Safety Of Anticoagulant Therapy Research Articles

Comparative Efficacy and Safety of Anticoagulant Therapy in Patients Planned for Percutaneous Coronary Intervention: A Network Meta-Analysis of Randomized Trials

Comparative Efficacy and Safety of Anticoagulant Therapy in Patients Planned for Percutaneous Coronary Intervention: A Network Meta-Analysis of Randomized Trials

Anticoagulation Therapy After Surgical Treatment of Spinal Dural Arteriovenous Fistula. Effectiveness and Long-Term Outcome Analysis.

Effectiveness and safety of anticoagulation therapy (AC) after treatment of spinal dural arteriovenous fistula (sdAVF) are still inadequately discussed in the literature and are addressed in this study. We retrospectively analyzed our medical database for patients with sdAVF treated in our institution between 2006 and 2016. Neurologic status at time of admission, discharge, and last follow-up was assessed via Aminoff-Logue disability score. Patient cohorts were dichotomized as group A (postoperative therapeutic heparinization) and group B (routine thromboembolic prophylaxis with low-dose heparin). Fifty-three patients were included in this analysis. In group A (n= 11), no acute deterioration was reported. In group B (n= 42), 4 patients developed acute postoperative deterioration; therapeutic AC was initiated in all 4 patients resulting in complete neurologic recovery within the inpatient stay. However, the incidence of postoperative deterioration did not reach statistical significance between treatment groups (P= 0.57). Data of 40 patients were available for long-term analysis (mean, 53.4 ± 36 months). Neurologic status did not differ significantly between both groups at time of admission (P=0.093), discharge (P= 0.723), and last follow-up (P=0.222). Acute postoperative deterioration in patients with sdAVF is a clinically relevant complication and was present in 7.5% of patients in our series. Although routine therapeutic AC did not decrease the rate of acute deterioration significantly, our findings imply that therapeutic AC in cases of acute postoperative deterioration might be a safe and efficient treatment option.

Anticoagulation in heart failure without atrial fibrillation: gaps and dilemmas in current clinical practice.

Data from observational and post-hoc analyses suggest that heart failure (HF) itself may be associated with higher risk of thromboembolic events compared to populations without HF. Although oral anticoagulants (OACs) might be a therapeutic option in individual cases, anticoagulation therapy in HF patients in sinus rhythm is not generally recommended, as the implementation of OACs in clinical practice in this HF population is not supported by large randomized clinical trials to date. Indeed, the available data suggest that the risk of major bleeding overshadows the potential anti-thromboembolic benefit of OACs in HF patients in sinus rhythm with no net beneficial effect on mortality rates. In this review we explore the current available evidence for the clinical outcomes of anticoagulation therapy in patients with HF in sinus rhythm, highlighting the current gaps in knowledge, which may guide the design of future randomized clinical trials focusing on the efficacy and safety of anticoagulant therapy in this HF population.

Фибрилляция предсердий как фактор риска развития когнитивных нарушений и деменции. Возможности антикоагулянтной терапии в их профилактике

This article presents an overview of data of Russian and foreign literature on possible associations between cognitive impairment and atrial fibrillation (AF). It includes modern classification of cognitive impairment, mechanisms of the effect of AF on cognitive functions and development of dementia, recommendations for the prevention of cognitive impairment in patients with AF. Special attention is paid to the assessment of cognitive status, and safe anticoagulant therapy, which is a priority in the prevention of cognitive impairment in patients with AF. Analysis of literature showed greater efficacy and safety of drugs from the group of Non-vitamin K Antagonist Oral Anticoagulants (NOAC), rivaroxaban in particular, in comparison with warfarin. Drugs from the NOAC group can be recommended for prevention stroke, cognitive impairment and dementia in elderly patients with AF.

