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64 (); 182-188
doi:
10.1016/j.jor.2025.05.014

“A prospective study on the effectiveness of monoprophylaxis with aspirin to prevent thromboembolism in total knee arthroplasty patients”

, ,
a Apollo Medics Hospital, Lucknow, India
b Department of Orthopaedics, Base Hospital Delhi Cantt, New Delhi, India
c Department of Orthopaedics, Military Hospital, Secunderabad, 500015, India

⁎Corresponding author: S. Vignesh. vigneshs.bonesurg@gmail.com

Received: , Accepted: ,
Professor P K Surendran Memorial Education Foundation
Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Abstract

Venous thromboembolism (VTE) is a significant and serious complication occurring after lower limb arthroplasty surgeries, increasing morbidity and mortality. It is estimated that almost half of lower limb arthroplasty patients might develop deep vein thrombosis (DVT) without adequate prophylaxis. Pulmonary embolism (PE) is a possible consequence of DVT and leads to increased perioperative mortality rates after total joint replacements. It is therefore imperative to develop a standard guideline for thromboprophylaxis for lower limb arthroplasty patients. Non availability of sensitive and specific diagnostic methods in the post-operative period further adds to the problem. Non-invasive diagnostic modalities such as compression ultrasonography (USG), real-time B mode compression and colour Doppler USG are generally preferred over invasive modality such as venography which is considered to be the gold standard. Thromboprophylaxis can be achieved by pharmacological as well as nonpharmacological means. However, no consensus exists on the ideal thromboprophylaxis method.

In this study, we have used aspirin as a single chemoprophylactic agent in patients of total knee replacement for the prophylaxis of symptomatic deep vein thrombosis for all patients with addition of mechanical prophylaxis as per risk stratified approach recommended by the AAOS. A total of 50 patients meeting the predefined selection criteria were enrolled for the study. Effectiveness of the same was measured by clinical & radiological assessment.

We found that aspirin as a chemical monoprophylaxis along with mechanical methods lead to total risk mitigation for VTE in 98 % of our study population. There was one case of distal DVT (2 %) which was successfully managed by pharmacotherapy.

Use of aspirin as a monoprophylaxis against DVT and PE is effective in patients undergoing total knee arthroplasty. Addition of a mechanical prophylaxis might be considered in higher risk patients.

Keywords

Thromboembolism
Venous thrombosis
Thromboprophylaxis
Risk stratification
Aspirin
Arthroplasty
Knee
1

1 Introduction

Venous thromboembolism (VTE) is one of the most frequent and serious complications in orthopaedic surgery involving lower limbs, increasing morbidity as well as mortality.1 It is estimated that without prophylaxis deep vein thrombosis (DVT) develops in about 50 % of patients undergoing hip & knee replacement surgeries most of whom are asymptomatic.2 About 20 % of patients may develop asymptomatic pulmonary emboli out of which 2 % of cases may be fatal.2,3 DVT & subsequent pulmonary embolism are some of the common causes of morbidity and mortality after total joint replacements.4 Triad of Virchow, namely, venous stasis, endothelial damage & hypercoagulability lead to an environment with increased propensity for development of thrombosis. In patients of osteoarthritis of knees venous stasis may occur preoperatively as well as post operatively due to decreased mobility. Endothelial damage may occur intra-operatively due to direct trauma to blood vessels.5 Hypercoagulable state is present in response to surgical intervention. The predisposition of Indian population, lack of awareness and fear of bleeding complications after chemoprophylaxis have made deep vein thrombosis (DVT) a serious problem in this population, hence standard guidelines for thromboprophylaxis are essential for lower limb arthroplasty patients.6,7

Several known risk factors include age, BMI,8 increased duration of surgical procedure and severity of underlying systemic disease. A hypercoagulable state persists in the body after trauma or surgery due to the release of thromboplastin from marrow fat and medullary sinusoids into the systemic circulation.9

There is no single best method for diagnosis of VTE10 and hence the reported incidences in the literature vary greatly due to non-standardised reporting. Non-invasive diagnostic modalities such as compression ultrasonography (USG), real-time B mode compression and colour Doppler USG are generally preferred over invasive modality such as venography which is considered to be the gold standard.10–12 Ventilation-Perfusion scan (V/Q) is a commonly used non-invasive diagnostic tool to diagnose PE whereas pulmonary angiography remains the gold standard for diagnosis of PE.

