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1.
Characteristics of patients receiving extended treatment after incident venous thromboembolism.
Albertsen, IE, Jensen, M, Abdelgawwad, K, Søgaard, M, Larsen, TB, Nielsen, PB
Basic & clinical pharmacology & toxicology. 2021;(4):332-342
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Abstract
Given high recurrence risk after venous thromboembolism (VTE), guidelines recommend extended dose rivaroxaban (10 mg OD) or apixaban (2.5 mg BID) to be considered after 6 months of initial treatment. This study aimed to provide insight into clinical practice regarding the use of extended preventive treatment and to describe duration of the initial treatment. Linkage of nationwide health registers identified all in- and outpatients with VTE from April 2017 through 2018. Hazard ratios (HR) with 95% confidence intervals (CIs) were calculated adjusting for other VTE-related factors. The study included 6030 patients with VTE. Among rivaroxaban users, 2.2% (n = 113) received the extended 10-mg dose after mean 9.4 (SD 3.1) months of standard treatment. For apixaban, 4.7% (n = 40) received extended 2.5-mg dose after mean 8.0 months (SD 3.9). After adjustments, incident pulmonary embolism (HR 1.81 95% CI 1.12;2.91) and trauma/fracture (HR 1.42 95% CI 0.46;4.43) were associated with switching to extended dose, whereas patients with unprovoked VTE were less likely to receive the extended dose (HR 0.68 95% CI 0.30;1.55). Less than 3% of patients with incident VTE received extended treatment after initial standard treatment. Even though international guidelines suggest that the risk-benefit balance is in favour of extended VTE treatment, this was yet to be translated into clinical practice as of 2018. Studies using contemporary data are warranted to investigate routine clinical practice of extended treatment for VTE recurrence.
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Risk of venous thromboembolism in elderly patients with vertebral compression fracture: A population-based case-control study.
Huang, CH, Wang, WH, Kor, CT, Hsiao, CH, Chang, CC
Medicine. 2020;(18):e20072
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Abstract
Vertebral compression fractures (VCFs) are common in elderly and are treated with immobilization. Moreover, immobilization and old age may increase venous thromboembolism (VTE) risk. However, the incidence of VCFs-related VTE is unknown in elderly. The purposes of this study were to determine the incidence of VTE among VCF patients, to explore whether percutaneous vertebroplasty (PV) intervention may reduce VTE risk in VCFs patients.We conducted a population-based case-control study by using the National Health Insurance Research Database. We identified 1407 patients aged ≥65 with VCF who received PV and 1407 VCFs patients who did not receive PV after developing a 1:1 propensity score-matched study cohort and were followed up for 5 years. Using PV intervention as the exposure factor, a cause-specific Cox's proportional hazards model was used to examine the association between PV and VTE.After propensity score matching, the mean age of the study participants was 78 years and ∼23% of the analyzed participants were men, incidence of VTE in the PV and control cohorts was 5.77 and 4.19 per 1000 person-years, respectively. Both groups were nonsignificant difference after examination with different adjustment models. Patients with VCF and a history of heart failure, coronary artery disease, receiving antihypertension medication were at a significantly increased VTE risk.Elderly patients with VCF who received PV had a neutral impact on risk of VTE. VCF patients with heart failure, coronary artery disease, and receiving antihypertension medication were prone to developing VTE should be monitored cautiously.
