scholarly journals Efficacy and safety of edoxaban tosylate hydrate 15 mg in the prevention of venous thromboembolism in patients with impaired renal function after orthopedic surgery of the lower extremities

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Teruhisa Kinoshita ◽  
Sayuri Otsuka ◽  
Shota Torii ◽  
Yoko Tsugeno ◽  
Shiori Fukaya ◽  
...  
Keyword(s):  
Renal Function ◽  
Venous Thromboembolism ◽  
Knee Arthroplasty ◽  
Normal Renal Function ◽  
Orthopedic Surgery ◽  
Impaired Renal Function ◽  
Lower Extremities ◽  
Efficacy And Safety ◽  
Intergroup Difference ◽  
Vte Prophylaxis

Abstract Background Although not indicated in the USA, edoxaban tosylate hydrate 15 mg is used for venous thromboembolism (VTE) prophylaxis after orthopedic surgery of the lower extremities in Japan. However, its efficacy and safety in patients with impaired renal function have not been fully evaluated. We aimed to investigate the intervention’s effectiveness in these patients. Methods From 2018 to 2020, patients who underwent total hip arthroplasty, total knee arthroplasty, hip fracture surgery, or knee arthroplasty single granule replacement and with renal dysfunction were evaluated. Safety was evaluated according to bleeding occurrence during edoxaban treatment and liver function endpoints. Patients were divided into the 15- and 30-mg oral groups, including 23 patients with impaired renal function and 209 with normal renal function, respectively. Results VTE incidence in the 15- and 30-mg groups was 8.7% and 8.6%, respectively; the intergroup difference was insignificant (odds ratio [OR] 0.99; 95% confidence interval [CI] 0.22–4.56; p = 1.00). Bleeding did not occur in the 15-mg group and was noted in 9 patients in the 30-mg group during treatment with edoxaban; the intergroup difference was insignificant (p = 1.00). The increase in aspartate aminotransferase and alanine aminotransferase levels was 30% in the 15-mg group and 19% in the 30-mg group, with no difference between the groups (p = 0.27). Multivariate analysis showed that the dose of edoxaban was not a significant factor associated with the incidence of VTE (adjusted OR 2.31; 95% CI 0.39–13.8; p = 0.36). Conclusions Edoxaban 15 mg in patients with impaired renal function may be as effective as edoxaban 30 mg in patients with normal renal function. However, the number of cases included in this study was small and the power was insufficient; therefore, a study with a larger sample size is desirable.

Venous Thromboembolism Prevention with LMWHs in Medical and Orthopedic Surgery Patients

2003 ◽  
Vol 37 (3) ◽  
pp. 402-411 ◽  
Author(s):  
Steven B Deitelzweig ◽  
Gordon J Vanscoy ◽  
Cynthia S Niccolai ◽  
Thomas L Rihn
Keyword(s):  
Risk Factors ◽  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Orthopedic Surgery ◽  
Low Molecular Weight ◽  
Medical Patients ◽  
Efficacy And Safety ◽  
Consensus Guidelines ◽  
Medline Search ◽  
Vte Prophylaxis

OBJECTIVE: To discuss the role of low-molecular-weight heparins (LMWHs) in the prevention of venous thromboembolism (VTE) in medical and orthopedic surgery patients. VTE prophylaxis trials in these practice settings establishing the current use of LMWHs marketed in the US are included. An overview is also provided of VTE incidence, risk factors, and prophylaxis consensus guidelines. DATA SOURCES AND STUDY SELECTION: Clinical trials, review articles, and meta-analyses for Food and Drug Administration–approved LMWHs were identified from a MEDLINE search (1980–March 2002). Search terms included dalteparin, enoxaparin, internal medicine, low-molecular-weight heparin, orthopedic surgery, risk factors, tinzaparin, and venous thromboembolism. DATA SYNTHESIS: Consensus guidelines are useful as an initial guide to appropriate VTE prophylaxis; however, a review of the primary literature is needed to identify optimal agents, regimens, or interventions. LMWHs have demonstrated sound efficacy in VTE prevention; however, the quantity and quality of literature are not always comparable for the available agents. CONCLUSIONS: Enoxaparin has demonstrated efficacy and safety in VTE prevention in medical patients, whereas information is limited or lacking for dalteparin and tinzaparin. Total hip replacement (THR) trials have been conducted with all US-marketed LMWHs and have demonstrated the efficacy and safety of each agent. Trials specifically establishing the efficacy of an LMWH in total knee replacement surgery (TKR) have been published for enoxaparin. One combination THR and TKR trial has been published for tinzaparin. These trial outcomes have positioned the LMWHs as key alternatives to adjusted-dose warfarin for VTE prophylaxis in orthopedic surgery. Inherent differences between LMWHs prevent the extrapolation of clinical outcomes from 1 trial to another.