Thromboprophylaxis can be achieved by pharmacological and non-pharmacological means.13,14 There are two major classes of pharmacological prophylaxis in general – antiplatelets and anticoagulants. Aspirin is an example of antiplatelet drug which inhibits platelet aggregation and prevent clot formation whereas there are several subclasses of anticoagulants available based on their mechanism of action depending on their target in the coagulation cascade. Pharmacological agents may cause significant bleeding episodes.15 Anticoagulants like warfarin, heparin, Factor Xa indirect inhibitor Fondaparinux, factor Xa direct inhibitor, orally active anticoagulant Rivaroxaban and the oral IIa inhibitor Melagatran and dabigatran are commonly used for chemical thromboprophylaxis. Recombinant human soluble thrombomodulin is a new and highly effective antithrombotic agent.16 Mechanical thromboprophylaxis methods are devoid of haemorrhagic complications.17 Mechanical agents include graduated pressure compression stockings and intermittent compression of calf by pneumatic compression devices.18,19 Prophylactic placement of vena cava filters in selected high risk arthroplasty patients may decrease the incidence of PE.

American Academy of Orthopaedic Surgeons (AAOS) has recommended a risk-stratified approach for classifying patients into low, moderate and high risk for postoperative venous thromboembolism with differing slightly recommendations for each group. In this study, we retain the concept of risk-stratification to classify the patients, but used only aspirin as sole chemoprophylaxis in all risk groups along with mechanical prophylaxis.

Although several methods exist for thromboprophylaxis in post-operative patients, the ideal agent is debatable and the role of aspirin as a monotherapy has been a crucial point of discussion in the literature.20–22 Many of the newer anticoagulants do not have a specific antidote potentially increasing the risk for bleeding episodes. Moreover, they also increase the total cost of treatment significantly. The main advantage of aspirin compared to other chemoprophylaxis agents is the lower cost of treatment while maintaining non-inferior risk reduction and adverse effect profile compared to newer agents in prior studies in literature.20–22

In this study, we aimed to evaluate the effectiveness of aspirin as monotherapy for chemoprophylaxis following total knee replacement along with mechanical prophylaxis methods. Effectiveness of the same was measured by clinical & imaging assessment.

2

2 Material and methods

This prospective longitudinal study was carried out on 50 consecutive and consenting patients at a tertiary care joint replacement centre, studying the efficacy of combined use of single agent soluble aspirin, mechanical prophylaxis and early mobilization in prevention of DVT in total knee arthroplasty patients as per risk stratification recommended by AAOS. Approval for the study was taken from institutional ethical committee and scientific review committee prior to the conduct of study.

The patients were risk stratified as per the recommendations of American Academy of Orthopedic Surgeons (AAOS) for DVT prophylaxis. Wells risk scoring is used in this study for risk stratification of patients undergoing total knee arthroplasty.23

2.1

2.1 Inclusion criteria

1.All patients above the age of 40 years who have undergone knee replacement surgery

Exclusion criteria: Since this study was aimed at the role of aspirin monotherapy in preventing postoperative VTE and the evaluation was to be done by doppler ultrasound which is sensitive for asymptomatic thrombus, any condition that could have led to pre-existing thrombotic state were excluded. Although we had excluded younger persons, we did not encounter any patient less than 40 years undergoing total knee replacement during our study.1.Presence of any condition known to cause a pre-existing thrombotic state.2.Use of medications other than aspirin for VTE prophylaxis.3.Those not consenting to participate in the study4.Participants below 40 years of age5.Revision surgeries6.BMI> 357.Those undergoing simultaneous bilateral knee replacement surgery)

2.2

2.2 Follow up

The patients were observed post operatively during hospital admission as well as up to 12 weeks post discharge from hospital. All of them received early mobilization, soluble aspirin (started on the day after surgery and continued 4 weeks post operatively) and application of pneumatic compression devices during hospital stay.

