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Cover of Evidence review for management of anticoagulant medication

Evidence review for management of anticoagulant medication

Perioperative care in adults

Evidence review F

NICE Guideline, No. 180

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-3827-8

1. Management of anticoagulant medication

1.1. Review question: What is the most clinically and cost effective strategy for managing anticoagulant medication?

1.2. Introduction

People taking vitamin K antagonists (VKA), with an international normalised ratio (INR) target greater than 3, are at a particularly high risk of developing deep vein thrombosis, pulmonary embolus or stroke. These are often people with mechanical heart valves and therefore require a greater level of blood thinning than other people using anticoagulant therapies, such as VKA with an INR target lower than 3 or a direct oral anticoagulant (DOAC).

To reduce this risk, it is usual practice to provide ‘bridging’ therapy in the perioperative period with either unfractionated heparin (UFH) or low molecular heparin (LMWH). Direct Oral Anticoagulants (DOACs) cannot be used in people with mechanical heart valves. UFH requires an intravenous infusion, and is therefore a more complicated therapy to administer than LMWH. The potential harm of bridging therapy is increased postoperative bleeding or wound infections. There is variation in the practice of bridging therapy in hospitals.

It would be useful to know if there is any difference between UFH and LMWH in terms of reducing risk of events, causing harm and costs.

1.3. PICO table

For full details see the review protocol in appendix A.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

1.4. Clinical evidence

1.4.1. Included studies

No relevant clinical studies comparing outpatient or self-administered low molecular weight subcutaneous heparin with inpatient intravenous unfractionated heparin were identified.

See also the study selection flow chart in appendix C.

Excluded studies

See the excluded studies list in appendix I.

1.4.2. Summary of clinical studies included in the evidence review

No relevant clinical studies were identified.

1.4.3. Quality assessment of clinical studies included in the evidence review

No relevant clinical studies were identified.

1.5. Economic evidence

1.5.1. Included studies

No health economic studies were included.

1.5.2. Excluded studies

No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in Appendix G:.

1.5.3. Unit costs

Relevant unit costs are provided below to aid consideration of cost effectiveness.

Low molecular weight heparin
Table 2. UK costs of low molecular weight heparin.

Table 2

UK costs of low molecular weight heparin.

Table 3. Costs associated with administering low molecular weight heparin.

Table 3

Costs associated with administering low molecular weight heparin.

Unfractionated heparin
Table 4. UK costs of unfractionated heparin.

Table 4

UK costs of unfractionated heparin.

The cost associated with a bed day required for administering unfractionated heparin is presented in Table 5. This is not bundled as part of the surgery they will have.

Table 5. Costs associated with administering unfractionated heparin.

Table 5

Costs associated with administering unfractionated heparin.

Cost of downstream events that could be avoided with the correct bridging therapy.

Table 6. Potential downstream costs.

Table 6

Potential downstream costs.

1.6. Evidence statements

1.6.1. Clinical evidence statements

No relevant published evidence was identified.

1.6.2. Health economic evidence statements

  • No relevant economic evaluations were identified.

1.7. The committee’s discussion of the evidence

1.7.1. Interpreting the evidence

1.7.1.1. The outcomes that matter most

The committee agreed that the main potential harm of bridging therapy is increased postoperative bleeding. As such, the committee considered critical outcomes for decision making to be health-related quality of life, mortality, bleeding, thromboembolism and stroke. The committee also considered length of hospital stay to be an important outcome towards decision making.

No evidence was identified for any of the outcomes.

1.7.1.2. The quality of the evidence

No evidence was identified.

1.7.1.3. Benefits and harms

No clinical evidence was identified.

In people at high risk of thrombosis, for example, people with mechanical heart valves, bridging therapy with low molecular weight heparin or intravenous unfractionated heparin when warfarin is temporarily discontinued may be beneficial. However, increases in bleeding events have also been reported. No evidence was found to address this issue. The committee concluded that there was insufficient evidence upon which to base a recommendation regarding management strategies for anticoagulant medication in those who require bridging for surgery and therefore made a research recommendation.

1.7.2. Cost effectiveness and resource use

No economic evidence was identified for this question.

