Methods: a search of the major databases was carried out to identify randomised controlled trials of intra-arterial 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. In addition, key journals were hand-searched and citations were also reviewed. Two reviewers independently performed data extraction and aggregate outcomes were obtained using a random effects meta-analysis.
Results: a total of 34 articles were found, but only 10 were reports of randomised controlled trials. Meta-analysis showed no significant differences between thrombolysis and surgery in terms of major amputation (relative risk (RR) 0.893 95% confidence interval (CI) 0.576, 1.383) and mortality (RR 1.24 95% CI 0.795, 1.9). However, there was an increased risk of haemorrhage with thrombolysis (RR 2.94 95% CI 1.1, 7.9). Sub-group analysis suggests that short-duration occlusions (relative risk reduction (RRR) 72%, numbers needed to benefit (NNB)=3) and occluded grafts (RRR 58%, NNB=4) may benefit from thrombolysis. However, thrombolysis should be avoided in occlusions of greater than 14 days - particularly native vessel occlusions.
Conclusion: despite the theoretical advantages of thrombolysis, there is still insufficient evidence to justify its widespread use except in graft occlusions and short-duration ischaemia.
Copyright 2000 Harcourt Publishers Ltd.