Fondaparinux for Prevention of Venous Thromboembolism in Major Orthopedic Surgery

2003 ◽  
Vol 37 (11) ◽  
pp. 1632-1643 ◽  
Author(s):  
Alison H Tran ◽  
Garvin Lee
Keyword(s):  
Venous Thromboembolism ◽  
Hip Fracture ◽  
Knee Replacement ◽  
Orthopedic Surgery ◽  
Factor Xa ◽  
Hip Fracture Surgery ◽  
Replacement Surgery ◽  
Dvt Prophylaxis ◽  
Major Orthopedic Surgery ◽  
Fracture Surgery

OBJECTIVE: To review clinical information related to fondaparinux, a synthetic pentasaccharide recently approved for the prevention of deep-vein thrombosis (DVT) in patients undergoing major orthopedic surgeries and for extended DVT prophylaxis after hip fracture surgery. DATA SOURCES: Primary and review articles were identified by MEDLINE (1983–June 2003) using the key words pentasaccharide, Org31540, SR90107A, DVT prophylaxis, and fondaparinux. Additional sources were found listed in articles, abstracts, and unpublished data on file from the manufacturer. Articles selected were based on their coverage of the pharmacology, pharmacokinetics, safety, and efficacy of fondaparinux. STUDY SELECTION AND DATA EXTRACTION: All of the articles identified were evaluated and all information deemed relevant was included. DATA SYNTHESIS: Fondaparinux is a selective antithrombin-dependent, indirect inhibitor of activated factor Xa. It has a favorable and predictable pharmacokinetic profile when administered subcutaneously, and has a long half-life, allowing once-daily dosing. Fondaparinux lacks in vitro cross-reactivity with heparin-induced antibodies. Major Phase III studies have demonstrated that subcutaneous fondaparinux sodium 2.5 mg given at least 6 hours postoperatively resulted in a 55% reduction in the risk of venous thromboembolism (VTE) in patients undergoing hip fracture surgery, total hip replacement surgery, or knee replacement surgery compared with standard enoxaparin therapy. It has a safety profile similar to that of enoxaparin with respect to clinically relevant major bleeding, including fatal bleeding, nonfatal bleeding, and bleeding requiring repeat surgery. The use of fondaparinux for prolonged prophylaxis after hip fracture has demonstrated further reduction in VTE events without increasing the risk of bleeding. CONCLUSIONS: Fondaparinux is the first of a new class of synthetic factor Xa inhibitors that demonstrated greater efficacy compared with enoxaparin for the prevention of VTE in major orthopedic surgery without an increase in clinically relevant bleeding. Given the favorable cost-effectiveness analysis and improved efficacy profile, fondaparinux should be considered for formulary addition for DVT prophylaxis in patients undergoing hip and knee replacement surgery. In patients undergoing hip fracture surgery, fondaparinux should be considered the DVT prophylaxis of choice. Extended thromboprophylaxis up to 28 days resulted in additional reduction in VTE (both symptomatic and venography-proven DVT) in patients with hip fracture surgery.

Fatal vascular outcomes following major orthopedic surgery

2005 ◽  
Vol 93 (05) ◽  
pp. 860-866 ◽  
Author(s):  
Joseph Caprini ◽  
Clifford Colwell ◽  
Simon Frostick ◽  
Sylvia Haas ◽  
Russell Hull ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Hip Fracture ◽  
Cohort Studies ◽  
Orthopedic Surgery ◽  
Fatal Pulmonary Embolism ◽  
Vascular Events ◽  
Hip Fracture Surgery ◽  
Major Orthopedic Surgery ◽  
Fracture Surgery ◽  
Overall Mortality

