Treatment with dabigatran or warfarin in patients with venous thromboembolism and cancer

2015 ◽  
Vol 114 (07) ◽  
pp. 150-157 ◽  
Author(s):  
Samuel Z. Goldhaber ◽  
Clive Kearon ◽  
Ajay K. Kakkar ◽  
Sebastian Schellong ◽  
Henry Eriksson ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Treatment Period ◽  
Low Molecular Weight ◽  
Efficacy And Safety ◽  
Patients With Cancer ◽  
Efficacy Outcome ◽  
Significant Difference ◽  
Recurrent Vte ◽  
Active Cancer ◽  
Similar Incidence

SummaryThe efficacy and safety of dabigatran for treatment of venous thromboembolism (VTE) were demonstrated in two trials. It is unclear if the results pertain to patients with cancer and VTE. Data from two randomised trials comparing dabigatran and warfarin for acute VTE were pooled. Primary efficacy outcome was symptomatic recurrent VTE and related death from randomisation to the end of the treatment period. Safety outcomes were major, major and clinically relevant non-major, and any bleeding during the oral-only treatment period. Patients with active cancer (=within 5 years) at baseline or diagnosed during the study were analysed. Compared with 4,772 patients without cancer, recurrent VTE occurred more frequently in 335 patients with cancer at any time (hazard ratio [HR] 3.3; 95 % confidence interval [CI], 2.1–5.3) and more often in 114 with cancer diagnosed during the study compared to 221 with cancer at baseline (HR 2.6; 95 % CI, 1.1–6.2). There was no significant difference in efficacy between dabigatran and warfarin for cancer at baseline (HR 0.75; 95 % CI, 0.20–2.8) or diagnosed during the study (HR 0.63; 95 % CI, 0.20–2.0). Major bleeding (HR 4.1; 95 % CI, 2.2–7.5) and any bleeding (HR 1.5; 95 % CI, 1.2–2.0) were more frequent in patients with cancer than without, but with similar incidence in cancer with dabigatran or warfarin. In conclusion, in cancer patients, dabigatran provided similar clinical benefit as warfarin. VTE recurrence or bleeding were similar in patients on dabigatran or warfarin. The efficacy of dabigatran has not been assessed in comparison with low-molecular-weight heparin.

Cancer-Associated Venous Thromboembolism Treatment With Anti-Xa Versus Weight-Based Enoxaparin: A Retrospective Evaluation of Safety and Efficacy

2021 ◽  
pp. 106002802098836
Author(s):  
Kayla Hart ◽  
Benjamin Andrick ◽  
Stacey Grassi ◽  
Jesse Manikowski ◽  
Jove Graham
Keyword(s):  
Venous Thromboembolism ◽  
Low Molecular Weight ◽  
Retrospective Evaluation ◽  
Inclusion Criteria ◽  
Health Records ◽  
Patients With Cancer ◽  
Major Bleed ◽  
Significant Difference ◽  
Recurrent Vte ◽  
Using Data

Background Venous thromboembolism (VTE) is a complication of cancer, for which low-molecular-weight heparin (LMWH) remains the preferred anticoagulant. Enoxaparin is traditionally dosed using weight. In certain populations, monitoring anti-Xa levels for therapeutic effect provides pharmacokinetic guidance for dose adjustments. There is a paucity of data regarding anti-Xa–directed enoxaparin dosing for treatment of VTE in patients with cancer. Objective This study aims to evaluate efficacy (recurrent VTE) and safety (major bleed) between enoxaparin anti-Xa–guided dose adjustments and weight-based dosing in patients with cancer-associated VTE. Methods This single-center, retrospective cohort study examined patients treated with enoxaparin for cancer-associated VTE using data from electronic health records. Results There were 674 patients who met the inclusion criteria, with 283 receiving anti-Xa–directed dose adjustments. Recurrent VTE, major bleed, or all-cause death occurred in 102 of 283 patients (36%) in the anti-Xa cohort and 166 of 391 patients (42.5%) in the weight-based cohort (hazard ratio [HR] = 0.73; 95% CI = 0.57-0.93; P = 0.01). When death was removed from the composite end point, there was no significant difference between the cohorts in recurrent VTE or major bleed (HR = 1.18; P = 0.38). In the anti-Xa cohort, a total of 1584 anti-Xa peak levels were collected, with 1324 (83.6%) drawn correctly in relation to enoxaparin administration. Of those, 714 (53.9%) were within therapeutic range. Conclusion and Relevance Patients with cancer receiving anti-Xa–guided enoxaparin dose adjustments for initial VTE, compared with weight-based dosing, had no significant difference in the rate of recurrent VTE or major bleed.

