Drug-eluting stents versus control therapy in the infrapopliteal disease: A meta-analysis of eight randomized controlled trials and two cohort studies

Backgroud: Drug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arteries disease. However, the long-term clinical impact of DES treatment in the vascular territory still remains uncertain.

Methods and results: Pubmed, Embase, Cochrane data, CNKI and Wanfang Data were searched until December 20, 2016 for eligible studies according to identical strategies. Additional data were manually retrieved. STATA ver. 12.0 software were used to Meta-analyze the efficacies of DES and control treatment (BMS or PTA) for infrapopliteal arteries disease. A total of 927 patients from 10 studies (8 randomized controlled trials and 2 cohort studies) were assigned to DESs (n = 484) versus control treatment (n = 443). The results showed that infrapopliteal DES therapy yielded higher primary patency and EFS, while decreased the risk of restenosis at 12-months compared to controls significantly. At 3 years there were no significant differences between two groups, pooled RRs and 95% CI were 1.639 [0.526-5.105], P = 0.394; 1.197 [0.432-3.317], P = 0.729 and 0.992 [0.960-1.024], P = 0.661, respectively. Subgroup analysis showed that infrapopliteal DES therapy using Sirolimus-eluting stents rather than Everolimus-eluting stents provided higher clinic benefits. Infrapopliteal DES therapy yielded no significant difference for TLR, overall survival, Rutherford-Becker class improvement, limb amputation at 12-months and 3-years compared with control treatment.

Conclusions: The results of the present meta-analysis indicate the non-superiority of infrapopliteal DES therapy over control therapies (BMS/PTA) at 3 years, although short-term benefits at 12 months after DES therapy were evident. Further randomized trials with longer follow-up are required to provide the best scientific evidence regarding the preferred endovascular treatment for patients with occlusive disease of infrapopliteal arteries.