Ximelagatran versus Warfarin for the Prevention of Venous Thromboembolism after Total Knee Arthroplasty

Francis, Charles W.; Davidson, Bruce L.; Berkowitz, Scott D.; Lotke, Paul A.; Ginsberg, Jeffrey S.; Lieberman, Jay R.; Webster, Anne; Whipple, James P.; Peters, Gary; Colwell, Clifford W.

doi:10.7326/0003-4819-137-8-200210150-00008

Cited by 194 publications

(102 citation statements)

References 27 publications

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“…Three randomized controlled trials satisfying the inclusion criteria were identified. [13][14][15] No articles were excluded. All studies gave details concerning the method used to detect VTE as well as defi nitions of clinical and laboratory outcomes, which were comparable between trials.…”

Section: Literature Search Results Literature Search Resultsmentioning

confidence: 99%

Section: Characteristics Of Included Characteristics Of Included Studmentioning

confidence: 99%

“…They were conducted in 115 13 15 The orthopedic surgery performed was knee replacement in two studies 13,14 and knee arthroplasty in one study. 15 Drug administration was oral in all groups. Warfarin (target INR [International Normalized Ratio] 2.5) was started in the evening of the day of the surgery and ximelagatran in the morning after the surgery in all three studies.…”

Section: Characteristics Of Included Characteristics Of Included Studmentioning

confidence: 99%

“…Warfarin (target INR [International Normalized Ratio] 2.5) was started in the evening of the day of the surgery and ximelagatran in the morning after the surgery in all three studies. [13][14][15] In one study, 15 . The use of graduated elastic stockings was not specifi ed in any of the three studies; planned pneumatic compression prophylaxis was an exclusion criterion in two studies.…”

Section: Characteristics Of Included Characteristics Of Included Studmentioning

confidence: 99%

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Ximelagatran versus warfarin for prophylaxis of venous thromboembolism in major orthopedic surgery: systematic review of randomized controlled trials

et al. 2006

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BACKGROUND: Ximelagatran has been recently studied for prophylaxis in surgical orthopedic cases. PURPOSE: We proposed to establish whether interventions involving ximelagatran, as compared with warfarin, would increase thromboembolic prophylaxis in patients undergoing major orthopedic knee surgery. DATA SOURCE: Studies with random assignment were identified by an electronic search of the medical literature up to 2006. Data were double-entered into the Review Manager software, version 4.2.5. DATA SYNTHESIS: We included three well-conducted clinical trials involving 4,914 participants. Sub-groups with two dosages of ximelagatran (24 mg and 36 mg, b.i.d.), were defined. Ximelagatran showed significantly lower frequency of total venous thromboembolism (VTE) than warfarin, but only with the 36-mg dosage (risk relative, RR: 0.72; 95% confidence interval, CI: 0.64-0.81; p < 0.00001). For the 24-mg subgroup, total VTE frequency was similar (RR: 0.86; 95% CI: 0.73-1.01; p = 0.06). No significant differences were shown with either ximelagatran dosage for deep vein thrombosis (DVT), pulmonary embolism, any bleeding or severe bleeding. At the end of the treatment, alanine aminotransferase (ALT) elevation was less frequent in the 24-mg ximelagatran sub-group (RR: 0.33; 95% CI: 0.12-0.91; p = 0.03], but during the follow-up period, the ALT elevation rate was greater in the 36-mg ximelagatran group (RR: 6.97; 95% CI: 1.26-38.50; p = 0.03]. CONCLUSIONS: Ximelagatran appears to be more effective than warfarin when used in higher dosages (36 mg b.i.d.), but at the expense of increased frequency of ALT elevation during the follow-up period.

