Fondaparinux Compared with Enoxaparin for the Prevention of Venous Thromboembolism after Hip-Fracture Surgery

Eriksson, Bengt I.; Bauer, Katrin; Mr, Lassen; Ag, Turpie

doi:10.1056/nejmoa011100

Cited by 586 publications

(425 citation statements)

References 31 publications

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“…This is in line with earlier enoxaparin studies in which there were no higher rates of wound complications compared with placebo-treated patients [29,30]. The low wound infection rate was similar to a study of enoxaparin and fondaparinux (0.7%) [31], and no correlation between wound infection and postoperative anticoagulation therapy following joint replacement was reported in two other studies [32,33]. Of particular concern to orthopaedic surgeons is the impact of anticoagulant treatment on wound healing.…”

Section: Discussionsupporting

confidence: 87%

Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement

Dahl¹,

Kurth²,

Rosencher

et al. 2011

International Orthopaedics (SICOT)

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Purpose Prospective, double-blind studies in orthopaedic patients have been conducted using the direct thrombin inhibitor dabigatran etexilate (hereafter referred to as dabigatran), with two doses investigated and approved for adults (220 mg and 150 mg once daily) to prevent venous thromboembolism (VTE). The European Medicines Agency decided that in major joint orthopaedic surgery, the lower dose should be used in elderly patients (aged over 75 years) and those with reduced renal function (creatinine clearance between 30 and 50 ml/min). Our objective was to understand the efficacy and bleeding data for the lower dose in this subpopulation.Methods We extracted and analysed data from the elderly or from moderately renally impaired patients (n 632 of = 5,539) from the orthopaedic clinical development programme of dabigatran. Results Dabigatran 150 mg once daily was as effective as the standard European enoxaparin regimen, with numerically fewer major bleeding events. Rates of major VTE were 4.3% vs 6.4% of patients, respectively. Major bleeding events occurred in four (1.3%) vs 11 (3.3%), which shows a trend towards lower bleeding with dabigatran 150 mg [odds ratio (OR) 0.40; 95% confidence interval (CI) 0.13-1.25; p=0.110]. Mean volume of blood loss was 395 vs 417 ml, and transfused units were 2.4 vs 2.5,

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Section: Discussionsupporting

confidence: 87%

Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement

Dahl¹,

Kurth²,

Rosencher

et al. 2011

International Orthopaedics (SICOT)

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“…Peri-operative thromboprophylaxis with acetylsalicylic acid, low-molecular weight heparin and fondaparinux have all been found to reduce the incidence of venous thromboembolic events after hip fracture surgery, but the effect on mortality is unresolved [96][97][98]. Studies have been prone to selection bias, excluding the frailest and those with increased risk of peri-operative bleeding, and so may not be representative of outcomes in the general hip fracture population.…”

Section: Postoperative Carementioning

confidence: 99%

Emergency surgery: the big three – abdominal aortic aneurysm, laparotomy and hip fracture

2013

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SummaryNational reports recommended that peri-operative care should be improved for elderly patients undergoing emergency surgery. Postoperative mortality and morbidity rates remain high, and indicate that emergency ruptured aneurysm repair, laparotomy and hip fracture fixation are high-risk procedures undertaken on elderly patients with limited physiological reserve. National audits have reported variations in care quality, data that are increasingly being used to drive quality improvement through professional guidance. Given that the number of elderly patients presenting for emergency surgery is likely to rise as the population ages, this review summarises the evidence on which such guidance is based, and provides information about how anaesthetists might participate in audit and research aimed at improving local and national outcomes for these most vulnerable of patients. More recently, national audits have reported several-fold variations in the care of elderly emergency surgical patients in the UK [4][5][6], and importantly, these data are beginning to be used to drive quality improvement [11] through professional guidance [12][13][14] that advocates early, focused, multidisciplinary 70

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“…It has been developed to provide a selective anticoagulant effect and to overcome some side effects of LMWH such as allergic reactions [5][6][7][8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of venous thromboembolism prophylaxis with fondaparinux or low molecular weight heparin in a large cohort of consecutive patients undergoing major orthopaedic surgery – findings from the ORTHO‐TEP registry

