Benefits versus risks of pharmacological prophylaxis to prevent symptomatic venous thromboembolism in unselected medical patients revisited. Meta-analysis of the medical literature

2012 ◽  
Vol 34 (1) ◽  
pp. 11-19 ◽  
Author(s):  
Moshe Vardi ◽  
Michal Steinberg ◽  
Michal Haran ◽  
Shai Cohen
2021 ◽  
pp. 26-40
Author(s):  
A. B. Sugraliyev ◽  
Sh. S. Aktayeva ◽  
Sh. B. Zhangelova ◽  
S. A. Shiller ◽  
Zh. M. Kussymzhanova ◽  
...  

Introduction. Venous thromboembolism (VTE) is a major public health issue that is frequently underestimated. The primary objective of this multicenter study was to identify patients at risk for VTE, and to define the rate of patients receiving appropriate prophylaxis in the regions of Kazakhstan.Materials and methods. Standardized case report forms were filled by trained medical doctors on one predefined day in selected hospitals. Data were analyzed by independent biostatistician. Risk of VTE was categorized according to Caprini score which was recommended by 2004 American College of Chest Physicians (ACCP) guidelines.Results. 432 patients from 4 regions of Kazakhstan; 169 (39.10%) medical patients and 263 (60.9%) surgical patients were eligible for the study. Patients were at low (10%), moderate (19.2%), high (33.6%) and very high risk (37.3%) for VTE. The main risk factors (RF) of VTE among hospitalized patients were heart failure (HF), obesity, prolonged bed rest, and the presence of acute non-infective inflammation. From total number of hospitalized patients with RF with indications to VTE prophylaxis, 58.1% of patients received pharmacological prophylaxis and only 24.6% of them received VTE prophylaxis according ACCP. On the other hand, 23.5% patients with the risk of VTE but who were not eligible for it received pharmacological prophylaxis.Conclusion. These results indicate the existence of inconsistency between eligibility for VTE prophylaxis on one hand and its application in practice (p < 0.001). Risk factors for VTE and eligibility for VTE prophylaxis are common, but VTE prophylaxis and guidelines application are low.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 905-905
Author(s):  
Francesco Dentali ◽  
Monica Gianni ◽  
Wendy Lim ◽  
James D. Douketis

Abstract Background: Despite good evidence that anticoagulants are effective in preventing venous thromboembolism in medical patients at risk for this disease, only one-third of such patients are receiving thromboprophylaxis. Underutilization of thromboprophylaxis in medical patients may be due to lack of evidence that thromboprophylaxis reduces mortality, concerns about anticoagulant-related bleeding, and questions about the clinical significance of surrogate (venographic) outcomes to assess efficacy in these trials. We performed a meta-analysis of randomized, placebo-controlled trials of anticoagulant thromboprophylaxis in medical patients to assess effects on mortality and bleeding. Methods: The MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases were searched until June 2005. Studies were included that were randomized, placebo-controlled trials investigated a prophylactic dose of unfractionated heparin, low-molecular-weight heparin, or fondaparinux in medical patients. Meta-analysis was done to obtain pooled estimates of the effects of anticoagulant thromboprophylaxis on mortality and clinically important (major) bleeding. The effect of treatment on venous thromboembolism was not pooled because of across-study difference in methods used to diagnose this, and use of asymptomatic (venographic) outcomes in some studies. Results: There were 8 studies of 20,631 patients in the assessment of mortality and 4 studies of 5,428 patients in the assessment of major bleeding. Death occurred in 536 of 10,321 (5.2%) patients who received thromboprophylaxis, and in 608 of 10,510 (5.8%) who received placebo. Thromboprophylaxis was associated with 10% decreased risk for all-cause mortality, although this effect was not quite statistically significant (odds ratio [OR] = 0.90; 95% confidence interval [CI]: 0.81, 1.01). Major bleeding occurred in 22 of 2,726 (0.8%) patients who received thromboprophylaxis, and in 11 of 2,702 (0.4%) patients who received placebo. Thromboprophylaxis was associated with 2-fold increased risk for major bleeding, although this effect was not quite statistically significant (OR = 2.04; 95% CI: 0.98, 4.23). Conclusion: In medical patients who are at increased risk for venous thromboembolism, anticoagulant thromboprophylaxis appears to confer a small reduction in mortality; this benefit should be balanced against an increased risk for major bleeding.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8019-8019 ◽  
Author(s):  
Brigitte Pegourie ◽  
Gilles Pernod ◽  
Lionel Karlin ◽  
Lofti Benboubker ◽  
Frederique Orsini ◽  
...  

