Melina Verso

Enoxaparin for the Prevention of Venous Thromboembolism Associated With Central Vein Catheter: A Double-Blind, Placebo-Controlled, Randomized Study in Cancer Patients

PURPOSE The extent of venous thromboembolism (VTE) associated with central vein catheters (CVC) in cancer patients remains unclear. The aim of this study was to evaluate the efficacy and safety of the low molecular weight heparin, enoxaparin, in the prevention of VTE. PATIENTS AND METHODS In a multicenter, double-blind study, consecutive cancer patients scheduled for CVC insertion were randomly assigned to receive either subcutaneous enoxaparin 40 mg once a day or placebo. Treatment was started 2 hours before CVC insertion and continued for 6 weeks. The primary end points of the study were deep vein thrombosis (DVT), confirmed by venography of the CVC limb performed 6 weeks after randomization, or clinically overt pulmonary embolism, confirmed by objective testing during the study drug administration. Patients were assessed for bleeding complications. RESULTS Three hundred eighty-five patients were randomized, of which 321 (83.4%) underwent venography. A venography was adequate for adjudication in 155 patients in each treatment group. A DVT was observed in 22 patients (14.1%) treated with enoxaparin and in 28 patients (18.0%) treated with placebo, corresponding to a relative risk of 0.78 (95% CI, 0.47 to 1.31). No major bleeding occurred. Five patients (2.6%) in the enoxaparin group and two patients (1.0%) in the placebo group died during the treatment period. CONCLUSION In this study, no difference in the rate of CVC-related VTE was detected between patients receiving enoxaparin and patients receiving placebo. The dose of enoxaparin used in this study proved to be safe. Clinical trials evaluating higher enoxaparin doses could optimize the efficacy of this agent for this indication.

Risk factors for catheter-related thrombosis (CRT) in cancer patients: a patient-level data (IPD) meta-analysis of clinical trials and prospective studies

Background: Knowledge of independent, baseline risk factors for catheter‐related thrombosis (CRT) may help select adult cancer patients who are at high risk to receive thromboprophylaxis. Objectives: We conducted a meta‐analysis of individual patient‐level data to identify these baseline risk factors. Patients/Methods: MEDLINE, EMBASE, CINAHL, CENTRAL, DARE and the Grey literature databases were searched in all languages from 1995 to 2008. Prospective studies and randomized controlled trials (RCTs) were eligible. Studies were included if original patient‐level data were provided by the investigators and if CRT was objectively confirmed with valid imaging. Multivariate logistic regression analysis of 17 prespecified baseline characteristics was conducted. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Results: A total sample of 5636 subjects from five RCTs and seven prospective studies was included in the analysis. Among these subjects, 425 CRT events were observed. In multivariate logistic regression, the use of implanted ports as compared with peripherally implanted central venous catheters (PICCs), decreased CRT risk (OR, 0.43; 95% CI, 0.23–0.80), whereas past history of deep vein thrombosis (DVT) (OR, 2.03; 95% CI, 1.05–3.92), subclavian venipuncture insertion technique (OR, 2.16; 95% CI, 1.07–4.34) and improper catheter tip location (OR, 1.92; 95% CI, 1.22–3.02), increased CRT risk. Conclusions: CRT risk is increased with use of PICCs, previous history of DVT, subclavian venipuncture insertion technique and improper positioning of the catheter tip. These factors may be useful for risk stratifying patients to select those for thromboprophylaxis. Prospective studies are needed to validate these findings.