The involved side (right or left), the type and duration of surgery, and limb and patient position during surgery were noted in all cases.

All patients were mobilized out of bed within two days after the surgery. Active and passive physical exercises were started on the day after surgery as per pain tolerance. Patients were assessed both clinically and by doppler sonography in their post-operative visits at 2, 6 and 12 weeks after surgery. Clinical examination included assessment for pain and swelling of the leg and foot, calf erythema and tenderness (Moses' sign) and painful passive dorsiflexion of foot (Homan's sign). The Doppler assessment included examination of all proximal and distal veins of leg to look for visualization of thrombus, drop in flow and pressures, and lack of compressibility or deep veins. A diagnosis of symptomatic deep vein thrombosis is made when a documented thrombus on ultrasound examination presented with any of the clinical signs mentioned above. Modified Wells criteria was applied to find the presence of acute pulmonary embolism. Presence of symptomatic acute deep vein thrombosis and/or acute pulmonary embolism is documented as occurrence of an adverse event in this study.

Sample size estimation: Highly variable prevalence of DVT is reported from the Asian studies. Overall prevalence of venous thrombosis in Asian population after total knee replacement Surgery in absence of prophylaxis is estimated to be around 26 %–60 %.24

Some studies report a low DVT prevalence in Asia after total knee replacement surgery as detected by colour Doppler in absence of prophylaxis to be around 7–9.25

Assuming 10 % desired precision, 80 % confidence level and 0.01 level of significance, the minimum sample size required for the study was estimated to be 50.

3

3 Results

3.1

3.1 Demography

Average age of study population was 66.35 years (SD = 9.5 years). The age distribution is shown in Fig. 1. The sex distribution was almost equal between males and females as shown in Fig. 1.

Chart showing the demographics (age, gender and BMI distribution) of the study participants.
Fig. 1 Chart showing the demographics (age, gender and BMI distribution) of the study participants.

Normal Body Mass Index (BMI) was considered to be between 18.5 and 24.9. Participant with BMI between 25 and 29.9 were categorised as overweight and those with BMI over 30 were categorised as obese. Majority of the participants (62 %) were overweight as shown in Fig. 1.

3.2

3.2 Comorbidities

Around 58 % (n = 29) of the participants had at least one comorbidity. Fig. 2 presents the distribution of co-morbidities in the participants. The major comorbidities were hypertension (HTN), diabetes mellitus type II (DM II), ischaemic heart disease (IHD), coronary heart disease (CAD), hypothyroidism, lumbar spondylosis and others including HBSAg positive status, breast cancer and ECG abnormality. Hypertension was the most frequent comorbidity present in almost 46 % of the participants. The anaesthesiologist grading as per the ASA guideline is taken as a risk stratification for the comorbid conditions. Around 62 % (n = 31) were graded ASA II and remaining 38 % (n = 19) were graded ASA III as shown in Fig. 3.

Distribution of comorbidities among the participants. Hypertension was the most prevalent comorbidity.
Fig. 2 Distribution of comorbidities among the participants. Hypertension was the most prevalent comorbidity.
Distribution of participants as per their preoperative ASA grade.
Fig. 3 Distribution of participants as per their preoperative ASA grade.
3.3

3.3 Preoperative clinical features

Table 1 shows duration from onset of symptoms to surgical procedure. Majority of the patients (68 %) underwent surgery at around 6–10 years after onset of symptoms. The most common symptom was pain in all the participants followed by deformity, stiffness and knee joint swelling as shown in Fig. 4.

