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Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral-Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial.
Kearon, C, Gu, CS, Julian, JA, Goldhaber, SZ, Comerota, AJ, Gornik, HL, Murphy, TP, Lewis, L, Kahn, SR, Kindzelski, AL, et al
Thrombosis and haemostasis. 2019;(4):633-644
Abstract
BACKGROUND AND OBJECTIVES The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not reduce post-thrombotic syndrome (PTS), but reduced moderate-to-severe PTS and the severity of PTS symptoms. In this analysis, we examine the effect of PCDT in patients with femoral-popliteal deep vein thrombosis (DVT) (without involvement of more proximal veins). PATIENTS AND METHODS Within the ATTRACT trial, 300 patients had DVT involving the femoral vein without involvement of the common femoral or iliac veins and were randomized to receive PCDT with anticoagulation or anticoagulation alone (no PCDT). Patients were followed for 24 months. RESULTS From 6 to 24 months, between the PCDT versus no PCDT arms, there was: no difference in any PTS (Villalta scale ≥ 5: risk ratio [RR] = 0.97; 95% confidence interval [CI], 0.75-1.24); moderate-or-severe PTS (Villalta scale ≥ 10: RR = 0.93; 95% CI, 0.57-1.52); severity of PTS scores; or general or disease-specific quality of life (p > 0.5 for all comparisons). From baseline to both 10 and 30 days, there was no difference in improvement of leg pain or swelling between treatment arms. From baseline to 10 days, major bleeding occurred in three versus none (p = 0.06) and any bleeding occurred in eight versus two (p = 0.032) PCDT versus no PCDT patients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 no PCDT patients (p = 0.24). CONCLUSION In patients with femoral-popliteal DVT, PCDT did not improve short- or long-term efficacy outcomes, but it increased bleeding. Therefore, PCDT should not be used as initial treatment of femoral-popliteal DVT. (NCT00790335).
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Platelet reactivity in patients with venous thrombosis who use rosuvastatin: a randomized controlled clinical trial.
Biedermann, JS, Cannegieter, SC, Roest, M, van der Meer, FJ, Reitsma, PH, Kruip, MJ, Lijfering, WM
Journal of thrombosis and haemostasis : JTH. 2016;(7):1404-9
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Abstract
UNLABELLED Essentials Statins, especially rosuvastatin, may reduce venous thrombosis risk, but the mechanism is unclear. We performed a randomized trial investigating the effect of rosuvastatin on platelet reactivity. Thromboxane-A2 mediated platelet aggregation was measured before and after rosuvastatin therapy. Rosuvastatin did not inhibit thromboxane-mediated platelet aggregation in venous thrombosis patients. SUMMARY Background Statins may exert a protective effect against the risk of venous thrombosis (VT), but the mechanism is unclear. Objectives In this open-label, randomized clinical trial (www.clinicaltrials.gov NCT01613794), we aimed to determine the ex vivo effect of rosuvastatin on platelet reactivity in patients with a history of VT. Methods Platelet reactivity, in platelet reaction units (PRUs), was measured at baseline and after 28 days with VerifyNow, which uses arachidonic acid to determine thromboxane-mediated platelet aggregation, in 50 consecutive patients included in our study (25 receiving rosuvastatin and 25 without intervention). Results Forty-seven of 50 (94.0%) consecutively enrolled patients had two valid PRU measurements. The mean PRUs in rosuvastatin users were 609 at baseline and 613 at the end of the study (mean change 5; 95% confidence interval [CI] - 18 to 27). The mean PRUs in non-users were 620 at baseline and 618 at the end of the study (mean change - 2; 95% CI - 15 to 12). The mean difference in PRU change between users and non-users was 6 (95% CI - 20 to 33). After exclusion of patients who used antiplatelet medication, or had thrombocytopenia, similar results were obtained, i.e. no apparent effect of rosuvastatin on PRUs, with a mean difference in PRU change between users and non-users of - 1 (95% CI - 20 to 19). Conclusions Rosuvastatin does not affect platelet reactivity when arachidonic acid is used as an agonist in patients with a history of VT.
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Indirect comparison and cost-utility of dabigatran etexilate and rivaroxaban in the treatment and extended anticoagulation of venous thromboembolism in a UK setting.