Seasonal Variation in the Occurrence of Venous Thromboembolism: Data From the MASTER Registry

Many studies showed that the occurrence of cardiovascular and cerebrovascular events exhibits a seasonal variation. As for venous thromboembolism (VTE), not univocal results are available, and studies are mainly retrospective. We aimed to confirm the existence of a seasonal pattern in the occurrence of VTE on a large prospective population. The analysis considered consecutive cases of VTE enrolled into the MASTER Registry in 25 Italian hospitals, between January 2002 and November 2004. The total population consisted of 2119 subjects (1056 men, mean age 59 ± 18 years). The total sample was divided into subgroups by gender, age (<40, 41—60, 61—80, ≥80 years), type of event (first episode; proximal or distal; upper or lower limb; idiopathic or secondary deep vein thrombosis or pulmonary embolism, or both), and underlying risk factors, eg, cancer, previous VTE, estroprogestinic therapy, lack of prophylaxis, immobilization, surgery, pregnancy or puerperium, and medical diseases. Cases were grouped according to season and month of occurrence, and the data were analyzed by either the χ2 test for goodness of fit and chronobiological analysis. VTE was most frequent in Autumn and less frequent in Spring (32.9% vs 19%, respectively, χ2 = 90.62; P < .001). This pattern was shown for most subgroups. Chronobiological analysis identified a significant rhythmic annual pattern, with a main September—October peak for several subgroups (men, age 41—60 and 61—80 years, secondary event, previous VTE, immobilization), and a trend for most of the others. It is possible that subjects at increased risk could perhaps deserve appropriate or potentiated VTE prophylaxis in certain periods of the year.

Risk factors for venous thromboembolism in the elderly: results of the master registry.

Approximately 50–75% of patients with venous thromboembolism have a readily identifiable risk factor, either transient or permanent, whereas the remaining episodes are classified as unprovoked. The incidence of first-time venous thromboembolism rises exponentially with age. Whether the prevalence and the relative weight of major risk factors differ between elderly and younger patients is unclear. We performed a multicenter, prospective, observational study on consecutive patients with objectively confirmed acute venous thromboembolism admitted to 25 Italian hospitals. Baseline characteristics and information on temporary and permanent risk factors at the time of the index event were secured by an electronic data network. We enrolled 2119 patients (49.8% men), of whom 440 (20%) were more than 75 years of age and 1679 (79.2%) 75 years of age or less. Elderly patients were more likely to have pulmonary embolism at presentation (33.6 and 25.6%, respectively, P < 0.001). After binary logistic regression analysis, we found that the risk of venous thromboembolism in the elderly, compared with the younger age group, was significantly associated with immobilization (odds ratio: 2.46, 95% confidence interval: 1.85–3.27) and with severe medical disorders (odds ratio: 1.99, 95% confidence interval: 1.41–2.80), whereas male sex (odds ratio: 0.53, 95% confidence interval: 0.42–0.66), surgery (odds ratio: 0.61, 95% confidence interval: 0.43–0.85), and trauma (odds ratio: 0.49, 95% confidence interval: 0.31–0.77) were less common risk factors in the elderly than in younger patients. Use of thromboprophylaxis prior to the index event was not different between the two age groups. Severe medical disorders and immobilization are strongly associated with the occurrence of venous thromboembolism in the elderly. Our findings stress the need for adequate thromboprophylaxis in this setting.

Prophylaxis of upper limb deep vein thrombosis in cancer patients with central vein catheter.

Prophylaxis of upper limb deep vein thrombosis in cancer patients with central vein catheter -

Prophylaxis against venous thromboembolism in patients with cancer.

n engl j med 371;13 nejm.org september 25, 2014 1262 the best antithrombotic treatment for subclinical atrial fibrillation. In the meantime, however, clinicians who treat patients with stroke need to comprehensively address these patients’ vascular risk factors. In the face of uncertainty about whether or not subclinical atrial fibrillation is directly involved in the pathogenesis of stroke, a prudent evaluation of cryptogenic stroke includes thoroughly ascertaining the presence of atrial fibrillation and, at the very least, following it closely for progression, because subclinical atrial fibrillation frequently progresses to clinically apparent atrial fibrillation,1 which is associated with a high risk of stroke recurrence.3 The CRYSTAL AF and EMBRACE trials, which sought to determine the best strategy for ascertaining atrial fibrillation after stroke, showed that several weeks or more of continuous heart-rhythm monitoring detects atrial fibrillation more reliably than routine follow-up. Hooman Kamel, M.D.