Safety and efficacy of drug eluting stents compared with bare metal stents for saphenous vein graft interventions: a comprehensive meta-analysis of randomized trials and observational studies comprising 7,994 patients.

ABSTRACT

BACKGROUND: Saphenous vein graft (SVG) lesions remain amongst the most challenging lesions for percutaneous coronary intervention (PCI). It is unknown whether drug eluting stents (DES) are superior to bare metal stents (BMS) for such lesions. Our objective is to determine the safety and efficacy of DES compared with BMS for SVG lesions by performing a meta-analysis of clinical trials and observational studies. DATA SOURCES PubMed, Cochrane Register of Controlled Trials, conference proceedings, and internet-based resources of clinical trials. STUDY SELECTION Studies comparing DES vs. BMS for SVG lesions with at least>30 patients in each study reporting the outcomes of interest [death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST), and the composite of death, TVR and MI (major adverse cardiac events; MACE)] with at least 6 months clinical follow-up. The primary outcome of interest was death. RESULTS: Two randomized trials, one subgroup analysis of a randomized trial and 26 observational studies comprising a total of 7,994 patients (4,187 patients in DES and 3,807 patients in BMS group) were included in the analysis. Mean follow-up duration was 21±11 months (6-48 months). In the overall population, MACE events were 19% in DES and 28% in BMS with a risk ratio (RR) of 0.7 (0.6, 0.8) P<0.00001. This effect of MACE was sustained in studies with >2 years follow-up with RR of 0.77 (0.65, 0.91) P=0.003. Death rate was 7.8% in DES and 9% in BMS with a RR of 0.82 (0.7, 0.97) P=0.02. MI rate was 5.7% in DES and 7.6% in BMS with RR of 0.72 (0.57, 0.91) P=0.007. TVR was 12% in DES and 17% in BMS with RR of 0.71 (0.59, 0.85) P=0.0002. ST was 1% in DES and 1.7 % in BMS RR of 0.61 (0.35, 1.06) P=0.08. Specifically in randomized controlled trials, DES were associated with no significant differences in overall mortality [RR=1.97; 95% confidence interval (CI), 0.17-23; P=0.58] or MI (RR=1.24; 95% CI, 0.3-5.5; P=0.78) compared with BMS. CONCLUSIONS: Based on the results of this meta-analysis, DES may be considered as a safe and efficacious option for the percutaneous intervention of SVG lesions.