Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (Part 2: Below the knee).

OBJECTIVE

To evaluate 1 to 48 month follow-up outcomes of different endovascular treatment strategies in below-the-knee (BTK) arterial segments in critical limb ischemia (CLI) patients.

METHODS

Medline and Embase were searched (last searched on 5 November 2013) for studies of randomized controlled trials comparing either balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another. Methodological quality of each trial was assessed using a Cochrane Collaboration's tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were wound healing, quality of life, change in Rutherford classification, amputation, death, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, and event-free survival with follow-up periods of at least 1 month.

RESULTS

Twelve trials including 1145 patients were identified, with 90% of patients having CLI. Six BS versus PTA and two DES versus PTA trials showed low-quality evidence of equal efficacy. One trial, comparing DEB with PTA, showed moderate-quality evidence of improved wound healing (RR 1.28; 95% CI: 1.05 to 1.56; p=.01), improvement in Rutherford classification (RR 1.32; 95% CI: 1.08 to 1.60; p=.008), and lower TLR (RR 0.41; 95% CI 0.23 to 0.74; p=.002) and binary restenosis (RR 0.36; 95% CI 0.24 to 0.54; p<.0001) in diabetic patients after 12 months. Amputation and death rate did not differ significantly. For DES versus BS, most trials showed equal efficacy between strategies.

CONCLUSION

Based on low- to moderate-quality evidence, PTA with optional bailout stenting using BS should remain the preferred strategy in treating CLI patients with BTK arterial lesions. Before other strategies can be implemented, larger and high-quality RCTs assessing clinically relevant outcomes are needed.