scholarly journals Safety and efficacy of direct oral anticoagulants (DOACs) vs low molecular weight heparin (LMWH) in malignancy induced venous thromboembolism-a systematic review and meta analysis

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
A Abdul Razzack ◽  
N Hussain ◽  
S Adeel Hassan ◽  
S Mandava ◽  
F Yasmin ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Low Molecular Weight Heparin ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Low Molecular Weight ◽  
Efficacy And Safety ◽  
Dichotomous Data ◽  
Significant Difference

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

scholarly journals Khorana Score: Νew Predictor of Early Mortality in Patients With Lung Adenocarcinoma

2018 ◽  
Vol 24 (8) ◽  
pp. 1347-1351 ◽  
Author(s):  
Ioannis Vathiotis ◽  
Evangelos P. Dimakakos ◽  
Paraskevi Boura ◽  
Angeliki Ntineri ◽  
Andiani Charpidou ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Adjuvant Chemotherapy ◽  
Lung Adenocarcinoma ◽  
Treatment Period ◽  
Predictive Value ◽  
First Line ◽  
Thromboembolic Risk ◽  
Patients With Cancer ◽  
Risk Of Death ◽  
Significant Difference

Venous thromboembolism (VTE) is a typical complication in patients with lung cancer. Khorana score is an established tool for thromboembolic risk stratification of ambulatory patients with cancer undergoing outpatient chemotherapy. The aim of this study was to evaluate the predictive value of the Khorana score for VTE and death in patients with lung adenocarcinoma during first-line or adjuvant chemotherapy. Medical records of 130 patients with lung adenocarcinoma receiving first-line or adjuvant chemotherapy were retrospectively studied during the time period June 2013 to May 2015. Venous thromboembolism occurred in 13 (10.0%) patients. Thromboembolic events were significantly correlated with reduced survival during treatment period (hazard ratio [HR]: 3.24; 95% confidence interval [CI]: 1.11-9.49; P = .032). The VTE rates did not present statistically significant difference between different Khorana score groups ( P = .96). In univariate analysis, the risk of death during treatment period (median: 16 weeks) was 3.75 times higher in high-risk versus intermediate-risk patients (HR: 3.75, 95% CI: 1.36-10.36; P = .001) and had 2.25 times higher per point increase in the Khorana score (HR: 2.25, 95% CI: 1.36-3.73; P = .002); the above results were also reproduced in multivariate analysis. Khorana score represents a valuable tool for identifying patients with cancer in low thromboembolic risk but does not preserve its predictive value for higher risk individuals. Khorana score is an independent risk factor for death in patients with lung adenocarcinoma receiving first-line or adjuvant chemotherapy.

An analysis of the efficacy and safety of direct oral anticoagulants (DOACs) in gastrointestinal cancer-associated venous thromboembolism (GI-CAVTE).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 505-505 ◽  
Author(s):  
Alejandro Recio Boiles ◽  
Hani M. Babiker ◽  
Aaron James Scott ◽  
Steve Malangone ◽  
Ali McBride ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Safety Profile ◽  
Bleeding Complications ◽  
Categorical Variables ◽  
Efficacy And Safety ◽  
Long Term Outcome ◽  
Historical Comparison ◽  
Significant Difference ◽  
Recurrent Vte ◽  
Active Cancer

