Efficacy and Safety of Low Molecular Weight Heparin (Ardeparin Sodium) Compared to Warfarin for the Prevention of Venous Thromboembolism after Total Knee Replacement Surgery: A Double-blind, Dose-ranging Study

1997 ◽  
Vol 77 (01) ◽  
pp. 032-038 ◽  
Author(s):  
John A Heit ◽  
Scott D Berkowitz ◽  
Robert Bona ◽  
Victor Cabanas ◽  
John D Corson ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Low Molecular Weight Heparin ◽  
Low Molecular Weight ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Replacement Surgery ◽  
Dose Warfarin ◽  
Total Knee ◽  
Adjusted Dose

SummaryWe performed a double-blind, randomized clinical trial to compare the efficacy and safety of three different subcutaneous (SC) low molecular weight heparin doses (ardeparin sodium 25,35, or 50 anti-XaU/kg twice daily [BID]) to adjusted-dose warfarin (international normalized ratio [INR] = 2.0 to 3.0), as venous thromboembolism prophylaxis after total knee replacement surgery. The primary endpoint was total venous thromboembolism prevalence, defined as deep vein thrombosis discovered at postoperative venography of the operated leg, or symptomatic, objectively-documented pulmonary embolism. Of 860 patients randomized, 680 (79%) had an evaluable venogram or pulmonary embolism. The total venous thromboembolism prevalence was significantly greater among patients prophylaxed with warfarin compared to ardeparin 50 BID (38% vs 27%, p = 0.019); the prevalence among ardeparin 25 BID (37%) and 35 BID (28%) patients was similar to warfarin and ardeparin 50 BID patients, respectively. Overt bleeding occurred in 22 (7.9%) ardeparin 50 BID patients compared to 12 (4.4%) warfarin patients (p = 0.08), and in seven ardeparin 25 and 35 BID patients each (5.2% and 5.0%, respectively). Compared to the warfarin group, blood loss was significantly greater in the ardeparin 50 and 25 BID groups, and not different in the ardeparin 35 BID group. Conclusions: Postoperative, unmonitored, fixed-dose ardeparin 50 anti-Xa U/kg SC BID is significantly more effective than adjusted-dose warfarin for this indication. Although overt bleeding among warfarin and ardeparin 50 BID patients did not differ significantly, ardeparin 50 BID patients had significantly greater blood loss. Ardeparin 35 anti-Xa U/kg SC BID may provide efficacy similar to ardeparin 50 anti-Xa U/kg SC BID but with reduced bleeding.

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

Low Molecular Weight Heparin Decreases Proximal and Distal Deep Venous Thrombosis Following Total Knee Arthroplasty

1998 ◽  
Vol 79 (05) ◽  
pp. 902-906 ◽  
Author(s):  
Andrew W. Howard ◽  
Shawn D. Aaron
Keyword(s):  
Molecular Weight ◽  
Total Knee Arthroplasty ◽  
Relative Risk ◽  
Venous Thrombosis ◽  
Knee Arthroplasty ◽  
Low Molecular Weight Heparin ◽  
Low Molecular Weight ◽  
Dose Heparin ◽  
Total Knee ◽  
Adjusted Dose

SummaryObjectives: To assess the efficacy and safety of low molecular weight heparin (LMWH) as deep venous thrombosis (DVT) prophylaxis following total knee arthroplasty. Data sources: Medline 1986 to June 1997, Embase, and manufacturers were used to identify randomized controlled trials. Review methods: Trials included were randomized studies of LMWH with routine radiological screening for DVT. Placebo or active controls were included. Two reviewers independently screened trials for inclusion, and assessed their quality. Pooled relative risk estimates of DVT and proximal DVT rates were calculated using a DerSimonian and Laird random effects model. Sensitivity of the results to the type of control used and the quality of the trial was assessed. Results: The relative risk of DVT for a patient given LMWH is 0.73 (95% CI 0.66 to 0.80) when compared with patients treated with adjusted dose heparin or warfarin controls. The relative risk for proximal DVT is 0.58 (95% CI 0.38 to 0.90). The relative risk of pulmonary emboli in the LMWH group was 0.55 (95% C.I. 0.20 to 1.57). No excess of bleeding was recorded in the LMWH group. Conclusions: Low molecular weight heparin is more efficacious than either adjusted dose heparin or adjusted dose warfarin, when used to prevent DVT and proximal DVT following total knee arthroplasty.

