Safety and efficacy of rivaroxaban compared to standard anticoagulant therapy in the treatment of deep vein thrombosis in Indian population

Background: Pulmonary embolism (PE) is relatively a common cardiovascular complication following acute deep vein thrombosis (DVT). Around 10% of DVT patients exhibit clinical manifestations of PE. Oral drugs with adequate efficacy and safety are preferred over parenteral medications in long term prevention of PE. Our study compared rivaroxaban (factor XA inhibitor) with standard therapy (acetrom) in terms of efficacy and safety in the Indian population.Methods: Patients presenting to department of general surgery at S. S. institute of medical science and research centre during the period from March 2018 to September 2020 with clinical signs and venous duplex study proven acute DVT were included in the study. Total of 64 patients were randomized into rivaroxaban group (N=28) and control group (N=36). Treatment included for rivaroxaban group was rivaroxaban (p/o) 15 mg twice daily for 21 days, followed by 20 mg once daily for 6 months. Treatment included for control group was enoxaparin (SC) overlapping with and followed by acitrom (p/o) for 6 months. The patients were looked for symptomatic recurrent PE and major or minor clinically relevant bleeding.Results: Recurrent vein thrombosis noted in 1 (3.57%) patient of the rivaroxaban group and 4 (11.10%) patients in the control group. Minor bleeding seen in 3 (10.70%) patients in the rivaroxaban group and in 7 (19.40%) patients in the control group. No major bleeding was observed in rivaroxaban group and in 1 patient in the control group.Conclusions: In patients with acute DVT, rivaroxaban is as efficacious as enoxaparin followed by acetram therapy, with a significantly lower rate of bleeding.

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Clinical study of asymptomatic deep vein thrombosis in patients with varicose veins of lower extremities

International Surgery Journal ◽

10.18203/2349-2902.isj20194218 ◽

2019 ◽

Vol 6 (10) ◽

pp. 3548

Author(s):

Basavarajappa M. ◽

Anantharaju G. S. ◽

Deepak G.

Keyword(s):

Deep Vein Thrombosis ◽

Varicose Veins ◽

Strong Association ◽

Medical Science ◽

Clinical Signs ◽

Lower Limbs ◽

Research Centre ◽

Vein Thrombosis ◽

Ceap Classification ◽

Deep Vein

Background: The main aim is to study the association between asymptomatic deep vein thrombosis (DVT) in patients with varicose veins in different gender and age groups. Secondly, to study the risk of developing DVT in patients having superficial venous thrombophlebitis (SVT) with varicose veins and finally to study the clinical correlation of clinical, etiological, anatomical and pathological (CEAP) classification with DVT in patients with varicose veins.Methods: Patients presenting to department of General surgery at SS Institute of Medical Science and Research Centre during the period from June 2017 to June 2019 with varicose veins of lower limbs and without clinical signs of DVT were included in this study. Patients were categorised according to CEAP classification. All patients were subjected to duplex scanning of lower limbs to look for presence of SVT and DVT.Results: In our study, 73% patients were males and 27% patients were females. Maximum patients were in age group of 40-60 years.16 patients had DVT, 38 patients had SVT, 166 patients belonged to C2 and 56 patients belonged to CEAP class C3 and beyond.Conclusions: There is a strong association between varicose veins and asymptomatic DVT .The presence of SVT is not a risk factor for concomitant DVT in varicose vein patients. Clinical presentation with C3 or more CEAP grade is one of the potential risk factors for concomitant DVT in varicose vein patients.

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Comparative study to establish significance of D-dimer, lipid profile and homocysteine level in cases of deep vein thrombosis

International Surgery Journal ◽

10.18203/2349-2902.isj20191899 ◽

2019 ◽

Vol 6 (5) ◽

pp. 1733

Author(s):

Vishal Sharma ◽

Mahendra Bendre ◽

Shahaji Chavan ◽

Sree Ganesh B.