505 Background: Two major trials and meta-analysis of patients (pts) with active cancer and VTE suggests that apixaban (A) and rivaroxaban (R) showed similar efficacy to enoxaparin and warfarin while having less associated major bleeding. GICA is associated with a higher incidence of VTE compared to other tumors. Moreover, bleeding complications of DOACs are not well defined in GICA pts. We compared the efficacy and safety of DOACs in pts with active GICA and VTE at the University of Arizona Cancer Center (UACC). Methods: A retrospective chart review of pts receiving DOACs with GICA and VTE treated at UACC was performed (11/2013-02/2017). GICA subgroup extracted from clinical trial delineations followed: active cancer, defined as cancer diagnosed at any stage +/- 6 months of VTE diagnosis. Efficacy outcomes were recurrent DVT, nonfatal pulmonary embolism (PE), or fatal PE. Safety outcomes for major bleeding were Hg drop of ≥2 g/dL, transfusion of ≥2 units of PRBC, bleeding in a critical site, or bleeding contributing to death. Fisher exact test is used for testing the difference in categorical variables for p-value < 0.05. Results: Our review included pts on A (n = 28) and R (n = 34). Pts had similar baseline characteristics compared to AMPLIFY (n = 81) and pooled-EINSTEIN (n = 71). Recurrent VTE at 6 months were 7.1% and 2.9% for pts on A and R, respectively. VTE historical comparison to AMPLIFY (3.7%) and EINSTEIN (2.8%) showed no significant difference. Major bleeding at 6 months were 7.1% and 14.7% for A and R, respectively, compared to 2.3% AMPLIFY / 2.8% EINSTEIN. R had the one recurrent non-fatal PE event and a significantly worse safety profile with 2 fatal bleeds (hemopericardium and upper GI bleed) and 2 critical bleeding sites (subarachnoid hemorrhage and retroperitoneal) [p = 0.0348], whereas A had non-significant of the before stated. Conclusions: To our knowledge, this is the first retrospective analysis to present long-term outcome data of DOACs in pts with GICA and VTE, which showed a similar risk of recurrent VTE and worse safety profile with R versus A. This data warrants further prospective clinical analysis of the efficacy and safety of DOACs in pts with GICA and VTE.

Vitamin K Antagonists Compared to Low-Molecular-Weight Heparins for Treatment of Cancer-Associated Venous Thromboembolism: An Observational Study in Routine Clinical Practice

2017 ◽  
Vol 117 (11) ◽  
pp. 2163-2167 ◽  
Author(s):  
Paul den Exter ◽  
José Hooijer ◽  
Tom van der Hulle ◽  
Julien van Oosten ◽  
Olaf Dekkers ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Vitamin K ◽  
Major Bleeding ◽  
Routine Clinical Practice ◽  
Bleeding Complications ◽  
Low Molecular Weight ◽  
Patients With Cancer ◽  
Recurrent Vte

AbstractSince several trials have demonstrated that low-molecular-weight-heparin (LMWH) is superior to vitamin K antagonist (VKA) in preventing recurrent venous thromboembolism (VTE) in patients with cancer-associated VTE, guidelines now recommend LMWH monotherapy in this setting. We evaluated whether this shift resulted in improved outcomes in routine clinical practice. We performed a cohort study of consecutive patients with cancer-associated VTE during 2001 and 2010. We compared the risks for recurrent VTE, major bleeding and mortality between patients diagnosed before and after 2008 during a 6-month routine follow-up. A total of 381 patients were included, of which 234 (61.4%) were diagnosed before 2008. Before 2008, 23% of the patients were treated with LMWH; thereafter, this percentage was higher: 67%. The 6-month incidence for recurrent VTE was 8.6% in patients diagnosed before 2008 versus 7.5% for patients diagnosed after 2008 (risk difference [RD]: −1.1%; 95% confidence interval [CI]: −6.3, 5.3). The respective risks for major bleeding were 6.4 versus 4.8% (RD: −1.6%; 95% CI: −3.8 to 5.8), and 39.7 versus 41.5% (RD: 1.8%; 95% CI: −8.8, 12) for overall mortality. The mean time in therapeutic range (TTR) of patients treated with VKA was 61%. Despite a clear shift toward LMWH as agent of choice for cancer-associated VTE, we did not observe a clear improvement in terms of recurrent VTE and bleeding complications.

scholarly journals Meta-Analysis of Direct Oral Anticoagulants for the Treatment of Venous Thromboembolism in Patients with Active Malignancy

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 363-363
Author(s):  
Rahul Mhaskar ◽  
Gautamkrishna Koipallil ◽  
Nelson Thomas ◽  
Nathan Visweshwar ◽  
Damian A. Laber ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Risk Ratio ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Low Molecular Weight ◽  
Patients With Cancer ◽  
Randomized Control ◽  
Recurrent Vte ◽  
Active Cancer