SummaryMajor orthopedic surgery is known to be associated with potentially serious arterial and venous vascular complications, although uncertainty exists about current event rates. Using electronic databases and investigator contact, we identified randomized and cohort studies reporting overall mortality and fatal vascular events. Where possible, studies reporting high autopsy rates (>60%) were examined. Pooled incidences were calculated from eligible studies. For Autopsy studies: Pooled overall mortality and fatal pulmonary embolism for patients undergoing elective hip and knee replacement without prophylaxis could not be calculated, while with prophylaxis they were 0.44% (95% confidence interval 0.02 to 0.87%) and 0.43% (0.01 to 0.85%). For patients undergoing hip fracture surgery, the corresponding rates without prophylaxis were 15.9% (14.5 to 17.3%) and 1.9% (1.4 to 2.4%). With prophylaxis, mortality and fatal pulmonary embolism rates were 8.5% (7.3 to 9.7%) and 1.0% (0.6 to 1.5%). Among Cohort studies: Pooled overall mortality and fatal pulmonary embolism for patients undergoing elective hip and knee replacement without prophylaxis were 0.93% (0.57 to 1.29%) and 0.36% (0.14 to 0.59%). For patients receiving prophylaxis (7 to 14 days), mortality and fatal pulmonary embolism were 0.57% (0.51 to 0.62%) and 0.18% (0.14 to 0.21%). Patients undergoing hip fracture surgery receiving prophylaxis had mortality and fatal pulmonary embolism rates of 3.2% (2.8 to 3.6%) and 0.30% (0 to 0.61%). Vascular events contributed towards approximately 50% of all deaths with similar proportions due to ischemic heart disease, cardiac failure and pulmonary embolism. In conclusion, although prophylaxis results in a reduction in overall mortality and fatal pulmonary embolism, vascular events continue to be a common cause of mortality.

scholarly journals Little Impact of Antiplatelet Agents on Venous Thromboembolism after Hip Fracture Surgery

2011 ◽  
Vol 26 (12) ◽  
pp. 1625 ◽  
Author(s):  
Hyung-Min Ji ◽  
Young-Kyun Lee ◽  
Yong-Chan Ha ◽  
Ki-Choul Kim ◽  
Kyung-Hoi Koo
Keyword(s):  
Venous Thromboembolism ◽  
Hip Fracture ◽  
Antiplatelet Agents ◽  
Hip Fracture Surgery ◽  
Fracture Surgery

scholarly journals Sarcopenia index based on serum creatinine and cystatin C predicts the risk of postoperative complications following hip fracture surgery in older adults

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiaoyan Chen ◽  
Yanjiao Shen ◽  
Lisha Hou ◽  
Binyu Yang ◽  
Birong Dong ◽  
...  
Keyword(s):  
Older Adults ◽  
Hip Fracture ◽  
Postoperative Complications ◽  
Serum Creatinine ◽  
Cystatin C ◽  
Binary Logistic Regression ◽  
Joint Replacement Surgery ◽  
Hip Fracture Surgery ◽  
Replacement Surgery ◽  
Fracture Surgery

Abstract Objective To assess the utility of the preoperative Sarcopenia index (SI) as a predictive marker of the risk of postoperative complications following hip fracture surgery in older adults. Study design This observational study enrolled older adults with hip fracture who were hospitalized in the Department of Orthopedics of West China Hospital, Sichuan University, from December 7, 2010 - June 14, 2017, and who underwent hip fracture surgery. Primary outcome and measures Clinical data were collected from medical records and serum creatinine and cystatin C were measured before surgery. Outcomes included postoperative complications such as pneumonia, urinary tract infection, respiratory failure, heart failure, and non-grade A healing. Binary logistic regression analyses were used to analyze association between SI and postoperative complications. Results A total of 897 patients aged 60 years and over were enrolled in this study (age range: 60 – 100 years), of whom 306(34.1%)were male, and 591(65.9%)were female. Postoperative complications included pneumonia (12%), urinary tract infections (1.8%), respiratory failure (1.5%), heart failure (1.6%), and non-A- grade healing (3.6%). In the patient group that received joint replacements, the incidence of pneumonia was negatively associated with SI values. After adjusting for potential confounding factors, binary logistic regression analyses showed that a higher SI was independently associated with a lower risk of pneumonia after joint replacement surgery (OR:0.39, 95% CI:0.18-0.89, P<0.05). However, we did not find statistically significant association between SI and the risk of postoperative complications other than pneumonia among patients with two types of hip fracture surgery. Conclusion The SI based on serum creatinine and cystatin C can predict pneumonia rather than other postoperative complications among older patients with hip fracture after joint replacement surgery.