Evaluation of rivaroxaban use in patients with gynecologic malignancies at an academic medical center: A pilot study

2017 ◽  
Vol 25 (2) ◽  
pp. 362-368 ◽  
Author(s):  
Jessie R Signorelli ◽  
Arpita S Gandhi
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Low Molecular Weight Heparin ◽  
Medical Center ◽  
Gynecologic Oncology ◽  
Low Molecular Weight ◽  
Efficacy And Safety ◽  
Gynecologic Malignancies ◽  
Oncology Patients ◽  
Safety And Efficacy

Background Patients with gynecologic malignancies are at an increased risk for venous thromboembolism. National guidelines recommend treatment of an acute venous thromboembolism with low molecular weight heparin for 5–10 days followed by long-term secondary prophylaxis with low molecular weight heparin for at least six months. Non-vitamin K oral anticoagulants are not currently recommended to be used in cancer patients for the management of venous thromboembolism because robust data on their efficacy and safety have yet to become available in cancer patients. The objectives of this study were to determine the proportion of gynecologic oncology patients with venous thromboembolism using rivaroxaban compared to warfarin or low molecular weight heparin as well as compare the safety and efficacy of these anticoagulants. Methods This study was a retrospective pilot analysis of adult patients with gynecologic malignancies who received either rivaroxaban, warfarin or low molecular weight heparin for treatment of venous thromboembolism at Augusta University Medical Center from 1 July 2013 to 30 June 2015. Statistical comparisons between the enoxaparin and rivaroxaban group were made using T-tests and Chi-square or Fisher’s exact tests, where appropriate. Results Out of the 49 patients, 37% (18) patients were on rivaroxaban, 53% (26) on enoxaparin, and 10% (5) on warfarin. Only one patient (4%) in the enoxaparin group experienced a recurrent deep vein thrombosis while there were no cases of recurrent venous thromboembolism in the rivaroxaban and warfarin group. The incidence of major bleeding was 17% ( n = 2), 20% ( n = 1), and 8% ( n = 2) in patients receiving rivaroxaban, enoxaparin, and warfarin, respectively. The rate of switching to a different anticoagulant than originally prescribed was 42% ( n = 14) in the enoxaparin arm, and 5.5% ( n = 1) in the rivaroxaban arm. Conclusion A high proportion of our gynecologic oncology patients received rivaroxaban for the management of venous thromboembolism. The sample size of this pilot analysis was too small to draw any conclusions regarding efficacy and safety of rivaroxaban compared with enoxaparin and warfarin. High rate of rivaroxaban use in gynecologic oncology patients at our institution highlights the need for larger, well-designed randomized controlled trials to confirm the safety and efficacy of its use in this population.

Efficacy and safety of apixaban in patients with active malignancy and acute deep venous thrombosis

Vascular ◽  
2020 ◽  
pp. 170853812097114
Author(s):  
Mostafa El Mokadem ◽  
Ahmed Hassan ◽  
Abdulaziz Z Algaby
Keyword(s):  
Molecular Weight ◽  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Major Bleeding ◽  
Low Molecular Weight Heparin ◽  
Massive Pulmonary Embolism ◽  
Low Molecular Weight ◽  
Efficacy And Safety

Objectives Low-molecular weight heparin (LMWH) has been approved for treatment of deep venous thrombosis and venous thromboembolism which are associated with cancer. The efficacy and safety of apixaban in management of acute deep venous thrombosis associated with active malignancy is still an unresolved issue. The aim of our study is to evaluate the efficacy and safety of apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous LMWH. Methods Of 138 randomized patients, 100 patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy were assigned to either oral apixaban therapy or subcutaneous low-molecular weight heparin (enoxaparin) through randomized clinical study in 1:1 ratio. All patients were followed up to six months. The primary end point was major bleeding, while secondary end points were recurrent deep venous thrombosis or venous thromboembolism, minor or non-fatal bleeding and mortality related to massive pulmonary embolism. Results Both groups were matched regarding their baseline demographic, clinical and laboratory characteristics. We had 84 patients with metastatic cancer (stage 4). The most prevalent type of malignancy was cancer colon (42% of cases). There was no significant difference between both groups regarding the incidence of primary and secondary end points. There were no reported mortality cases related to massive pulmonary embolism in both groups. Conclusion In this limited study, there was no difference in the major bleeding, recurrent deep venous thrombosis or minor bleeding in patients with active malignancy when treated with either apixaban or LMWH. Trial registration: ClinicalTrials.gov (NCT04462003). Registered 7 July 2020 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04462003

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