Low dose compared to variable dose Warfarin and to Fondaparinux as prophylaxis for thromboembolism after elective hip or knee replacement surgery; a randomized, prospective study

Thrombosis Journal

Benjamin E. Bierbaum²  Gerald B. Miley⁴  Laura Hou¹  Ronna H. Berezin¹  James V. Bono²  David A. Mattingly²  Damon J. Spitz²  Daniel M. Ward²  John R. Richmond²  Elizabeth Deeran¹  Diane Hazel¹  Murray M. Bern³ 

[1] Research, New England Baptist Hospital, Boston, MA, USA;Tufts University School of Medicine, Boston, MA, USA;University of New Mexico Cancer Center, 1201 Camino de Salud, Albuquerque 87131, NM, USA;Harvard Medical School, Boston, MA, USA

关键词: Pulmonary embolus;    Deep vein thrombosis;    Warfarin;    Thrombophlebitis;    Prophylaxis;    Knee replacement;    Hip replacement;    Fondaparinux;    Arthroplasty;   

Others  :  1230451
DOI  :  10.1186/s12959-015-0062-0

 received in 2015-03-16, accepted in 2015-06-15,  发布年份 2015

【 摘 要 】

Background

Deep vein thrombosis (DVT) and pulmonary emboli (PE), known together as venous thromboembolic (VTE) disease remain major complications following elective hip and knee surgery. This study compares three chemoprophylactic regimens for VTE following elective primary unilateral hip or knee replacement, one of which was designed to minimize risk of post-operative bleeding.

Methods

Patients were randomized and stratified for hip vs. knee to receive A: variable dose warfarin (first dose on the night preceding surgery with subsequent target INR 2.0–2.5), B: 2.5 mg fondaparinux daily starting 6–18 h postoperatively, or C: fixed 1.0 mg dose warfarin daily starting 7 days preoperatively. All treatments continued until bilateral leg venous ultrasound day 28 ± 2 or earlier upon a VTE event. The study examined primary endpoints including leg DVT, PE or death due to VTE and secondary endpoints including effects on D-dimer, estimated blood loss (EBL) at surgery and hemorrhagic complications.

Results

Three hundred fifty-five patients were randomized. None was lost to follow-up. Taking 1.0 mg warfarin for seven days preoperatively did not prolong the prothrombin time (PT). Two patients in Arm C had asymptomatic distal DVT. One major bleed occurred in Arm B and one in Arm C (ischemic colitis). Elevated d-dimer did not predict delayed VTE for one year.

Conclusions

Fixed low dose warfarin started preoperatively is equivalent to two other standards of care under study (95 % CI: -0.0428, 0.0067 for both) as VTE prophylaxis for the patients having elective major joint replacement surgery.

Trial registration

ClinicalTrials.gov identifier # NCT00767559

FDA IND: 103,716

【 授权许可】

   
2015 Bern et al.

【 图 表 】

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