The committee were presented with some examples of unit costs. There are considerable differences in the upfront costs of the two interventions. Low molecular weight heparin has a lower upfront cost, as adults self-administer their heparin and do not need to be in hospital. The cost of low molecular weight heparin is dependent on the patient’s weight; ranging from £20 to £70 for five days. Some patients may require assistance from a district nurse to administer the injections, and it was assumed that this might apply to 10% of patients, which would cost an additional £25 per patient. Adherence may also be lower because of the self-administration required, which could have implications for whether the surgery could go ahead.

Unfractionated heparin involves an infusion, which is more expensive, and also requires up to five days in hospital pre-surgery, which has a high cost. Unfractionated heparin dose is also dependent on the weight of the adult, and ranges from £77 to £219. As adults who receive unfractionated heparin have to be in hospital, this leads to a high cost for their hospital stay. Based on NHS reference costs the average cost of a hospital bed day is around £365 and the total cost of five days would amount to £2,035.

Potential downstream costs are also of importance and were presented to the committee. The postoperative length of stay could depend on how well the adult has responded to their bridging therapy and can have an impact on their chances of having events such as a stroke, deep vein thrombosis, pulmonary embolism or bleeding events. These events have a high cost associated with them, for example, the average cost of a stroke is £6,176 and the average cost of deep vein thrombosis is £1,107. Also, the intervention that leads to better outcomes will have a positive impact on the adult such as improved quality of life.

As there is uncertainty about which intervention is more effective, the committee agreed to make a research recommendation.

1.7.3. Other factors the committee took into account

The committee noted that people taking vitamin K antagonists (VKA), with an international normalised ratio (INR) target greater than 3 are at a particularly high risk of developing deep vein thrombosis, pulmonary embolus or stroke. These are often people with mechanical heart valves and therefore require a greater level of blood thinning than other people using anticoagulant therapies, such as VKA with an INR target lower than 3 or a direct oral anticoagulant (DOAC).

The committee was aware of other published evidence suggesting that novel oral anticoagulants/direct oral anticoagulants are not licensed and are contraindicated in people with mechanical heart values. Low molecular weight heparin has similar pharmacodynamic properties, so may be equally effective in this population; however, no evidence was identified to support or refute this.

The committee discussed an INR of 2.5 as recommended in some International guidelines. However, it was noted that values are not the ones used in current practice. For example, for people with heart valves the range is between 2.5 and 3.5 and the target is 3.0. For this reason 3.0 was chosen as the INR value for the research recommendation. In addition, the BNF refers to target INR ranges rather than target values, however a target range is generally taken to be within 0.5 of the target (that is, a target value 3.5 equates to a target range of 3 to 4).

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Appendices

Appendix B. Literature search strategies

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual 2014, updated 2018.41

For more detailed information, please see the Methodology Review.

B.1. Clinical search literature search strategy

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the search where appropriate.

Table 9. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

Cochrane Library (Wiley) search terms

B.2. Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to the perioperative care population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional health economics searches were run on Medline and Embase.

Table 10. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

Appendix D. Clinical evidence tables

No relevant clinical studies were identified.

Appendix E. Forest plots

No relevant clinical studies were identified.

Appendix F. GRADE tables

No relevant clinical studies were identified.

Appendix H. Health economic evidence tables

None.

Appendix I. Excluded studies

I.2. Excluded health economic studies

Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2003 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below. See the health economic protocol for more details.

Table 12. Studies excluded from the health economic review

Appendix J. Research recommendations

J.1. Anticoagulant medication

Research question: What is the most clinically and cost effective strategy for managing anticoagulant medication?

Why this is important:

The search criteria revealed no evidence comparing the different strategies for bridging anticoagulation in the perioperative period for patients requiring an INR >3.0. Evidence is required to compare the use of unfractionated heparin as an inpatient and LMWH as an outpatient in terms of clinical and cost effective outcomes.

Criteria for selecting high-priority research recommendations

Final

Evidence reviews underpinning recommendation 1.3.9 in the NICE guideline

This evidence review was developed by the National Guideline Centre

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2020.
Bookshelf ID: NBK561978PMID: 32931180

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