Abstract Introduction Venous thromboembolism (VTE), is the second leading cause of death in patients with cancer. The risk of VTE in patients with cancer is 4 to 7-fold, when compared to the general population. Even during anticoagulant treatment, the cumulative incidence of recurrent VTE is 3.5 times higher in patients with cancer than in cancer-free patients. Low-molecular-weight heparin has been the "gold standard" for the of treatment for VTE in cancer associated thrombosis, following the landmark trial by Lee et al. Methods We conducted a meta-analysis to evaluate the safety and efficacy of direct oral anticoagulants in patients with cancer. We systematically searched Medline for randomized-control clinical trials and post-hoc analyses. For each study, data on recurrent VTE, major or clinically relevant non-major bleeding (CRNMB), and major bleeding (MB) were extracted. We included randomized control trials (RCT's) where interventions consisted of direct oral anticoagulants (DOA) versus vitamin K antagonists (VKA) or low molecular weight heparins (LMWH), in which all or a part of the study population had active cancer. We excluded studies that were not comparing DOA versus VKA/LMWH or did not have a subset of active cancer patients. Results Seven studies met our eligibility criteria. Data for recurrent VTE was extractable from all 7 RCT's. There were 2178 enrolled participants total. The pooled results show evidence for a lower incidence of recurrent VTE with the use of DOA versus VKA/LMWH. The pooled risk ratio for recurrent VTE was 0.68 (95% confidence interval 0.50 to 0.93; P = 0.01). There was negligible heterogeneity among the trials (I2 = 0%; P = 0.99). Data for major bleeds was extractable from 6 RCT's, including 1952 enrolled participants total. The pooled results show no evidence for a difference in frequency of major bleeds with the use of DOA versus VKA/LMWH. The pooled risk ratio was 1 (95% CI 0.53 to 1.87; P= 0.99). There was moderate heterogeneity among trials (I2 = 40%; P = 0.17) Data for clinically relevant bleeding was extractable from 6 RCT's, including 1952 enrolled participants total. The pooled results show no evidence for a difference in frequency of nonmajor but clinically relevant bleeds with the use of DOA versus VKA/LMWH. The pooled risk ratio was 1.06 (95% CI 0.80 to 1.42; P= 0.68). There was negligible heterogeneity among trials (I2 = 27%; P = 0.24). Data for all bleeds (major or nonmajor) was extractable from all 7 RCT's. There were 2178 enrolled participants total. The pooled results show no evidence for a difference in frequency of bleeds with the use of DOA versus VKA/LMWH. The pooled risk ratio was 0.95 (95% CI 0.68 to 1.32; P= 0.74). There was substantial heterogeneity among trials (I2 = 65%; P = 0.02). Conclusions Our results suggest that DOACs might reduce the incidence of VTE recurrence in patients with cancer without putting them at high risk for major bleeds or clinically relevant nonmajor bleeds. Table. Table. Disclosures No relevant conflicts of interest to declare.

Effectiveness and Safety of Rivaroxaban in Treatment of Venous Thromboembolism in Cancer Patients

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2319-2319 ◽  
Author(s):  
Khine Z Win ◽  
Nathan Wilson ◽  
David D Stenehjem ◽  
Natalee Tanner ◽  
George M. Rodgers ◽  
...  
Keyword(s):  
Platelet Count ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Median Time ◽  
Low Molecular Weight Heparin ◽  
Low Molecular Weight ◽  
Major Bleed ◽  
Recurrent Vte ◽  
Cancer Associated Thrombosis ◽  
Active Cancer

