John A. Heit, MD; C. Gregory Elliott, MD; Arthur A. Trowbridge, MD; Bernard F. Morrey, MD; Michael Gent, DSc; Jack Hirsh, MD; for the Ardeparin Arthroplasty Study Group*
Acknowledgments: The authors thank the surgical, nursing, pharmacy, and support staff at all the study sites. They also thank Dr. D. Scott Holloway and Ms. Joanne DiLiberto, Wyeth-Ayerst Research.
Grant Support: By Wyeth-Ayerst Research, Philadelphia, Pennsylvania.
Requests for Single Reprints: John A. Heit, MD, Hematology Research, Plummer 549, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
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Current Author Addresses: Dr. Heit: Hematology Research, Plummer 549, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Dr. Elliott: LDS Hospital, University of Utah, Eighth Avenue and C Street, Salt Lake City, UT 84143.
Dr. Trowbridge: Texas A&M University, 2401 South 31st Street, Temple, TX 76508.
Dr. Morrey: Mayo Clinic, 200 First Street, SW, Rochester, MN 55905.
Drs. Gent and Hirsh: Hamilton Civic Hospitals Research Centre, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.
Author Contributions: Conception and design: C.G. Elliott, B.F. Morrey, J.A. Heit, J. Hirsh.
Analysis and interpretation of the data: C.G. Elliott, A.A. Trowbridge, M. Gent, J.A. Heit, J. Hirsh.
Drafting of the article: A.A. Trowbridge, M. Gent, J.A. Heit, J. Hirsh.
Critical revision of the article for important intellectual content: C.G. Elliott, A.A. Trowbridge, M. Gent, J.A. Heit, J. Hirsh.
Final approval of the article: C.G. Elliott, A.A. Trowbridge, B.F. Morrey, J.A. Heit, J. Hirsh.
Provision of study materials or patients: C.G. Elliott, A.A. Trowbridge, J.A. Heit, B.F. Morrey.
Statistical expertise: M. Gent.
Administrative, technical, or logistic support: M. Gent.
Collection and assembly of data: C.G. Elliott, J.A. Heit.
The optimal duration of prophylaxis against venous thromboembolism after total hip or knee replacement is uncertain.
To determine the efficacy and safety of extended out-of-hospital prophylaxis with low-molecular-weight heparin (ardeparin sodium).
Randomized, double-blind, placebo-controlled trial.
33 community, university, or university-affiliated hospitals.
1195 adults who had elective total hip or knee replacement and completed 4 to 10 days of postoperative ardeparin prophylaxis.
Daily subcutaneous ardeparin (100 IU/kg of body weight) or placebo from time of hospital discharge to 6 weeks after surgery.
Symptomatic, objectively documented venous thromboembolism or death, along with major bleeding, from time of hospital discharge to 12 weeks after surgery.
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%]).
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.
*For members of the Ardeparin Arthroplasty Study Group, see Appendix.
John A. Heit, C. Gregory Elliott, Arthur A. Trowbridge, Bernard F. Morrey, Michael Gent, Jack Hirsh, et al. Ardeparin Sodium for Extended Out-of-Hospital Prophylaxis against Venous Thromboembolism after Total Hip or Knee Replacement: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 2000;132:853–861. doi: 10.7326/0003-4819-132-11-200006060-00002
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Published: Ann Intern Med. 2000;132(11):853-861.
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