Enoxaparin plus Compression Stockings Compared with Compression Stockings Alone in the Prevention of Venous Thromboembolism after Elective Neurosurgery

作者：Giancarlo Agnelli, Franco Piovella, Pio Buoncristiani, Paolo Severi, Mario Pini, Armando D’Angelo, Chiara Beltrametti, Marcello Damiani, Gian Carlo Andrioli, Raffaelino Pugliese, Alfonso Iorio, Gianluigi Brambilla · 发表于：New England Journal of Medicine · 年份：1998 · DOI：10.1056/nejm199807093390204 · 被引用次数：523 · 研究领域：Venous Thromboembolism Diagnosis and Management、Cardiac and Coronary Surgery Techniques、Atrial Fibrillation Management and Outcomes

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 pe...