Surgery versus thrombolysis for acute limb ischaemia: initial management.

BACKGROUND: Peripheral arterial thrombolysis is a useful technique for the management of peripheral arterial ischaemia. Much is known about the indications, risks and benefits of thrombolysis, although data from randomised controlled studies are not extensive. However, it is not known whether thrombolysis works better than surgery in the initial treatment of acute limb ischaemia.

OBJECTIVES: To determine the preferred initial treatment, surgery or thrombolysis, for acute limb ischaemia.

SEARCH STRATEGY: The Cochrane Controlled Trials Register (Issue 3, 2001), and the Specialised Trials Register of the Cochrane Peripheral Vascular Diseases Group (September 2001) were searched. Proceedings from all British Vascular Surgical Society, European Vascular Surgical Society and North American Society of Vascular Surgery meetings, Society of Cardiovascular and Interventional Radiology (SCVIR) and Cardiovascular and Interventional Society of Europe (CIRSE), were handsearched. Pharmaceutical firms and trialists were asked for information about unpublished trials.

SELECTION CRITERIA: All randomised studies comparing thrombolysis and surgery in the initial management of acute limb ischaemia.

DATA COLLECTION AND ANALYSIS: Assessment of trial quality and data extraction was done independently by all reviewers.

MAIN RESULTS: Five trials with a total of 1,283 patients were included. Two trials used a list of procedures of increasing severity of intervention. If lytic treatment were successful, further intervention might prove unnecessary. There was no significant difference in limb salvage or death at 30 days, six months or one year between initial surgery and initial thrombolysis. However, with initial lysis, stroke was significantly more frequent at 30 days, 8/640 patients compared to 0/540 patients receiving initial surgery [Odds ratio (95% CI) 6.41(1.57, 26.22)]; major haemorrhage was more likely at 30 days, 52/588 versus 16/482 [Odds ratio (95% CI) 2.80 (1.70, 4.60)]; and distal embolisation was more likely at 30 days, 42/340 versus 0/338 [Odds ratio (95% CI) 8.35 (4.47, 15.58)]. Patients treated by initial lysis underwent a less severe degree of intervention [Odds ratio (95% CI) 5.37 (3.99, 7.22)], and displayed equivalent overall survival compared to initial surgery [Odds ratio (95% CI) 0.87(0.61, 1.25)].

REVIEWER'S CONCLUSIONS: Universal initial treatment with either surgery or thrombolysis cannot be advocated on the available evidence. There is no overall difference in limb salvage or death at one year between initial surgery and initial thrombolysis. Thrombolysis may be associated with a higher risk of ongoing limb ischaemia, and of haemorrhagic complications, including stroke. The higher risk of complications must be balanced against risks of surgery in each patient.