Rivaroxaban for Thromboprophylaxis After Total Hip or Knee Replacement Surgery: Comparison of Outcomes of the XAMOS and RECORD Studies

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 500-500
Author(s):  
Alexander G.G. Turpie ◽  
André Schmidt ◽  
Michael Rud Lassen ◽  
Lorenzo Mantovani ◽  
Reinhold Kreutz ◽  
...  
Keyword(s):  
Knee Replacement ◽  
Major Bleeding ◽  
Orthopedic Surgery ◽  
Standard Of Care ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Knee Replacement Surgery ◽  
Total Hip ◽  
Replacement Surgery ◽  
Major Orthopedic Surgery

Abstract Abstract 500 Rivaroxaban for Thromboprophylaxis after Total Hip or Knee Replacement Surgery: Comparison of Outcomes of the XAMOS and RECORD Studies. Patients undergoing major orthopedic surgery are at risk of venous thromboembolism (VTE). Rivaroxaban has been approved for clinical use in this indication based on the extensive phase III RECORD program, which investigated the efficacy and safety of oral rivaroxaban regimens compared with subcutaneous enoxaparin regimens in patients undergoing elective total hip or knee replacement surgery. XAMOS is a phase IV, non-interventional, open-label cohort study that compared rivaroxaban with any pharmacological prophylaxis used in routine clinical practice for VTE prevention after major orthopedic surgery of the hip or knee. An additional aim of the XAMOS study was to assess whether the results from the phase III RECORD studies would be reflected in routine clinical practice. The XAMOS study, which ran from 2009 to 2011, collected data on the incidence of adverse events (including symptomatic thromboembolic and bleeding events) in adult patients from 252 centers in 37 countries worldwide, who underwent elective hip or knee replacement surgery (or hip fracture surgery, where appropriate) and received rivaroxaban or other pharmacological prophylaxis (standard of care). The attending physician determined the type, duration, and dose of drug. Of the 17,701 patients enrolled, 8778 received rivaroxaban and 8635 received standard of care, of whom 7055 (81.7%) received low molecular weight heparin (LMWH). Primary hip/knee replacement surgery accounted for >90% of all procedures. Baseline demographics (e.g. age, sex, body weight, and ethnicity) were similar for patients receiving rivaroxaban, standard of care, or LMWH, and were also similar to those of patients who received rivaroxaban in the RECORD program. LMWH was the comparator in the RECORD program; therefore, the XAMOS study also compared outcomes with LMWH and rivaroxaban. Data for the LMWH group were similar to the standard-of-care group. Rates of symptomatic arterial, venous, and all thromboembolic events in XAMOS were lower in the rivaroxaban group compared with the LMWH group (Figure 1). The data are consistent with the results of the RECORD1–4 pooled analysis, which showed a significantly lower incidence of symptomatic VTE and all-cause mortality in patients receiving rivaroxaban compared with those receiving enoxaparin (Figure 2). The rates of treatment-emergent major bleeding events (RECORD definition) were 0.4% vs 0.3% in the rivaroxaban and LMWH groups, respectively (odds ratio [OR]=1.28; 95% confidence interval [CI] 0.75–2.18; Figures 1 and 2), and were similar to those in the RECORD1–4 pooled analysis (day 12±2 active treatment pool: 0.3% [rivaroxaban] vs 0.2% [enoxaparin]; OR=1.62; 95% CI 0.77–3.53; Figure 2). When the European Medicines Agency (EMA) definition for treatment-emergent major bleeding was used, the incidence of major bleeding was slightly higher (nonsignificant) for patients receiving rivaroxaban compared with those receiving LMWH in the XAMOS study (1.7% vs 1.4%; OR=1.19; 95% CI: 0.92–1.53; Figures 1 and 2); these results were also similar to those of the RECORD1–4 pooled analysis (day 12±2 active treatment pool: 2.0% [rivaroxaban] vs 1.7% [enoxaparin]; OR=1.20; 95% CI: 0.91–1.57). XAMOS is the first study presenting real-world experience of the efficacy and safety of rivaroxaban for the prevention of VTE after major orthopedic surgery of the hip or knee. The results of XAMOS showed that rivaroxaban was associated with a significantly lower incidence of symptomatic VTE compared with LMWH, without a significant increase in the risk of major bleeding. These findings are consistent with those obtained in the RECORD studies, and indicate that the results of the RECORD program can be translated into the routine clinical setting. Disclosures: Turpie: GSK: Speakers Bureau; GSK, JnJ: Consultancy. Schmidt:Bayer: Employment, Equity Ownership. Lassen:Bayer: Speakers Bureau; Bristol-Myers Squibb; GlaxoSmithKline; Bayer; Boehringer: Consultancy; Sanofi-Aventis: Research Funding. Mantovani:Bayer Healthcare Pfizer Merck Serono Baxter Astellas: Speakers Bureau; Bayer Healthcare Pfizer Bristol-Meyer Squibb Amgen Merck&Co: Consultancy; Bayer Healthcare Pfizer Bristol-Meyer Squibb Biogen Idec Medtronic Admirall Otsuka Amgen Merck&Co Merck-Serono: Research Funding. Kreutz:Bristol-Myers Squibb, Bayerm Daichii Sankyo, Berlin-Chemie Menarini: Speakers Bureau; Bayer, Daichii Sankyo: financial and material support, financial and material support Other. Holberg:Bayer Healthcare: Employment. Haas:Sanofi Aventis: Speakers Bureau; Sanofi Aventis, Bristol-Myers Squibb: Consultancy.