Abstract Introduction Patients with active cancer have a high risk for venous thromboembolism (VTE). The current treatment of choice for cancer-associated thrombosis is low molecular weight heparin (LMWH). Evidence for the efficacy and safety of the target-specific oral anticoagulants in the prevention and treatment of cancer-associated thrombosis is limited. In the EINSTEIN trials, comparing rivaroxaban to LMWH plus a vitamin K antagonist, only a small number of patients with active cancer received treatment with rivaroxaban (6.8% [n=118] in EINSTEIN-DVT1 and 4.7% [n=114] in EINSTEIN-PE2). The use of rivaroxaban over LMWH for cancer-associated thrombosis is not recommended by the current guidelines.3 However, due to the parenteral route of administration and high cost burden of LMWH, some cancer patients at our institution have received rivaroxaban for cancer-associated thrombosis. Method An observational chart review was performed to determine the effectiveness and safety of rivaroxaban for the treatment of VTE in cancer patients by observing recurrent VTE and bleeding events. For the effectiveness endpoint, patients who received rivaroxaban for less than one month were excluded from the study. For the safety analysis, patients who received at least one dose of rivaroxaban were included in the study. Result A total of 92 cancer patients with VTE who received rivaroxaban at Huntsman Cancer Institute were selected for the study. Median age was 60 years old and 54% (n=50) were male. Average estimated creatinine clearance at the initiation of rivaroxaban was 96.2 mL/min (range 31.8-241 mL/min, Cockcroft-Gault). Thirty-eight patients (41%) were treated for DVT (deep venous thromboses), 32 patients (35%) had PE (pulmonary embolism), and 19 patients (21%) had both DVT and PE. A total of 20 patients (21.7%) had a bleeding event while on therapy (see table). Ten patients (10.8%) experienced a major bleed and the median time to major bleeding was 4.4 months (IQR 2.4-11.6 months). One patient had a fatal intracranial bleed. Four patients (4.3%) had critical bleeding and 5 patients (5.4%) had a clinically relevant bleeding with ≥ 2g/dL drop in hemoglobin level and/or required ≥2 units of red blood cell transfusion. Pharmacodynamic interactions may have contributed to 3 major bleeds, including one patient on aspirin, another on ibuprofen, and the third patient on both aspirin and clopidogrel at the time of bleeding. Seven patients were taking rivaroxaban 20 mg daily at the time of the major bleed. The median platelet count at the time of bleeding was 170k/µL (IQR 108-333k/µL). One patient had a platelet count of 17 k/µL and was admitted with sepsis at the time of bleed. Ten patients (10.8%) experienced minor symptomatic bleeds and the median time to bleeding was 2.5 months (IQR 0.73-4.8 months). Only 4 patients (4.3%) experienced recurrent VTE while on rivaroxaban. Two patients had recurrent DVT. Two patients developed recurrent PE and both were admitted to the hospital for parenteral anticoagulation. The median time to recurrent VTE was 5.7 months (IQR 2.5-11 months). The median platelet count at the time of recurrence was 120 k/µL (range 26-216k/µL). One patient had a known thrombophilia, Factor V Leiden mutation. Conclusion These data suggest that rivaroxaban may be a safe and acceptable alternative to LMWH for the treatment and secondary prevention of cancer-associated thrombosis. Table 1.Huntsman Cancer Institute (n=92)EINSTEIN-DVT1(Cancer sub-group, n=118)EINSTEIN-PE2(Cancer sub-group, n=114)CLOT trial4(n=336)Major bleeding10.8% (n=10)14.4% (n=17)12.3% (n=14)14% (n=47)Clinically relevant non-major bleeding10.8% (n=10)Recurrent DVT2.2% (n=2)3.4% (n=4)n/a4.2% (n=14)Recurrent PE2.2% (n=2)n/a1.8% (n=2)3.9% (n=13) References: 1. Bauersachs R, Berkowitz SD, Brenner B, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N. Engl. J. Med. 2010;363(26):2499-2510. 2. Büller HR, Prins MH, Lensin AWA, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N. Engl. J. Med. 2012;366(14):1287-1297. 3. NCCN Clinical Practice Guidelines in Oncology. Cancer-Associated Venous Thromboembolic Disease, v2.2014. www.nccn.org. 4. Lee AYY, Levine MN, Baker RI, et al. Low-molecular-weight heparin versus a coumadin for the prevention of recurrent venous thromboembolism in patients with cancer. N. Engl. J. Med. 2003;349(2):146-153. Disclosures No relevant conflicts of interest to declare.

scholarly journals Direct oral anticoagulants for cancer-associated venous thromboembolism: a systematic review and meta-analysis

Blood ◽  
2020 ◽  
Vol 136 (12) ◽  
pp. 1433-1441 ◽  
Author(s):  
Frits I. Mulder ◽  
Floris T. M. Bosch ◽  
Annie M. Young ◽  
Andrea Marshall ◽  
Robert D. McBane ◽  
...  
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Patients With Cancer ◽  
Recurrent Vte

Abstract Direct oral anticoagulants (DOACs) are an emerging treatment option for patients with cancer and acute venous thromboembolism (VTE), but studies have reported inconsistent results. This systematic review and meta-analysis compared the efficacy and safety of DOACs and low-molecular-weight heparins (LMWHs) in these patients. MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and conference proceedings were searched to identify relevant randomized controlled trials. Additional data were obtained from the original authors to homogenize definitions for all study outcomes. The primary efficacy and safety outcomes were recurrent VTE and major bleeding, respectively. Other outcomes included the composite of recurrent VTE and major bleeding, clinically relevant nonmajor bleeding (CRNMB), and all-cause mortality. Summary relative risks (RRs) were calculated in a random effects meta-analysis. In the primary analysis comprising 2607 patients, the risk of recurrent VTE was nonsignificantly lower with DOACs than with LMWHs (RR, 0.68; 95% CI, 0.39-1.17). Conversely, the risks of major bleeding (RR, 1.36; 95% CI, 0.55-3.35) and CRNMB (RR, 1.63; 95% CI, 0.73-3.64) were nonsignificantly higher. The risk of the composite of recurrent VTE or major bleeding was nonsignificantly lower with DOACs than with LMWHs (RR, 0.86; 95% CI, 0.60-1.23). Mortality was comparable in both groups (RR, 0.96; 95% CI, 0.68-1.36). Findings were consistent during the on-treatment period and in those with incidental VTE. In conclusion, DOACs are an effective treatment option for patients with cancer and acute VTE, although caution is needed in patients at high risk of bleeding.