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Rivaroxaban for non-valvular atrial fibrillation and venous thromboembolism in the Netherlands: a real-world data based cost-effectiveness analysis.
de Jong, LA, Gout-Zwart, JJ, van den Bosch, M, Koops, M, Postma, MJ
Journal of medical economics. 2019;(4):306-318
Abstract
BACKGROUND Non-vitamin K antagonist oral anticoagulants (NOACs) have been included in international guidelines as important alternatives to vitamin K antagonists (VKAs) for the treatment of venous thromboembolism (VTE) and stroke prevention in non-valvular atrial fibrillation (NVAF). Meanwhile, in the Netherlands, NOACs are widely used next to VKAs. The objective of this study is to estimate the cost-effectiveness of treatment with rivaroxaban compared to VKAs in NVAF and VTE patients in the Netherlands, using data from international prospective observational phase IV studies. METHODS Two models were developed to represent NVAF and VTE patients, populated with patients from the XANTUS (NCT01606995) and XALIA (NCT01619007) international prospective observational studies. The 1-year cost-effectiveness of rivaroxaban use, compared to VKAs, was explored in a population consisting of NVAF and VTE patients (base case) as well as for four scenarios with sub-populations: NVAF patients only, VTE patients only, NVAF patients with unstable international normalized ratio (INR), and NVAF patients using an INR self-measuring device. RESULTS In the base case, rivaroxaban saved €72,350 and gained 21 quality-adjusted life-years (QALYs) in a simulation of 2,000 patients over the use of VKAs. Ergo, rivaroxaban was dominant over VKAs. The probabilistic sensitivity analysis showed a probability of 85% for rivaroxaban being dominant and 100% at a willingness-to-pay threshold of €20,000/QALY. Rivaroxaban appeared to be dominant in all scenarios as well, except for the NVAF-patients-only scenario where the incremental cost-effectiveness ratio (ICER) was €157/QALY. CONCLUSIONS In patients with NVAF or VTE, rivaroxaban treatment is likely to be cost-effective and a potentially cost-saving alternative to VKA in the Netherlands.
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Traditional thromboprophylaxis in elderlies with atrial fibrillation: What we can achieve in real life.
Dubrava, M, Nemeth, F, Drobna, T, Gerlich, L
Bratislavske lekarske listy. 2019;(10):764-768
Abstract
OBJECTIVES To investigate real-world data on warfarinisation rates and results in the elderly patients with atrial fibrillation (AF). BACKGROUND AF is the most frequent arrhythmia in the elderlies with considerable risk of devastating stroke-related consequences. Guidelines prefer non-vitamin K antagonist oral anticoagulants (NOAC) to warfarin for thromboprophylaxis. Nevertheless, warfarin is still widely used, even if it is challenging, especially in polymorbid elderlies, to achieve the therapeutic international normalised ratio (INR). There are only scarce real-world data on INR in warfarinised elderly AF patients. METHODS The study was based on multicentric observational Slovak audit of atrial fibrillation in seniors (SAFIS) performed on 4,252 hospitalised AF patients aged over 64 years (mean age 80.9 yrs.). INR data from warfarinised patients were analysed (955 at admission and 870 at discharge). RESULTS At hospital admission and discharge, the warfarin medication rates were 22.6 % and 23.5 %, respectively, INR lower than 2 was present in 41.8 % and 30.6 % of patients, respectively, and INR higher than 3 was in 27.0 % and 7.7 %, respectively and altogether, 68.8 % and 38.3 % of warfarinised patients, respectively, were out of therapeutic range. CONCLUSION Warfarin is still frequently used in the elderlies with AF, but the success rates are unsatisfactory in a huge number of patients. It is urgent to improve seniors' access to NOAC (Fig. 2, Ref. 34).
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To What Extent Does Posthospital Discharge Chemoprophylaxis Prevent Venous Thromboembolism After Bariatric Surgery?: Results From a Nationwide Cohort of More Than 110,000 Patients.
