Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II)

2011 ◽  
Vol 105 (04) ◽  
pp. 721-729 ◽  
Author(s):  
Ola Dahl ◽  
Michael Huo ◽  
Andreas Kurth ◽  
Stefan Hantel ◽  
Karin Hermansson ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Group Versus ◽  
Primary Efficacy ◽  
Once Daily ◽  
Primary Efficacy Outcome ◽  
Total Hip ◽  
Efficacy Outcome ◽  
Enoxaparin Group ◽  
Subcutaneous Enoxaparin

SummaryThis trial compared the efficacy and safety of oral dabigatran, a direct thrombin inhibitor, versus subcutaneous enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. A total of 2,055 patients were randomised to 28–35 days treatment with oral dabigatran, 220 mg once-daily, starting with a half-dose 1–4 hours after surgery, or subcutaneous enoxaparin 40 mg once-daily, starting the evening before surgery. The primary efficacy outcome was a composite of total venous thromboembolism [VTE] (venographic or symptomatic) and death from all-causes. The main secondary composite outcome was major VTE (proximal deep-vein thrombosis or non-fatal pulmonary embolism) plus VTE-related death. The main safety outcome was major bleeding. In total, 2,013 were treated, of whom 1,577 operated patients were included in the primary efficacy analysis. The primary efficacy outcome occurred in 7.7% of the dabigatran group versus 8.8% of the enoxaparin group, risk difference (RD) –1.1% (95%CI –3.8 to 1.6%); p<0.0001 for the pre-specified non-inferiority margin. Major VTE plus VTE-related death occurred in 2.2% of the dabigatran group versus 4.2% of the enoxaparin group, RD –1.9% (-3.6% to –0.2%); p=0.03. Major bleeding occurred in 1.4% of the dabigatran group and 0.9% of the enoxaparin group (p=0.40). The incidence of adverse events, including liver enzyme elevations and cardiac events, during treatment was similar between the groups. Extended prophylaxis with oral dabigatran 220 mg once-daily was as effective as sub-cutaneous enoxaparin 40 mg once-daily in reducing the risk of VTE after total hip arthroplasty, and superior to enoxaparin for reducing the risk of major VTE. The risk of bleeding and safety profiles were similar.

Application of thromboelastography in comparing coagulation difference of rivaroxaban and enoxaparin for thromboprophylaxis after total hip arthroplasty

2021 ◽  
Vol 29 (3) ◽  
pp. 230949902110426
Author(s):  
Chao-wen Bai ◽  
Ru-xin Ruan ◽  
Sheng Pan ◽  
Chao-ran Huang ◽  
Xing-chen Zhang ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Maximum Amplitude ◽  
Thrombin Time ◽  
Once Daily ◽  
Total Hip ◽  
Enoxaparin Group ◽  
Significant Difference ◽  
Coagulation Tests ◽  
Routine Coagulation

Purpose: The purpose of this study was to compare the coagulation difference in patients with either rivaroxaban or enoxaparin as thromboprophylaxis after total hip arthroplasty (THA) regarding thromboelastography (TEG) and routine coagulation tests. Patients and methods: Two hundred and twenty-eight patients undergoing primary THA were recruited in this study. They were divided into two groups according to a computer-generated random sequence. Patients in the rivaroxaban group received 10 mg of rivaroxaban orally once daily. Patients in the enoxaparin group received 4000 AxaIU (0.4 mL) of enoxaparin subcutaneously once daily. Rivaroxaban and enoxaparin were started 6–8 h after surgery. The administration of the anticoagulant prophylaxis was lasted for a minimum of 14 days. TEG and routine coagulation tests were performed on the day before the operation and 1 day and 7 days after the operation. Results: No difference was observed in the incidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) between the two groups. There was no significant difference with regard to prothrombin time (PT), activated partial thromboplastin time (PTT), international normalized ratio (INR), and thrombin time (TT) between the two groups. However, while considering TEG, R time of the rivaroxaban group was significantly higher than that of the enoxaparin group ( p = 0.003), whereas the maximum amplitude (MA) ( p = 0.036) value and coagulation index (CI) ( p = 0.002) value were significantly lower than those of the enoxaparin group. Conclusion: With regard to TEG analysis, there was coagulation difference in patients with rivaroxaban and those with enoxaparin as thromboprophylaxis after THA. Under recommended dose of rivaroxaban and enoxaparin, patients undergoing THA were in hypercoagulability on 7days postoperative.

