Efficacy and safety profiles of mechanical and pharmacological thromboprophylaxis.
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ABSTRACT:
SUBMITTER: Ganau M
PROVIDER: S-EPMC6789350 | biostudies-literature | 2019 Sep
REPOSITORIES: biostudies-literature
Publications
Efficacy and safety profiles of mechanical and pharmacological thromboprophylaxis.
Ganau Mario M Ligarotti Gianfranco K I GKI Meloni Marco M Chibbaro Salvatore S
Annals of translational medicine 20190901 Suppl 6
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Project description:Thromboprophylaxis for venous thromboembolism is widely used in critically ill patients. However, only limited evidence exists regarding the efficacy and safety of the various thromboprophylaxis techniques, especially mechanical thromboprophylaxis. Therefore, we performed meta-analysis of randomized controlled trials (RCTs) that compared the overall incidence of deep vein thrombosis (DVT) for between unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and intermittent pneumatic compression (IPC) in critically ill patients. A Bayesian random effects model for multiple treatment comparisons was constructed. The primary outcome measure was the overall incidence of DVT at the longest follow-up. The secondary outcome measure was the incidence of major bleeding, as defined by the original trials. Our analysis included 8,622 patients from 12 RCTs. The incidence of DVT was significantly lower in patients treated with UFH (OR, 0.45; 95% CrI, 0.22-0.83) or LMWH (OR, 0.38; 95% CrI, 0.18-0.72) than in patients in the control group. IPC was associated with a reduced incidence of DVT compared to the control group, but the effect was not statistically significant (OR, 0.50; 95% CrI, 0.20-1.23). The risk of DVT was similar for patients treated with UFH and LMWH (OR, 1.16; 95% CrI, 0.68-2.11). The risk of major bleeding was similar between the treatment groups in medical critically ill patients and also in critically ill patients with a high risk of bleeding. In critically ill patients, the efficacy of mechanical thromboprophylaxis in reducing the risk of DVT is not as robust as those of pharmacological thromboprophylaxis.
| S-EPMC5056218 | biostudies-literature
Project description:Obesity increases the risk for venous thromboembolism (VTE), but whether high-dose thromboprophylaxis is safe and effective in morbidly obese inpatients is unknown. It was the objective of this study to quantify the efficacy and safety of high-dose thromboprophylaxis with heparin or enoxaparin in inpatients with weight >?100 kilograms (kg) within the BJC HealthCare system. Ina retrospective cohort study, we analysed 9,241 inpatients with weight >?100 kg discharged from three hospitals in the BJC HealthCare system from 2010 through 2012. We compared the incidence of VTE in patients who received high-dose thromboprophylaxis (heparin 7,500 units three times daily or enoxaparin 40 mg twice daily) to those who received standard doses (heparin 5,000 units two or three times daily or enoxaparin 40 mg once daily). The primary efficacy outcome was hospital-acquired VTE identified by International Classification of Diseases (ICD)-9 diagnosis codes. The primary safety outcome was bleeding events identified by ICD-9 codes. Among the 3,928 morbidly obese inpatients (weight >?100 kg and body mass index [BMI] ? 40 kg/m²), high-dose thromboprophylaxis approximately halved the odds of symptomatic VTE (odds ratio [OR] 0.52, 95% confidence interval [CI] 0.27-1.00; p = 0.050). The rate of VTE was 1.48% (35/2,369) in these morbidly obese inpatients who received standard doses of thromboprophylaxis, compared to 0.77% (12/1,559) in those who received high doses. High-dose thromboprophylaxis did not increase bleeding (OR 0.84, 95% CI 0.66-1.07, p = 0.15). Independent predictors of VTE were surgery, male sex, cancer, and BMI. In conclusion, high-dose thromboprophylaxis nearly halves the rate of VTE in morbidly obese inpatients.
| S-EPMC4505726 | biostudies-literature
Project description:BackgroundThrombosis is a common complication in patients with cancer. Whether thromboprophylaxis could benefit patients with cancer is unclear. The aim of this systematic review was to determine the efficacy and safety of thromboprophylaxis in patients with cancer undergoing surgery or chemotherapy.MethodsWe searched the Cochrane Library, EMBASE, MEDLINE, EBSCOhost, and Web of Science for studies published before May 2018 to investigate whether thromboprophylaxis measures were more effective than a placebo in patients with cancer.ResultsIn total, 33 trials with 11,942 patients with cancer were identified. In patients with cancer undergoing surgery, the administration of thromboprophylaxis was associated with decreasing trends in venous thromboembolism (VTE) [relative risk (RR) 0.51, 95% confidence interval (CI) 0.32-0.81] and DVT (RR 0.53, 95% CI 0.33-0.87). In patients with cancer undergoing chemotherapy, the administration of thromboprophylaxis reduced the incidences of VTE, DVT, and pulmonary embolism compared with no thromboprophylaxis (RR 0.54, 95% CI 0.40-0.73; RR 0.47, 95% CI 0.31-0.73; RR 0.51, 95% CI 0.32-0.81, respectively). The pooled results regarding major bleeding showed no significant difference between prophylaxis and no prophylaxis in either the surgical or the chemotherapy groups (RR 2.35, 95% CI 0.74-7.52, p = 0.1482, I2 = 0%; RR 1.30, 95% CI 0.93-1.83, p = 0.1274, I2 = 0%, respectively).ConclusionThromboprophylaxis did not increase major bleeding events or the incidence of thrombocytopenia. All-cause mortality was not significantly different between those who received thromboprophylaxis and those who did not. This meta-analysis provides evidence that thromboprophylaxis can reduce the number of VTE and DVT events, with no apparent increase in the incidence of major bleeding in patients with cancer.
