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January 1, 2011Thrombosis and Haemostasis

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

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Why the study?

Does oral dabigatran reduce total venous thromboembolism and all-cause death compared to subcutaneous enoxaparin in patients undergoing total hip arthroplasty?

Population

2,055 patients undergoing primary total hip arthroplasty

Comparison

Oral dabigatran 220 mg once-daily, starting with… vs Subcutaneous enoxaparin 40 mg once-daily…

Design

RCT, randomised

Follow-up

28-35 days

Authors

ODOla DahlThrombosis Research InstituteMHMichael H. HuoSouthwestern Medical CenterAKAndreas KurthGoethe University Frankfurt

Discussion

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Overview

Supports oral dabigatran as convenient VTE prophylaxis after hip arthroplasty; confirms non-inferiority to enoxaparin in RCT.

Structured PICO

Does oral dabigatran reduce total venous thromboembolism and all-cause death compared to subcutaneous enoxaparin in patients undergoing total hip arthroplasty?

P
Population
2,055 patients undergoing primary total hip arthroplasty
I
Intervention
Oral dabigatran 220 mg once-daily, starting with a half-dose 1-4 hours after surgery, for 28-35 days
C
Comparator
Subcutaneous enoxaparin 40 mg once-daily, starting the evening before surgery, for 28-35 days
O
Outcome
Composite of total venous thromboembolism [VTE] (venographic or symptomatic) and death from all-causescomposite

Oral dabigatran 220 mg once-daily is non-inferior to subcutaneous enoxaparin 40 mg once-daily for VTE prophylaxis after total hip arthroplasty, with similar bleeding risks.

Cite This Study

Dahl et al. (2011) studied this question.

synapsesocial.com/papers/6a7cec240c48a91e15f02ecbhttps://doi.org/10.1160/th10-10-0679
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement2003 · 252 citations
  2. 2Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation2009 · 2,108 citations
  3. 3Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement2005 · 296 citations
  4. 4Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism2009 · 2,591 citations
  5. 5Dabigatran versus Warfarin in Patients with Atrial Fibrillation2009 · 11,282 citations