Donath¹,

Lützner

Werth³

et al. 2012

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THE TOPIC• Patients undergoing major orthopaedic surgery are at high risk of venous thromboembolism.• Medical thromboprophylaxis is effective to reduce this risk and in large trials, fondaparinux proved superiority over low molecular weight heparin (LMWH) in this indication with the downside of higher complication rates.• Patients in clinical trials are a selected subpopulation and efficacy and safety results need to be confirmed in large cohorts of unselected patients.WHAT THIS STUDY ADDS• In unselected patients undergoing major orthopaedic surgery, thromboprophylaxis with fondaparinux was equally effective to prevent major venous thromboembolism (VTE), but inferior to prevent distal deep vein thrombosis (DVT) compared with low molecular weight heparin.• The rates of bleeding complications or blood transfusions were similar for patients receiving fondaparinux and LMWH, but use of fondaparinux was associated with significantly lower rates of surgical complications, which contributed to a shorter hospital stay.• Overall, we found much higher rates of symptomatic VTE and bleeding events in our large cohort of unselected patient in daily care compared with results of large phase III trials evaluating anticoagulants in this indication, indicating a selection bias in these prospective trials.AIMS In large randomized trials, thromboprophylaxis with fondaparinux in major orthopaedic surgery (MOS) has been shown to be superior to low molecular weight heparin (LMWH) prophylaxis with comparable safety. However, patients treated under trial conditions are different from unselected patients and efficacy and safety outcomes may be different in unselected patients in daily practice. We performed a retrospective cohort study to compare the efficacy and safety of venous thromboembolism (VTE) prophylaxis with fondaparinux or LMWH in 3896 consecutive patients undergoing major orthopaedic surgery at our centre.METHODS All patients undergoing MOS between January 2006 and December 2009 were retrospectively analyzed using patient charts, hospital admission and discharge database, quality management database, transfusion unit database and VTE event documentation. VTE standard prophylaxis at our institution was LMWH (3000–6000 aXa units once daily) from January 2006 to December 2007 or fondaparinux 2.5 mg from January 2008 to December 2009. In these two large cohorts of unselected consecutive patients, in‐hospital incidences of VTE, surgical complications, severe bleeding and death were evaluated.RESULTS Symptomatic VTE was found in 4.1% of patients in the LMWH group (62/1495 patients; 95% CI 0.032, 0.052) compared with 5.6% of patients receiving fondaparinux (112/1994 patients, 95% CI 0.047, 0.067; P= 0.047). Distal deep vein thrombosis (DVT) was significantly more frequent in the fondaparinux group (3.9%, 95% CI 0.031, 0.048; vs. 2.5%; 95% CI 0.018, 0.034; P= 0.021). No significant differences in the rates of major VTE or death were found. Rates of severe bleeding, transfusion of RBC concentrates, plasma and platelet concentrates were comparable between both treatment groups. However, patients receiving fondaparinux had significantly lower rates of surgical revisions (1.6%, 95% CI 0.011, 0.022 vs. 3.7%, 95% CI 0.028, 0.047; P < 0.001). Multivariate analysis revealed previous VTE (HR 18.2, 95% CI 11.6, 28.5; P < 0.001) and female gender (HR 1.9, 95% CI 1.3, 2.7; P < 0.001), but not fondaparinux prophylaxis (HR1.3, 95% CI 0.9, 1.7; P= 0.184) to be associated with significantly increased VTE risk.DISCUSSION Thromboprophylaxis with fondaparinux is less effective to prevent distal VTE than LMWH in unselected patients undergoing MOS, but is equally effective with regard to rates of major VTE and death. However, differences in efficacy of LMWH or fondaparinux are of little relevance compared with a history of VTE or female gender, which were found to be the main VTE risk factors in MOS. The safety profile of fondaparinux was comparable with LMWH with regard to rates of severe bleeding complications, but patients receiving fondaparinux had significantly less surgical complications requiring surgical revisions. Both our efficacy and safety findings differ from data derived from large phase III trials testing fondaparinux against LMWH in MOS, where overall rates of symptomatic VTE were lower and the safety profile of fondaparinux was different.CONCLUSION We conclude that the strict patient selection and surveillance in phase‐III trials results in lower VTE and bleeding event rates compared with unselected routine patients. Consequently, the efficacy and safety profile of thromboprophylaxis regimens needs to be confirmed in large registries or phase IV trials of unselected patients.

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Fondaparinux Compared with Enoxaparin for the Prevention of Venous Thromboembolism after Hip-Fracture Surgery

Abstract: In patients undergoing surgery for hip fracture, fondaparinux was more effective than enoxaparin in preventing venous thromboembolism and equally safe.

Cited by 586 publications

References 31 publications

Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement

Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement

Emergency surgery: the big three – abdominal aortic aneurysm, laparotomy and hip fracture

Efficacy and safety of venous thromboembolism prophylaxis with fondaparinux or low molecular weight heparin in a large cohort of consecutive patients undergoing major orthopaedic surgery – findings from the ORTHO‐TEP registry

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