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Apixaban or enoxaparin_ Which is better forthromboprophylaxis after total hip a
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2022/5/31
Apixaban or enoxaparin: Which is better for thromboprophylaxis after total hip and total knee arthroplasty in Indian patients? - Kunal - 202
…
https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.14959 1/14
British Journal of Clinical Pharmacology / Volume 88, Issue 2 / p. 830-835
SHORT COMMUNICATION
Full Access
Apixaban or enoxaparin: Which is better for thromboprophylaxis after total hip
and total knee arthroplasty in Indian patients?
First published: 29 June 2021
https://doi.org/10.1111/bcp.14959
The authors conrm that the PI for this paper is Kishor Kunal and that he had direct clinical responsibility for
patients.
Data available on request from the authors.
Abstract
Kishor Kunal, Sumit Banerjee, Pawan Kumar Garg, Abhay Elhence
Both apixaban and enoxaparin are Food and Drug Administration-approved standard
therapy for prophylaxis of deep-vein thrombosis; however, the superiority of one over the
other is still controversial. With an objective to observe ecacy and safety outcomes of
apixaban and enoxaparin in patients undergoing total hip (THA) and knee (TKA)
arthroplasty, 96 patients undergoing THA/TKA (October 2018 to August 2019) were
randomly allocated into 2 groups; (n = 48) apixaban; and (n = 48) enoxaparin. Ecacy
outcomes and safety outcomes were recorded at 2 and 5 weeks post-TKA/THA. Follow-up
functional scoring was done at 6 months postoperatively. Apixaban and enoxaparin were
found to be equally ecacious in preventing venous thromboembolism; however, apixaban
had a better safety prole. The apixaban group had nonsignicant higher tendency for
wound discharge, atrial brillation and transient ischaemic attack. Enoxaparin had
nonsignicant greater tendency for bleeding, wound dehiscence and pulmonary
complications. Apixaban is a safe alternative to conventionally used enoxaparin for
chemoprophylaxis in patients undergoing THA or TKA.
What is already known about this subject
Approximately 40% patients undergoing hip and knee arthroplasty develop
asymptomatic venous thromboembolism (VTE) within few days of surgery.
2022/5/31
Apixaban or enoxaparin: Which is better for thromboprophylaxis after total hip and total knee arthroplasty in Indian patients? - Kunal - 202
…
https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.14959 2/14
Symptomatic VTE ranges from 1 to 5% in the above group compared to 0.1–0.2%
in the general population.
Both apixaban and enoxaparin are used as standard therapies for prophylaxis of
deep-vein thrombosis and have been approved by the Food and Drug
Administration. Some studies have shown no improved benet of apixaban over
enoxaparin, while others have shown apixaban is more eective in preventing
major thromboembolic episode without increased risk of bleeding.
There is no signicant dierence in functional outcomes with or without
thromboprophylaxis.
What this study adds
First observational study in Indian population to compare safety and ecacy of 2
commonly used drugs for thromboprophylaxis in patients undergoing total hip
and knee arthroplasty.
First observational study to compare the functional outcomes between apixaban
and enoxaparin in patients undergoing total hip and knee arthroplasty in
literature.
First study to compare 6-month follow-up of safety and ecacy outcomes of
apixaban and enoxaparin in patients receiving the same for chemoprophylaxis of
VTE following total hip and knee arthroplasty in literature.
Considering the similar (nonsignicant numerically better) safety and ecacy
proles of oral apixaban in Indian patients with convincing results in European
population, it can be recommended for thromboprophylaxis in Indian setting,
over traditionally prescribed parenteral enoxaparin, which can be costly and have
local complications. Also, this study can form the basis for further research in an
Indian setting, given the similarity of patient proles and medical infrastructure
and guidelines.
1 INTRODUCTION
Approximately 40% patients undergoing hip and knee arthroplasty develop asymptomatic
venous thromboembolism (VTE) within few days of surgery. Symptomatic VTE ranges from 1
to 5% in the above group compared to 0.1 to 0.2% in the general population. Falck-Ytter et al.
reported that risk of symptomatic VTE in patients using pharmacological prophylaxis is 1.2%
(0.8% deep-vein thrombosis [DVT] and 0.4% pulmonary embolism [PE]) within 14 days following
1, 2
3-5
2022/5/31
Apixaban or enoxaparin: Which is better for thromboprophylaxis after total hip and total knee arthroplasty in Indian patients? - Kunal - 202
…
https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.14959 3/14
surgery. The overall reduction in symptomatic and asymptomatic VTE following
pharmacological thromboprophylaxis has been observed at 50–70%.
6
7, 8
2 METHODOLOGY
The study design was prospective observational study- Level 2b evidence. It included all the
patients meeting inclusion criteria (Table 1) between 1 October 2018 and 31 August 2019 who
underwent elective total hip (THA) and knee (TKA) arthroplasty at our institution, unless the
patient met an exclusion criterion (Table 1).
TABLE 1. Inclusion–exclusion criteria and safety and ecacy outcome
Enoxaparin 40 mg (0.4 mL) was administered subcutaneously every 24 hours and apixaban 2.5
mg was administered orally in tablet form every 12 hours for 2 weeks in TKA and 5 weeks in
Inclusion
criteria
Patients were considered eligible if they were undergoing either elective unilateral or simultaneous
bilateral total knee arthroplasty and total hip arthroplasty and were willing to undergo Doppler studies.
Informed written consent was obtained from all patients undergoing the above-mentioned procedures
Exclusion
criteria
• hereditary (rst degree) or acquired bleeding or coagulation disorder.
• known or suspected history of heparin-induced thrombocytopenia.
• need for ongoing treatment with a parenteral or oral anticoagulant (e.g., subjects with mechanical
valves, warfarin-eligible atrial brillation).
• known coagulopathy.
• active bleeding.
• active hepatobiliary disease.
• any condition, in the opinion of the investigator, for which surgery or administration of an
anticoagulant was contraindicated.
• hypersensitivity to unfractionated heparin, low molecular weight heparin, porcine products, or
iodinated contrast medium.
• pre-operative deep vein thrombosis detected in Doppler ultrasound and patients with previous
known/documented history of thrombogenic events such as deep-vein thrombosis (DVT) and pulmonary
embolism.
Ecacy • symptomatic DVT
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