Abstract 17269: Incidence of Atrial Fibrillation in Patients With Cobalt and Chromium Containing Hip Arthroplasty

Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Sunita Sharma ◽  
Shiva Ponamgi ◽  
Christopher Desimone ◽  
Cody Wyles ◽  
Philip Sun ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Group Versus ◽  
True Incidence ◽  
Total Hip ◽  
Metal On Metal ◽  
All Cause Mortality ◽  
Metal Group ◽  
Serum Cobalt

Background: Worldwide, approximately one million patients have had total hip arthroplasty with 35% being cobalt and chromium Metal-on-Metal (MoM) or Metal-on-Polythelene (MoP) implants. Animal models have suggested that cobalt and chromium can affect all chambers, but there seems to be an atrial predilection. There are several case reports of metal containing hip arthroplasty causing atrial arrhythmias but the true incidence of atrial fibrillation associated with metal hip arthroplasty remains undefined. Objective: We sought to determine the incidence of atrial fibrillation in patients with metal containing hip arthroplasty. We also examined the association between serum cobalt and chromium levels and arrhythmias in this cohort and all cause mortality. Methods: We retrospectively examined the records of patients from the Mayo Clinic total hip arthroplasty registry (Metal group - Metal-on-Metal: MoM and Metal-on-Polyethylene: MoP, Non-Metal group - Ceramic-on-Ceramic: CoC and Ceramic-on-Polyethylne: CoP) to obtain demographic data, comorbidities, laboratory, ECG, and echocardiographic data. Out of a total of 1756 patients, Cobalt and Chromium levels were available in 138 patients. Results: The mean age of patients with metal containing hip replacement was 50 years and were predominantly male. During a follow up period of 10 years, the incidence of atrial fibrillation in our study population was 8% in metal group compared to 2% (p=0.11) in non-metal group. There was no association between cobalt or chromium levels with the incidence of atrial fibrillation. All-cause mortality was significantly higher in metal group versus non-metal group (p=0.005). Conclusion: The incidence of atrial fibrillation was relatively more in patients with metal versus non-metal hip arthroplasty but there was no association of serum cobalt or chromium levels with incidence of atrial fibrillation in the subset of patients. In addition, all-cause mortality was significantly higher in the metal group suggesting potential toxic effects of metal containing hip arthroplasty.

Efficacy and Safety of Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism Following Total Hip Arthroplasty: STARS J-V trial

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3320-3320 ◽  
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai ◽  
Yukihiro Koretsune ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Major Bleeding ◽  
Thromboembolic Events ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Primary Efficacy Outcome ◽  
Treatment Groups ◽  
Efficacy Outcome ◽  
Lead Investigator

Abstract Abstract 3320 Introduction: Edoxaban is an oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. The aim of this non-inferiority trial was to determine the efficacy and safety of edoxaban compared with enoxaparin sodium (enoxaparin) after total hip arthroplasty (THA) in Japan. Methods: This was a randomized, double-blind, double-dummy, enoxaparin-controlled, multicenter trial. Patients were randomized to oral edoxaban 30 mg once daily (QD) or subcutaneous enoxaparin 2,000 IU, equivalent to 20 mg, twice daily (BID) for 11 to 14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery which is the Japanese standard of care. The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT), and pulmonary embolism (PE). The primary safety outcome was the incidence of major and clinically relevant non-major bleeding. Results: A total of 610 patients were randomized. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 62.8 years and mean body weight was 57.4 kg (Efficacy analysis set). The primary efficacy outcome occurred in 6 of 255 (2.4%) patients receiving edoxaban and 17 of 248 (6.9%) patients receiving enoxaparin (relative risk reduction=65.7%; absolute risk difference -4.5%, 95% CI, -8.6% to -0.9%; P<0.001 for non-inferiority; P=0.0157 for superiority). The thromboembolic events were all asymptomatic DVT (Table). No symptomatic DVT or PE was observed in both treatment groups. The incidence of major and clinically relevant non-major bleeding events was 2.6% (8/303) vs 3.7% (11/301) in the edoxaban and enoxaparin groups, respectively (P=0.475). Major bleeding occurred in 0.7% of the edoxaban group and 2.0% of the enoxaparin group. The rates of elevated serum aminotransferase levels of more than 3 times the upper limit of normal was 2.6% with edoxaban versus 10% with enoxaparin. Conclusions: The STARS J-V trial demonstrated that oral edoxaban 30 mg QD has efficacy superior to enoxaparin 2,000 IU BID in the prevention of thromboembolic events following THA and is associated with a similar incidence of major and clinically relevant non-major bleeding events. Disclosures: Fuji: Astellas: Consultancy; Showa Ikakogyo: Consultancy; Daiichi Sankyo: Consultancy; Bayer: Consultancy. Fujita:Daiichi Sankyo: Consultancy; Astellas: Consultancy; GlaxoSmithkline: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Toyama Chemical: Consultancy. Koretsune:Daiichi Sankyo: Consultancy, National Lead Investigator. Yamashita:Daiichi Sankyo: Consultancy, National Lead Investigator; Otsuka Pharmaceutical: Paid instructor; Sanofi-aventis: Paid instructor; Teijin Pharma: Paid instructor. Nakamura:Daiichi Sankyo: Consultancy; GlaxoSmithkline: Consultancy; Astellas: Consultancy.