Aspirin for the Prophylaxis of Venous Thromboembolic Events in Orthopedic Surgery Patients: A Comparison of the AAOS and ACCP Guidelines with Review of the Evidence

2013 ◽  
Vol 47 (1) ◽  
pp. 63-74 ◽  
Author(s):  
David W Stewart ◽  
Jessica E Freshour
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Knee Arthroplasty ◽  
Orthopedic Surgery ◽  
Patient Population ◽  
Surrogate Marker ◽  
Improvement Project ◽  
Vte Prophylaxis ◽  
Mesh Terms ◽  
Venous Thromboembolic Events

BACKGROUND The American Academy of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP) have both developed evidence-based guidelines to prevent venous thromboembolism (VTE) in high-risk orthopedic surgery patients. Recent changes to these documents have brought them into agreement as to the inclusion of aspirin as an appropriate option for VTE prophylaxis in this patient population. OBJECTIVE To evaluate the appropriateness of aspirin to prevent VTE in high-risk orthopedic surgery patients. DATA SOURCES Guidelines published by the AAOS in 2011 and the ACCP in 2012 were compared regarding their recommendations on the use of aspirin for the prevention of VTE. A literature search was also conducted to identify clinical trials that evaluated the use of aspirin for the prevention of VTE in this patient population. Search terms included the MeSH terms venous thromboembolism; venous thrombosis; pulmonary embolism; aspirin; arthroplasty, replacement, knee; arthroplasty, replacement, hip; and hip fractures/surgery. STUDY SELECTION AND DATA EXTRACTION Any study that evaluated aspirin, even in combination with another method of prophylaxis (such as pneumatic compression devices), and had been published during or after 1985 was included. DATA SYNTHESIS Randomized controlled trials, meta-analyses, and other large pooled and retrospective reviews have failed to consistently arrive at similar conclusions regarding the efficacy and safety of aspirin as an option for VTE prophylaxis in patients undergoing total knee arthroplasty (TKA), total hip arthroplasty (THA), or hip fracture surgery (HFS). Disagreements in the appropriateness of surrogate markers for safety and efficacy have resulted in differing recommendations from the ACCP and AAOS. The primary argument lies in the appropriateness of deep vein thrombosis as a surrogate marker for more serious outcomes such as pulmonary emboli. CONCLUSIONS Recent changes to both the ACCP and AAOS guidelines are in agreement for those who choose to use aspirin for chemoprophylaxis of VTE. Current surgical care improvement project measures do not include aspirin as an appropriate sole option for the prevention of VTE, but in patients undergoing elective TKA or who have a contraindication to pharmacologic prophylaxis and undergo a THA or HFS, aspirin in conjunction with compression devices as part of a multimodal approach would meet these measures. Data do not support the hypothesis that aspirin is less likely to cause adverse bleeding events than more potent anticoagulants.

scholarly journals The Efficacy and Safety of Rivaroxaban for Venous Thromboembolism Prophylaxis after Total Hip and Total Knee Arthroplasty

Thrombosis ◽  
2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Robert D. Russell ◽  
William R. Hotchkiss ◽  
Justin R. Knight ◽  
Michael H. Huo
Keyword(s):  
Total Knee Arthroplasty ◽  
Venous Thromboembolism ◽  
Knee Arthroplasty ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Vte Prophylaxis ◽  
Total Hip ◽  
Increased Risk ◽  
Total Knee

Venous thromboembolism (VTE) is a common complication after total hip and total knee arthroplasty. Currently used methods of VTE prophylaxis after these procedures have important limitations, including parenteral administration, and unpredictable plasma levels requiring frequent monitoring and dose adjustment leading to decreased patient compliance with recommended guidelines. New oral anticoagulants have been demonstrated in clinical trials to be equally efficacious to enoxaparin and allow for fixed dosing without the need for monitoring. Rivaroxaban is one of the new oral anticoagulants and is a direct factor Xa inhibitor that has demonstrated superior efficacy to that of enoxaparin. However, the data also suggest that rivaroxaban has an increased risk of bleeding compared to enoxaparin. This paper reviews the available data on the efficacy and safety of rivaroxaban for VTE prophylaxis after total hip and total knee arthroplasty.

