Impact of stage 3B chronic kidney disease on thrombosis and bleeding outcomes after orthopedic surgery in patients treated with desirudin or enoxaparin: insights from a randomized trial.
BACKGROUND
Venous thromboembolism (VTE) remains a significant complication of major orthopedic surgery, and chronic kidney disease (CKD) is common among elderly patients undergoing total hip replacement (THR).


OBJECTIVE
The purpose of this study was to evaluate thrombosis and bleeding outcomes in patients with stage 3B CKD treated with either desirudin or enoxaparin after elective THR.


METHODS
This was a post hoc subgroup analysis of a randomized, multicenter, double-blind study of desirudin vs. enoxaparin in patients undergoing elective THR.


RESULTS
Patients received either subcutaneous desirudin 15 mg twice daily or subcutaneous enoxaparin 40 mg once daily. Of the 2078 randomized patients who received study medication, 577 had stage 3B CKD or worse (27.8%), and the proportion of these patients who experienced a major VTE in the enoxaparin treatment group was found to be much higher than in the desirudin treatment group (11.1% vs. 3.4%, model-adjusted odds ratio 3.52, 95% confidence interval 1.48-8.40, P=0.004). There was no statistically significant difference between treatment groups in terms of rates of major bleeding, regardless of stage of renal function.


CONCLUSIONS
CKD has been reported previously to increase the risk of bleeding with anticoagulants, and these findings suggest that CKD may also increase the risk of major VTE for patients treated with enoxaparin, but not for patients treated with desirudin. Clinicians should consider the impact of CKD on the risk of VTE when choosing a prophylaxis agent.
Pulmonary and Critical Care Medicine, Washington Hospital Center, Washington, DC 20010, USA. andrew.shorr@gmail.com
A F
AF
Shorr
B I
BI
Eriksson
A K
AK
Jaffer
J
J
Smith
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects*; D004334:Drug Administration Schedule; D017984:Enoxaparin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006629:Hirudins / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016017:Odds Ratio; D018579:Patient Selection; D019106:Postoperative Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000175:diagnosis; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000925:Anticoagulants; D017984:Enoxaparin; D006629:Hirudins; D011994:Recombinant Proteins; C060225:desirudin