scholarly journals Effectiveness and safety of rivaroxaban compared with low-molecular-weight heparin in cancer-associated thromboembolism

2020 ◽  
Vol 4 (17) ◽  
pp. 4045-4051
Author(s):  
Olivia S. Costa ◽  
Christine G. Kohn ◽  
Nicole M. Kuderer ◽  
Gary H. Lyman ◽  
Thomas J. Bunz ◽  
...  

Abstract Guidelines provide differing recommendations regarding direct-acting oral anticoagulants vs low-molecular-weight heparin (LMWH) for treatment of cancer-associated thrombosis (CAT). This study was undertaken to evaluate the effectiveness and safety of rivaroxaban vs LMWH for treatment of CAT. Using US Surveillance, Epidemiology and End Results-Medicare–linked data from 2013 through 2016, we evaluated adults with active breast, lung, ovarian, or pancreatic cancer, who were admitted to the hospital or treated in the emergency department for CAT and were prescribed rivaroxaban or LMWH for outpatient anticoagulation. Patients with luminal gastrointestinal or genitourinary cancers were excluded. Rivaroxaban and LMWH users were 1:1 propensity score matched. Outcomes included the composite of recurrent thrombosis or major bleeding, each outcome separately, and mortality at 6 months, using an intent-to-treat approach. On-treatment analysis after 12 months was also performed. Proportional hazards models for the subdistribution of competing risk were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). We included 529 rivaroxaban- and 529 LMWH-treated patients with CAT. Rivaroxaban was not associated with differences in risk of the composite outcome (HR, 0.71; 95% CI, 0.41-1.22), major bleeding (HR, 1.01; 95% CI, 0.50-2.01), or mortality (HR, 0.87; 95% CI, 0.70-1.07) vs LMWH, but it reduced recurrent thrombosis (HR, 0.37; 95% CI, 0.15-0.95). On-treatment analysis at 12 months showed similar results. Rivaroxaban may be a reasonable alternative to LMWH for patients with CAT without gastrointestinal or genitourinary cancer.

2018 ◽  
Vol 25 (4) ◽  
pp. 793-800 ◽  
Author(s):  
Megan K Phelps ◽  
Tracy E Wiczer ◽  
H Paige Erdeljac ◽  
Kelsey R Van Deusen ◽  
Kyle Porter ◽  
...  

Introduction Low-molecular-weight heparins are the standard treatment for cancer-associated thrombosis. Recently, direct oral anticoagulants are a new option for thrombosis treatment; however, data supporting the use of direct oral anticoagulants for cancer-associated thrombosis are limited. Objectives The primary objective of this study was to determine the rate of recurrent cancer-associated thrombosis and major bleeding within 6 months of starting either low-molecular-weight heparin or direct oral anticoagulant for treatment of cancer-associated thrombosis. Secondary objectives were to determine the rates of clinically relevant-non-major bleeding and all-cause mortality. Patients/methods This is a retrospective cohort study including adults with cancer-associated thrombosis treated with low-molecular-weight heparin or direct oral anticoagulant between 2010 and 2016 at the Ohio State University. Medical records were reviewed for 6 months after initiation of anticoagulation or until the occurrence of recurrent cancer-associated thrombosis, major bleeding, cessation of anticoagulation of interest, or death, whichever occurred first. Results Four hundred and eighty patients were included (290 low-molecular-weight heparin and 190 direct oral anticoagulant). Patients treated with direct oral anticoagulant were found to carry “lower risk” features including cancer with lower VTE risk and lower rate of metastatic disease. After adjustment for baseline differences, there was no significant difference in the rate of recurrent cancer-associated thrombosis (7.2% low-molecular-weight heparin vs 6.3% direct oral anticoagulant, p = 0.71) or major bleeding (7.6% low-molecular-weight heparin vs 2.6% direct oral anticoagulant, p = 0.08). Conclusions Our study demonstrates that in a select population of cancer patients with VTE, direct oral anticoagulant use can be as effective and safe compared to the standard therapy with low-molecular-weight heparin.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24102-e24102
Author(s):  
Melissa McShane ◽  
Jordan Senchak ◽  
Anthony Stack ◽  
Justina Frimpong ◽  
Van T Hellerslia ◽  
...  

