Vascular surgical society of great britain and ireland: systematic review of intra-arterial thrombolytic therapy for peripheral vascular occlusions
BACKGROUND: A systematic review of intra-arterial thrombolytic therapy for peripheral vascular occlusions was undertaken. METHODS: The four major electronic databases (Medline, Cinhal, Embase and The Cochrane Library) were searched to identify randomized controlled trials of thrombolytic therapy in the treatment of limb ischaemia. The search was limited to English language articles, or those that provided a sufficiently detailed English summary, and to articles published after 1980. Trials were considered for inclusion if they were randomized controlled trials, systematic reviews or meta-analyses. Data were extracted independently by two reviewers and aggregate outcomes were obtained using a random effects meta-analysis. RESULTS: A total of 32 articles were found but only 12 were assessed to be of sufficient quality to be included in the review. There was a distinct lack of large randomized controlled trials comparing thrombolysis with surgical management. The exceptions were the Thrombolysis or Peripheral Arterial Surgery (TOPAS) and Surgery versus Thrombolysis for Ischemia of the Lower Extremity (STILE) trials, but both had some methodological flaws. The STILE trial did not achieve the sample size originally determined and the TOPAS trials had a large number of contributing centres (113) compared with the sample size (548). Meta-analysis showed no significant differences between thrombolysis and surgery in terms of major amputation (relative risk (RR) 0.9 (95 per cent confidence interval 0.6-1.4)) and death (RR 1.2 (0.8-1.9)). However, there was an increased risk of residual ischaemia with thrombolysis (RR 1.8 (1.2-2.5)) and haemorrhage (RR 2.9 (1.1-7.9)). Patients who were shown to benefit from thrombolysis were those with short-duration ischaemia (RR reduction, 72 per cent; numbers needed to treat, three) and occluded grafts (RR reduction, 58 per cent; numbers needed to treat, four). CONCLUSION: Despite the theoretical advantages of thrombolysis, there is still insufficient evidence to justify its widespread use except in patients with graft occlusions and short-duration ischaemia.