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Section: Literature Search Results Literature Search Resultsmentioning

confidence: 99%

Section: Characteristics Of Included Characteristics Of Included Studmentioning

confidence: 99%

Section: Characteristics Of Included Characteristics Of Included Studmentioning

confidence: 99%

Section: Characteristics Of Included Characteristics Of Included Studmentioning

confidence: 99%

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Ximelagatran versus warfarin for prophylaxis of venous thromboembolism in major orthopedic surgery: systematic review of randomized controlled trials

et al. 2006

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“…In one study, seven to 12 days of fixed-dose ximelagatran 24 mg twice daily was at least as effective as warfarin, both regimens being initiated the morning after TKR. 45 In the second study, ximelagatran at a dose of 36 mg twice-daily for seven to 12 days was more effective than warfarin regarding the primary composite endpoint defined as total DVT, PE and death from all causes (20.3 vs 27.6%). Rates of bleeding were similar between the two groups.…”

Section: Direct Thrombin Inhibitorsmentioning

confidence: 96%

Prevention of postoperative venous thromboembolism. Risk assessment and methods of prophylaxis

Motte

Samama

Guay

et al. 2006

Can J Anesth/J Can Anesth

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Purpose: To describe risk assessment models that have been developed to stratify patients into different risk levels of postoperative venous thromboembolism (VTE) and then to review the different methods of prophylaxis and to outline the evidence supporting their effectiveness and safety.Source: Our review of the literature is focused on consensus documents, recent large randomized trials and meta-analyses. Principal findings:The risk of VTE is determined by the type of surgery and underlying patient factors. Risk assessment models are useful in stratifying patients into different VTE risk levels. However, multiple risk factors are often present in the same patient and in practice the evaluation of their relative contribution to the overall risk remains difficult. A variety of prophylactic strategies including physical and pharmacological methods have been shown to be effective in different patient groups. Patients with a moderate or high risk of VTE should receive prophylaxis consisting of an antithrombotic agent, unless contraindicated, used alone or in combination with a mechanical method. Recommendations concerning which prophylaxis to use and how intensive it should be are based mainly on data from trials using surrogate endpoints, and do not translate easily into practical decisions aiming to reduce the incidence of symptomatic events. Conclusion:Although risk assessment models and recommendations provided by consensus documents are of practical assistance, a decision concerning any patient is best made by combining recommendations of the literature with clinical judgment, including individual patient risk factors for thrombosis and bleeding.

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Management of Venous Thromboembolism

Hyers

2003

Arch Intern Med

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Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, represents a significant source of morbidity and mortality in the United States and worldwide. The pharmacologic management of venous thromboembolic disease has witnessed significant advances since oral anticoagulant and heparin therapies began to gain widespread use more than 50 years ago. Cumulative clinical experience gained from using these 2 classes of antithrombotic agents for the prevention and treatment of venous thromboembolism in high-risk patients pointed to a number of efficacy and safety limitations. This prompted further research and the eventual introduction, in the 1980s, of low-molecular-weight heparin(s) as a potentially superior therapeutic modality. Within the last decade the pace of development of newer classes of antithrombotic agents for venous thromboembolism prevention and treatment (as well as other indications) has accelerated. Among agents at late stages of investigation are ximelagatran (a direct thrombin inhibitor), nematode anticoagulant peptide c2 (a tissue factor VIIa inhibitor), and sodium N-[8(2-hydroxylbenzoyl)amino]caprylate (SNAC)/heparin (a heparin derivative). The most recently approved agents for venous thromboembolism indications include the heparinoid, danaparoid sodium, and the newly introduced selective factor Xa inhibitor, fondaparinux.

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Ximelagatran versus Warfarin for the Prevention of Venous Thromboembolism after Total Knee Arthroplasty

Abstract: For prophylaxis of venous thromboembolism, fixed-dose ximelagatran started the morning after total knee arthroplasty is well tolerated and at least as effective as warfarin, but it does not require coagulation monitoring or dose adjustment.

Cited by 194 publications

References 27 publications

Ximelagatran versus warfarin for prophylaxis of venous thromboembolism in major orthopedic surgery: systematic review of randomized controlled trials

Ximelagatran versus warfarin for prophylaxis of venous thromboembolism in major orthopedic surgery: systematic review of randomized controlled trials

Prevention of postoperative venous thromboembolism. Risk assessment and methods of prophylaxis

Management of Venous Thromboembolism

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