scholarly journals Direct Oral Anticoagulants Compared to Low Molecular Weight Heparin in the Treatment of Cancer-Associated Thromboembolism: An Updated Meta-Analysis of Randomized Controlled Trails

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4962-4962
Author(s):  
Sariya Wongsaengsak ◽  
Somedeb Ball ◽  
Nuvneet Khandelwal ◽  
Alay Tikue ◽  
Arunee Motes ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Low Molecular Weight Heparin ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Low Molecular Weight ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Recurrent Vte

Introduction: Cancer patients have approximately 4 times higher risk of developing venous thromboembolism (VTE) compared to the general population. High tendency of bleeding from anticoagulant use in this population makes the treatment of cancer-associated thromboembolism (CAT) very challenging. Low molecular weight heparin (LMWH) is still considered as standard treatment for CAT. Direct oral anticoagulants (DOAC) have emerged as a potential alternative for LMWH due to the ease of administration and predictable pharmacokinetics, but data on DOACs in CAT is limited. Few randomized controlled trials (RCT) published recently have compared the efficacy and safety of DOACs with LMWH in the treatment of CAT. Hence, we conducted an updated meta-analysis of RCTs to determine the relative risk of recurrent VTE and bleeding complications associated with DOACs compared to LMWH in the treatment of thromboembolism in patients with cancer, and to evaluate if the risk estimates have changed since prior report (Li et al.). Methods: We performed a systemic search using Embase, Medline, and the meeting abstracts with appropriate keywords through 06/30/19, to find all RCTs comparing a DOAC with LMWH in treatment of patients with CAT. The search strategy, study selection, data extraction and analysis were performed in accordance with the Preferred Reporting Items for Meta-Analyses (PRISMA) guidelines. We pooled the point estimates in form of risk ratios (RR) with respective 95% confidence intervals (CI), using the random effects model (Mantel-Haenszel method) of Der Simonian and Laird. Heterogeneity of effect size across studies was quantified using I2 statistic and Cochran's Q. Publication bias was assessed by the Egger's regression test. All the statistical analyses were performed with the RevMan 5.3 software. Copenhagen: The Nordic Cochrane Centre, the Cochrane Collaboration, 2014. Results: Overall a total of 1,739 patients with CAT (870 in the DOAC arms and 869 in LMWH arms) from three RCTs were included in the final analysis. Characteristics of studies included in the analysis are summarized in table 1. Different DOACs (Select-D: rivaroxaban, Hokusai VTE cancer: edoxaban and ADAM VTE: apixaban) were used to compare with dalteparin in included trials. Duration of anticoagulation was 6 to 12 months in these studies. Use of DOAC was associated with a significantly lower risk of recurrent VTE in comparison with LMWH [pooled RR 0.48, 95%CI: 0.26-0.87, p = 0.02, I2 = 56%, figure 1]. In addition, there was no statistically significant increase in the risk of major bleeding in patients on the DOAC arms, as compared to those on LMWH arms [ pooled RR 1.55 ,95%CI: 0.79-3.04, p = 0.20, I2 = 29%, figure 2]. Criteria for major bleeding in the studies were defined by the International Society on Thrombosis and Hemostasis. The pooled RR for clinically relevant non major bleeding (CRNMB) was 1.80 [95%CI: 0.96-3.38, p = 0.07, I2 = 60%, figure 3], thus suggesting no significant difference in risk of CRNMB between DOAC and LMWH groups. Moderate heterogeneity was noted across trials. We found no publication bias among studies included in the analysis. Conclusion: In our meta-analysis, use of DOACs for the treatment of CAT was associated with a significantly decreased risk of recurrent VTE compared to LMWH. There was no significant difference in the incidence of major or non-major bleeding events between DOAC and LMWH groups. These study results provide additional evidence for potential use of DOAC as a safe and effective alternative to LMWH for the treatment of thromboembolism in patients with cancer. Disclosures No relevant conflicts of interest to declare.

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