Objectives: To determine the relative effectiveness of intra-arterial thrombolysis compared with surgery for the treatment of lower-limb ischemia. Methods: MEDLINE and EMBASE were searched for randomized controlled trials related to thrombolysis. The search was limited to English-language articles or trials which provided a detailed English summary of trial design and results, and trials that were published after 1980. Hand searching and review of citations was used to identify other papers. Randomized controlled trials (RCTs) only were included in the analysis; a quality score was given to each trial using the CONSORT statement. Data extraction was performed independently by two reviewers. A random effects model was used. Outcomes: Mortality, amputation, major bleeding. Results: A total of 34 papers were retrieved: 10 were RCTs and the remaining 24 were review articles, case series, or cohort studies. Seven were RCTs that compared surgery to thrombolysis. No significant differences in the rates of death or amputation were observed between patients who were randomized to thrombolysis compared to surgery. The odds ratios comparing thrombolysis to surgery for death at 30 days, and 6 and 12 months were 1.07, p = 0.73; 1.11, p = 0.72; and 0.59, p = 0.49, respectively. The odds ratios comparing thrombolysis to surgery for amputation at 30 days, and 6 and 12 months were 1.08, p = 0.78; 1.18, p = 0.38; and 1.14, p = 0.49, respectively. A significant excess of major bleeding was observed in the thrombolysis group. The odds ratio comparing thrombolysis to surgery for major bleeding at 30 days was 2.95 (95% CI: 1.62-5.36, p = 0.001). The 6 and 12 months odds ratios for bleeding were not reported. Conclusion: The authors conclude that there is insufficient evidence to justify the widespread use of thrombolytic therapy in patients with leg ischemia, although subgroup analyses suggest benefit of thrombolysis in patients who have synthetic graft occlusions, and in patients who receive therapy after a short duration of ischemic symptoms, i.e. less than 14 days.