Thereaux, J, Lesuffleur, T, Czernichow, S, Basdevant, A, Msika, S, Nocca, D, Millat, B, Fagot-Campagna, A
Annals of surgery. 2018;(4):727-733
Abstract
OBJECTIVE The aim of the present study was to assess the incidence, risk factors, and the impact of posthospital discharge (PHD) chemoprophylaxis on venous thromboembolism (VTE) in patients undergoing bariatric surgery (BS). BACKGROUND VTE is a major concern after BS, especially during the PHD period. No large-scale study has previously focused on the clinical value of PHD chemoprophylaxis. METHODS In this nationwide observational population-based cohort study, all data from patients undergoing BS were extracted from the French National Health Insurance database (SNIIRAM) from 1st January 2012 to 31st September 2014. Logistic regression models were used to compute odds ratios for potential risk factors for VTE occurring within 90 postoperative days (PODs). The association between use of PHD chemoprophylaxis (heparin) and VTE was also assessed. RESULTS The majority (56%) of the 110,824 patients had sleeve gastrectomy. VTE rates during the first 30 and 90 PODs were 0.34% and 0.51%, respectively. On multivariate analyses, the major risk factors for VTE during the first 90 PODs were history of VTE [odds ratio = 6.33 95% confidence interval (4.44-9.00)], postoperative complications [9.23 (7.30-11.70)], heart failure [2.45 (1.48-4.06)], and open surgery [2.38 (1.59-3.45)]. PHD chemoprophylaxis was delivered to 75% of patients. No use of PHD chemoprophylaxis [1.27 (1.01-1.61)] was an independent predictive factor of VTE during the first 90 PODs [in the gastric bypass group: 1.51 (1.01-2.29)). CONCLUSIONS In the modern era of BS, this nationwide study shows a non-negligible rate of VTE especially after sleeve gastrectomy, depending on the individual risk level. Use of PHD chemoprophylaxis may decrease the risk of PHD VTE.
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Rationale, design, and methodology of the observational INSIGHTS-SVT study on the current state of care and outcomes of patients with superficial vein thrombosis.
Bauersachs, R, Gerlach, HE, Heinken, A, Hoffmann, U, Langer, F, Noppeney, T, Pittrow, D, Klotsche, J, Rabe, E, ,
Journal of vascular surgery. Venous and lymphatic disorders. 2017;(4):553-560.e1
Abstract
OBJECTIVE Superficial vein thrombosis (SVT) is a common disease in clinical practice. In terms of pathophysiology and outcomes, the condition is related to venous thromboembolism, bearing a potential for severe thromboembolic complications if it is not treated adequately. A wide range of treatment approaches (including oral and injectable anticoagulants, pain medication, nondrug therapy including compression therapy, and no treatment at all) are applied in clinical practice, but there is sparse information about selection of patients for therapies, current treatment pathways, and drug use as well as outcomes. The INvestigating SIGnificant Health TrendS in the management of Superficial Vein Thrombosis (INSIGHTS-SVT) study aims to close this gap by collecting representative data on the current treatment of SVT. METHODS The observational prospective study of about 1200 patients is carried out by up to 120 clinical and office-based physicians who regularly treat patients with SVT and are capable of conducting appropriate compression ultrasound diagnostics, such as vascular physicians, phlebologists, internists, vascular surgeons, and general practitioners. Patients are eligible for inclusion if they have ultrasound-confirmed acute, isolated SVT of the lower extremities. Documentation about the characteristics of the patients, diagnostics, comorbidities, and medical and nonmedical treatment is collected at baseline, at 10 ± 3 days or at approximately 45 days (depending on treatment), at approximately 3 months, and at approximately 12 months. Patients are requested to fill in quality of life questionnaires (on pain, Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms [VEINES-QOL/Sym], EuroQol-5 Dimension 5-Level [EQ-5D-5L]) at baseline and at approximately 3 months. Interventions are not stipulated by the trial protocol. RESULTS The primary efficacy outcome is the incidence of venous thromboembolism at 3 months; the primary safety outcome is the combined incidence of major and clinically relevant bleeding events at 3 months. As quality measures, plausibility checks at data entry, queries based on statistical analyses that focus on outliers and distribution of values, monitoring visits, and adjudication procedures will be applied. CONCLUSIONS This large study is expected to provide a comprehensive picture of patients with SVT under clinical practice conditions in Germany.