Table 1 Duration since onset of symptoms until surgery.
Years Number of patients (n) Percentage (%)
0–5 years 4 8
6–10 years 34 68
11years and above 12 24
Clinical features in the pre-operative evaluation of the participants.
Fig. 4 Clinical features in the pre-operative evaluation of the participants.
3.4

3.4 Postoperative protocol

DVT prophylaxis in all patients included a mechanical prophylaxis with intermittent pneumatic compression device as shown in Fig. 5 while in hospital followed by anti-embolic stockings upon discharge, and chemoprophylaxis with oral aspirin monotherapy started from the day after surgery.

Mechanical intermittent pneumatic calf pump used for DVT prophylaxis in this study.
Fig. 5 Mechanical intermittent pneumatic calf pump used for DVT prophylaxis in this study.

96 % (n = 48) of the patients were mobilized on the day 1 after surgery. Two patients were mobilized on day 2 due to pain and discomfort after surgery. However, calf pumping and other exercises were started on bed.

According to risk stratification as per AAOS guideline, all the patients were at risk for VTE. Of them 8 % (n = 4) were considered to be moderate to high risk for VTE due to multiple comorbidities as shown in Fig. 6. All patients irrespective of their risk status were given oral asprin prophylaxis for 4 weeks.

Risk stratification of patients into standard and high risk for venous thromboembolism in this study.
Fig. 6 Risk stratification of patients into standard and high risk for venous thromboembolism in this study.
3.5

3.5 Postoperative clinical features

The most common symptom in the early post-operative period at 2 weeks and 6 weeks was pain in the knee, present in all patients. Swelling in the knee was present in all patients at 2 weeks which subsided to insignificant levels in majority (92 %, n = 46) by 6 weeks. All patients achieved range of knee movements up to 110° by 6 weeks. Terminal extension lag of up to 10° was noted in 14 % (n = 7) patients by 6 weeks which improved to full extension by 12 weeks.

Calf tenderness was present in one patient (2 %) at 2 and 6 weeks postoperatively. Moses’ sign (squeezing the calf against tibia) was positive at 6 weeks. However, both were absent at 12 weeks, after intervention with therapeutic dose of low molecular weight heparin (LMWH).

3.6

3.6 Postoperative imaging

All patients underwent colour doppler ultrasound imaging at 2, 6 and 12 weeks after surgery. Of the two patients who had clinical features of calf tenderness, one who had a low risk of DVT/PE as per initial AAOS stratification also had doppler USG evidence of DVT in distal circulation at 6 weeks which had cleared off following therapeutic intervention by 12 weeks after surgery. The outcomes of this study are summarised in Table 2.

Table 2 Summary of clinical and radiological outcomes of this study.
Status Calf tenderness (6 weeks) USG evidence of significant DVT (6 weeks) DVT therapy/prophylaxis given Clinico-radiological evidence of DVT at 12 weeks
Yes 2 1 Therapy with LMWH/other drugs 0
No 48 49 Prophylaxis with Aspirin 50
4

4 Discussion

Even though clinical examination findings such as Homan sign, Moses’ sign and calf tenderness are poorly sensitive and specific for DVT, they are the usual first clinical evidences of symptomatic DVT.

The American association of orthopaedic surgeons (AAOS, last updated in 2011) and American college of chest physicians (ACCP, last updated in 2012) guidelines are widely followed worldwide for thromboprophylaxis and management of VTE.26,27 The 2008 ACCP guidelines were comprehensive mentioning the drug choices, dosages, target INR ranges and duration of prophylaxis.28 However, they did not seem to take serious note on operative site bleeding. The later ACCP guidelines (2012) are more accommodative of varied pharmacologic prophylaxis and definitions of adequacy.26 ACCP (2012) guidelines recommend Aspirin as a choice for prophylaxis besides several new drugs such as factor Xa and thrombin inhibitors. In addition, they have standardised the end points to be more clinically relevant. The same has been advocated by the AAOS.27