Evaluation of anticoagulant therapy after cerebral hemorrhage combined with deep vein thrombosis of lower extremity

Objective To evaluate the efficacy and safety of anticoagulant therapy with low-molecular-weight heparin after cerebral hemorrhage combined with deep vein thrombosis of lower extremity. Methods One hundred and fifty-three cases of deep vein thrombosis of lower extremity after intracerebral hemorrhage were collected of Beijing Tiantan Hospital, Capital Medical University from June 2014 to June 2016. According to whether accepted anticoagulant therapy with low-molecular-weight heparin, the patients were divided into treatment group (n=79) and control group(n=74). Compared the head CT images and the ultrasound of lower extremity venous in the day when admissed to hospital and in the 7th day after treatment. The measurement data was adopted by t test, Chi-square test was adopted in the count data. Results Before the low-molecular-weight heparin therapy, the average bleeding volume in intracerebral was(1.38±0.45) ml for the anticoagulant therapy group. After 7 days of low-molecular-weight heparin therapy, the average bleeding volume in intracerebral was(1.01±0.54) ml, there was no increasing cerebral hemorrhage, with a statistically significant difference(P=0.000). The bleeding volume in intracerebral was(1.47±0.47) ml of control group cases, and after 7 days it became (1.17±0.52) ml, with a statistically significant difference (P=0.000), all these showed that cerebral hemorrhage had significantly absorbed. There was no statistically significant difference between the treatment group and the control group (P=0.123). It explained that anticoagulation was not increased intracranial hemorrhage with low-molecular-weight heparin. ultrasound showed that the lower extremity venous thrombosis was stable or decreased before and after anticoagulant therapy, and the difference was statistically significant (P=0.000), indicating that the anticoagulant therapy was effective. Conclusions It is safe and effective in low-molecular-weight heparin anticoagulant therapy for deep vein thrombosis of lower extremity after intracerebral hemorrhage. But patients need strict screening, and follow the individualized treatment. Key words: Cerebral hemorrhage; Venous thrombosis; Heparin, low-molecular-weight; Anticoagulants

GW28-e1146 Effectiveness and safety of anticoagulation therapy with dabigatran etexilate in patients undergoing catheter ablation and cardioversion procedures for atrial fibrillation

GW28-e1146 Effectiveness and safety of anticoagulation therapy with dabigatran etexilate in patients undergoing catheter ablation and cardioversion procedures for atrial fibrillation

GW28-e1152 Effectiveness and safety of anticoagulant therapy with different ways of administration rivaroxaban in patients after radiofrequency catheter ablation of atrial fibrillation

To compare the effectiveness and safety of the different methods of anticoagulation with rivaroxaban in patient after radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). 178 patients with non-valvularparoxysmal atrial fibrillation treated by radiofrequency ablation in General

P7-1 - Home Medical Care Support for Patients With Left Ventricular Assist Device Using Social Networking Service

Continuous-flow left ventricular assist devices (CF-LVAD) are increasingly used to support for the patients with advanced heart failure as bridge to heart transplantation. However, various complications management is necessary for patients at home after discharge. For two patients needed treatment for driveline infection site, we started management using Social Networking Service (SNS), evaluate the pictures taken by patients themselves, sharing how to care of wound site with visiting nurses. Subsequently, multidisciplinary medical staff such as Certified Nurse, Clinical Engineer, Wound Ostomy and Continence Nurse and Collaborating hospital doctor participated, we have started comprehensive VAD management including not only wound management but also anticoagulant therapy and device management. On the screen used only by medical staff, we can share patient condition smoothly anywhere and discuss treatment strategies with all staff. When a patient's device failure or pump thrombus was suspected, we instructed the patient an emergency visit, exchanged controller and adjusted acute phase anticoagulant therapy in short-term hospitalization. Then patient continued drip infusion at home care and collaborating hospital, performed safe anticoagulant therapy by measuring INR themselves every other day and adjusting the medication using SNS. Discussion: By using SNS, we could share more medical information and provide appropriate support system, which led to support of patient self-monitoring and to maintain both safety and quality of life.