Meta-analysis comparing impact of age, sex and renal function on the efficacy and safety of new oral anticoagulants vs. vitamin K antagonists for the treatment of acute venous thromboembolisms

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J She ◽  
B.Z Zhuo
Keyword(s):  
Renal Function ◽  
Venous Thromboembolism ◽  
Creatinine Clearance ◽  
Vitamin K ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Funding Source ◽  
Efficacy And Safety ◽  
Acute Venous Thromboembolism

Abstract Background New direct oral anticoagulants (NOACs), as a preferable treatment option for acute venous thromboembolism (VTE) have been recommended with practical advantages as compared to Vitamin K antagonists (VKAs) in clinical practice. Purpose In our study, we performed a meta-analysis to determine the efficacy and safety of NOACs vs. VKAs in patients with different age, sex and renal function for the treatment of VTE. Methods Electronic databases (accessed October 2019) were systematically searched to identify RCTs evaluating apixaban, dabigatran, edoxaban, and rivaroxaban versus VKAs for the treatment of acute venous thromboembolism. Results NOACs was associated with a borderline higher efficacy in female (OR 0.79, 95% CI 0.62–1.02), and a significantly higher efficacy in patients with age more than 75 (OR 0.51, 95% CI 0.32–0.80) and creatinine clearance less than 50 mL/min (OR 0.57, 95% CI 0.32–0.99). NOACs also show advantage in terms of major or clinically relevant non-major bleeding in male (OR 0.72, 95% CI 0.60–0.86), and patients with creatinine clearance more than 50 mL/min (OR 0.75, 95% CI 0.67–0.84). Conclusions NOACs have exhibited clinical preference among patients with acute VTE as compared to VKA with significantly decreased thrombosis events and lower bleeding complications, especially in patients with age more than 75 and creatinine clearance less than 50 mL/min. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): This study was supported by the National Natural Science Foundation of China (81800390) and the Natural Science Foundation of Shaanxi province (2018KW067).

Venous Thromboembolism Prophylaxis

2006 ◽  
Author(s):  
Richard C. Becker ◽  
Frederick A. Spencer
Keyword(s):  
Venous Thromboembolism ◽  
Orthopedic Surgery ◽  
Large Scale ◽  
Development Program ◽  
Thromboembolism Prophylaxis ◽  
Double Blind ◽  
Vte Prophylaxis ◽  
Vein Thrombosis ◽  
Disease States ◽  
Phase Ii Studies

Venous thromboembolism represents a true worldwide medical problem that is encountered within all realms of practice. Venous thromboembolism (VTE) occurs in approximately 100 patients per 100,000 population yearly in the United States and increases exponentially with each decade of life (White, 2003). Approximately one-third of patients with symptomatic deep vein thrombosis (DVT) experience a pulmonary embolism (PE). Death occurs within 1 month in 6% of patients with DVT and 12% of those with PE. Early mortality is associated strongly with presentation as PE, advanced age, malignancy, and underlying cardiovascular disease. An experience dating back several decades has provided a better understanding of disease states and conditions associated with VTE (Anderson and Spencer, 2003). Given the potential morbidity and mortality associated with VTE, it is apparent that prophylaxis represents an important goal in clinical practice. A variety of anticoagulants including unfractionated heparin, low-molecular-weight heparin (LMWH), and warfarin have been studied. More recently, two new agents have been developed that warrant discussion. Fondaparinux underwent a worldwide development program in orthopedic surgery for the prophylaxis of VTE. The program consisted mainly of four large, randomized, double-blind phase II studies comparing fondaparinux (SC), at a dose of 2.5 mg starting 6 hours postoperatively, with the two enoxaparin regimens approved for VTE prophylaxis—40 mg qd or 30 mg twice daily beginning 12 hours postoperatively. The results support a greater protective effect with fondaparinux, yielding a 55.2% relative risk reduction of VTE (Bauer et al., 2001; Eriksson et al., 2001; Lassen et al., 2002; Turpie et al., 2001, 2002; ). A European program of three large-scale clinical trials (MElagatran for THRombin inhibition in Orthopedic surgery [METHRO] I, II, and III, and EXpanded PRophylaxis Evaluation Surgery Study [EXPRESS]) (Eriksson et al., 2002a, b, 2003a, b) evaluated the safety and efficacy of subcutaneous melagatran followed by oral ximelagatran compared with LMWH for thromboprophylaxis following total hip replacement (THR) and total knee replacement (TKR) surgery.

scholarly journals Efficacy and safety of nebivolol in elderly heart failure patients with impaired renal function: insights from the SENIORS trial

2009 ◽  
Vol 11 (9) ◽  
pp. 872-880 ◽  
Author(s):  
Alain Cohen-Solal ◽  
Dipak Kotecha ◽  
Dirk J van Veldhuisen ◽  
Daphne Babalis ◽  
Michael Böhm ◽  
...  
Keyword(s):  
Heart Failure ◽  
Renal Function ◽  
Impaired Renal Function ◽  
Efficacy And Safety ◽  
Heart Failure Patients

scholarly journals Comparative efficacy and safety of anticoagulants for prevention of venous thromboembolism after hip and knee arthroplasty