Keyword(s):

Deep Vein Thrombosis ◽

Comparative Study ◽

Lipid Profile ◽

Homocysteine Level ◽

Research Centre ◽

Control Group ◽

Study Group ◽

Vein Thrombosis ◽

Deep Vein ◽

D Dimer

Background: The purpose of the study was to establish the relationship of D-dimer, lipid profile and homocysteine level in deep-vein thrombosis (DVT). The purpose of this study was to assess the value of D-dimer in the detection of early DVT.Methods: A hospital based comparative study was conducted at Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune with 100 patients to compare the level of D-dimer and lipid profile in cases of Deep Vein Thrombosis (DVT) with healthy controls. The study was carried out with following two groups of 50 patients each: study group : 50 cases with DVT; control group: 50 healthy controls.Results: The D-Dimer levels was significantly higher in study group as compared to control group (748.44±93.17 vs. 426.06±78.11 ng/ml) and statistically significant as per student t-test (p<0.05). It was observed that total cholesterol (r=0.714; p<0.05), triglyceride (r=0.534; p<0.05), LDL (r=0.662; p<0.05), HDL (r=0.655; p<0.05), homocysteine (r=0.285; p<0.05) and D-dimer (r=0.368; p<0.05) were strongly and directly correlated with DVT.Conclusions: In our study most sensitive test for early diagnosis of DVT is D-dimer as it is considered to be useful as a screening test for DVT in hospitalized patients with acute medical diseases/episodes. D-dimer assay is an important preliminary test to detect deep vein thrombosis in post-operative cases. Its extreme sensitivity and high negative predictive value make it an ideal single test to screen patients suspected of having deep vein thrombosis. A negative test rules out deep vein thrombois and a positive test report needs further investigation for its confirmation. In case of increased lipid profile levels, patients are more prone to develop DVT hence there should be regular screening for DVT.

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The frequencies of FV Leiden and FII G20210A mutations in patients with different clinical manifestations of venous thromboembolism: Experience from large Serbian cohort

Genetika ◽

10.2298/gensr1602609t ◽

2016 ◽

Vol 48 (2) ◽

pp. 609-616

Author(s):

Branko Tomic ◽

Maja Gvozdenov ◽

Iva Pruner ◽

Mirjana Kovac ◽

Nebojsa Antonijevic ◽

...

Keyword(s):

Pulmonary Embolism ◽

Deep Vein Thrombosis ◽

Venous Thromboembolism ◽

Clinical Manifestations ◽

Rflp Analysis ◽

Control Group ◽

Vein Thrombosis ◽

G20210a Mutation ◽

Fv Leiden ◽

Deep Vein

Venous thromboembolism is a multifactorial disorder with two manifestations: deep-vein thrombosis and pulmonary embolism. Pulmonary embolism is usually considered as the complication of deep-vein thrombosis, but there are reported cases of isolated pulmonary embolism. FV Leiden and FII G20210A mutations are most common genetic risk factors for the venous thromboembolism. Several studies reported "FV Leiden paradox": lower prevalence of FV Leiden mutation among patients with isolated pulmonary embolism than among those with deep-vein thrombosis. The aim of this study was to determine FV Leiden and FII G20210A mutations frequency in thrombophilic patients in Serbian population. We tested prevalence of these mutations carriers in 1427 individuals divided in three groups of patients (with deep-vein thrombosis, deep-vein thrombosis/ pulmonary embolism and isolated pulmonary embolism) and control group. All subjects were tested for these mutations using PCR-RFLP analysis. Detected frequency of FV Leiden heterozygous carriers in patients with isolated pulmonary embolism was 6.9% (for FII G20210A 11.6%), while in other two groups of patients with deep-vein thrombosis and deep vein thrombosis/pulmonary embolism, frequency was 18.6% (for FII G20210A mutation were 11.6% and 8.3%, respectively). Our results showed that FV Leiden mutation is less frequent in patients with isolated pulmonary embolism than in patients with deep-vein thrombosis or deep-vein thrombosis accompanied with pulmonary embolism, confirming "FV Leiden paradox". On the other hand, detected frequency of FII G20210A mutation carriers was similar in all three groups of patients.

