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Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet]. Chichester, UK: John Wiley & Sons, Ltd; 2003-. doi: 10.1002/14651858.CD002784.pub2

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet].

Surgery versus thrombolysis for initial management of acute limb ischaemia

First published: June 6, 2013.

Link to full article: [Cochrane Library]

Plain language summary

Thrombolysis involves dissolving a blood clot by injecting an enzyme into the blood clot. It is used as an alternative to surgery for managing severely reduced blood flow (acute ischaemia) in the leg. A blood clot (thrombosis) forms in a leg blood vessel where there is severe narrowing (stenosis) in a natural artery or a bypass graft.

The review authors identified five controlled trials with a total of 1283 participants who were randomly allocated to receive initial peripheral arterial thrombolysis or surgery for the immediate management of acute limb ischaemia. There was no evidence in favour of either initial thrombolysis or initial surgery as the preferred option in terms of preventing the need for major amputation (limb salvage) or death within one year. More major complications occurred within 30 days of the procedure with thrombolysis, including stroke and major bleeding (haemorrhage). A total of 1.3% of patients receiving thrombolysis had a stroke compared to none in surgery patients; 8.8% had a major haemorrhage after thrombolysis compared to 3.3% in surgery patients. People receiving initial thrombolysis underwent a less severe degree of intervention but may have a higher risk of ongoing limb ischaemia. These higher risks of complications with thrombolysis have to be weighted against individual risks in surgery. Either recombinant tissue plasminogen activator or urokinase were the agents used for thrombolysis.

Abstract

Background: Peripheral arterial thrombolysis is technique used in the management of peripheral arterial ischaemia. Much is known about the indications, risks and benefits of thrombolysis. 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 methods: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (last searched March 2013) and CENTRAL (2013, Issue 2).

Selection criteria: All randomised studies comparing thrombolysis and surgery for the initial treatment of acute limb ischaemia.

Data collection and analysis: Each author independently assessed trial quality and extracted data. Agreement was reached by consensus.

Main results: Five trials with a total of 1283 participants were included. 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, stroke was significantly more frequent at 30 days in thrombolysis participants (1.3%) compared to surgery participants (0%) (Odds ratio (OR) 6.41; 95% confidence interval (CI) 1.57 to 26.22). Major haemorrhage was more likely at 30 days in thrombolysis participants (8.8%) compared to surgery participants (3.3%) (OR 2.80; 95% CI 1.70 to 4.60); and distal embolization was more likely at 30 days in thrombolysis participants (12.4%) compared to surgery participants (0%) (OR 8.35; 95% CI 4.47 to 15.58).

Participants treated by initial thrombolysis underwent a less severe degree of intervention (OR 5.37; 95% CI 3.99 to 7.22) and displayed equivalent overall survival compared to initial surgery (OR 0.87; 95% CI 0.61 to 1.25).

Authors' 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 haemorrhagic complications including stroke. The higher risk of complications must be balanced against risks of surgery in each person.

Editorial Group: Cochrane Vascular Group.

Publication status: New search for studies and content updated (no change to conclusions).

Citation: Berridge DC, Kessel DO, Robertson I. Surgery versus thrombolysis for initial management of acute limb ischaemia. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD002784. DOI: 10.1002/14651858.CD002784.pub2. Link to Cochrane Library. [PubMed: 23744596]

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

PMID: 23744596

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