8019 Background: The risk of venous thromboembolism (VTE) is higher in myeloma patients recieving IMiD* compounds (IMiD*: registered). A VTE prophylaxis using low-molecular-weight heparin or aspirin is proposed. Apixaban is an oral direct anti-Xa. Several studies have shown the efficiency and safety of apixaban in VTE prophylaxis compared to enoxaparin. The objective of this prospective pilot study was to assess the risk of VTE and bleeding in patients with myeloma treated with IMiD* compounds, using apixaban in a preventive scheme. Methods: Myeloma patients requiring Melphalan-Prednisone-Thalidomide in first line, or Lenalidomide-Dexamethasone in relapse, asymptomatic regarding VTE at inclusion, were enrolled between 2014 - 2016. All patients recieved apixaban, 2.5 mg x 2/day for 6 months, and were monthly monitored. Venous (pulmonary embolism – PE, or symptomatic proximal or distal deep vein thrombosis - DVT, or all proximal asymptomatic events detected by systematic proximal bilateral compression ultrasound) or arterial thrombotic events, and bleeding events (ISTH 2005) were registered. Based on meta-analysis of Carrier regarding VTE recurrence, and results from the ADOPT study in medical conditions regarding hemorrhages, < 13 symptomatic VTE events, < 3 severe and < 14 clinically relevant non major (CRNM) bleeding were expected on the treatment period. Results: 104 patients were enrolled (mean age 69.8 +/- 7.8yrs), 11 in first line, 93 in relapse. No PE or arterial cardiovascular events were reported. Two venous thrombotic events were registered, i.e an asymptomatic proximal DVT (patient in relapse) and a symptomatic distal DVT, although apixaban was stopped 14 days before, due to Lenalidomide-induced thrombopenia. Only one major and 11 CRNM hemorrhages were reported. Conclusions: Referring to the incidence of thromboembolic events in Carrier’s meta-analysis, and to hemorrhagic events in medical patients recieving apixaban in primary VTE prophylaxis, apixaban used in a preventive scheme seems to be efficient and safe in preventing VTE in myeloma patients treated with IMiD* compounds. Clinical trial information: NCT02066454.


2000 ◽  
Vol 83 (01) ◽  
pp. 14-19 ◽  
Author(s):  
Silvy Laporte-Simitsidis ◽  
Bernard Tardy ◽  
Michel Cucherat ◽  
Andréa Buchmüller ◽  
Daphné Juillard-Delsart ◽  
...  

SummaryThe prevention of venous thromboembolic disease is less studied in medical patients than in surgery.We performed a meta-analysis of randomised trials studying prophylactic unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in internal medicine, excluding acute myocardial infarction or ischaemic stroke. Deepvein thrombosis (DVT) systematically detected at the end of the treatment period, clinical pulmonary embolism (PE), death and major bleeding were recorded.Seven trials comparing a prophylactic heparin treatment to a control (15,095 patients) were selected. A significant decrease in DVT and in clinical PE were observed with heparins as compared to control (risk reductions = 56% and 58% respectively, p <0.001 in both cases), without significant difference in the incidence of major bleedings or deaths. Nine trials comparing LMWH to UFH (4,669 patients) were also included. No significant effect was observed on either DVT, clinical PE or mortality. However LMWH reduced by 52% the risk of major haemorrhage (p = 0.049).This meta-analysis, based on the pooling of data available for several heparins, shows that heparins are beneficial in the prevention of venous thromboembolism in internal medicine.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 676-676
Author(s):  
Jacqueline M. Cohen ◽  
David Morrison ◽  
Ian Shrier ◽  
Vicky Tagalakis ◽  
Jessica D. Emed ◽  
...  