Jugrin, AV, Hösel, V, Ustyugova, A, De Francesco, M, Lamotte, M, Sunderland, T
Journal of medical economics. 2016;(1):1-10
Abstract
BACKGROUND Acute venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is traditionally managed with a short course of parenteral anticoagulation followed by 3-6 months of a vitamin-K antagonist. Non-vitamin K oral anticoagulants (NOACs) do not require routine monitoring and dose adjustment, thus potentially provide an alternative treatment option. METHODS AND RESULTS Because of the lack of head-to-head clinical studies, an indirect comparison was conducted of dabigatran etexilate and rivaroxaban based on the respective phase III clinical trial. The derived relative safety and efficacy estimates were used to evaluate the cost-utility of dabigatran compared with rivaroxaban in the treatment and secondary prevention of VTE. The results of the indirect comparison showed no significant difference between dabigatran and rivaroxaban in avoiding recurrent VTE following index PE, index DVT, or DVT/PE combined, in treatment and extended anticoagulation. Dabigatran has significantly less major or clinically relevant bleeds (MCRBE) compared to rivaroxaban in treatment after index DVT and treatment after DVT or PE combined, but was not significantly different from rivaroxaban after index PE or in extended anticoagulation. In cost-utility deterministic analyses, dabigatran was projected dominant in all analyzed settings, given its marginally lower total cost and marginally higher QALYs gained compared to rivaroxaban. Probabilistic analyses results showed a high likelihood of dabigatran being considered good value for money in the UK, in treatment and in secondary prevention of VTE. CONCLUSION The cost-effectiveness evaluations showed that dabigatran can be considered the dominant treatment strategy compared to rivaroxaban in the patients' sub-groups considered, given the projected marginally higher clinical benefits and lower treatment costs.
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Post-thrombotic syndrome in patients treated with rivaroxaban or enoxaparin/vitamin K antagonists for acute deep-vein thrombosis. A post-hoc analysis.
Cheung, YW, Middeldorp, S, Prins, MH, Pap, AF, Lensing, AW, Ten Cate-Hoek, AJ, Villalta, S, Milan, M, Beyer-Westendorf, J, Verhamme, P, et al
Thrombosis and haemostasis. 2016;(4):733-8
Abstract
Post-thrombotic syndrome (PTS) is a common complication of deep-vein thrombosis (DVT). Poor quality treatment with vitamin K antagonists (VKA) is a risk factor for PTS. We hypothesised that treatment with the direct oral anticoagulant (DOAC) rivaroxaban may lower PTS incidence as compared to enoxaparin/VKA, as DOACs have a more stable pharmacologic profile than VKA. We performed a post-hoc subgroup analysis of the Einstein DVT trial (n=3449). Kaplan-Meier survival analysis was performed to compare the cumulative incidence of PTS between the rivaroxaban and enoxaparin/VKA groups. Hazard ratios (HR) and 95 % confidence intervals (CI) were calculated using Cox proportional hazards models. We included 336 patients with a mean age of 58 ± 16 years and a median follow-up after index DVT of 57 months (interquartile range 48-64). Of these, 162 (48 %) had been treated with rivaroxaban and 174 (52 %) with enoxaparin/VKA. The cumulative PTS incidence at 60 months follow-up was 29 % in the rivaroxaban group and 40 % in the enoxaparin/VKA group. After adjusting for age, gender, body mass index, previous VTE, ipsilateral recurrent DVT, extent of DVT, idiopathic DVT, duration of anticoagulant treatment, compliance to assigned study medication, elastic compression stocking use and active malignancy, the HR of PTS development for rivaroxaban was 0.76 (95 % CI: 0.51-1.13). In conclusion, treatment of acute DVT with rivaroxaban was associated with a numerically lower but statistically non-significant risk of PTS compared to enoxaparin/VKA treatment. The potential effect on reducing PTS deserves evaluation in a large randomised trial.
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Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism.
