Dataset Information

Postoperative decreased levels of D-dimer in patients with gynecologic cancer with enoxaparin and fondaparinux thromboprophylaxis.

ABSTRACT: The purpose of the present study was to evaluate the effects of enoxaparin (ENO) and fondaparinux (FPX) on postoperative plasma D-dimer levels and risk factors associated with postoperative venous thromboembolism (VTE) and pulmonary thromboembolism (PTE) in patients with gynecologic cancer. For this study, 434 patients with gynecologic cancer were recruited and a surgical treatment strategy was employed. Plasma D-dimer levels were measured prior to surgery, as well as on a schedule up to 3 weeks postoperatively and again after day 28. Patients with clinical signs and elevation of the plasma D-dimer level underwent multidetector row computed tomography. The D-dimer value was significantly lower in patients with ENO or FPX on postoperative days 3-10 compared to patients with gynecologic cancers who were not receiving ENO or FPX. The D-dimer value was significantly lower in patients with FPX compared to patients with ENO on postoperative days 5-7. The D-dimer value on postoperative day 3, the use of erythropoiesis-stimulating agents (ESAs), advancing age and non-O blood group were independent risk factors for postoperative VTE. The D-dimer value on postoperative day 3 and the use of ESAs were independent risk factors for postoperative PTE. The postoperative D-dimer value was significantly lower in patients with gynecologic cancer who were administered ENO or FPX compared to patients were not administered either ENO or FPX. The use of ESAs and high plasma D-dimer levels on postoperative day 3 were independent risk factors for postoperative VTE and PTE.

SUBMITTER: Kodama J

PROVIDER: S-EPMC3915345 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Postoperative decreased levels of D-dimer in patients with gynecologic cancer with enoxaparin and fondaparinux thromboprophylaxis.

Kodama Junichi J Seki Noriko N Fukushima Chikako C Kusumoto Tomoyuki T Nakamura Keiichiro K Hiramatsu Yuji Y

Molecular and clinical oncology 20130514 4

The purpose of the present study was to evaluate the effects of enoxaparin (ENO) and fondaparinux (FPX) on postoperative plasma D-dimer levels and risk factors associated with postoperative venous thromboembolism (VTE) and pulmonary thromboembolism (PTE) in patients with gynecologic cancer. For this study, 434 patients with gynecologic cancer were recruited and a surgical treatment strategy was employed. Plasma D-dimer levels were measured prior to surgery, as well as on a schedule up to 3 weeks ...[more]

PMID: 24649238

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Project description:BackgroundAcute coronary syndrome (ACS) refers to a spectrum of life-threatening cardiac diseases usually due to coronary artery plaque rupture, subsequent thrombin generation plaque activation and thrombus formation. To date, no economic analyses have been published about the use of fondaparinux in NSTE-ACS patients in Canada. The purpose of our study is to estimate the lifetime cost-effectiveness of fondaparinux compared to enoxaparin for non-ST-elevation acute coronary syndrome (NSTE-ACS) patients in a Canadian hospital setting.MethodsAs an extension of a previous published economic analysis for US patients, an event-based decision analytic model was constructed using clinical and resource use data from OASIS-5, a randomized trial of 20,078 patients from 41 countries. A public payer perspective in the hospital setting was adopted. Resource use data from the trial were valued using Canadian costs. A cost regression model was developed to estimate the mean cost of managing the clinical events over the 180 day period. Annual costs of long-term care for ACS patients were added after 180 days until death. Long-term survival was incorporated using Canadian life tables with further adjustment for additional risks associated with NSTE-ACS. Quality-of-life (utility) decrements from published sources were applied to clinical events. Lifetime costs (2009 CAD$) and quality-adjusted life-years (QALYs), discounted annually at 5 %, were estimated for the typical patient in OASIS-5 (i.e., at mean covariate values).ResultsThe trial data showed that fondaparinux is protective against all clinical events observed in the trial. The model showed that: over 180 days, fondaparinux dominates enoxaparin, producing similar estimates of QALYs gained and saving $439; over a patient's lifetime, fondaparinux yields an ICER of $4293/QALY. Based on PSA, the probabilities that fondaparinux dominates enoxaparin (less costly and more effective) and that is cost-effective at a $50,000 threshold were 42 % and 96 %, respectively.ConclusionsIn the Canadian hospital setting, fondaparinux is cost-effective when compared to enoxaparin for the treatment of NSTE-ACS. This result holds both in the immediate post-event period and over the lifetimes of patients.