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Risk of cancer after anticoagulation in patients with unprovoked venous thromboembolism: an observational cohort study.
Eischer, L, Kammer, M, Traby, L, Kyrle, PA, Eichinger, S
Journal of thrombosis and haemostasis : JTH. 2017;(7):1368-1374
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Abstract
UNLABELLED Essentials Data on long-term cancer risk are controversial in patients with venous thromboembolism (VTE). We assessed long-term rates and risk factors of cancer in patients with VTE. Cancer risk after anticoagulation is not higher in VTE patients than in the general population. VTE recurrence is not predictive of a future cancer diagnosis. SUMMARY Background Patients with venous thromboembolism (VTE) are at risk of having a subsequent cancer diagnosis. The risk is highest during the first 6 months. Reports on cancer rates thereafter are controversial. We aimed to assess long-term rates and risk factors of cancer in patients with VTE. Methods and Results We followed patients with a first unprovoked VTE after discontinuation of anticoagulation, and excluded those receiving long-term antithrombotic therapy or with major thrombophilia. The study endpoint was the occurrence of cancer. Sixty-two (5.2%) of 1188 patients developed cancer during a median follow-up of 98 months. The cumulative incidence rates of cancer were 0.7% (95% confidence interval [CI] 0.2-1.2%), 3.1% (95% CI 2.0-4.1%) and 9% (95% CI 6.5-11.5) after 1, 5 and 15 years; these were not significantly different from those in the matched general population (0.6%, 3.4%, and 12.2%, respectively). The corresponding standardized incidence ratios (ratio of the observed cancer cases and the number of cases based on national cancer incidence rates) of 1.1 (95% CI 0.5-2.5), 1.0 (95% CI 0.6-1.4) and 0.9 (95% CI 0.7-1.2) did not indicate a difference in cancer incidence between our cohort and the general population. Advancing age (hazard ratio [HR] per decade 1.5, 95% CI 1.2-2.0) and shorter duration of anticoagulation (HR per 1-month decrease 1.3, 95% CI 1.1-1.6) were associated with an increased cancer risk, whereas VTE recurrence was not (HR 1.17, 95% CI 0.66-2.07). Conclusions Asymptomatic patients with unprovoked VTE who have completed anticoagulation therapy do not have a higher cancer risk. The inverse association between the duration of anticoagulation and the incidence of cancer warrants further investigation.
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Effectiveness of self-managed oral anticoagulant therapy in patients with recurrent venous thromboembolism. A propensity-matched cohort study.
Larsen, TB, Skjøth, F, Grove, EL, Nielsen, PB, Christensen, TD
Thrombosis and haemostasis. 2016;(3):524-9
Abstract
Patient-self-management (PSM) of oral anticoagulant therapy (OAT) with vitamin K antagonists for venous thromboembolism (VTE) has demonstrated efficacy in randomised, controlled trials. The aim of this study was to evaluate the effectiveness of PSM of OAT in everyday clinical practice. Prospectively registered patient data were obtained from databases at two hospitals, and cross-linkage with national patient registries provided detailed information on comorbidities and events. Patients with VTE performing PSM affiliated to major PSM centres were included as cases (N=444). A control group of patients on conventional treatment was propensity score selected in a ratio of 1:5 (N=2220) within matched groups. The effectiveness and safety was estimated using recurrent VTE, major bleeding events and all-cause death as outcomes. We found a lower rate of recurrent VTE among PSM patients compared to the control group with a hazard ratio (HR) of 0.63; 95 % confidence interval (CI) 0.42-0.95, whereas no difference was seen with bleeding (HR: 0.95; 95 % CI 0.44-2.02). The risk of all-cause death was lower for PSM patients (HR: 0.41; 95 % CI 0.21-0.81). A net clinical benefit analysis sums the effect on recurrent VTE and bleeding up to a weighted rate difference of 0.86 (95 % CI 0.00-1.72) in favour of PSM. In conclusion, PSM of anticoagulant treatment was associated with a statistically significant lower rate of recurrent VTE and all-cause death compared to patients on conventionally managed anticoagulant treatment. All major thromboembolic outcomes were less frequent among self-managed patients, whereas bleedings were observed with similar frequency.