| S-EPMC7081475 | biostudies-literature
Project description:BACKGROUND:Lymphangioleiomyomatosis (LAM) is a rare, low-grade multisystem neoplastic disease. Most LAM patients are at a high risk of losing lung function at an accelerated rate and developing progressive dyspnea. Recently, several studies have reported their experience with pharmacological treatments for LAM. Therefore, we conducted a systematic review and meta-analysis to assess the efficacy and safety of these therapies. METHODS:PubMed (Medline), EMBASE, Cochrane Library, Web of Science and EBSCO Host were searched (until March 31, 2019) for eligible prospective studies regarding LAM patients treated with pharmacological treatments. Random effect models were used for quantitative analysis. RESULTS:Fourteen prospective studies regarding five pharmacological treatments (including sirolimus, everolimus, doxycycline, triptorelin, and a combination therapy of sirolimus and hydroxychloroquine) were enrolled in our systematic review, and ten of them were used for the meta-analysis. Seven prospective studies reported that sirolimus was effective at improving or stabilizing lung function and alleviating renal angiomyolipoma (AML) in LAM patients. Subsequent quantitative analyses showed that during sirolimus treatment, the pooled values of lung function and 6-min walk distance (6MWD) were not significantly changed (P > 0.05), with the pooled response rate of AML being 0.62 (95% confidence intervals [CIs]: 0.43 to 0.82, I2 = 65%). Regarding everolimus, three prospective studies reported similar effects to those of sirolimus with regard to preserving lung function and reducing AMLs. The meta-analysis showed that the changes in lung function during everolimus treatment were not statistically significant (P > 0.05), while the pooled response rate of AML was 0.78 (95% CI: 0.68 to 0.88, I2 = 8%). Neither the qualitative nor the quantitative results confirmed the benefits of doxycycline or triptorelin treatment, and the effects of the combination therapy were unclear in LAM patients. Most of the adverse events during pharmacological treatments were low or moderate grade and tolerable. CONCLUSIONS:Overall, sirolimus and everolimus were recommended for the treatment of LAM because they could stabilize lung function and alleviate renal AML. Doxycycline and triptorelin were not recommended for the treatment of LAM because no beneficial outcomes were consistently observed. The efficacy and safety of combination therapy remain to be further explored.
| S-EPMC7023761 | biostudies-literature
Project description:ObjectiveOur purpose is to evaluate the efficacy and safety of pharmacologic thromboprophylaxis following caesarean section (CS).MethodsWe searched PubMed, Embase, and the Cochrane Library. Then the systematic review was performed by analysing studies that met the eligibility criteria.ResultsSeven studies with 1243 participants were included, including 6 RCTs and 1 prospective cohort. Results from the meta-analysis showed that low molecular weight heparin (LMWH) was associated with no obvious decrease in the risk of thrombus compared with UHF and negative control. However, LMWH was observed to be associated with a definite increase in the risk of bleeding or haematomas in comparison to negative control (RR: 8.47, CI: 1.52-47.11).ConclusionAccording to current evidences, the efficacy of pharmacologic thromboprophylaxis which increases the risk of bleeding or hematomas remains controversial.
| S-EPMC6287903 | biostudies-literature
Project description:ImportanceVenous thromboembolism (VTE) is a leading cause of morbidity and mortality after bariatric surgery. Clinical end point studies on thromboprophylaxis with direct oral anticoagulants in patients undergoing bariatric surgery are lacking.ObjectiveTo assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery.Design, setting, and participantsThis assessor-blinded, phase 2, multicenter randomized clinical trial was conducted from July 1, 2018, through June 30, 2021, with participants from 3 academic and nonacademic hospitals in Switzerland.InterventionPatients were randomized 1 day after bariatric surgery to 10 mg of oral rivaroxaban for either 7 days (short prophylaxis) or 28 days (long prophylaxis).Main outcomes and measuresThe primary efficacy outcome was the composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days after bariatric surgery. Main safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and mortality.ResultsOf 300 patients, 272 (mean [SD] age, 40.0 [12.1] years; 216 women [80.3%]; mean body mass index, 42.2) were randomized; 134 received a 7-day and 135 a 28-day VTE prophylaxis course with rivaroxaban. Only 1 thromboembolic event (0.4%) occurred (asymptomatic thrombosis in a patient undergoing sleeve gastrectomy with extended prophylaxis). Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm.Conclusions and relevanceIn this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups.Trial registrationClinicalTrials.gov Identifier: NCT03522259.