Enoxaparin and Dabigatran Thromboprophylaxis after Total Hip Arthroplasty

2011 ◽  
Vol 18 (2) ◽  
pp. 67-70 ◽  
Author(s):  
Andrey Pavlovich Momot ◽  
I V Merkulov ◽  
E V Grigor'eva ◽  
M Yu Panov ◽  
A P Momot ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Blood Clotting ◽  
Dabigatran Etexilate ◽  
Thrombin Inhibitor ◽  
Low Molecular Weight ◽  
Total Hip ◽  
Compliance Testing ◽  
Thrombotic Complications ◽  
Subcutaneous Enoxaparin

Comparative assessment of the efficacy and safety of enoxaparin and dabigatran thromboprophylaxis after total hip arthroplasty was performed. Hemorrhagic and thrombotic complications as well as indices of laboratory tests after application of new oral thrombin inhibitor Dabigatran Etexilate were taken into account. Study included 161 patients who were randomized into two groups and operated on under spinal anesthesia. First group (81 patients) was on subcutaneous enoxaparin (40 mg/day), second group (80) was on dagibartan (200 mg/day). The day before surgery and on 5th and 10th days after arthroplasty duplex angioscanning of lower extremities and assessment of blood clotting parameters was performed. It was shown that in case of significant intraoperative blood loss thromboprophylaxis with both enoxaparin and dabigatran was similar to that with low-molecular-weight heparin. Postoperative thrombogenic risk by D-dimers level was higher with enoxaparin versus dabigatran application. Peroral use of anticoagulants is more acceptable due to its noninvasiveness, safety, low requirements in laboratory monitoring and convenience of application in out-patient conditions. In patients with low compliance testing of blood plasma thrombin can be used for the confirmation of dabigatran intake when necessary.

Barbed sutures reduce arthrotomy closure duration and suture utilisation compared to interrupted conventional sutures for primary total hip arthroplasty: a randomised controlled trial

2020 ◽  
pp. 112070002091189
Author(s):  
Kavin Sundaram ◽  
Nicolas S. Piuzzi ◽  
Alison K. Klika ◽  
Robert M. Molloy ◽  
Carlos A. Higuera-Rueda ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Group Versus ◽  
Standard Of Care ◽  
Barbed Suture ◽  
Care Group ◽  
Barbed Sutures ◽  
Total Hip ◽  
Closure Duration ◽  
Suture Group

Introduction: The broad aim of this study was to compare the safety and efficacy of using barbed sutures and running closure versus interrupted placement of standard of care sutures for closure of the arthrotomy during total hip arthroplasty (THA). Specifically, we compared duration of arthrotomy closure, the number of sutures utilised for arthrotomy closure, and 90-day outcomes including wound-related readmission, reoperation, and complications. Methods: A total of 60 patients undergoing 60 THAs were enrolled in a prospective, single-blinded trial and randomised to receive either running closure of the arthrotomy with barbed sutures ( n = 30) or interrupted closure with standard of care sutures ( n = 30). Patients were eligible if they were undergoing primary THA for osteoarthritis and excluded if they had a BMI > 45 kg/m2 or age > 80 years or <18 years. Results: Arthrotomy closure duration was significantly shorter in the barbed suture group (3 minutes ± 9 seconds) versus the standard of care group (8 minutes ± 26 seconds, p < 0.001). The suture utilisation for arthrotomy closure was 1 suture in the barbed sutured group 28/30 (93%) patients versus 2–4 sutures in 27/30 (90%) in the standard of care group ( p < 0.001). The overall number of wound-related complications in the barbed suture group was 1/30 (3%) versus 1/30 (3%) in the standard of care group ( p = 1.00). The rate of suture abscesses was 1/30 (3%) in barbed suture group versus the standard of care ( p = 1.00). There was trochanter bursitis 1/30 (3%) in the standard of care group versus zero in the barbed suture group ( p = 1.00). Conclusions: These results suggest that barbed suture utilisation may be faster and more resource efficient than use of standard of care sutures for arthrotomy closure in THA. ClinicalTrials.gov Identifier: NCT03285555