Project description:BackgroundVenous thromboembolism (VTE) is a leading cause of maternal mortality and morbidity, with the highest incidence occurring during the postpartum period. This study compared the ability of two types of low-molecular-weight heparin, enoxaparin and bemiparin, to decrease the incidence of VTE following elective caesarean section, emergency caesarean section, and vaginal delivery in women who had risk factors for thromboembolism.MethodsIn this prospective clinical trial using a sequential group allocation method, 7020 haemodynamically stable women delivered vaginally or abdominally at the Maternity Teaching Hospital, Kurdistan region, Erbil, Iraq, between May 1, 2012, and November 1, 2013. These women had risk factors for VTE and were allocated to the following groups: treatment with 3500 IU/day of bemiparin, 4000 IU/day of enoxaparin, or no intervention (control). The first dose was administered 6 hours after vaginal or abdominal delivery, or 8 hours after delivery in women receiving spinal anaesthesia. Subsequent doses were administered daily for up to 6 days. The incidence of VTE was assessed for up to 40 days postpartum. Data were analyzed using the Statistical Package for Social Sciences version 19. Proportions were compared using the chi square test of association or Fisher's exact test. Binary logistic regression analysis was used with VTE as the dependent variable.ResultsVTE occurred in 1 (0.042%) woman in the bemiparin group, two (0.085%) women in the enoxaparin group, and nine (0.384%) women in the control group (P = 0.017). Regression analysis showed that women on bemiparin (OR = 0.106; 95% CI = 0.013-0.838) and enoxaparin (OR = 0.226; 95% CI = 0.049-1.049) were at lower risk of developing VTE than control women. Adverse events in the enoxaparin group included wound dehiscence, haematoma, and separation. None of these occurred in the bemiparin group.ConclusionsPostpartum bemiparin is significantly effective as a prophylaxis for VTE. Wound complications develop after use of enoxaparin, but not after bemiparin.Trial registrationClinicalTrials.gov; Identifier: NCT01588171 ; date: April 26, 2012.

Project description:ImportanceCurrent guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic.ObjectiveTo investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer.Design, setting, and participantsThis was a patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. Women undergoing surgery for suspected or confirmed gynecologic cancer were approached for recruitment. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis. Data analysis was performed from October to December 2019.InterventionsWomen were randomized to 28 days of apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously daily).Main outcomes and measuresThe primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction.ResultsOf 500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received apixaban and 196 received enoxaparin. Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic). There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88; 95% CI, 0.87-4.1; P = .11), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57; 95% CI, 0.26-9.50; P = .68), adverse events, medication adherence, or quality of life between the groups. Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 patients [58.8%]; OR, 0.06; 95% CI, 0.01-0.25; P < .001) and pain associated with taking the medication (4 patients [2.1%] vs 92 patients [49.2%]; OR, 9.20; 95% CI, 2.67-31.82; P < .001).Conclusions and relevanceThese findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent.Trial registrationClinicalTrials.gov Identifier: NCT02366871.

Dataset Information

Postoperative decreased levels of D-dimer in patients with gynecologic cancer with enoxaparin and fondaparinux thromboprophylaxis.

Publications

Postoperative decreased levels of D-dimer in patients with gynecologic cancer with enoxaparin and fondaparinux thromboprophylaxis.

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