e24102 Background: Over the past decade, there has been an increase in the use of direct oral anticoagulants (DOACs) in the cancer population despite limited data comparing its use against low molecular weight heparin (LMWH), the standard of care in cancer patients. Increasing data supporting DOACs in cancer-associated thrombosis has emerged over the past few years. Nonetheless, this study will evaluate the relative safety and efficacy of DOACs versus LMWH in cancer-associated thrombosis within an urban setting associated with low socioeconomic status. Methods: This is a retrospective chart review of medical records from patients treated at an urban academic medical center from October 2010 through October 2018. Patients met study inclusion if they had a diagnosis of venous thromboembolism occurring after the date of diagnosis of active cancer and were prescribed a direct oral anticoagulant (rivaroxaban, apixaban, dabigatran, edoxaban) or a low molecular weight heparin (dalteparin, enoxaparin, or fondaparinux) as monotherapy for the treatment of venous thromboembolic disease. Patients were excluded if they had less than 6 months of follow up data for reasons other than death. The primary outcomes were recurrent venous thromboembolism, major bleeding and death. Results: Of the 914 patients who met inclusion criteria, 286 were excluded due to lack of follow up data. The remaining patients included 472 in the LMWH arm and 156 in the DOAC arm. At 6 months, recurrent thromboembolism occurred in 5 of the 472 patients (1.1%) in the LMWH group as compared with 4 of the 156 patients (2.6%) in the DOAC group (p = 0.170). Major bleeding occurred in 36 patients (7.6%) in the LMWH group and 11 patients (7.0%) in the DOAC group (p = 0.813). Death within 6 months of starting anticoagulation occurred in 76 patients (16.1%) in the LMWH group and 16 patients (9.6%) in the DOAC group (p = 0.046). Discontinuation before 6 months of treatment occurred in 241 patients (51.2%) in the LMWH group and 46 patients (29.5%) in the DOAC group. Conclusions: The LMWH and DOAC groups had similar rates of recurrent thromboembolism and major bleeding. The mortality rate within 6 months of starting anticoagulation was significantly higher in the LMWH group and this difference requires further evaluation. These results help support the continued use of DOACs for the treatment of cancer-associated thrombosis and demonstrate that DOACs are as safe and effective as LMWH in this patient population.


2021 ◽  
Author(s):  
Tarinee Rungjirajittranon ◽  
Weerapat Owattanapanich ◽  
Yingyong Chinthammitr ◽  
Theera Ruchutrakool ◽  
Bundarika Suwanawiboon

Abstract BackgroundThe association between gastrointestinal (GI) cancer and a high incidence of venous thromboembolism (VTE) is well known. Previous randomized controlled studies demonstrated that direct oral anticoagulants (DOACs) effectively treat cancer-associated VTE (CAT). However, some DOACs appeared to increase the risk of bleeding, particularly in patients with GI malignancies. Therefore, the current systematic review and meta-analysis was conducted to evaluate the safety and efficacy of DOACs in GI cancer-associated thrombosis.MethodsAll relevant studies that compared DOACs and low-molecular-weight heparin (LMWH) in GI cancer-associated thrombosis that were published before December 2020 were individually searched in two databases (MEDLINE and EMBASE) by two investigators. The effect estimates and 95% confidence intervals (CI) from each eligible study were combined using the Mantel-Haenszel method.ResultsA total of 1,418 patients were included in this meta-analysis. The rate of major bleeding was not significantly different between groups (relative risk [RR]: 1.57, 95% CI: 0.93-2.65, P=0.09, I2=34%). However, the rate of clinically relevant non-major bleeding (CRNMB) was significantly higher in the DOACs group (RR: 1.98, 95% CI: 1.34-2.91, P=0.0005, I2=0%). The risk of recurrent VTE was not significantly different between groups (RR: 0.72, 95% CI: 0.41-1.28, P=0.27, I2=0%).ConclusionsThe current data suggests that treatment of GI cancer-associated thrombosis with DOACs significantly increases the risk of CRNMB, and a trend towards major bleeding risk in DOACs group. The efficacy of DOACs for preventing recurrent VTE in GI cancer was comparable to that of LMWHs.Trial registration: INPLASY202180113