Abstract Abstract 676 Introduction: Venous thromboembolism (VTE) is a leading cause of morbidity and mortality in hospitalized patients. Numerous randomized clinical trials (RCTs) show that the use of thromboprophylaxis in hospitalized patients at risk for VTE is safe, effective and cost-effective. Despite this, prophylactic therapies for VTE are underutilized. System-wide interventions may be more effective to improve the use of VTE prophylaxis than relying on individual providers' prescribing behaviors. Objectives: In this review, we aimed to determine the effectiveness of various system-wide interventions designed to increase the use of thromboprophylaxis in hospitalized medical and surgical patients at risk for VTE. Methods: We searched MEDLINE, EMBASE, and SCOPUS databases to identify studies that assessed an intervention designed to increase use of prophylaxis and/or decrease incidence of VTE. Extracted data included study design, setting, intervention, and outcomes including proportions receiving prophylaxis (RP) and receiving appropriate prophylaxis (RAP). Risk of bias was assessed using Cochrane guidelines. We performed meta-analysis for RCTs and non-randomized studies (NRS) separately. We categorized the interventions into three groups: education (e.g. grand rounds, self-administered course), alerts (e.g. electronic, human), and multifaceted interventions (e.g. combination of education, audit and feedback and alert). We performed a random effects meta-analysis and assessed heterogeneity using the I2 statistic. Results were pooled if three or more studies were available for a particular intervention group. Results: Out of 1802 records included in our primary screen of titles and abstracts, 79 studies were assessed for eligibility. Fifty-six studies were included in our systematic review, including eight RCTs (N=17,601) and 48 NRS (N=62,770). Among the RCTS, 4 studies included medical patients, 2 included medical and surgical patients, 1 included post-acute care patients and 1 did not report the types of patients included. The NRS were primarily before-and-after design. Fourteen included surgical patients, 10 included medical patients, 10 included medical and surgical patients, 8 included patients from other departments and 6 did not report the types of patients included. Our primary outcomes included received prophylaxis (RP) and received appropriate prophylaxis (RAP). Among the RCTs, there was sufficient data to pool one outcome (RP) for one intervention type (alert). Among the NRS, there was sufficient data to pool two outcomes (RP, RAP) for each intervention type (education, alert, multifaceted). I2 results showed substantial statistical heterogeneity among studies. A sensitivity analysis showed that multifaceted interventions which included an alert were more effective at improving rates of RP and RAP than those without an alert. Conclusions: We reviewed a large number of studies which implemented a variety of system-wide strategies aimed to improve thromboprophylaxis rates in many settings and patient populations. We found statistically significant improvements in prescription of prophylaxis associated with alerts and multifaceted interventions, and improvements in prescription of appropriate prophylaxis with the use of education, alerts or multifaceted interventions. Multifaceted interventions with an alert component seem to be the most effective. We chose to pool effect estimates despite significant heterogeneity because the results were generally in the same direction but of different magnitudes. We are continuing to investigate sources of heterogeneity including patient population, setting, baseline prophylaxis rates, and intervention characteristics. The results of our review will help physicians, hospital administrators and policy makers make practical decisions about adoption of specific system-wide measures to improve prevention of VTE. Funded by Canadian Institutes for Health Research Disclosures: Kahn: sanofi aventis: Honoraria, Research Funding; Leo Pharma: Honoraria.


2019 ◽  
Vol 119 (09) ◽  
pp. 1517-1526
Author(s):  
Jian Xie ◽  
Mingyang Jiang ◽  
Yunni Lin ◽  
Huachu Deng ◽  
Xiaoyong Xie ◽  
...  

Aim This article evaluates the preventive effects of rivaroxaban versus aspirin on venous thromboembolism (VTE) through meta-analysis of recent randomized controlled trials (RCTs). Methods RCTs were retrieved from medical literature databases. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated to compare the primary and safety endpoints. Results In total, 9 trials (11 trial comparisons) were retrieved which contained 7,656 patients. Among these patients, 4,383 patients (57.2%) received rivaroxaban, whereas 3,273 patients (42.8%) received aspirin. Compared with aspirin, rivaroxaban significantly reduced VTE (1.3% vs. 3.5%) (RR: 0.36, 95% CI, 0.26–0.48, I 2 = 27.9%), but significantly increased nonmajor bleeding (11.5% vs. 7.5%) (RR: 1.28, 95% CI, 1.13–1.44, I 2 = 38.6%). There were no significant differences in the all-cause mortality (0.3% vs. 0.3%) (RR: 0.75, 95% CI, 0.35–1.61, I 2 = 32.0%) and major bleeding (0.3% vs. 0.4%) (RR: 0.81, 95% CI, 0.42–1.55, I 2 = 33.7%) between the two groups. Conclusion This meta-analysis indicated that rivaroxaban can significantly reduce the incidence of VTE when compared with aspirin. The preventive effect of rivaroxaban on VTE was more potent than that of aspirin. However, rivaroxaban had some negative side effects to patients such as nonmajor bleeding compared to aspirin.


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