Edoxaban in Patients Undergoing Total Hip Arthroplasty: A Phase IIb Dose-Finding Study.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2098-2098 ◽  
Author(s):  
Takashi Fuji ◽  
Chen-Jen Wang ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai
Keyword(s):  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Thromboembolic Events ◽  
Post Dose ◽  
Double Blind ◽  
Total Hip ◽  
Symptomatic Pulmonary Embolism ◽  
Enoxaparin Group

Abstract Abstract 2098 Poster Board II-75 Introduction: Edoxaban (the free base of DU-176b) is an oral, selective, reversible direct factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. The aim of this study was to evaluate the efficacy, safety, and dosage regimen of edoxaban in patients undergoing total hip arthroplasty (THA) in Japan and Taiwan. Patients and Methods: This was a randomized, enoxaparin-controlled, multicenter, parallel group study. Double-blind edoxaban 15 mg or 30 mg once daily or open-label, subcutaneous enoxaparin 20 mg BID was administered for 11 to 14 days. Treatment of edoxaban was started within 6 to 24 hours and treatment of enoxaparin was started within 24 to 36 hours after surgery. The primary efficacy endpoint was the incidence of thromboembolic events (composite of asymptomatic deep vein thrombosis [DVT], symptomatic pulmonary embolism [PE], or symptomatic DVT). Bilateral venography was performed at the end of the study and centrally adjudicated. The primary safety endpoint was the incidence of major and clinically relevant non-major bleeding. Prothombin time (PT), PT/international normalized ratio (PT-INR), activated partial thromboplastin time (aPTT) and edoxaban plasma concentration was also assessed. Results: A total of 264 patients were randomized. There were no clinically relevant differences in demographic or baseline characteristics between the treatment groups. The incidence of thromboembolic events was 3.8% (3/78), 2.8% (2/72), and 4.1% (3/74) in 15 mg, 30 mg edoxaban, and enoxaparin groups, respectively. The thromboembolic events were all distal asymptomatic DVT. PT, prothrombin PT-INR, and aPTT were prolonged at 1 to 3 hours post-dose on Day 7 in both edoxaban dose groups. The prolongation observed in the edoxaban dose groups was directly proportional to the plasma edoxaban concentration. No prolongation in PT, PT-INR, or aPTT was observed in the enoxaparin group. The incidence of major and clinically relevant non-major bleeding was 2.2% (2/89) in the 15 mg edoxaban group, 1.2% (1/85) in the 30 mg edoxaban group, and 2.3% (2/87) in the enoxaparin group. There was one major bleeding event in the 30 mg edoxaban group classified as clinically overt bleeding accompanied by a decrease in hemoglobin > 2g/dL. The incidence of adverse drug reactions was 18.0% (16/89) in the 15 mg group, 25.9% (22/85) in the 30 mg of edoxaban group, and 52.9% (46/87) in the enoxaparin group. Conclusions: Oral administration of edoxaban 15 mg and 30 mg showed potential efficacy similar to enoxaparin for the prevention of thromboembolic events in patients undergoing total hip arthroplasty. The incidence of major and clinically relevant non-major bleeding was comparable to that of enoxaparin. Disclosures: Fuji: Daiichi Sankyo: Consultancy; Astellas: Consultancy; Showa Ikakogyo: Consultancy. Wang:Daiichi Sankyo: Consultancy. Fujita:Daiichi Sankyo: Consultancy; Astellas: Consultancy; GlaxoSmithKline: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Toyama Chemical: Consultancy.