van Bellen, B, Bamber, L, Correa de Carvalho, F, Prins, M, Wang, M, Lensing, AW
Current medical research and opinion. 2014;(5):829-37
Abstract
OBJECTIVE The phase III EINSTEIN DVT and EINSTEIN PE trials demonstrated the potential of oral rivaroxaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The length of initial hospitalization in patients presenting with either symptomatic DVT or PE was assessed using hospitalization records from these trials. METHODS Analyses were carried out in the intention-to-treat population, using non-parametric and parametric statistical methods. RESULTS Overall, 52% (1781/3434) of EINSTEIN DVT patients and 90% (4328/4821) of EINSTEIN PE patients were admitted to hospital. The proportion of hospitalized patients with a length of stay of five or fewer days receiving rivaroxaban was 54% compared with 31% for enoxaparin/vitamin K antagonist (VKA) in patients with DVT. For patients with PE, the corresponding values were 45% and 33%. Stays of 6-10 days were observed in 29% of rivaroxaban-treated patients compared with 45% of enoxaparin/VKA-treated patients for DVT. For patients with PE, these values were 39% and 46% in the rivaroxaban and enoxaparin/VKA groups, respectively. Overall, length of stay was significantly shorter in the rivaroxaban group, compared with the enoxaparin/VKA group across all analyses performed (p < 0.0001). Across regions, the observed admission rates and length of stay duration varied greatly: Asia had the longest overall hospitalization rates, whereas the lowest rates were reported in North America, Australia and New Zealand. Nevertheless, a consistent trend was observed: length of hospital stay in patients with DVT or PE receiving rivaroxaban was shorter than, or at least similar to, patients receiving enoxaparin/VKA. CONCLUSION A single-drug regimen with rivaroxaban may reduce the burden on healthcare systems and patients, and provides effective and well tolerated treatment. The studies shared an open-label design that allowed comparison of initial hospitalization, but limitations include the well monitored clinical trial setting in which decisions on admission and discharge could vary from real-world management.
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Development of a tool to identify patients' preference for vitamin K antagonist or direct oral anticoagulant therapy.
Zolfaghari, S, Harenberg, J, Froelich, L, Wehling, M, Weiss, C
Seminars in thrombosis and hemostasis. 2014;(1):121-8
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Abstract
Direct oral anticoagulants (DOACs) were developed for the treatment of thromboembolic diseases to overcome limitations of vitamin K antagonists (VKA). International guidelines on atrial fibrillation acknowledge patients' for antiembolic therapy with VKA or DOAC as relevant decision criteria. The objective assessment of patients' preference social interactions and psychological factors are hard to measure albeit representing important contributors. After a series of structured interviews and pilot studies assessing the preparedness to use DOAC as an anticoagulant and the motivation of patients to participate in clinical studies with DOAC, seven items were identified from several questionnaires by regression analysis. Those items were seen the best to describe the willingness to change anticoagulation from VKA to DOAC. By their use, we aim to develop a tool for the objective identification of the patients' preferences for VKA or for DOAC to increase adherence to therapy and to reduce anticoagulant undertreatment. German-speaking patients were asked to fill out a questionnaire consisting of biographic data and the seven selected items, and 180 patients completed the questionnaire so far. Of these, 90 patients were on treatment with VKA (group 1), 57 patients changed anticoagulation from VKA to DOAC (group 2), 29 patients were DOAC naive patients (group 3), and 4 patients changed from DOAC to VKA (group 4). Overall, 94 patients received VKA, 29 patients received dabigatran, 50 patients received rivaroxaban, and 7 patients received apixaban as an anticoagulant. Eight patients were younger than 40 years, 35 patients were aged between 40 and 59 years, 53 patients were aged between 60 and 70 years, and 84 patients were aged older than 70 years. Indication for anticoagulation were atrial fibrillation (n = 106), pulmonary embolism (n = 24), deep vein thrombosis (n = 40), artificial heart valve replacement (n = 8), or other diseases (n = 2). Based on the results of the analysis, a score will be suggested to identify the preference of patients for anticoagulation with VKA or DOAC. This tool may be useful for practitioners and health-care professionals to support patient adherence to therapy, and thereby increase treatment effectiveness.
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Computed tomography (CT) venography with dual-energy CT: low tube voltage and dose reduction of contrast medium for detection of deep vein thrombosis.
Ichikawa, S, Ichikawa, T, Motosugi, U, Imaizumi, A, Sano, K, Morisaka, H
Journal of computer assisted tomography. 2014;(5):797-801
Abstract
OBJECTIVES To assess whether low-dose contrast medium and low-tube voltage computed tomography (CT) venography can be used for clinical diagnosis. METHODS This prospective study included 63 patients who were randomized into 3 groups and administered contrast medium of either 600, 500, or 400 mg of iodine per kilogram (mgI/kg). All patients underwent dual-energy CT at either 80 or 135 kilovolt (peak) (kV[p]). Control images (120 kV[p]) were acquired from them and were compared with 80-kV(p) images. The mean CT values of the bilateral femoral and popliteal veins were compared. RESULTS The mean CT values of the 80-kV(p) images were significantly higher than 120-kV(p) images for all doses. No significant difference was observed for the CT values of the 80-kV(p) images with the 400-mgI/kg dose and the control images (600 mgI/kg at 120 kV[p]). CONCLUSIONS Low tube voltage enabled a reduction of contrast medium to 400 mgI/kg for CT venography.