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Feasibility Study of Catheter-directed Thrombolysis with Recombinant Staphylokinase in Deep Venous Thrombosis

Thrombosis and Haemostasis ◽

10.1055/s-0037-1614936 ◽

1998 ◽

Vol 79 (03) ◽

pp. 517-519 ◽

Cited By ~ 13

Author(s):

Stephane Heymans ◽

Raymond Verhaeghe ◽

Luc Stockx ◽

Désiré Collen

Keyword(s):

Deep Vein Thrombosis ◽

Continuous Infusion ◽

High Speed ◽

Minor Bleeding ◽

Vein Thrombosis ◽

Catheter Directed Thrombolysis ◽

Long Term Follow Up ◽

Valve Function ◽

Rotating Impeller ◽

Deep Vein

SummaryThe feasibility of catheter-directed thrombolysis with recombinant staphylokinase was evaluated in six selected patients with deep vein thrombosis. The patients underwent intrathrombus infusion of recombinant staphylokinase (2 mg bolus followed by a continuous infusion of 1 mg/h). Heparin was given via the catheter as a bolus (5000 U) and as a continuous infusion (1000 U/h). Complete lyis was obtained in five patients and partial lysis in one patient. Complications consisted of minor bleeding in four subjects. Symptomatic reocclusion occurred in one. Debulking of the thrombus mass by a high speed rotating impeller (n = 1) and stenting (n = 3) were used as additional interventions. An underlying anatomical abnormality was present in two patients. Long term follow up revealed normal patency in all patients and normal valve function in four patients. Symptomatic venous insufficiency with valve dysfunction was present in the two with a second thrombotic episode.Thus catheter-directed infusion of recombinant staphylokinase in patients with deep vein thrombosis appears feasible and may be associated with a high frequency of thrombolysis. Larger studies to define the clinical benefit of this treatment appear to be warranted.

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Deep Vein Thrombosis and Fibrinolysis

Thrombosis and Haemostasis ◽

10.1055/s-0038-1646432 ◽

1991 ◽

Vol 66 (04) ◽

pp. 426-429 ◽

Cited By ~ 16

Author(s):

Marcel Levi ◽

Anthonie W A Lensing ◽

Harry R Büller ◽

Paolo Prandoni ◽

Gerard Dooijewaard ◽

...

Keyword(s):

Deep Vein Thrombosis ◽

Plasminogen Activator ◽

Plasminogen Activator Inhibitor ◽

Tissue Type ◽

Controlled Study ◽

First Episode ◽

Control Group ◽

Vein Thrombosis ◽

Type Plasminogen Activator ◽

Deep Vein

SummaryIn the present study 57 consecutive patients with a first episode of venographically proven deep vein thrombosis were investigated to evaluate the release of tissue-type plasminogen activator (t-PA) and of urokinase-type plasminogen activator (u-PA) in response to DDAVP stimulation as well as the resting plasminogen activator inhibitor (PAI) concentration, comparing this to the results obtained in 66 similar patients with a clinical suspicion of thrombosis but with a normal venogram. All assays were performed without knowledge of the patient's status.Four patients in the deep vein thrombosis-group (7%) had an absent u-PA antigen response upon DDAVP infusion, while a normal response was observed in all control subjects. Patients and controls showed similar increases in t-PA antigen level upon DDAVP. High resting PAI antigen levels were encountered in 5 patients in the deep vein thrombosis-group (9%) and in 6 subjects in the control group (9%).The results from this controlled study indicate that a defective release of u-PA may occur in patients with deep vein thrombosis and may have pathogenetic significance. Furthermore it is concluded that elevation of PAI levels cannot be considered as a specific risk factor for venous thrombosis.

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Controlled Trial of the Sequential Use of Streptokinase and Ancrod in the Treatment of Deep Vein Thrombosis of Lower Limb

Thrombosis and Haemostasis ◽

10.1055/s-0038-1649223 ◽

1977 ◽

Vol 37 (02) ◽

pp. 222-232 ◽

Cited By ~ 12

Author(s):

D. A Tibbutt ◽

C. N Chesterman ◽

E. W Williams ◽

T Faulkner ◽

A. A Sharp

Keyword(s):

Deep Vein Thrombosis ◽

Clinical Improvement ◽

Anticoagulant Therapy ◽

Lower Limb ◽

Oral Anticoagulant ◽

Controlled Trial ◽

Oral Anticoagulant Therapy ◽

Control Group ◽

Vein Thrombosis ◽

Deep Vein

SummaryTreatment with streptokinase (‘Kabikinase’) was given to 26 patients with venographically confirmed deep vein thrombosis extending into the popliteal vein or above. Treatment was continued for 4 days and the patients were allocated randomly to oral anticoagulant therapy or a course of treatment with ancrod (‘Arvin’) for 6 days followed by oral anticoagulant therapy. The degree of thrombolysis as judged by further venographic examination at 10 days was not significantly different between the 2 groups. The majority of patients showed clinical improvement but there was no appreciable difference between the groups at 3 and 6 months. Haemorrhagic complications were a more serious problem during the period of treatment with ancrod than during the equivalent period in the control group.