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
A Abdul Razzack ◽  
N Hussain ◽  
S Adeel Hassan ◽  
S Mandava ◽  
F Yasmin ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background- Low molecular weight heparin (LMWH) and direct oral anticoagulants (DOACs) have been proven to be more effective in the management of venous thromboembolism (MVTE). The efficacy and safety of LMWH or DOACs in treatment of recurrent or malignancy induced VTE is not studied in literature. Objective To compare the efficacy and safety of LMWH and  DOACs in the management of malignancy induced  VTE Methods- Electronic databases ( PubMed, Embase, Scopus, Cochrane) were searched from inception to November  28th, 2020. Dichotomous data was extracted for prevention of VTE and risk of major bleeding in patients taking either LMWH or DOACs. Unadjusted odds ratios (OR) were calculated from dichotomous data using Mantel Haenszel (M-H) random-effects with statistical significance to be considered if the confidence interval excludes 1 and p < 0.05.  Results- Three studies with 2607 patients (DOACs n = 1301 ; LMWH n = 1306) were included in analysis. All the study population had active cancer of any kind diagnosed within the past 6 months. Average follow-up period for each trial was 6 months. Patients receiving DOACs have a lower odds of recurrence of MVTE as compared to LMWH( OR 1.56; 95% CI 1.17-2.09; P = 0.003, I2 = 0). There was no significant difference in major bleeding among patients receiving LMWH or DOACs  (OR-0.71, 95%CI 0.46-1.10, P = 0.13, I2 = 22%) (Figure 1). We had no publication bias in our results (Egger’s regression p > 0.05). Conclusion- DOACs are superior to LMWH in prevention of MVTE and have similar major bleeding risk as that of LMWH. Abstract Figure. A)VTE Recurrence B)Major Bleeding events


Author(s):  
Ayman Elbadawi ◽  
Mina Shnoda ◽  
Karim Mahmoud ◽  
Islam Y Elgendy

Abstract Aims To examine the efficacy and safety of direct oral anticoagulants (DOACs) vs. low molecular weight heparin (LMWH) in patients with cancer-related venous thromboembolism (VTE). Methods and results An electronic search of the MEDLINE, SCOPUS, and Cochrane databases without language restrictions was performed through April 2020 for randomized controlled trials that compared the outcomes with DOACs vs. LMWH among patients with cancer-related VTE. Summary estimates were reported using random effects model. The main efficacy outcome was VTE recurrence, while the main safety outcome was major bleeding . The final analysis included four randomized trials with a total of 2907 patients. The weighted mean follow-up was 6.1 months. Compared with LMWH, DOACs were associated with lower incidence of VTE recurrence [5.7% vs. 9.1%, risk ratio (RR) 0.62; 95% confidence interval (CI) 0.44–0.87; P = 0.01], driven by lower incidence of deep venous thrombosis (RR 0.60, 95% CI 0.39–0.93; P = 0.02). There was no difference in the incidence of major bleeding between DOACs and LMWH (4.8% vs. 3.6%, RR 1.33; 95% CI 0.84–2.11; P = 0.23). The incidence of all-cause mortality was similar (RR 0.99; 95% CI 0.84–1.16; P = 0.91). Subgroup analysis suggested no differences according to the type of DOAC regarding recurrent VTE or major bleeding (Pinteraction = 0.53 and Pinteraction = 0.11, respectively). Conclusion Among patients with cancer-related VTE, DOACs were associated with lower incidence of VTE recurrence and no difference in the incidence of major bleeding compared with LMWH. Future studies examining the subset of cancer patients who drive the most benefit are encouraged.


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4277-4277
Author(s):  
Mariasanta Napolitano ◽  
Giorgia Saccullo ◽  
Simona Raso ◽  
Salvatrice Mancuso ◽  
Alessandra Casuccio ◽  
...  