Modular junction may be more problematic than bearing wear in metal-on-metal total hip arthroplasty

2018 ◽  
Vol 29 (3) ◽  
pp. 262-269 ◽  
Author(s):  
Pascal-André Vendittoli ◽  
Vincent Massé ◽  
Marc-Olivier Kiss ◽  
Daniel Lusignan ◽  
Martin Lavigne
Keyword(s):  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Metal Ion ◽  
Modular Group ◽  
Group Versus ◽  
Femoral Stem ◽  
Total Hip ◽  
Wear And Corrosion ◽  
Metal On Metal ◽  
Metal Ion Release

Introduction: In total hip arthroplasty (THA), local adverse reaction to metal debris (ARMD) may be caused by abnormal metal ion release from a metal-on-metal (MoM) bearing, or by wear and corrosion of the implant’s modular junction. The aim of this study was to compare ion levels and rate of ARMD between patients sharing the same MoM bearing but 1 group having monoblock stems versus another having modular stems. Materials and methods: Whole blood cobalt (Co) and chromium (Cr) ion concentrations, ARMD rate, revision rate, and function measured by UCLA and WOMAC scores were compared between groups. Results: ARMD rate was significantly higher in the modular group (46%) compared with the monoblock group (16%, p = 0.031). Revision for ARMD was performed at 52.8 ± 8.1 months in the modular group versus 98.2 ± 15.5 months after primary THA in the monoblock group. ARMD originated from wear and corrosion of the junction between stem and femoral head adapter sleeve in all monoblock cases, and the junction between stem and modular neck in all the modular ones. Cr and Co ions levels were significantly higher in the modular stem group ( p < 0.001 for both). Conclusions: Although both groups had MoM bearings, corrosion at stem/neck or neck/head junctions combining dissimilar metal (Ti and Cr-Co) was seen as the source of excess metal ions release leading to ARMD. Poor performance of the modular junction may be more deleterious than wear of the bearing. To avoid such complications, THA femoral stem modular junctions should be eliminated (return to a full monoblock implant) or have improved junction design.

The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE

2016 ◽  
Vol 115 (06) ◽  
pp. 1240-1248 ◽  
Author(s):  
Alex Spyropoulos ◽  
Julie Zrubek ◽  
Walter Ageno ◽  
Gregory Albers ◽  
C. Elliott ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Hospital Discharge ◽  
Assessment Model ◽  
Primary Efficacy ◽  
Medical Patients ◽  
Once Daily ◽  
Primary Efficacy Outcome ◽  
Efficacy Outcome ◽  
D Dimer

SummaryHospital-associated venous thromboembolism (VTE) is a leading cause of premature death and disability worldwide. Evidence-based guidelines recommend that anticoagulant thromboprophylaxis be given to hospitalised medical patients at risk of VTE, but suggest against routine use of thromboprophylaxis beyond the hospital stay. The MARINER study is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of thromboprophylaxis using rivaroxaban, begun at hospital discharge and continued for 45 days, for preventing symptomatic VTE in high-risk medical patients. Eligible patients are identified using the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE VTE) risk score, combined with a laboratory test, D-dimer. The rivaroxaban regimen is 10 mg once daily for patients with CrCl ≥ 50 ml/min, or 7.5 mg once daily for patients with CrCl ≥ 30 ml/min and < 50 ml/ min. The primary efficacy outcome is the composite of symptomatic VTE (lower extremity deep-vein thrombosis and non-fatal pulmonary embolism) and VTE-related death. The principal safety outcome is major bleeding. A blinded clinical events committee adjudicates all suspected outcome events. The sample size is event-driven with an estimated total of 8,000 patients to acquire 161 primary outcome events. Study design features that distinguish MARINER from previous and ongoing thromboprophylaxis trials in medically ill patients are: (i) use of a validated risk assessment model (IMPROVE VTE) and D-dimer determination for identifying eligible patients at high risk of VTE, (ii) randomisation at the time of hospital discharge, (iii) a 45-day treatment period and (iv) restriction of the primary efficacy outcome to symptomatic VTE events.

