Enoxaparin plus compression stockings compared with compression stockings alone in the prevention of venous thromboembolism after elective neurosurgery.

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.

[Clinical course and incidence of post-thrombophlebitic syndrome after profound asymptomatic deep vein thrombosis. Results of a transverse epidemiologic study]. / Decorso clinico ed incidenza della sindrome post-tromboflebitica dopo trombosi venosa profonda asintomatica. Risultani di uno studio epidemiologico trasversale.

UNLABELLED: Currently, there are not reliable data on the incidence and prevalence of post-phlebitic syndrome (PTS) after an episode of asymptomatic postoperative deep vein thrombosis (DVT). In order to evaluate the epidemiology and the clinical course of PTS in patients who were submitted to hip and knee replacement, we performed a cross sectional study in orthopedic patients with previous asymptomatic postoperative DVT. For reducing potential biases, we used currently accepted and objectively documented criteria to define the clinical manifestations and severity of PTS. RESULTS: 98 of 217 (45.1%) patients, who underwent orthopedic surgery in the previous 2-4 years, have been included in the study. 46 of them (46.9%) had postoperative asymptomatic DVT, confirmed by venograph 23.9% satisfied criteria to be classified as having PTS. When compared with the control group (PTS 3.8%), the difference in the incidence of PTS was statistically significant (p = 0.03). The comparison of the distribution of proximal and distal thrombi in patients with PTS showed that proximal venous involvement constitutes and independent risk factor for developing PST (RR 4). We conclude that: a) about 24% of patients with previous asymptomatic postoperative DVT developed the SPT in the following 2-4 years, b) in asymptomatic DVTs, the localization of thrombi in the proximal venous segment is the most important independent risk factor for the PTS. Therefore, these results can influence the use and the choice of an adequate antithrombotic prophylaxis for reducing the incidence of postoperative proximal DVT.

[Venous thromboembolism: epidemiology and risk factors]. / Tromboembolismo venoso. Epidemiologia e fattori di rischio.

The prevalence of DVT in the general community has been estimated from large descriptive studies of symptomatic patients; the annual incidence of proximal DVT has been reported to be 48 cases for 100,000. When associated to known risk factors, the incidence of DVT is strongly elevated; postoperative DVT occurs, for instance, in 5% to 40% of patients undergoing surgical procedures. Estimated of the incidence and prevalence of PE are less reliable than for DVT because the ante-morten diagnosis of PE is difficult and the post-mortem diagnosis highly selective. An analysis conducted on 11,000 autopsies showed that 316 of these had macroscopic pulmonary emboli; nevertheless, 11% of cases only had the diagnosis before death, while 32% of the patients were diagnosed as died of myocardial infarction, 15% of cerebrovascular disease and 14% of pneumonia. Update results, indicate that mortality due to PE is the first cause of death in hospitalized patients. Venous thromboembolism is a common disease often misdiagnosed because of low accuracy of clinical diagnosis; correct approaches for prophylaxis, therapy and to diagnosis are necessary to manage high-risk patients for DVT and/or PE and to reduce costs and social impact.