Abstract Introduction. The optimal duration of Low Molecular Weight Heparin (LMWH) after cancer associated deep vein thrombosis (DVT) is unknown; current guidelines suggest to prolong anticoagulation until cancer is active. We have recently demonstrated, in a randomized trial, that detection of Residual Vein Thrombosis (RVT) after 6 months of LMWH identify patients who require or not extension of therapy with anticoagulants (JCO in press). Now we present data of a prospective study evaluating a RVT-based management of patients with cancer-associated DVT, in whom LMWH has been extended up to 2 years in patients considered at high-risk for recurrent DVT because of persistence of RVT. Material and Methods. Patients were included at the time of a first diagnosis of cancer-associated DVT of the lower limbs. All received LMWH at therapeutic dosage for the first month (approximately 100 UI anti-FXa b.i.d.) then reduced at 75% for the following months. After 6 months of heparin, the presence of RVT was detected: those without RVT (no-RVT group) suspended treatment, while those with RVT (RVT group) continued LMWH for up to 2 years. Recurrent thrombosis and/or bleeding events were recorded during treatment and one year after LMWH withdrawal. Baseline differences between groups were assessed by the chi-square test (Yates’ correction) for categorical variables and ANOVA test or Kruskal-Wallis test for parametric and nonparametric analyses. Relative risks (RRs) and 95% confidence intervals (CIs) were evaluated. Results. Between January 2009 and April 2011, 211 cancer patients were enrolled; RVT was detected in 129 patients (61.1%). Recurrent VTE occurred in 19 (14.7%); 4 episodes (3.1%) occurred while on heparin. Among patients without RVT (82), 3 (3.6%) developed recurrent VTE (after LMWH therapy). Adjusted HR for RVT vs no-RVT group was 5.8 (95% CI, 1.9 to 19.2; p 0.0003). Three major bleeding events occurred in RVT group and one in no-RVT group (during LMWH administration). The HR for major bleeding (RVT vs no-RVT group) was 2.58 (95% CI, 0.66 to 12.43;p 0.103). Overall, 44 patients (20.8%) died during follow-up as a result of cancer progression. Conclusions. These results indicate that in patients without RVT, a short period of treatment with a LMWH is sufficient; in those with persistent RVT, treatment extended to 2 years substantially reduces, but does not eliminate, the risk of recurrent thrombosis. However, when still on LMWH, the risk for recurrent VTE is low. Disclosures No relevant conflicts of interest to declare.


Medwave ◽  
2021 ◽  
Vol 21 (04) ◽  
pp. e8178-e8178
Author(s):  
Natalia Méndez ◽  
Constanza Norambuena ◽  
Symón Silva ◽  
Valentín López

Introduction Low molecular weight heparin is currently the standard therapy for the primary prevention of thromboembolic disease in cancer patients. The use of direct-acting anticoagulants could be an alternative, but its efficacy and safety profile in these types of patients remains unclear. Methods We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple sources of information, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from identified reviews, analyzed data from primary studies, performed a meta-analysis, and prepared a summary table of results using the GRADE method. Results and conclusions We identified four systematic reviews that together included two primary studies, of which both correspond to trials. We conclude that the use of direct-acting oral anticoagulants probably increases the outcome of major bleeding and likely slightly increases the risk of thromboembolic disease. No studies were found that evaluated the outcome of quality of life or mortality.


2018 ◽  
Vol 24 (9_suppl) ◽  
pp. 182S-187S ◽  
Author(s):  
Diana M. Sobieraj ◽  
William L. Baker ◽  
Eni Smith ◽  
Katarzyna Sasiela ◽  
Stephanie E. Trexler ◽  
...  

To perform a systematic review and network meta-analysis evaluating the efficacy and safety of low-molecular-weight heparins (LMWHs), vitamin K antagonists (VKAs), and direct-acting oral anticoagulants (DOACs) for the treatment of cancer-associated thrombosis (CAT). We searched MEDLINE, Cochrane Central Register of Controlled Trials, and conference abstracts through March 2018. Randomized controlled trials (RCTs) enrolling adults with CAT comparing 2 or more full-dose anticoagulants (LMWH, VKA, and DOAC) and evaluating recurrent venous thromboembolism (VTE), major bleeding, and/or all-cause mortality were included. Reviewers identified studies, extracted data, and assessed the quality of the evidence in duplicate. A frequentist network meta-analysis, which uses direct and indirect evidence to simultaneously compare multiple interventions, was performed using a random-effects approach. Results are reported as pooled relative risks (RRs) with 95% confidence intervals (CIs). We included 13 RCTs (n = 6292): 7 compared LMWHs with VKAs, 4 compared DOACs with VKAs, and 2 compared DOACs with LMWHs. The risk of recurrent VTE was significantly reduced by 28% and 54% with a DOAC compared to an LMWH and a VKA, respectively. Low-molecular-weight heparins significantly reduced the risk of recurrent VTE by 36% versus VKAs. The risk of major bleeding was 14% higher with DOACs compared to LMWHs and 15% and 25% lower with DOACs and LMWHs versus VKAs, although 95% CIs included unity for each. The risk of all-cause mortality appeared similar for all 3 comparisons (RR = 1.0 for each comparison). Direct-acting oral anticoagulants appeared superior in reducing recurrent VTE in patients with CAT compared to LMWH and VKAs, but an increased risk of major bleeding versus LMWH cannot be ruled out.


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