Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy.
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ABSTRACT:
SUBMITTER: Di Nisio M
PROVIDER: S-EPMC6463937 | biostudies-literature | 2016 Dec
REPOSITORIES: biostudies-literature
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Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy.
Di Nisio Marcello M Porreca Ettore E Candeloro Matteo M De Tursi Michele M Russi Ilaria I Rutjes Anne Ws AW
The Cochrane database of systematic reviews 20161201
<h4>Background</h4>Venous thromboembolism (VTE) often complicates the clinical course of cancer. The risk is further increased by chemotherapy, but the trade-off between safety and efficacy of primary thromboprophylaxis in cancer patients treated with chemotherapy is uncertain. This is the second update of a review first published in February 2012.<h4>Objectives</h4>To assess the efficacy and safety of primary thromboprophylaxis for VTE in ambulatory cancer patients receiving chemotherapy compar ...[more]
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Project description:UnlabelledThe occurrence of malignant disease increases the risk for venous thromboembolism (VTE). Here we evaluate the risk for VTE in a large unselected cohort of patients with cancer receiving chemotherapy.MethodsThe United States IMPACT health care claims database was retrospectively analyzed to identify patients with a range of solid tumors who started chemotherapy from January 2005 through December 2008. International Classification of Diseases, 9th revision, Clinical Modification Codes were used to identify cancer location, presence of VTE 3.5 months and 12 months after starting chemotherapy, and incidence of major bleeding complications. Health care costs were assessed one year before initiation of chemotherapy and one year after initiation of chemotherapy.ResultsThe overall incidence of VTE 3.5 months after starting chemotherapy was 7.3% (range 4.6%-11.6% across cancer locations) rising to 13.5% at 12 months (range 9.8%-21.3%). The highest VTE risk was identified in patients with pancreatic, stomach, and lung cancer. Patients in whom VTE developed had a higher risk for major bleeding at 3.5 months and at 12 months (11.0% and 19.8% vs. 3.8% and 9.6%, respectively). Health care costs were significantly higher in patients in whom VTE developed.ConclusionThose undergoing chemotherapy as outpatients are at increased risk for VTE and for major bleeding complications. Thromboprophylaxis may be considered for such patients after carefully assessing the risks and benefits of treatment.
| S-EPMC3868427 | biostudies-literature
Project description:Immunomodulatory drugs (IMiDs), including thalidomide, lenalidomide, and pomalidomide, have improved survival of patients with multiple myeloma (MM). However, these therapies are associated with an increased risk of venous thromboembolism (VTE). Apixaban has been approved for treatment of acute VTE and for risk reduction of recurrent VTE following initial therapy. In this phase IV single-arm study (NCT02958969), we aim to prospectively evaluate the safety and efficacy of apixaban for primary prevention of VTE in patients with MM. The primary efficacy objective of this trial is to determine the rate of symptomatic VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), over 6 months. The primary safety objective is to determine the rate of major bleeding in MM patients receiving apixaban prophylaxis. If proven safe and effective, apixaban will emerge as a promising option for oral VTE prophylaxis in MM patients.
| S-EPMC6401636 | biostudies-literature
Project description:Efficacy of clinical guidelines to improve patient care is highly dependent on the ability of hospital teams to interpret and implement advised standards of care. Trimester and bi-annual rotation changes often see transference and loss of acquired experience and knowledge from wards with ensuing shortfalls in patient safety and care quality. Such shortfalls were noticed in the ability of our unit to adhere to national venous thromboembolism (VTE) prophylaxis measures. A prospective quality improvement audit was embarked upon to address this. An initial audit of VTE prophylaxis in 112 patients demonstrated just 71% compliance with suggested measures. Errors were predominantly medical in origin and secondary to poor understanding, interpretation, and knowledge of VTE guidelines. Errors were also noted in nursing and patient compliance to measures. Repeated re-auditing demonstrated increased error (following initial improvement post audit) after periods of medical staff rotation. Through education of junior medical and nursing staff, and of patients, the unit was able to achieve 100% compliance. Rota changes often induce conflict of interest between maintaining adequate services and high levels of patient care or providing suitable and informed induction programmes for new medical staff. Emphasised education of VTE prophylaxis guidelines has now become part of induction of junior medical staff, whilst ward based measures ensure daily compliance. The success of the audit strategy has led to its use throughout other surgical units within the hospital.