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Evaluation of the SAMe-TT2R2 score to predict the quality of anticoagulation control in a cohort of patients with venous thromboembolism treated with vitamin K antagonists.
Demelo-Rodríguez, P, Postigo-Esteban, A, García-Fernández-Bravo, I, Agud, M, Calpena, S, Camacho, M, Del Toro-Cervera, J
Thrombosis research. 2016;:58-60
Abstract
OBJECTIVE The SAMe-TT2R2 score has been recently proposed to predict the quality of anticoagulation control in patients with atrial fibrillation treated with vitamin K antagonists (VKA). We aimed at calculating this score in a cohort of patients with Venous Thromboembolism (VTE) and determine its usefulness. METHODS We included all consecutive patients with VTE treated with VKA for >90days. We collected all variables included in the score (female sex, age<60years, medical history [>2 comorbidities], treatment [interacting drugs: e.g. amiodarone], tobacco [doubled], race [doubled]) and analyzed the relationship between the SAMe-TT2R2 score and time in therapeutic range (TTR), determined by the Rosendaal method and by the percentage of INR determinations (after excluding the first month). RESULTS 135 patients were treated with VKA for >90days, with a median TTR 65%. No differences in INR controls within range were found between patients with score 0-1 vs ≥2 (64.7±19.5% vs 66.0±20.5%, p=0.728). No differences were found in INR controls above (21.5±18.1% vs 21.2±21.3%, p=0.605) or below (3.9±14% vs 2.9±15.9%, p=0.517) the therapeutic range. CONCLUSION The SAMe-TT2R2 score is not useful to predict quality of anticoagulation control in patients with VTE treated with VKA.
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Anticoagulation Management Practices and Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Clinical Research Study.
Insam, C, Méan, M, Limacher, A, Angelillo-Scherrer, A, Aschwanden, M, Banyai, M, Beer, JH, Bounameaux, H, Egloff, M, Frauchiger, B, et al
PloS one. 2016;(2):e0148348
Abstract
Whether anticoagulation management practices are associated with improved outcomes in elderly patients with acute venous thromboembolism (VTE) is uncertain. Thus, we aimed to examine whether practices recommended by the American College of Chest Physicians guidelines are associated with outcomes in elderly patients with VTE. We studied 991 patients aged ≥65 years with acute VTE in a Swiss prospective multicenter cohort study and assessed the adherence to four management practices: parenteral anticoagulation ≥5 days, INR ≥2.0 for ≥24 hours before stopping parenteral anticoagulation, early start with vitamin K antagonists (VKA) ≤24 hours of VTE diagnosis, and the use of low-molecular-weight heparin (LMWH) or fondaparinux. The outcomes were all-cause mortality, VTE recurrence, and major bleeding at 6 months, and the length of hospital stay (LOS). We used Cox regression and lognormal survival models, adjusting for patient characteristics. Overall, 9% of patients died, 3% had VTE recurrence, and 7% major bleeding. Early start with VKA was associated with a lower risk of major bleeding (adjusted hazard ratio 0.37, 95% CI 0.20-0.71). Early start with VKA (adjusted time ratio [TR] 0.77, 95% CI 0.69-0.86) and use of LMWH/fondaparinux (adjusted TR 0.87, 95% CI 0.78-0.97) were associated with a shorter LOS. An INR ≥2.0 for ≥24 hours before stopping parenteral anticoagulants was associated with a longer LOS (adjusted TR 1.2, 95% CI 1.08-1.33). In elderly patients with VTE, the adherence to recommended anticoagulation management practices showed mixed results. In conclusion, only early start with VKA and use of parenteral LMWH/fondaparinux were associated with better outcomes.