ROLE OF ANTICOAGULATION THERAPY AFTER ANTERIOR WALL ST-ELEVATION MYOCARDIAL INFRACTION IN PREVENTING LV THROMBUS: A META-ANALYSIS AND META-REGRESSION

Background: Anticoagulation (AC) is used for treatment of left ventricle thrombus (LVT) after anterior wall ST-elevation myocardial infarction (STEMI). Whether AC should be used for prevention in this setting is debated. Our objective was to evaluate the efficacy and safety of AC therapy compared

WARFARIN AND ITS IMPORTANCE IN THE ERA OF NEW ORAL ANTICOAGULANTS. ISSUES OF MONITORING THE EFFECTIVENESS AND SAFETY OF TREATMENT

Oral anticoagulant (OAC) therapy is currently gaining special importance due to the significant spread of atrial fibrillation (AF) in the population (especially in older age groups). The use of OAC in AF has an extensive evidence base, which confirms a significant decrease in the number of strokes and total mortality in the context of anticoagulation therapy (ACT) in AF. Currently, the gold standard of the OAC is warfarin, which has proved effectiveness in all categories of patients with AF. A whole group of new OAC (NOAC) also appeared. In Russia, dabigatran, rivaroxaban and apixaban have been registered. All NOAC were studied in randomized clinical trials (RCTs) in comparison with warfarin, mainly in patients with non-valvular AF, therefore, in valvular AF, as well as in patients with severe renal failure, warfarin remains the drug of choice. Advantages of warfarin in comparison with NOAC are the presence of known antidote and standardized indicator of the efficacy and safety of the anticoagulation therapy – International Normalized Ratio (INR), as well as low price of the drug. The leading problem in the treatment of warfarin is the complexity and, at the same time, a strong need to maintain INR within the therapeutic window of at least 60% of the treatment time. Obviously, the optimal solution to this problem is the possibility of self-testing of this indicator by the patient himself and, probably, the ability to adjust the dosage of warfarin independently, to achieve the necessary values of INR (self-management) or titrate the dose with the help of a medical consultation by phone (self-monitoring). To date, several devices have been developed for self-monitoring of anticoagulation therapy – coagulometers. Their use leads to a decrease in the number of thromboembolic complications, and from the results of some RCTs – to a decrease in the number of large bleedings and total mortality, and to improve the quality of life of AF patients who need constant anticoagulation therapy. The high economic efficiency of using coagulometers has also been confirmed. Coagulometer CoaguChek (Roche, Switzerland) has the largest evidence base for self-monitoring of INR and its impact on the efficacy and safety of anticoagulation therapy.

EXPERIENCE IN THE USE OF ORAL ANTICOAGULANTS IN OUTPATIENT CLINICS

Since 2011, with the emergence of new classes of antithrombotic drugs – inhibitors of the activated X coagulation factor (rivoroxaban, apixaban, edoxaban) and thrombin inhibitor (dabigatran), antithrombotic therapy has received a new impetus to development and wider introduction into practice. New oral anticoagulants (NOAC) do not require laboratory monitoring for correction and dose selection, which makes their appointment more simple and convenient, compared with vitamin K antagonists (warfarin). The purpose of the presented work was to evaluate the efficacy and The safety of anticoagulant therapy in patients with atrial fibrillation in out-patient practice. The study was conducted for 1 year. There were 168 patients (108 men, 60 women, mean age 70. 6 ± 2.46 years) with atrial fibrillation. 90 patients received PLA (53% – dabigatran, 41% – rivaroxaban, 6% – apixaban), 78 – warfarin. 74% of patients included in the study had 3 or more points on the scale CHA2DS2-Vasc. During the observation period in the PLA group, ONMC was registered in 2 patients (2.2%), PE – 0. In 1 patient, embolism in the brachial artery was observed against the background of anticoagulant withdrawal due to the planned surgical intervention. In the group receiving warfarin as an anticoagulant, 2 strokes were registered during the year (2.3%) (1 of them fatal). The frequency of bleeding in the PLA group: large – 0, macrogematuria – 3, nasal 2, conjunctival – 2. In the warfarin group: large – 1 (fatal stratification of the aneurysm of the abdominal aorta), macrogemaria – 4, nasal 1, conjunctival – 1. Reliable differences in The frequency of bleeding was not revealed.