| S-EPMC4645802 | biostudies-literature
Project description:Extended venous thromboembolism prophylaxis (EVTEP) with low-molecular weight heparin such as enoxaparin for 28 days following surgery for cancer significantly reduces venous thromboembolic events compared to a standard 6-10 day course. National Institute of Clinical Excellence (NICE) guidelines suggest EVTEP should be offered to patients undergoing colorectal cancer surgery. Local EVTEP prescribing and monitoring guidelines in a busy inner city teaching hospital colorectal surgery unit, were devised to ensure NICE guidelines are followed. Adherence to local EVTEP guidelines was recorded through a retrospective audit of patients undergoing elective colorectal cancer surgery during February 2011 (n=19). Prospective re-audit cycles were undertaken during April-May (n=17) and September-December 2012 (n=17). The first audit cycle revealed that overall standards were not being met with just 11% of 'at risk' patients being correctly identified in pre-operative assessment clinic and continued low adherence to guidelines on the ward with only 44% of patients being prescribed EVTEP at discharge. Following each audit cycle, educational interventions were directed towards the multi-disciplinary team involved in the care of patients undergoing colorectal cancer surgery. This involved education of the team members regarding EVTEP, presentation of the audit results with instruction for improvement. Results of the second and third audit cycles showed improvements in guideline adherence with 100% of patients in these cohorts having been prescribed EVTEP at discharge. Marked improvements were also seen in the correct identification of 'at risk' patients, patient education in pre-operative assessment clinic, and warning of potential side-effects. This project has shown a significant global improvement in EVTEP-related patient care and adherence to local guidelines following education of the multi-disciplinary team involved, which consequently reduced the risk of venous thromboembolism within this patient cohort.
| S-EPMC4663830 | biostudies-literature
Project description:IntroductionVenous thromboembolism (VTE) is a common complication in patients with cancer and has a determining role in the disease prognosis. The risk is significantly increased with certain types of cancer, such as lung cancer. Partly due to difficulties in managing haemorrhage in outpatient settings, anticoagulant prophylaxis is only recommended for ambulatory patients at high risk of VTE. This requires a precise VTE risk assessment in individual patients. Although VTE risk assessment models have been developed and updated in recent years, there are conflicting reports on the effectiveness of such risk prediction models in patient management. The aim of this systematic review is to gain a better understanding of the available VTE risk assessment tools for ambulatory patients with lung cancer and compare their predictive performance.Methods and analysisA systematic review will be conducted using MEDLINE, Cochrane Library, CINAHL, Scopus and Web of Science databases from inception to 30 September 2021, to identify all reports published in English describing VTE risk prediction models which have included adult ambulatory patients with primary lung cancer for model development and/or validation. Two independent reviewers will conduct article screening, study selection, data extraction and quality assessment of the primary studies. Any disagreements will be referred to a third researcher to resolve. The included studies will be assessed for risk of bias and applicability. The Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies will be used for data extraction and appraisal. Data from similar studies will be used for meta-analysis to determine the incidence of VTE and the performance of the risk models.Ethics and disseminationEthics approval is not required. We will disseminate the results in a peer-reviewed journal.Prospero registration numberCRD42021245907.
| S-EPMC8638451 | biostudies-literature
Project description:ObjectiveTo study the impact of multiphase quality improvement efforts to enhance appropriate use of chemical and mechanical venous thromboembolism (VTE) prophylaxis (VTEP) on the rate of hospital-acquired VTE and determine whether efforts have been associated with increased bleeding complications.Patients and methodsAll adult inpatients discharged between January 1, 2005, and December 31, 2015, were included in the study. Retrospective interrupted time series analysis compared VTEP performance, VTE outcomes, and unintended consequences (derived from linked administrative and clinical data) across 5 improvement phases: baseline (January 1, 2005-December 31, 2006), paper order set phase (January 1, 2007-February 9, 2009), electronic order set phase (February 10, 2009-December 16, 2009), active reminder phase (December 17, 2009-May 31, 2012), and maintenance phase (June 1, 2012-September 30, 2015).ResultsGuideline VTEP plan adherence at the end of the study period (including documenting contraindications) reached 88.8% (654,138 of 736,384 patient days). Delivery of pharmacological VTEP increased from 43.9% (49,155 of 111,906 patients) to 60.8% (75,784 of 124,676 patients); delivery of mechanical or pharmacological VTEP increased less (65.0% [431,791 of 664,087 patient days] to 67.4% [496,625 of 736,384 patient days]). Mean VTE rates decreased from 4.6 per 1000 hospitalizations (21.7 VTEs per month) at baseline to 4.3 per 1000 hospitalizations (18.0 VTEs per month) during the maintenance phase (P<.001). More than 97% of patients who had development of VTE (534 of 548) received VTEP, but 65.7% (360 of 548) experienced gaps of 1 or more days in VTEP delivery. Measured in-hospital bleeding rates were fairly consistent over the study (4.6% [5,198 of 111,906 patients] at baseline to 5.3% [6,662 of 124,676 patients] during the reminder phase). There was little change in rates of 7-day readmission with bleeding or VTE.ConclusionOur VTEP project improved guideline compliance, increased the proportion of patients receiving VTEP, and was associated with a decrease in VTE. Gaps in VTEP delivery occurred despite protocoled order sets and electronic feedback. Further improvements in VTE may require new approaches.
