Ardeparin sodium for extended out-of-hospital prophylaxis against venous thromboembolism after total hip or knee replacement. A randomized, double-blind, placebo-controlled trial.

Abstract

BACKGROUND:

The optimal duration of prophylaxis against venous thromboembolism after total hip or knee replacement is uncertain.

OBJECTIVE:

To determine the efficacy and safety of extended out-of-hospital prophylaxis with low-molecular-weight heparin (ardeparin sodium).

DESIGN:

Randomized, double-blind, placebo-controlled trial.

SETTING:

33 community, university, or university-affiliated hospitals.

PATIENTS:

1195 adults who had elective total hip or knee replacement and completed 4 to 10 days of postoperative ardeparin prophylaxis.

INTERVENTION:

Daily subcutaneous ardeparin (100 anti-Xa IU/kg of body weight) or placebo from time of hospital discharge to 6 weeks after surgery.

MEASUREMENTS:

Symptomatic, objectively documented venous thromboembolism or death, along with major bleeding, from time of hospital discharge to 12 weeks after surgery.

RESULTS:

Patients who received ardeparin (n = 607) and those who received placebo (n = 588) did not differ significantly in the cumulative incidence of venous thromboembolism or death (9 cases [1.5%] compared with 12 cases [2.0%]; odds ratio, 0.7 [95% CI, 0.3 to 1.7]; P > 0.2; absolute difference, -0.56 percentage points [CI, -2.2 to 1.1 percentage points]) or major bleeding (2 cases [0.3%] compared with 3 cases [0.5%]).

CONCLUSIONS:

Among patients who had total knee or total hip replacement and received 4 to 10 days of postoperative ardeparin prophylaxis, the cumulative incidence of symptomatic venous thromboembolism or death after hospital discharge was not significantly reduced by extended out-of-hospital ardeparin prophylaxis. Extended ardeparin use could provide a maximum 2.2-percentage point true reduction in such events. The benefit of extended ardeparin use is not clinically important for most patients. Future research should identify high-risk patients who would benefit most from extended prophylaxis.

• Authors: J A Heit, C G Elliott, A A Trowbridge, B F Morrey, M Gent, J Hirsh
• Journal: Annals of internal medicine (Ann Intern Med) Vol. 132 Issue 11 Pg. 853-61 (Jun 06 2000) ISSN: 0003-4819 [Print] United States
• PMID: 10836911 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Heparin, Low-Molecular-Weight
• Placebos
• ardeparin

Topics

• Adult
• Aged
• Ambulatory Care
• Arthroplasty, Replacement, Hip (adverse effects)
• Arthroplasty, Replacement, Knee (adverse effects)
• Cause of Death
• Double-Blind Method
• Drug Administration Schedule
• Female
• Hemorrhage (chemically induced)
• Heparin, Low-Molecular-Weight (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Placebos
• Pulmonary Embolism (etiology, prevention & control)
• Thrombocytopenia (chemically induced)
• Thromboembolism (etiology, prevention & control)
• Venous Thrombosis (etiology, prevention & control)