Oral Dabigatran Etexilate Versus Enoxaparin for Prevention of Venous Thromboembolism After Total Hip or Knee Arthroplasty: A Pooled Analysis of Four Randomized Trials

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2312-2312
Author(s):  
Michael H Huo ◽  
Andreas A Kurth ◽  
Ola E Dahl ◽  
Andreas Clemens ◽  
Stefan Hantel ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Knee Arthroplasty ◽  
Dabigatran Etexilate ◽  
Pooled Analysis ◽  
Total Hip ◽  
Efficacy Outcome ◽  
Enoxaparin Group ◽  
All Cause Mortality ◽  
Hip And Knee Arthroplasty ◽  
Subcutaneous Enoxaparin

Abstract Abstract 2312 Introduction: Thromboprophylaxis after major orthopaedic surgery reduces the risk of venous thromboembolism (VTE). Four randomized, double-blind, non-inferiority trials compared oral dabigatran etexilate doses of 220 mg or 150 mg once daily (qd) with subcutaneous enoxaparin for the primary prevention of VTE in patients undergoing elective total hip or knee arthroplasty. In the hip arthroplasty trials (RE-NOVATE® and RE-NOVATE® II) the treatment duration was 28–35 days; in the knee arthroplasty trials it was 6–10 days (RE-MODEL™) and 12–15 days (RE-MOBILIZE®). Three of the trials used a comparator enoxaparin regimen of 40 mg qd started the evening before surgery, while in RE-MOBILIZE® enoxaparin was given in the North American regimen of 30 mg twice daily starting 12–24 hours after surgery. In countries where dabigatran etexilate is approved, a dose of 220 mg qd is recommended for most patients; 150 mg qd is for patients with moderate renal impairment (creatinine clearance 30–50 mL/min) and elderly patients (> 75 years). Methods: The primary efficacy outcome for each trial was a composite of total VTE (venographic and symptomatic) and death from all causes during the treatment period. The main composite outcome for the pooled analysis of the four trials was major VTE (proximal deep vein thrombosis or non-fatal pulmonary embolism) plus VTE-related death, which was the main secondary endpoint on the individual trial level. This endpoint was chosen for the pooled analysis, because the event rates are similar across hip and knee arthroplasty, whereas the rate of total VTE and all-cause mortality is substantially higher across all treatment groups for the knee compared to the hip. The main safety outcome was major bleeding (clinically overt bleeding associated with ≥ 20 g/L fall in haemoglobin or transfusion ≥ 2 units of packed cells or blood; or bleeding that was fatal, retroperitoneal, intracranial, intraocular, intraspinal, warranted treatment cessation or led to reoperation) measured from a preoperative baseline in all four trials. Results: In the pooled analysis of the four trials, the main efficacy outcome of major VTE and VTE-related death occurred in 2.8% (80/2838) of the dabigatran etexilate 220 mg group, 3.8% (78/2071) of the dabigatran etexilate 150 mg group and 3.5% (102/2891) of the enoxaparin group; risk difference (RD) versus enoxaparin –0.7% (95% confidence interval [CI] –1.6% to 0.2%) for 220 mg and 0.2% (95% CI –0.8% to 1.3%) for 150 mg. The composite of total VTE and all-cause mortality occurred in the pooled hip trials in 6.8% (114/1672) of the dabigatran etexilate 220 mg group, 8.6% (75/874) of the dabigatran etexilate 150 mg group and 7.7% (129/1683) of the enoxaparin group; RD versus enoxaparin –0.8% (95% CI –2.6% to 0.9%) for 220 mg and 0.9% (95% CI –1.3% to 3.2%) for 150 mg. Major bleeding occurred in 1.4% (52/3692), 1.1% (29/2737) and 1.3% (48/3719), of the dabigatran etexilate 220 mg, 150 mg and enoxaparin groups, respectively; RD versus enoxaparin 0.1% (95% CI –0.4% to 0.6%) for 220 mg and –0.2% (95% CI –0.8 to 0.3%) for 150 mg. Conclusions: Prophylaxis with oral dabigatran etexilate 220 mg qd or 150 mg qd was as effective as subcutaneous enoxaparin at reducing the risk of total VTE and all-cause mortality after total hip arthroplasty with a similar bleeding profile. With regard to the endpoint of major VTE and VTE-related death, dabigatran etexilate 220 mg and 150 mg showed similar efficacy versus enoxaparin in the pooled hip and knee arthroplasty trials. Disclosures: Huo: Boehringer Ingelheim: Consultancy. Kurth:Boehringer Ingelheim: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Clemens:Boehringer Ingelheim: Employment. Hantel:Boehringer Ingelheim: Employment. Feuring:Boehringer Ingelheim: Employment. Friedman:Johnson and Johnson: Consultancy. Eriksson:Bristol-Myers Squibb: Consultancy; Bayer: Consultancy; Astellas: Consultancy.

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