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Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis.
Bamber, L, Wang, MY, Prins, MH, Ciniglio, C, Bauersachs, R, Lensing, AW, Cano, SJ
Thrombosis and haemostasis. 2013;(4):732-41
Abstract
Rivaroxaban, an oral, direct factor Xa inhibitor, has been approved for the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE as a fixed-dose, single-drug regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. This study evaluated patient-reported treatment satisfaction in EINSTEIN DVT--a large, open-label, randomised study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic DVT without PE. As part of EINSTEIN DVT, a total of 1,472 patients in seven countries were asked to complete a new, validated measure of treatment satisfaction--the Anti-Clot Treatment Scale (ACTS)--at scheduled visits throughout 12 months of treatment. ACTS scores were compared between study groups in the intention-to-treat population. Patients reported greater satisfaction in the rivaroxaban group compared with the enoxaparin/VKA group, with higher mean ACTS scores across visits. Mean ACTS Burdens scores were 55.2 vs 52.6 (p<0.0001) in favour of rivaroxaban, equivalent to a moderate effect size of 0.42. The treatment effect was consistent over time, with the mean score difference ranging from 2.18 (month 2) to 3.18 (month 12). Overall mean ACTS Benefits scores were 11.7 vs 11.5 in favour of rivaroxaban (p=0.006). This was associated with a small overall effect size of 0.12. The improvement in ACTS Benefits for rivaroxaban became apparent at month 2 and subsequent visits. Rivaroxaban results in improved treatment satisfaction compared with enoxaparin/VKA among patients with DVT, particularly in reducing patient-reported anticoagulation burden.
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CT venography for deep vein thrombosis using a low tube voltage (100 kVp) setting could increase venous enhancement and reduce the amount of administered iodine.
Cho, ES, Chung, JJ, Kim, S, Kim, JH, Yu, JS, Yoon, CS
Korean journal of radiology. 2013;(2):183-93
Abstract
OBJECTIVE To investigate the validity of the 100 kVp setting in CT venography (CTV) in the diagnosis of deep vein thrombosis (DVT), and to evaluate the feasibility of reducing the amount of administered iodine in this setting. MATERIALS AND METHODS After receiving the contrast medium (CM) of 2.0 mL/kg, 88 patients underwent CTV of the pelvis and lower extremities by using one of four protocols: Group A, 120 kVp setting and 370 mgI/mL CM; group B, 120 kVp and 300 mgI/mL; group C, 100 kVp and 370 mgI/mL; group D, 100 kVp and 300 mgI/mL. The groups were evaluated for venous attenuation, vein-to-muscle contrast-to-noise ratio (CNR(VEIN)), DVT-to-vein contrast-to-noise ratio (CNR(DVT)), and subjective degree of venous enhancement and image quality. RESULTS Venous attenuation and CNR(VEIN) were significantly higher in group C (144.3 Hounsfield unit [HU] and 11.9), but there was no significant difference between group A (118.0 HU and 8.2) and D (122.4 HU and 7.9). The attenuation value of DVT was not significantly different among the four groups, and group C had a higher absolute CNR(DVT) than the other groups. The overall diagnostic image quality and venous enhancement were significantly higher in group C, but there was no difference between groups A and D. CONCLUSION The 100 kVp setting in CTV substantially help improve venous enhancement and CNR(VEIN). Furthermore, it enables to reduce the amount of administered iodine while maintaining venous attenuation, as compared with the 120 kVp setting.
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[Clinical research on Sanmiao powder combined fibrinogenase for injection in treatment of acute deep venous thrombosis of lower limbs].
Zhou, T, Sun, DQ, Wu, P
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2012;(7):918-21
Abstract
OBJECTIVE To observe the clinical effectiveness of Sanmiao Powder (SP) combined fibrinogenase for injection in treatment of acute deep venous thrombosis (ADVT) of lower limbs. METHODS Eighty patients with ADVT were randomly assigned to two groups according to the disease course (within 7 days or 7-28 days), 40 in each group. Every time phase was also divided into two groups, i. e., one group treated with fibrinogenase for injection alone (Group A and C) and another group treated with fibrinogenase for injection + SP administration (Group B and D) , 20 in each group. The clinical effectiveness was observed after 2-week treatment. RESULTS The fibrinogenase for injection + SP administration showed better effects in alleviating the swelling of limbs, relieving pain, and lowering fibrinogen. Better effects were obtained in the group with the disease course less than 7 days. CONCLUSION Better effect on ADVT was obtained by integrative medicine.