Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Hip Arthroplasty

Eriksson, Bengt I.; Borris, Lars C.; Friedman, Richard J.; Haas, Sylvia; Huisman, Menno V.; Kakkar, Ajay K.; Bandel, Tiemo J.; Beckmann, H.; Muehlhofer, Eva; Misselwitz, Frank; Geerts, William

doi:10.1056/nejmoa0800374

Cited by 1,305 publications

(1,108 citation statements)

References 25 publications

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“…During the development of the oral anticoagulants for prevention of VTE in THR and TKR surgery, multiple phase II dose‐finding trials and phase III trials have typically been conducted for the different types of surgery and comparator dose regimens 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38. The results of the current analyses suggest that the outcome of a single study in one type of surgery with one comparator dose regimen, used in conjunction with the model‐based meta‐analysis, would be sufficient to determine the optimal dose for both types of surgery and compared with both regimens of comparator.…”

Section: Discussionmentioning

confidence: 99%

Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta‐analysis

Boyd

DiCarlo

Mandema³

2017

Clinical Translational Sci

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We carried out a dose–response model‐based meta‐analysis to assess venous thromboembolism (VTE) and bleeding with factor Xa (FXa) inhibitors (apixaban, edoxaban, rivaroxaban) and a thrombin inhibitor (dabigatran) compared with European (EU) (40 mg q.d.) and North American (NA) (30 mg Q12H) dose regimens of a low molecular weight heparin (enoxaparin) following orthopedic surgery. Statistically significant differences in both VTE and bleeding outcomes were found between the NA and EU doses of enoxaparin, with odds ratios (95% confidence interval) for the NA vs. EU dose of 0.73 (0.71–0.76) and 1.20 (1.14–1.29) for total VTE and major bleeding, respectively. At approved doses, estimated odds ratios vs. both doses of enoxaparin for the three FXa inhibitors (range: 0.35–0.75 for VTE; 0.76–1.09 for bleeding) compared with those for dabigatran (range: 0.66–1.21 for VTE; 1.10–1.38 for bleeding) suggested generally greater efficacy and less bleeding for the FXa inhibitors.

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Section: Discussionmentioning

confidence: 99%

Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta‐analysis

Boyd

DiCarlo

Mandema³

2017

Clinical Translational Sci

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“…In the RECORD program, men and women at least 18 years old who were scheduled to undergo elective THA or TKA were eligible for inclusion. Eligible patients were randomized to receive 10 mg oral rivaroxaban once daily (6 to 8 hours after wound closure) or 40 mg subcutaneous enoxaparin once daily (RECORD1-3 trials; initiated 12 hours before surgery and restarted 6 to 8 hours after wound closure) or 30 mg enoxaparin twice daily (RECORD4 trial; initiated 12 to 24 hours after wound closure) [8,10,12,24]. Study drugs were administered for 31 to 39 days in RECORD1, rivaroxaban was administered for 31 to 39 days and enoxaparin for 10 to 14 days plus placebo in RECORD2, and for 10 to 14 days in the RECORD3 and RECORD4 trials [8,10,12,24].…”

Section: Methodsmentioning

confidence: 99%

“…Bleeding events were defined as reported previously [8,10,12,24]. The bleeding outcomes assessed were any bleeding events after the start of study medication and major or nonmajor clinically relevant bleeding events.…”

Section: Methodsmentioning

confidence: 99%

Complication Rates After Hip or Knee Arthroplasty in Morbidly Obese Patients

Friedman¹,

Hess

Berkowitz

et al. 2013

Clinical Orthopaedics &Amp; Related Research

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173

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Background Morbid obesity has been shown to be a risk factor for increased complications after THA and TKA; however, large studies that would determine the effect size are lacking. Questions/purposes The purposes of this study were to determine whether morbid obesity increased the risk of: (1) venous thromboembolism (VTE), (2) bleeding, (3) other adverse events, and (4) infections during the early postoperative period (up to 6 to 8 weeks) after THA or TKA? Methods Data from the REgulation of Coagulation in ORthopaedic surgery to prevent Deep vein thrombosis and pulmonary embolism (RECORD) clinical trial program of rivaroxaban for prevention of VTE after THA or TKA were analyzed retrospectively. Data for 12,355 patients were reviewed to identify complication rates in morbidly obese patients (BMI C 40 kg/m 2 ) compared with patients with a BMI less than 40 kg/m 2 . Explorative analyses compared the rates of asymptomatic deep vein thrombosis (DVT), symptomatic DVT, symptomatic pulmonary embolism, bleeding, and other adverse events by BMI group. Results There were no significant differences in asymptomatic DVT, symptomatic DVT, symptomatic pulmonary embolism, or bleeding, but there were increases in other adverse events (including receipt of blood transfusion, erythema, peripheral edema, diarrhea, gastrointestinal or abdominal pain) and infections (including respiratory tract or lung infections, wound inflammation or infection, and extrasurgical-site infections), in patients with a BMI of 40 kg/m 2 or greater compared with patients with a BMI less than 40 kg/m 2 . Conclusions After THA or TKA, morbid obesity is not associated with an increased risk of VTE or bleeding but is associated with increased early postoperative complications, including erythema, peripheral edema, diarrhea and gastrointestinal or abdominal pain, wound inflammation or infection, extrasurgical-site infections, and respiratory tract or lung infections.

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“…Rivaroxaban's effectiveness in prevention of venous thrombosis in lower extremity orthopedic surgery was studied in four phase III clinical trials-two in THA and two in TKA [13,14,21,22]. The standard dose of rivaroxaban was 10 mg daily started 6-8 hr after wound closure.…”

Section: Prevention Of Deep Venous Thrombosismentioning

confidence: 99%

“…The standard dose of rivaroxaban was 10 mg daily started 6-8 hr after wound closure. In THA, rivaroxaban compared to 40 mg of enoxaparin for 35 days was more effective in preventing thrombosis-including proximal thrombosis-with no increase in bleeding [21]. In RECORD 2 THA trial, the comparator was a short course of enoxaparin 40 mg daily for 10-14 days compared to 42 days of rivaroxaban 10 mg daily [22].…”

Section: Prevention Of Deep Venous Thrombosismentioning

confidence: 99%

Practical aspects of the oral new anticoagulants

DeLoughery

2011

American J Hematol

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After years of only oral vitamin K antagonists, there are new many new antithrombotic agents in development and on entering the marketplace. This review will analyze clinical trial results for these new agents—especially dibigatran, rivaroxaban, and apixiban. Also to be discussed are practical aspects of use of these new agents such monitoring, reversal, and use before procedures. Am. J. Hematol. 2011. © 2011 Wiley‐Liss, Inc.

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Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Hip Arthroplasty

Cited by 1,305 publications

References 25 publications

Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta‐analysis

Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta‐analysis

Complication Rates After Hip or Knee Arthroplasty in Morbidly Obese Patients

Practical aspects of the oral new anticoagulants

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