Methods: a search of the major databases was carried out to identify random
ised controlled trials of intra-arterial thrombolytic therapy in the treatm
ent of limb ischaemia. The search was limited to English language articles,
or those that provided a sufficiently detailed English summary, and to art
icles published after 1980. In addition, key journals were hand-searched an
d 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 ran
domised controlled trials. Meta-analysis showed no significant differences
between thrombolysis and surgery in terms of major amputation (relative ris
k (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 t
hat short-duration occlusions (relative risk reduction (RRR) 72%, numbers n
eeded to benefit (NNB) = 3) and occluded grafts (RRR 58%, NNB - 4) may bene
fit from thrombolysis. However, thrombolysis should be avoided in occlusion
s of greater than 14 days - particularly native vessel occlusions.
Conclusion: despite the theoretical advantages of thrombolysis, there is st
ill insufficient evidence to justify its widespread use except in graft occ
lusions and short-duration ischaemia.