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Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer.

Bergqvist, D; Agnelli, G; Cohen, AT; Eldor, A; Nilsson, Paul LU ; Le Moigne-Amrani, A and Dietrich-Neto, F (2002) In New England Journal of Medicine 346(13). p.975-980
Abstract
Background: Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown. Methods: We conducted a double-blind, multicenter trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin (40 mg subcutaneously) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin or placebo for another 21 days. Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred. The primary end point with respect to efficacy was the incidence of venous thromboembolism between days 25 and 31. The primary safety end point was bleeding during... (More)
Background: Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown. Methods: We conducted a double-blind, multicenter trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin (40 mg subcutaneously) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin or placebo for another 21 days. Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred. The primary end point with respect to efficacy was the incidence of venous thromboembolism between days 25 and 31. The primary safety end point was bleeding during the three-week period after randomization. The patients were followed for three months. Results: The intention-to-treat analysis of efficacy included 332 patients. The rates of venous thromboembolism at the end of the double-blind phase were 12.0 percent in the placebo group and 4.8 percent in the enoxaparin group (P=0.02). This difference persisted at three months (13.8 percent vs. 5.5 percent, P=0.01). Three patients in the enoxaparin group and six in the placebo group died within three months after surgery. There were no significant differences in the rates of bleeding or other complications during the double-blind or follow-up periods. Conclusions: Enoxaparin prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis, as compared with enoxaparin prophylaxis for one week. (N Engl J Med 2002;346:975-80.) Copyright (C) 2002 Massachusetts Medical Society. (Less)
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author
organization
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type
Contribution to journal
publication status
published
subject
in
New England Journal of Medicine
volume
346
issue
13
pages
975 - 980
publisher
Massachusetts Medical Society
external identifiers
  • pmid:11919306
  • wos:000174608600004
  • scopus:0037187892
ISSN
0028-4793
language
English
LU publication?
yes
id
62467ba8-5393-440f-b737-11cd1101dfa8 (old id 893700)
date added to LUP
2008-01-17 11:07:14
date last changed
2017-11-19 03:40:05
@article{62467ba8-5393-440f-b737-11cd1101dfa8,
  abstract     = {Background: Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown. Methods: We conducted a double-blind, multicenter trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin (40 mg subcutaneously) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin or placebo for another 21 days. Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred. The primary end point with respect to efficacy was the incidence of venous thromboembolism between days 25 and 31. The primary safety end point was bleeding during the three-week period after randomization. The patients were followed for three months. Results: The intention-to-treat analysis of efficacy included 332 patients. The rates of venous thromboembolism at the end of the double-blind phase were 12.0 percent in the placebo group and 4.8 percent in the enoxaparin group (P=0.02). This difference persisted at three months (13.8 percent vs. 5.5 percent, P=0.01). Three patients in the enoxaparin group and six in the placebo group died within three months after surgery. There were no significant differences in the rates of bleeding or other complications during the double-blind or follow-up periods. Conclusions: Enoxaparin prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis, as compared with enoxaparin prophylaxis for one week. (N Engl J Med 2002;346:975-80.) Copyright (C) 2002 Massachusetts Medical Society.},
  author       = {Bergqvist, D and Agnelli, G and Cohen, AT and Eldor, A and Nilsson, Paul and Le Moigne-Amrani, A and Dietrich-Neto, F},
  issn         = {0028-4793},
  language     = {eng},
  number       = {13},
  pages        = {975--980},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer.},
  volume       = {346},
  year         = {2002},
}