Does perioperative use of tranexamic acid in hip fracture patients increase the risk of venous thromboembolism and reduce the need for postoperative transfusions?

2020 ◽  
Vol 30 (12) ◽  
pp. 378-382
Author(s):  
James Geddes ◽  
Greg McConaghie
Keyword(s):  
Venous Thromboembolism ◽  
Hip Fracture ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Hip Fractures ◽  
Hip Fracture Surgery ◽  
Postoperative Blood Transfusion ◽  
Increased Risk ◽  
Fracture Surgery ◽  
Postoperative Haemoglobin

Perioperative tranexamic acid use is a popular choice among many surgeons for reducing surgical blood loss and its sequelae. While there is evidence in the literature that tranexamic acid use is effective in reducing blood loss in surgery for patients with hip fractures, there is less information on whether it leads to thromboembolic complications. We undertook a retrospective study in patients with hip fractures at two local hospitals to investigate if there was an increased risk of venous thromboembolism in patients who received tranexamic acid, and whether it reduced perioperative blood loss and the need for transfusion. We found that tranexamic acid used in patients undergoing hip fracture surgery reduced the drop in postoperative haemoglobin and the need for postoperative blood transfusion but was not associated with an increased risk of venous thromboembolism.

The Incremental Cost of Inpatient Venous Thromboembolism After Hip Fracture Surgery

2020 ◽  
Vol 34 (4) ◽  
pp. 169-173
Author(s):  
Nikunj N. Trivedi ◽  
Matthew V. Abola ◽  
Chang Y. Kim ◽  
Lakshmanan Sivasundaram ◽  
Eric J. Smith ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Hip Fracture ◽  
Incremental Cost ◽  
Hip Fracture Surgery ◽  
Fracture Surgery
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