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Original Article
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Volume 339:80-85 July 9, 1998 Number 2
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Enoxaparin plus Compression Stockings Compared with Compression Stockings Alone in the Prevention of Venous Thromboembolism after Elective Neurosurgery
Giancarlo Agnelli, M.D., Franco Piovella, M.D., Pio Buoncristiani, M.D., Paolo Severi, M.D., Mario Pini, M.D., Armando D'Angelo, M.D., Chiara Beltrametti, M.D., Marcello Damiani, M.D., Gian Carlo Andrioli, M.D., Raffaelino Pugliese, M.D., Alfonso Iorio, M.D., and Gianluigi Brambilla, M.D.

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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 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.


Source Information

From the Istituto di Medicina Interna e Medicina Vascolare, Università di Perugia, and Divisione di Neurochirurgia, Ospedale Silvestrini, Perugia (G.A., P.B., M.D., A.I.); the Clinica Neurochirurgica and Clinica Medica II, Università di Pavia, Pavia (F.P., C.B., R.P., G.B.); the Divisione di Neurochirurgia, Ospedale Galliera, Genoa (P.S., G.C.A.); V Divisione Medica, Azienda Ospedaliera, Parma (M.P.); and the Divisione di Neurochirurgia and Servizio di Coagulazione, Ospedale S. Raffaele, Milan (A.D.) — all in Italy.

Address reprint requests to Professor Agnelli at the Istituto di Medicina Interna e Medicina Vascolare, Università di Perugia, Via Enrico dal Pozzo, 06123 Perugia, Italy.

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Related Letters:

Enoxaparin in Neurosurgical Patients
Connolly E. S., Mocco J, Agnelli G., Iorio A.
Extract | Full Text  
N Engl J Med 1998; 339:1639-1640, Nov 26, 1998. Correspondence

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