There is a long-standing controversy about the use of Aspirin as a thrombo-prophylactic agent, especially in orthopaedic surgeries. The 2008 guidelines from the American college of chest physicians had cautioned against the use of Aspirin as a single agent for thromboprophylaxis because of lack of evidence on its efficacy. Although the antithrombotic trialist collaboration (ATC),29 showed evidence of risk reduction of symptomatic DVT and PE cases, the ACCP analysis did not recommend the ATC results citing poor quality data and sub-standard methodology. In a prospective trial icvolving 696 patients Woller et al.30 concluded that the standard risk patients receiving aspirin had a significantly higher rate of symptomatic PE (4.6 % versus 0.7 %, P < . 0 3 0) and VTE (7.9 % versus 1.2 %, P < . 0 0 1) than the patients receiving warfarin. In 2012, the ACCP had taken a complete turn from their previous position and had given a strong recommendation for use of Aspirin for thromboprophylaxis (grade 1B). Latest available recommendations from ACCP state that low-dose Aspirin thromboprophylaxis for 35 days following arthroplasty will result in seven fewer symptomatic VTEs per 1000 patients. Although the use of Aspirin had resulted in slightly more non-fatal bleeding episodes compared to placebo (relative risk = 1.12), there were no increased risks of re-operation or death due to bleed.

The latest international consensus meeting for thromboprophylaxis in orthopaedic surgeries 31was the largest of its kind where consensus was achieved for thromboembolic prophylaxis in most sub-specialties of orthopaedic surgery. They recommended the use of aspirin as a monoprophylaxis in standard risk patients undergoing joint replacement. The strength of recommendation is moderate for early ambulation, anti DVT stockinette and intermittent compression device as mechanical modalities for VTE prophylaxis.

A comparative analysis of available literature is shown in Table 3.

Table 3 Comparable studies from the literature on aspirin monotherapy for VTE prophylaxis in arthroplasty patients.
S.No. Study Design/Methodology Outcome
1 Hood BR et al. (2019)20 Non-inferiority study from a retrospective cohort of 41,537 patients undergoing TKA from Michigan registry between 2013 and 2015. Aspirin-only regimen was noninferior for the composite VTE outcome as well as for bleeding complication when compared with those receiving other chemoprophylaxis
2 Lavu MS (2024)21 Retrospective database analysis. Between 2012 and 2022, 126,694 who underwent TKA across 60 centres in USA were included Use of aspirin increased to approximately 50 % in both low-risk as well as high-risk patients. Also, aspirin-only chemoprophylaxis showed reduced incidence of DVT/PE, bleeding and other complications compared to other regimens
3 Azboy I et al. (2020)22 Systematic review - 45 studies included. To study the effectiveness of low-dose aspirin vs high-dose aspirin There were no significant differences in symptomatic pulmonary embolism, symptomatic deep vein thrombosis, 90-day mortality, or major bleeding between patients receiving low-dose or high-dose aspirin.
4 Bala A et al. (2017)32 Large database study, identifying all primary TKAs between 2007 and 2016 (Humana and Medicare database, USA) Aspirin provided comparable VTE prophylaxis compared with factor Xa inhibitors with improved VTE prophylaxis compared with enoxaparin and warfarin with the lowest risk of bleeding.
5 Chu JN et al. (2017)33 Retrospective cohort study of 231,780 adults who underwent total knee arthroplasty and 110,621 who underwent total hip arthroplasty in 2009–2012 Patients who received aspirin-only had similar rates of post-operative VTE compared to patients who received anticoagulants.
6 Anderson DR et al. (2018)34 Multicenter, double-blind, randomized, controlled trial in 3424 patients undergoing TKA/THA. Rivaroxaban for first five days for all patients. After five days, randomly assigned to either continue rivaroxaban or switch to low-dose aspirin Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban

This prospective study was designed to evaluate efficacy of risk stratified approach to prophylaxis for DVT in patients with osteoarthritis affecting knee joints undergoing total knee arthroplasty patients.