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Low-Dose Heparin and Deep-Vein Thrombosis after Total Hip Replacement

Thrombosis and Haemostasis ◽

10.1055/s-0038-1648020 ◽

1976 ◽

Vol 36 (01) ◽

pp. 157-164 ◽

Cited By ~ 34

Author(s):

P. M Mannucci ◽

Luisa E. Citterio ◽

N Panajotopoulos

Keyword(s):

Deep Vein Thrombosis ◽

Total Hip Replacement ◽

Hip Replacement ◽

Low Dose ◽

Control Group ◽

Total Hip ◽

Vein Thrombosis ◽

Dose Heparin ◽

Deep Vein ◽

Low Dose Heparin

SummaryThe effect of subcutaneous low-dose heparin on postoperative deep-vein thrombosis (D. V. T.) (diagnosed by the 125I-labelled fibrinogen test) has been investigated in a trial of 143 patients undergoing the operation of total hip replacement. Two randomized studies were carried out: in one the scanning for D.V.T. was carried out daily for 7 days post operatively and in the other for 15 days. In both, the incidence of D.V.T. was significantly lower in the heparin-treated patients (P<0.005). Bilateral D.V.T. was also prevented (P<0.05), through the extension of D.V.T. to the distal veins of the thigh was not significantly reduced. Heparin treatment was, however, followed by a higher incidence of severe postoperative bleeding (P< 0.02) and wound haematoma formation (P< 0.005), and the postoperative haemoglobin was significantly lower than in the control group (P<0.005). A higher number of transfused blood units was also needed by the heparin treated patients (P<0.001).

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Intensive Initial Oral Anticoagulation and Shorter Heparin Treatment in Deep Vein Thrombosis

Thrombosis and Haemostasis ◽

10.1055/s-0038-1661195 ◽

1984 ◽

Vol 52 (03) ◽

pp. 276-280 ◽

Cited By ~ 17

Author(s):

Sam Schulman ◽

Dieter Lockner ◽

Kurt Bergström ◽

Margareta Blombäck

Keyword(s):

Deep Vein Thrombosis ◽

Oral Anticoagulation ◽

Dose Group ◽

Low Dose ◽

Clinical Signs ◽

Coagulation Factor ◽

High Dose ◽

Vein Thrombosis ◽

Heparin Treatment ◽

Deep Vein

SummaryIn order to investigate whether a more intensive initial oral anticoagulation still would be safe and effective, we performed a prospective randomized study in patients with deep vein thrombosis. They received either the conventional regimen of oral anticoagulation (“low-dose”) and heparin or a more intense oral anticoagulation (“high-dose”) with a shorter period of heparin treatment.In the first part of the study 129 patients were randomized. The “low-dose” group reached a stable therapeutic prothrombin complex (PT)-level after 4.3 and the “high-dose” group after 3.3 days. Heparin was discontinued after 6.0 and 5.0 days respectively. There was no difference in significant hemorrhage between the groups, and no clinical signs of progression of the thrombosis.In the second part of the study another 40 patients were randomized, followed with coagulation factor II, VII, IX and X and with repeated venograms. A stable therapeutic PT-level was achieved after 4.4 (“low-dose”) and 3.7 (“high-dose”) days, and heparin was discontinued after 5.4 and 4.4 days respectively. There were no clinical hemorrhages, the activity of the coagulation factors had dropped to the same level in both groups at the time when heparin was discontinued and no thromboembolic complications occurred.Our oral anticoagulation regimen with heparin treatment for an average of 4.4-5 days seems safe and reduces in-patient costs.