| S-EPMC7140013 | biostudies-literature
Project description:Patients with pancreatic cancer (PC) carry the highest risk of venous thromboembolism (VTE) amongst all cancer patients. Appropriate use of primary thromboprophylaxis might significantly and safely reduce its burden. We performed a systematic review of published studies and meeting abstracts using MEDLINE and EMBASE through July 2020 to evaluate the efficacy and safety of primary thromboprophylaxis in ambulatory PC patients receiving chemotherapy. The Mantel-Haenszel random effect model was used to estimate the pooled event-based risk ratio (RR) and the pooled absolute risk difference (RD) with a 95% confidence interval (CI). Five randomized controlled studies with 1003 PC patients were included in this meta-analysis. Compared to placebo, thromboprophylaxis significantly decreased the risk of VTE (pooled RR 0.31, 95% CI 0.19-0.51, p < 0.00001, I2 = 8%; absolute RD -0.08, 95% CI -0.12--0.05, p < 0.00001, I2 = 0%), with an estimated number needed to treat of 11.9 patients to prevent one VTE event. Similar reductions of VTE were observed in studies with parenteral (RR 0.30, 95% CI 0.17-0.53) versus oral anticoagulants (RR 0.37, 95% CI 0.14-0.99) and in studies using prophylactic doses of anticoagulants (RR 0.34, 95% CI 0.17-0.70) versus supra-prophylactic doses of anticoagulants (RR 0.27, 95% CI 0.08-0.90). The pooled RR for major bleeding was 1.08 (95% CI 0.47-2.52, p = 0.85, I2 = 0%) and the absolute RD was 0.00 (95% CI -0.02-0.03, p = 0.85, I2 = 0%). Evidence supports a net clinical benefit of thromboprophylaxis in ambulatory PC patients receiving chemotherapy. Adequately powered randomized phase III studies assessing the most effective anticoagulant and the optimal dose, schedule and duration of thromboprophylaxis to be used are warranted.
| S-EPMC7464699 | biostudies-literature
Project description:BackgroundVenous thromboembolism (VTE) in ovarian cancer (OC) patients has been widely investigated, but our knowledge on the role of VTE in OC patients receiving chemotherapy is limited. The aim of our study was to investigate the prevalence, risk factors, and prognostic value of chemotherapy-associated VTE in OC.MethodsThree databases (PubMed, Embase, and the Cochrane Library) were systematically searched from inception to October 14, 2020. The primary outcome was the prevalence of VTE in OC patients receiving chemotherapy. The risk factors and prognostic value of VTE were the secondary outcomes. The pooled prevalence of VTE was estimated using the generic inverse-variance method. The statistical heterogeneity was evaluated with Cochran's Q test and I2 statistic. Funnel plot, Begg's test, and Egger's test were used to assess the potential publication bias in the meta-analysis.ResultsA total of eleven observational studies with 4759 OC patients were included. The pooled prevalence of VTE was 9% (95% CI, 0.06-0.12) in OC patients receiving chemotherapy. The results of subgroup analysis and sensitivity analysis were basically consistent with the overall pooled estimate. Multiple significant risk factors associated with VTE were also identified including advanced age, D-dimer > 0.5 mg/mL, and tumor diameter > 10 cm. Only two included studies reported the prognostic value of VTE in OC patients receiving chemotherapy, but with inconsistent results. Funnel plot showed that there existed potential publication bias, which was further verified by statistical test, but the results of the trim-and-fill method showed the pooled estimate kept stable after adding two "missing" studies.ConclusionsThis current study revealed that the pooled prevalence of chemotherapy-related VTE in OC was approximately 9% in OC patients. Risk factors for chemotherapy-related VTE were also identified which may contribute to targeting potentially preventative measures for VTE in OC.
| S-EPMC7807708 | biostudies-literature
Project description: Not available
| S-EPMC7389147 | biostudies-literature
Project description:Background The purpose of this study was to investigate the association between anticoagulant dosing intensity in coronavirus disease 2019 (COVID-19) infected patients and its outcomes on venous thromboembolism (VTE) and all-cause mortality. Methods This is a retrospective observational study that examined different anticoagulation regimens among COVID-19 patients for prophylaxis of VTE. Primary outcomes of the study were VTE incidence and all-cause mortality for patients receiving prophylaxis-intensity (PPX) and therapeutic-intensity (TX) anticoagulation. Secondary outcomes were incidence of hemorrhagic events and hospital length of stay. Patients were matched (1:1) based on age and Charlson comorbidity score. Sub-group analyses evaluated outcomes within critically ill patients, between specific anticoagulant agents and comorbid conditions. Results The primary outcome of VTE occurred in six patients within the prophylactic dose group and eight patients in the therapeutic-intensity dose group (risk ratio (RR): 2.02 (95% confidence interval (CI): 0.7 - 5.2); P = 0.2). Bleeding occurred in 15 (11%) patients in the prophylactic group and 27 (19%) patients in the therapeutic group (RR: 0.5 (95% CI: 0.3 - 1.0); P < 0.049). Hospital length of stay was shorter by 4 days in those treated with prophylactic-intensity anticoagulation (P = 0.003). Intensive care unit admission and ventilation were negatively correlated with mortality in a multivariate analysis. Conclusions Among hospitalized COVID-19 patients, the use of therapeutic-intensity anticoagulation did not show any benefits in reducing the occurrence of VTE. An increase in mortality and in the incidence of hemorrhagic events was statistically significant in the therapeutic-intensity group. Future prospective studies are warranted to evaluate anticoagulation therapy in COVID-19 infected patients.
| S-EPMC9635799 | biostudies-literature