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Meta-Analysis
. 2020 Apr 17;4(4):CD009894.
doi: 10.1002/14651858.CD009894.pub3.

Low molecular weight heparin for prevention of microvascular occlusion in digital replantation

Pei-Tzu Lin  1   2 , Shu-Hui Wang  3   4 , Ching-Chi Chi  5   6
Affiliations
Meta-Analysis

Low molecular weight heparin for prevention of microvascular occlusion in digital replantation

Pei-Tzu Lin et al. Cochrane Database Syst Rev. .

Abstract

Background: The success of digital replantation is highly dependent on the patency of the repaired vessels after microvascular anastomosis. Antithrombotic agents are frequently used for preventing vascular occlusion. Low molecular weight heparin (LMWH) has been reported to be as effective as unfractionated heparin (UFH) in peripheral vascular surgery, but with fewer adverse effects. Its benefit in microvascular surgery such as digital replantation is unclear. This is an update of the review first published in 2013.

Objectives: To assess if treatment with subcutaneous LMWH improves the salvage rate of the digits in patients with digital replantation after traumatic amputation.

Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers, to 17 March 2020. The authors searched PubMed, China National Knowledge Infrastructure (CNKI) and Chinese Electronic Periodical Services (CEPS) on 17 March 2020 and sought additional trials from reference lists of relevant publications.

Selection criteria: We included randomised or quasi-randomised controlled trials comparing treatment with LMWH versus any other treatment in participants who received digital replantation following traumatic digital amputation.

Data collection and analysis: Two review authors (PL, CC) independently extracted data and assessed the risk of bias of the included trials using Cochrane's 'Risk of bias' tool. Disagreements were resolved by discussion. We assessed the certainty of evidence using the GRADE approach.

Main results: We included two new randomised trials in this update, bringing the total number of included trials to four. They included a total of 258 participants, with at least 273 digits, from hospitals in China. Three studies compared LMWH versus UFH, and one compared LMWH versus no LMWH. The mean age of participants ranged from 24.5 to 37.6 years. In the studies reporting the sex of participants, there were a total of 145 men and 59 women. The certainty of the evidence was downgraded to low or very low because all studies were at high risk of performance or reporting bias (or both) and there was imprecision in the results due to the small numbers of participants. The three studies comparing LMWH versus UFH reported the success rate of replantation using different units of analysis (participant or digit), so we were unable to combine data from all three studies (one study reported results for both participants and digits). No evidence of a benefit in success of replantation was seen in the LMWH group when compared with UFH, regardless of whether the outcomes were reported by number of participants (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.87 to 1.10; 130 participants, 2 studies; very low-certainty evidence); or by number of digits (RR 0.97, 95% CI 0.90 to 1.04; 200 digits, 2 studies; low-certainty evidence). No studies reported the incidence of compromised microcirculation requiring surgical or non-surgical therapy, or any systemic/other causes of microvascular insufficiency. There was no evidence of a clear difference between the LMWH and UFH groups in occurrence of arterial occlusion (RR 1.08, 95% CI 0.16 to 7.10; 54 participants, 1 study; very low-certainty evidence) or venous occlusion (RR 0.81, 95% CI 0.20 to 3.27; 54 participants, 1 study; very low-certainty evidence). Two studies reported adverse effects. The LMWH and UFH groups showed no evidence of a difference in wound bleeding (RR 0.53, 95% CI 0.23 to 1.23; 130 participants, 2 studies; low-certainty evidence), haematuria (RR 0.43, 95% CI 0.09 to 2.11; 130 participants, 2 studies; very low-certainty evidence), ecchymoses (RR 0.82, 95% CI 0.21 to 3.19; 130 participants, 2 studies; very low-certainty evidence), epistaxis (RR 0.27, 95% CI 0.03 to 2.32; 130 participants, 2 studies; very low-certainty evidence), gingival bleeding (RR 0.18, 95% CI 0.02 to 1.43; 130 participants, 2 studies; very low-certainty evidence), and faecal occult blood (RR 0.27, 95% CI 0.03 to 2.31; 130 participants, 2 studies; very low-certainty evidence). We could not pool data on coagulation abnormalities as varying definitions and tests were used in the three studies. One study compared LMWH versus no LMWH. The success rate of replantation, when analysed by digits, was reported as 91.2% success in the LMWH group and 82.1% in the control group (RR 1.11, 95% CI 0.93 to 1.33; 73 digits, 1 study; very low-certainty evidence). Compromised microcirculation requiring surgical re-exploration, analysed by digits, was 11.8% in the LMWH group and 17.9% in the control group (RR 0.86, 95% CI 0.21 to 3.58; 73 digits, 1 study; very low-certainty evidence). Compromised microcirculation requiring incision occurred in five out of 34 digits (14.7%) in the LMWH group and eight out of 39 digits (20.5%) in the control group (RR 0.72, 95% CI 0.26 to 1.98; 73 digits; very low-certainty evidence). Microvascular insufficiency due to arterial occlusion, analysed by digits, was 11.8% in the LMWH group and 17.9% in the control group (RR 0.66, 95% CI 0.21 to 2.05; 73 digits, 1 study; very low-certainty evidence), and venous occlusion was 14.7% in the LMWH group and 20.5% in the control (RR 0.72, 95% CI 0.26 to 1.98; 73 digits, 1 study; very low-certainty evidence). The study did not report complications or adverse effects.