| S-EPMC10214035 | biostudies-literature
Project description:ObjectiveTo evaluate the cost-effectiveness of using mechanical thromboprophylaxis for patients undergoing a cesarean delivery in Brazil.MethodsA decision-analytic model built in TreeAge software was used to compare the cost and effectiveness of intermittent pneumatic compression to prophylaxis with low-molecular-weight heparin or no prophylaxis from the perspective of the hospital. Related adverse events were venous thromboembolism, minor bleeding, and major bleeding. Model data were sourced from peer-reviewed studies through a structured literature search. A willingness-to-pay threshold of R$15,000 per avoided adverse event was adopted. Scenario, one-way, and probabilistic sensitivity analyses were performed to evaluate the impact of uncertainties on the results.ResultsThe costs of care related to venous thromboembolism prophylaxis and associated adverse events ranged from R$914 for no prophylaxis to R$1,301 for low-molecular-weight heparin. With an incremental cost-effectiveness ratio of R$7,843 per adverse event avoided. Intermittent pneumatic compression was cost-effective compared to no prophylaxis. With lower costs and improved effectiveness, intermittent pneumatic compression dominated low-molecular-weight heparin. The probabilistic sensitivity analyses showed that the probability of being cost-effective was comparable for intermittent pneumatic compression and no prophylaxis, with low-molecular-weight heparin unlikely to be considered cost-effective (0.07).ConclusionsIntermittent pneumatic compression could be a cost-effective option and is likely to be more appropriate than low-molecular-weight heparin when used for venous thromboembolism prophylaxis for cesarean delivery in Brazil. Use of thromboprophylaxis should be a risk-stratified, individualized approach.
| S-EPMC10309987 | biostudies-literature
Project description:BackgroundVenous thrombosis represents a significant complication after deceased-donor liver transplantation, yet there are currently no established protocols for thromboprophylaxis after deceased-donor liver transplantation. The aim of this study was to evaluate the efficacy and safety of prophylactic anticoagulation in patients undergoing deceased-donor liver transplantation.MethodsA dual-centre RCT of patients assigned to receive either enoxaparin or normal saline after liver transplantation was conducted. The primary efficacy outcome was the incidence of venous thrombosis (portal vein thrombosis and deep vein thrombosis) and the primary safety outcome was the incidence of major bleeding.ResultsA total of 462 patients were recruited. In the intention-to-treat analysis, 89 patients (19.3%) experienced venous thrombosis and 141 patients (30.5%) experienced major bleeding within 90 days after transplantation. No significant differences were observed in the incidence of venous thrombosis, portal vein thrombosis, or deep vein thrombosis between the two groups in the intention-to-treat cohort. The anticoagulant group demonstrated a markedly elevated incidence of major bleeding (35.5% versus 25.5%, P = 0.020). Subgroup analysis revealed that anticoagulation was associated with a lower risk of deep vein thrombosis in hepatocellular carcinoma patients (HR 0.44 (95% c.i. 0.23 to 0.86), P = 0.016), without a significantly higher risk of major bleeding.ConclusionUse of prophylactic anticoagulation with enoxaparin is associated with a significantly higher incidence of major bleeding in patients undergoing deceased-donor liver transplantation, rather than a lower likelihood of venous thrombosis.Registration numberChiCTR2000032441 (www.chictr.org.cn).
| S-EPMC11848516 | biostudies-literature
Project description: Not available
| S-EPMC11910217 | biostudies-literature
Project description:BackgroundWe aimed to update the 2018 systematic literature review on the efficacy and safety of treatments for hand osteoarthritis (OA), which was based on 126 studies.MethodsWe performed a systematic literature search on randomised controlled trials from June 2017 up to 31 December 2023. Risk of bias was assessed using the RoB2 tool. Meta-analyses of previous and new studies regarding the efficacy for pain, function, grip strength and OMERACT/OARSI responders were performed. Certainty of evidence was judged using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) tool.ResultsSixty-five new studies were included. For non-pharmacological interventions, there was low-certainty evidence for a small long-term effect of hand exercises and a moderate long-term effect of thumb orthoses for pain, and moderate-certainty evidence that assistive devices had a moderate long-term effect on function. Concerning pharmacological interventions, there was low-certainty evidence for a moderate short-term effect of oral non-steroidal anti-inflammatory drugs (NSAIDs) on pain, high- and moderate-certainty evidence for a small short-term effect of topical NSAIDs and oral glucocorticoids on function, respectively, and low-certainty evidence that oral glucocorticoids had a small short-term effect on function. Further, there was low-certainty evidence that methotrexate had a small long-term effect on pain. The heterogeneity of studies did not allow for any meta-analyses on surgery.ConclusionThe results largely support current treatment recommendations. However, there is a lack of interventions that efficiently improve grip strength, and the evidence for most current treatments is still limited. To better understand action mechanism of different treatments, future trials should include hand OA subtyping and be powered for subgroup analyses.
| S-EPMC11749855 | biostudies-literature