Oral Thrombin Inhibitor Dabigatran Etexilate vs North American Enoxaparin Regimen for Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery

Ginsberg, Jeffrey S.; Davidson, Bruce L.; Francis, Charles W.; Friedman, Richard J.; Huo, Michael H.; Lieberman, Jay R.; Muntz, James E.; Raskob, Gary E.; Clements, Mary Lou; Hantel, Stefan; Schnee, Janet; Caprini, Joseph A.

doi:10.1016/j.arth.2008.01.132

Cited by 460 publications

(67 citation statements)

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“…Pooled estimates were then used to calculate rivaroxaban vs dabigatran risk differences, as explained. In the indirect comparison, dabigatran was perceived as a "reference" due to the fact that dabigatran trials (11)(12)(13) chronologically preceded the rivaroxaban trials (7)(8)(9)(10). All risk differences were low, with 2-4 decimal places.…”

Section: Analysis and Data Presentationmentioning

confidence: 99%

“…SMR and SRR are based on number of events per observed person-time. VTE-related and bleeding-related mortalities were reported for the period "during treatment" (7)(8)(9)(10)(11)(12)(13). Regardless of the treatment (rivaroxaban, dabigatran, enoxaparin), treatment period in thromboprophylaxis after THA/TKA is defined by the setting: 4-5 weeks after THA and 8-15 days after TKA (1-3).…”

Section: Analysis and Data Presentationmentioning

confidence: 99%

“…Dabigatran was used at two dose levels: 220 mg or 150 mg once daily (11)(12)(13). Since the efficacy and safety outcomes were practically identical for the two doses, all analyses of dabigatran trials were based on pooled dabigatran data.…”

Section: Analysis and Data Presentationmentioning

confidence: 99%

“…Randomeffects meta-analysis was conducted on each outcome separately for the rivaroxaban (7-10) and dabigatran (11)(12)(13) trials to obtain pooled treatment effects of each drug vs enoxaparin. Risk difference was used as an effect measure since it was used in the original individual trials (7)(8)(9)(10)(11)(12)(13). Cochran Q and I 2 statistic were used as indicators of heterogeneity (inconsistency) of trial results.…”

Section: Analysis and Data Presentationmentioning

confidence: 99%

“…In the European Union, both drugs are approved as effective and acceptably safe in prevention of VTE after THA/TKA (5,6) based on pivotal trials (7)(8)(9)(10)(11)(12)(13), in which they were compared with enoxaparin, a low molecular weight heparin preparation. Inherently, they also increase bleeding tendency but provide the convenience of simple dosing (orally, once daily), predictive effects not requiring routine coagulation monitoring, and low potential for drug interactions (5,6).…”

mentioning

confidence: 99%

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Rivaroxaban vs Dabigatran for Thromboprophylaxis After Joint-replacement Surgery: Exploratory Indirect Comparison Based on Meta-Analysis of Pivotal Clinical Trials

Trkulja

Kolundžić

2010

Croat Med J

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AimTo indirectly compare rivaroxaban and dabigatran for prevention of venous thromboembolism (VTE) after total hip or knee arthroplasty (THA, TKA) based on their pivotal efficacy/safety trials embracing a total of 20 618 patients.Methods Pooled risk differences (RD) for rivaroxaban vs enoxaparin and dabigatran vs enoxaparin obtained from separate meta-analyses of two sets of trials were used to indirectly estimate RDs for rivaroxaban vs dabigatran.Results Primary efficacy (any VTE+all-cause mortality) and safety (major bleeding) outcomes in enoxaparin arms largely differed across similarly designed rivaroxaban and dabigatran trials (differences in venography adjudication and bleeding events definitions). However, incidence of symptomatic VTE and incidence of major/non-major clinically relevant bleeding (including surgical site) were consistent in this respect. RDs (as percentages) for symptomatic VTE were: rivaroxaban-enoxaparin = -0.4% (95% confidence interval [CI], -0.9 to 0.05); dabigatran-enoxaparin = -0.09% (95% CI, -1.0 to 0.8); rivaroxaban-dabigatran = -0.3% (95% CI, -1.3 to 0.7; P = 0.275). RDs for major/clinically relevant bleeding were rivaroxaban-enoxaparin = 0.99% (95%CI, 0.29 to 1.69); dabigatran-enoxaparin = 0.02% (95% CI, -1.0 to 1.0); rivaroxaban-dabigatran = 0.97 (95% CI, -0.43 to 2.37; P = 0.085). Mortality rates (all-cause, VTE-related, bleeding-related) were very low not indicating differences between any two of the three treatments. ConclusionMethodological differences disable indirect comparisons of rivaroxaban vs dabigatran that would be based on major efficacy/safety outcomes of their pivotal trials. The two drugs do not seem to differ regarding incidence of symptomatic VTE. Risk of a relevant bleeding is higher with rivaroxaban than with enoxaparin and the same tendency exists also vs dabigatran. Direct rivaroxaban vs dabigatran comparisons in this setting are needed. CLINICAL SCIENCES

