Endovascular revascularisation versus surgical revascularisation in patients with lower limb atherosclerosis obliterans: a protocol for systematic review and meta-analysis with trial sequential analysis and meta-regression
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ABSTRACT: Introduction
The revascularisation strategy for lower limb atherosclerosis obliterans (ASO) remains controversial. In this meta-analysis, we will summarise existing evidence to compare the long-term and short-term outcomes between endovascular revascularisation and open revascularisation for patients with ASO. Methods
Relevant randomised controlled trials (RCTs) and cohort studies are included from the following databases: MEDLINE/PubMed, Embase and the Cochrane Library. The last search time is 1 August 2022. Two reviewers will independently identify RCTs and cohort studies according to eligibility and exclusion criteria. The risk of bias of included cohort studies, and RCTs are assessed with the Newcastle-Ottawa Scale, Methodological Index of Non-randomized Studies and Cochrane Collaboration’s tool, respectively. The primary outcomes include overall survival, amputation-free survival and 30-day mortality. TSA Beta Software V.0.9.5.10 is used to perform the trial sequential analysis for primary outcomes. The Grades of Recommendations, Assessment, Development and Evaluation (GRADE) tool will be used to assess the level of evidence for outcome from RCTs. Stata V.17.0 software is used to pool primary outcomes. Ethics and dissemination
This study will be disseminated through peer-reviewed journals or conference reports. No ethical approval requirements are required because the results presented in this study are conducted based on published data. PROSPERO registration number
CRD42022359591
SUBMITTER: Huang Q
PROVIDER: S-EPMC9743393 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundConsensus is lacking regarding intervention for patients with acute lower limb ischaemia (ALI). The aim was to study amputation-free survival in patients treated for ALI by either primary open or endovascular revascularization.MethodsThe Swedish Vascular Registry (Swedvasc) was combined with the Population Registry and National Patient Registry to determine follow-up on mortality and amputation rates. Revascularization techniques were compared by propensity score matching 1 : 1.ResultsOf 9736 patients who underwent open surgery and 6493 who had endovascular treatment between 1994 and 2014, 3365 remained in each group after propensity score matching. Results are from the matched cohort only. Mean age of the patients was 74·7 years; 47·5 per cent were women and mean follow-up was 4·3 years. At 30-day follow-up, the endovascular group had better patency (83·0 versus 78·6 per cent; P < 0·001). Amputation rates were similar at 30 days (7·0 per cent in the endovascular group versus 8·2 per cent in the open group; P = 0·113) and at 1 year (13·8 versus 14·8 per cent; P = 0·320). The mortality rate was lower after endovascular treatment, at 30 days (6·7 versus 11·1 per cent; P < 0·001) and after 1 year (20·2 versus 28·6 per cent; P < 0·001). Accordingly, endovascular treatment had better amputation-free survival at 30 days (87·5 versus 82·1 per cent; P < 0·001) and 1 year (69·9 versus 61·1 per cent; P < 0·001). The number needed to treat to prevent one death within the first year was 12 with an endovascular compared with an open approach. Five years after surgery, endovascular treatment still had improved survival (HR 0·78, 99 per cent c.i. 0·70 to 0·86) but the difference between the treatment groups occurred mainly in the first year.ConclusionPrimary endovascular treatment for ALI appeared to reduce mortality compared with open surgery, without any difference in the risk of amputation.
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