In present study, 68 % of patients had symptomatic knee osteoarthritis for last 6–10 years and 24 % were symptomatic for more than 11 years. Prolonged duration of pain and stiffness would mean that these patients were on reduced mobility for a long duration before surgery thus significantly increasing the risk for DVT. Both knees were affected in most of the cases (66 %) and 80 % had varus deformity at the knee. One patient had valgus deformity at the knee. Only 20 % of the patients were of normal BMI in range of 18.5–24.9, rest were either overweight or obese, thus significantly increasing risk or developing DVT. The recent international consensus meeting agrees with a moderate strength of recommendation that both reduced mobility and obesity increases the risk for VTE.31

All patients except two (4 %) were mobilized from post-op day 1. These two patients had excessive pain and apprehension and could be mobilized well from post-op day 2. However, they were kept on mechanical as well as chemical DVT prophylaxis. Mild to moderate knee pain was present in all of the patient till 06 weeks post-operatively but it was significantly reduced by 12 weeks follow-up. The pain-free functional status in the early post operative period has enabled accelerated rehabilitation which might have been benefitted in preventing VTE beyond this time point. Calf and leg swelling was present in almost all patient at 2 weeks after surgery which reduced to only 8 % of the participants having significant swelling at 6 weeks. However, calf tenderness was present in only one patient (2 %) at 2 weeks post-surgery.

DVT was assessed by colour Doppler and flow index (CDFI) at 2 and 6 weeks and 3 months postoperatively. We found CDFI was negative for occlusion and flow reduction in all patients at 2 weeks. One patient (2 %) developed distal deep vein thrombosis, detected by both clinical symptoms & CDFI at 6 weeks. This patient was managed by therapeutic dosage of low molecular weight heparin (LMWH) and went on to uneventful recovery both clinically and radiologically by 12 weeks.

Serial colour Doppler examination revealed that all patients were free from DVT at the end of 3 months.

This prospective cohort study is not without limitations. Firstly, the study design has its own intrinsic limitations in interpretation of the results. Secondly, our definition of an adverse event included only symptomatic thromboembolic event. Asymptomatic micro-thrombo-emboli are known to be more prevalent after surgery. Thirdly, since our focus was to study the crucial 90-day postoperative VTE events, any event occurring beyond that period were not studied.

5

5 Conclusion

The aim of conducting this study was to examine the effectiveness of DVT prophylaxis administered by a risk stratified approach to patients undergoing knee arthroplasty at our centre. Ever since the ACCP had dropped aspirin monoprophylaxis in their previous recommendation, the cost of healthcare has risen significantly due to alternate methods of chemoprophylaxis. Adherence to prophylaxis was found to be an issue in this governmental set-up leading to occasional cases of VTE and PE after arthroplasty surgery. In this study, we have found that using aspirin as a single agent chemoprophylaxis is effective in preventing symptomatic DVT and PE in 98 % of our study population. Additionally, there were no observed bleeding episodes in the participants of this study. We recommend further randomized controlled trials on monoprophylaxis with aspirin in the South Asian, especially the Indian population. Use of aspirin as a monoprophylaxis against symptomatic episodes DVT and PE found to be effective in thromboprophylaxis against major symptomatic thromboembolic episodes patients undergoing total knee arthroplasty. Addition of a mechanical prophylaxis may be considered for improved outcomes.

CRediT authorship contribution statement

Narinder Kumar: Supervision, Writing – review & editing, Project administration. M.A. Jafri: Investigation, Formal analysis, Methodology, Writing – original draft. Vignesh S.: Validation, Formal analysis, Writing – review & editing, Resources, Software.

Ethical clearance

Institutional ethics committee (IEC) MH Kirkee approved on Apr 10, 2015.

Ethics statement

Approval of Institutional ethical committee (IEC) was acquired prior to the start of the study. No concerns were raised by the committee for the conduct as per the proposed study methodology.

Funding statement

This study has been conducted at a tertiary care hospital of the Indian Armed Forces. No funds, grant, honorarium had been received from any organization. The authors declare no conflict of interest.

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