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INVESTIGATING EFFECT OF NURSING INTERVENTIONS, BASED ON WELLS SCORE RESULTS, ON THE INCIDENCE OF DEEP VEIN THROMBOSIS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i5.24939 ◽

2018 ◽

Vol 11 (5) ◽

pp. 377

Author(s):

Morteza Habibi Moghadam ◽

Marzieh Asadizaker ◽

Simin Jahani ◽

Elham Maraghi ◽

Hakimeh Saadatifar ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Deep Vein Thrombosis ◽

Intervention Group ◽

Control Group ◽

Nursing Interventions ◽

Vein Thrombosis ◽

Wells Score ◽

Deep Vein ◽

Pitting Edema

Objective: Venous thromboembolism, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complaint in critically ill patients. Therefore, the present study was conducted to determine the effect of nursing interventions, based on the Wells results, on the incidence of DVT in intensive care unit (ICU) patients.Methods: The present clinical trial was conducted on 72 ICU patients without DVT and PE who met the inclusion criteria according to Wells score in Dr. Ganjavian Hospital, Dezful in 2012. The participants were investigated and randomly divided into intervention (n=36) and control groups (n=36). The intervention group received preventive nursing measures based on the risk level determined by the Wells score, and routine therapeutic interventions were performed for the control group. Then, patients were evaluated using Wells score, D-dimer testing, and Doppler sonography on the 1st, 5th, and 10th days. Data were finally coded and entered into SPSS version 23. Data analysis was performed using Chi-square, Fisher’s exact, and Mann–Whitney U tests.Results: The incidence of DVT in both groups showed that 2 patients of the control group who were identified to be at risk using the Wells score were diagnosed with DVT while none of the patients of the intervention group experienced DVT. The present study showed that 22.2% of the patients of the control group suffered from non-pitting edema, which was significantly different from the intervention group (p=0.005).Conclusion: The results of the present study showed that using the Wells score for early identification of the at-risk patients and nursing interventions based on this score’s results is helpful in the prevention of DVT. Appropriate nursing interventions were also effective in reducing the incidence of non-pitting edema in the lower extremities.

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Correlation of clinical features with the risk of lower limb deep vein thrombosis assessed by duplex ultrasound

Jornal Vascular Brasileiro ◽

10.1590/s1677-54492013000200005 ◽

2013 ◽

Vol 12 (2) ◽

pp. 118-122

Author(s):

Liz Andrea Villela Baroncini ◽

Graciliano Jose Franca ◽

Aguinaldo de Oliveira ◽

Enrique AntonioVidal ◽

Carlos Eduardo Del Valle ◽

...

Keyword(s):

Risk Factors ◽

Deep Vein Thrombosis ◽

Clinical Symptoms ◽

Clinical Signs ◽

Duplex Ultrasound ◽

Iliac Vein ◽

Vein Thrombosis ◽

Below The Knee ◽

Clinical Conditions ◽

Deep Vein

BACKGROUND: Symptoms and clinical signs suggestive of deep vein thrombosis (DVT) are common but may have numerous possible causes. OBJECTIVES: 1) To identify the most frequent clinical symptoms and correlate them with duplex ultrasound scan (DS) findings; 2) to identify high-risk clinical conditions for DVT; and 3) to evaluate time since the onset of symptoms and DS examination. METHODS: A total of 528 patients with a clinical suspicion of DVT were evaluated by DS performed by experienced vascular ultrasonographists. RESULTS: DVT was present in 192 (36.4%) of the patients. The external iliac vein was involved in 53 patients (10.04%), the femoral veins in 110 (20.83%), the popliteal vein in 124 (23.48%), and veins below the knee were involved in 157 (29.73%) of the cases. Limb swelling was present in 359 cases (68%), and 303 (57.4%) complained of pain. Sixty nine patients received a DS due to suspected or proven pulmonary embolism (PE); 79 patients were in postoperative period. In the multivariate analysis, independent risk factors for DVT included age>65 years (OR=1.49; 95% confidence interval [95%CI] 1.01-2.18; p=0.042), edema (OR=2.83; 95%CI 1.72-4.65; p<0.001), pain (OR=1.99; 95%CI 1.3-3.05; p=0.002), cancer (OR=2.32; 95%CI 1.45-3.72; p<0.001), and PE (OR=2.62; 95%CI 1.29-5.32; p=0.008).Time since the onset of symptoms did not differ between the groups. CONCLUSIONS: In the present study, 36.4% of the patients referred to DS had DVT. Age > 65 years, presence of limb swelling, pain, cancer, and suspected or proven PE should be considered as major risk factors for DVT.

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