Enoxaparin plus compression stockings compared with compression stockings alone in the prevention of venous thromboembolism after elective neurosurgery - PubMed
- ️Thu Jan 01 1998
Clinical Trial
. 1998 Jul 9;339(2):80-5.
doi: 10.1056/NEJM199807093390204.
F Piovella, P Buoncristiani, P Severi, M Pini, A D'Angelo, C Beltrametti, M Damiani, G C Andrioli, R Pugliese, A Iorio, G Brambilla
Affiliations
- PMID: 9654538
- DOI: 10.1056/NEJM199807093390204
Free article
Clinical Trial
Enoxaparin plus compression stockings compared with compression stockings alone in the prevention of venous thromboembolism after elective neurosurgery
G Agnelli et al. N Engl J Med. 1998.
Free article
Abstract
Background: Compression stockings are recommended for prophylaxis against venous thromboembolism in patients undergoing neurosurgery, but anticoagulant agents have not gained wide acceptance because of concern about intracranial bleeding.
Methods: In a multicenter, randomized, double-blind trial, we assessed the efficacy and safety of enoxaparin in conjunction with the use of compression stockings in the prevention of venous thromboembolism in patients undergoing elective neurosurgery. Enoxaparin (40 mg once daily) or placebo was given subcutaneously for not less than seven days beginning within 24 hours after the completion of surgery. The primary end point was symptomatic, objectively confirmed venous thromboembolism or deep-vein thrombosis assessed by bilateral venography, which was performed in all patients on day 8+/-1. Bleeding side effects were carefully assessed.
Results: Among the 307 patients assigned to treatment groups, 129 of the 154 patients receiving placebo (84 percent) and 130 of the 153 patients receiving enoxaparin (85 percent) had venographic studies adequate for analysis. An additional patient in the placebo group died before venography of autopsy-confirmed pulmonary embolism. In this analysis, 42 patients given placebo (32 percent) and 22 patients given enoxaparin (17 percent) had deep-vein thrombosis (relative risk in the enoxaparin group, 0.52; 95 percent confidence interval, 0.33 to 0.82; P=0.004). The rates of proximal deep-vein thrombosis were 13 percent in patients receiving placebo and 5 percent in patients receiving enoxaparin (relative risk in the enoxaparin group, 0.41; 95 percent confidence interval, 0.17 to 0.95; P=0.04). Two patients in the placebo group died of autopsy-confirmed pulmonary embolism on days 9 and 16. Major bleeding occurred in four patients receiving placebo (intracranial bleeding in all four) and four patients (intracranial bleeding in three) receiving enoxaparin (3 percent of each group).
Conclusions: Enoxaparin combined with compression stockings is more effective than compression stockings alone for the prevention of venous thromboembolism after elective neurosurgery and does not cause excessive bleeding.
Comment in
- ACP J Club. 1999 Jan-Feb;130(1):9
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Enoxaparin in neurosurgical patients.
Connolly ES, Mocco J. Connolly ES, et al. N Engl J Med. 1998 Nov 26;339(22):1639-40. doi: 10.1056/NEJM199811263392213. N Engl J Med. 1998. PMID: 9867528 No abstract available.
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