2017 ◽  
Vol 88 (6) ◽  
pp. 634-641 ◽  
Author(s):  
Min Hur ◽  
Sun-Kyung Park ◽  
Chang-Hoon Koo ◽  
Eun Dhong Jung ◽  
Pyoyoon Kang ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Knee Arthroplasty ◽  
Efficacy And Safety ◽  
Comparative Efficacy ◽  
Hip And Knee Arthroplasty

Low-Dose Aspirin is Safe and Effective for Venous Thromboembolism Prevention in Patients Undergoing Revision Total Knee Arthroplasty: A Retrospective Cohort Study

2020 ◽  
Author(s):  
Alex Tang ◽  
Stephen G. Zak ◽  
Daniel Waren ◽  
Richard Iorio ◽  
James D. Slover ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Venous Thromboembolism ◽  
Knee Arthroplasty ◽  
Total Joint Replacement ◽  
Joint Infection ◽  
Revision Total Knee Arthroplasty ◽  
Bleeding Complications ◽  
Vte Prophylaxis ◽  
Significant Difference ◽  
Total Knee

AbstractVenous thromboembolism (VTE) events are rare, but serious complications of total joint replacement affect patients and health care systems due to the morbidity, mortality, and associated cost of its complications. There is currently no established universal standard of care for prophylaxis against VTE in patients undergoing revision total knee arthroplasty (rTKA). The aim of this study was to determine whether a protocol of 81-mg aspirin (ASA) bis in die (BID) is safe and/or sufficient in preventing VTE in patients undergoing rTKAs versus 325-mg ASA BID. In 2017, our institution adopted a new protocol for VTE prophylaxis for arthroplasty patients. Patients initially received 325-mg ASA BID for 1 month and then changed to a lower dose of 81-mg BID. A retrospective review from 2011 to 2019 was conducted identifying 1,438 consecutive rTKA patients and 90-day postoperative outcomes including VTE, gastrointestinal, and wound bleeding complications, acute periprosthetic joint infection, and mortality. In the 74 months prior to protocol implementation, 1,003 rTKAs were performed and nine VTE cases were diagnosed (0.90%). After 26 months of the protocol change, 435 rTKAs were performed with one VTE case identified (0.23%). There was no significant difference in rates or odds in postoperative pulmonary embolism (PE; p = 0.27), DVT (p = 0.35), and total VTE rates (p = 0.16) among patients using either protocol. There were also no differences in bleeding complications (p = 0.15) or infection rate (p = 0.36). No mortalities were observed. In the conclusion, 81-mg ASA BID is noninferior to 325-mg ASA BID in maintaining low rates of VTE and may be safe for use in patients undergoing rTKA.

scholarly journals An Update on Venous Thromboembolism Rates and Prophylaxis in Hip and Knee Arthroplasty in 2020

Medicina ◽  
2020 ◽  
Vol 56 (9) ◽  
pp. 416 ◽  
Author(s):  
Daniel C. Santana ◽  
Ahmed K. Emara ◽  
Melissa N. Orr ◽  
Alison K. Klika ◽  
Carlos A. Higuera ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Knee Arthroplasty ◽  
High Volume ◽  
Optimal Choice ◽  
Slight Reduction ◽  
Vte Prophylaxis ◽  
Prophylactic Agent ◽  
Total Hip ◽  
Number Of Patients ◽  
Hip And Knee Arthroplasty

Patients undergoing total hip and knee arthroplasty are at high risk for venous thromboembolism (VTE) with an incidence of approximately 0.6–1.5%. Given the high volume of these operations, with approximately one million performed annually in the U.S., the rate of VTE represents a large absolute number of patients. The rate of VTE after total hip arthroplasty has been stable over the past decade, although there has been a slight reduction in the rate of deep venous thrombosis (DVT), but not pulmonary embolism (PE), after total knee arthroplasty. Over this time, there has been significant research into the optimal choice of pharmacologic VTE prophylaxis for individual patients, with the objective to reduce the rate of VTE while minimizing adverse side effects such as bleeding. Recently, aspirin has emerged as a promising prophylactic agent for patients undergoing arthroplasty due to its similar efficacy and good safety profile compared to other pharmacologic agents. However, there is no evidence to date that clearly demonstrates the superiority of any given prophylactic agent. Therefore, this review discusses (1) the current prevalence and trends in VTE after total hip and knee arthroplasty and (2) provides an update on pharmacologic VTE prophylaxis in regard to aspirin usage.

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