Authors' conclusions: There is currently low to very low-certainty evidence, based on four RCTs, suggesting no evidence of a benefit from LMWH when compared to UFH on the success rates of replantation or affect microvascular insufficiency due to vessel occlusion (analysed by digit or participant). LMWH had similar success rates of replantation; and the incidence rate of venous and arterial microvascular insufficiency showed no evidence of a difference between groups when LMWH was compared to no LMWH (analysed by digit). Similar rates of complications and adverse effects were seen between UFH and LMWH. There was insufficient evidence to draw conclusions on any effect on coagulation when comparing LMWH to UFH or no LMWH. The certainty of the evidence was downgraded due to performance and reporting bias, as well as imprecision in the results. Further adequately powered studies are warranted to provide high-certainty evidence.

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Conflict of interest statement

PTL: none known SHW: none known CCC: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 LMWH versus UFH, Outcome 1 Success rate of replantation.
1.2
1.2. Analysis
Comparison 1 LMWH versus UFH, Outcome 2 Microvascular insufficiency due to vessel occlusion.
1.3
1.3. Analysis
Comparison 1 LMWH versus UFH, Outcome 3 Complications and adverse reactions.
2.1
2.1. Analysis
Comparison 2 LMWH versus no‐LMWH, Outcome 1 Success rate of replantation.
2.2
2.2. Analysis
Comparison 2 LMWH versus no‐LMWH, Outcome 2 Incidence of compromised microcirculation requiring invasive intervention.
2.3
2.3. Analysis
Comparison 2 LMWH versus no‐LMWH, Outcome 3 Microvascular insufficiency due to vessel occlusion.
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References

References to studies included in this review

Chen 2001 {published data only}
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Hu 2013 {published data only}
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Li 2012a {published data only}
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Xu 2013 {published data only}
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References to studies excluded from this review

Chen 2015 {published data only}
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Chen 2016 {published data only}
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Chen 2018 {published data only}
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Han 2015 {published data only}
    1. Han ZM, Ding YH. Influence of auxiliary application of Xuesaitong injection on blood coagulation indices and thromboembolic complications in patients after finger replantation. China Pharmacist 2015;12:2087‐9.
Li 2012b {published data only}
    1. Li Y, Wei P, Sun T, Li L, Zhou DY, Chen H, et al. Efficacy of low molecular weight heparin combined with felodipine on vascular crisis prevention after finger replantation. Chinese Journal of New Drugs and Clinical Remedies 2012;31(10):607‐10.
Li 2016 {published data only}
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Liu 2015 {published data only}
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Ma 2017 {published data only}
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Meng 2013 {published data only}
    1. Meng X, Yue Q, Yue WJ, Li W, Meng QG. Clinical study on hemorheological effect of low molecular weight heparin calcium on small vascular injury. Progress in Modern Biomedicine 2013;22:4284‐7.
Shu 2011 {published data only}
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Zhao 2017 {published data only}
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Zhou 2017 {published data only}
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References to other published versions of this review

Chen 2012
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