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Section: Analysis and Data Presentationmentioning

confidence: 99%

Section: Analysis and Data Presentationmentioning

confidence: 99%

Section: Analysis and Data Presentationmentioning

confidence: 99%

Section: Analysis and Data Presentationmentioning

confidence: 99%

mentioning

confidence: 99%

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Rivaroxaban vs Dabigatran for Thromboprophylaxis After Joint-replacement Surgery: Exploratory Indirect Comparison Based on Meta-Analysis of Pivotal Clinical Trials

Trkulja

Kolundžić

2010

Croat Med J

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Symptomatic In-Hospital Deep Vein Thrombosis and Pulmonary Embolism Following Hip and Knee Arthroplasty Among Patients Receiving Recommended Prophylaxis

Januel

Chen²,

Ruffieux³

et al. 2012

JAMA

239

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Efficacy and Safety Considerations With Dose-Reduced Direct Oral Anticoagulants

et al. 2022

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IMPORTANCE Dose-reduced regimens of direct oral anticoagulants (DOACs) may be used for 2 main purposes: dose-adjusted treatment intended as full-intensity anticoagulation (eg, for stroke prevention in atrial fibrillation [AF] in patients requiring dose reduction) or low-intensity treatment (eg, extended-duration treatment of venous thromboembolism [VTE]). We reviewed randomized clinical trials (RCTs) to understand the scenarios in which dose-adjusted or low-intensity DOACs were tested and reviewed the labeled indications by regulatory authorities, using data from large registries to assess whether the use of dose-reduced DOACs in routine practice aligned with the findings of RCTs. OBSERVATIONS Among 4191 screened publications, 35 RCTs that used dose-adjusted DOACs were identified for dabigatran, apixaban, rivaroxaban, and edoxaban. Of these 35 RCTs, 29 were related to stroke prevention in AF. Efficacy and safety results for dose-adjusted DOACs in large RCTs of AF were similar to those found for full-dose DOACs. To our knowledge, dabigatran, apixaban, and rivaroxaban have not been studied as dose-adjusted therapy for acute VTE treatment. Low-intensity DOACs were identified in 37 RCTs. Low-intensity DOACs may be used for extended-duration treatment of VTE (apixaban and rivaroxaban), primary prevention in orthopedic surgeries (dabigatran, apixaban, and rivaroxaban), primary prevention in ambulatory high-risk cancer patients (apixaban and rivaroxaban) or (postdischarge) high-risk medical patients (rivaroxaban), in stable atherosclerotic vascular disease, or after a recent revascularization for peripheral artery disease in conjunction with aspirin (rivaroxaban). Minor variations exist between regulatory authorities in different regions regarding criteria for dose adjustment of DOACs. Data from large registries indicated that dose-reduced DOACs were used occasionally with doses or for clinical scenarios different from those studied in RCTs or recommended by regulatory authorities.CONCLUSIONS AND RELEVANCE Dose adjustment and low-intensity treatment are 2 different forms of dose-reduced DOACs. Dose adjustment is mostly relevant for AF and should be done based on the approved criteria. Dose adjustment of DOACs should not be used for acute VTE treatment in most cases. In contrast, low-intensity DOACs may be used for primary or secondary VTE prevention for studied and approved indications. Attention should be given to routine practice patterns to align the daily clinical practice with existing evidence of safety and efficacy.

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Oral Thrombin Inhibitor Dabigatran Etexilate vs North American Enoxaparin Regimen for Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery

Cited by 460 publications

References 11 publications

Rivaroxaban vs Dabigatran for Thromboprophylaxis After Joint-replacement Surgery: Exploratory Indirect Comparison Based on Meta-Analysis of Pivotal Clinical Trials

Rivaroxaban vs Dabigatran for Thromboprophylaxis After Joint-replacement Surgery: Exploratory Indirect Comparison Based on Meta-Analysis of Pivotal Clinical Trials

Symptomatic In-Hospital Deep Vein Thrombosis and Pulmonary Embolism Following Hip and Knee Arthroplasty Among Patients Receiving Recommended Prophylaxis

Efficacy and Safety Considerations With Dose-Reduced Direct Oral Anticoagulants

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