Venous thromboembolism in centenarians: Findings from the RIETE registry

BackgroundThe balance between the efficacy and safety of anticoagulant therapy in patients aged ≥100years receiving anticoagulant therapy for venous thromboembolism (VTE) is uncertain. MethodsWe used data from the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to assess the rate of VTE recurrences, bleeding events, and mortality appearing during the course of anticoagulant therapy in VTE patients aged ≥100years. ResultsOf 61,173 patients enrolled in RIETE as of January 2016, 47 (0.08%) were aged ≥100years. Of these, 10 (21%) were men, 21 (45%) presented with pulmonary embolism (PE), and 26 with deep vein thrombosis alone. Overall, 35 patients (74%) had severe renal insufficiency, 14 (30%) chronic heart failure, 30 (64%) anemia, 16 (34%) were taking antiplatelets, and 6 (13%) corticosteroids or non-steroidal anti-inflammatory drugs. Most patients (95%) were treated initially with low-molecular-weight heparin (LMWH) (mean daily dose, 168±42IU/kg). Then, 14 (30%) switched to vitamin K antagonists and 29 (62%) kept receiving long-term LMWH therapy (mean, 148±51IU/kg/day). During the course of anticoagulant therapy (mean duration, 139days), mortality was high (15/47; 32%). Two patients died of PE (initial PE one, recurrent PE one) and 5 (11%) had minor bleeding, but no major bleeding was reported. ConclusionsAmong patients with acute VTE aged ≥100years, the risk of VTE recurrences during the course of anticoagulation outweighed the risk of bleeding. Our data suggest the use of standard anticoagulant therapy in this patient population, even if they have severe renal insufficiency.

Anticoagulation therapy — the cardiological and neurological point of view

Ustalenie właściwego, czyli skutecznego i bezpiecznego leczenia przeciwkrzepliwego stanowi często złożony, interdyscyplinarny problem. Terapia doustnymi antykoagulantami niebędącymi antagonistami witaminy K, preparatami bezpieczniejszymi i co najmniej tak skutecznymi jak warfaryna stwarza pewne możliwości, nie jest jednak pozbawiona ograniczeń i powikłań. W niniejszej pracy zaprezentowano przypadki pacjentek w wieku 45 i 86 lat, których leczenie wymagało szerokich działań ze strony zarówno neurologów, jak i kardiologów, a dobór odpowiedniej terapii antykoagulacyjnej był trudny.

The polyphosphate/factor XII pathway in cancer-associated thrombosis: novel perspectives for safe anticoagulation in patients with malignancies

Cancer is an established risk factor for venous thromboembolism (VTE) and VTE is the second leading cause of death in patients with cancer. The incidence of cancer-related thrombosis is rising and is associated with worse outcomes. Despite our growing understanding on tumor-driven procoagulant mechanisms including cancer-released procoagulant proteases, expression of tissue factor on cancer cells and derived microvesicles, as well as alterations in the extracellular matrix of the cancer cell milieu, anticoagulation therapy in cancer patients has remained challenging. This review comments on a newly discovered cancer-associated procoagulant pathway. Experimental VTE models in mice and studies on patient cancer material revealed that prostate cancer cells and associated exosomes display the inorganic polymer polyphosphate on their plasma membrane. Polyphosphate activates blood coagulation factor XII and initiates thrombus formation via the intrinsic pathway of coagulation. Pharmacologic inhibition of factor XII activity protects mice from VTE and reduces thrombin coagulant activity in plasma of prostate cancer patients. Factor XII inhibitors provide thrombo-protection without impairing hemostatic mechanisms and thus, unlike currently used anticoagulants, do not increase bleeding risk. Interference with the polyphosphate/factor XII pathway may provide the novel opportunity for safe anticoagulation therapy in patients with malignancies.

New VTE Guidelines Favor NOACs Over Warfarin

New VTE Guidelines Favor NOACs Over Warfarin

Efficacy and safety of anticoagulant therapy in three specific populations with sepsis: a meta‐analysis of randomized controlled trials

ESSENTIALS: Most anticoagulant therapy has failed to demonstrate a survival benefit in the overall sepsis population. We conducted separate meta-analyses of anticoagulant therapy in three different populations. Survival benefit was observed only in the septic disseminated intravascular coagulation (DIC) population. Further randomized controlled trials should focus on specific populations with septic DIC. Although many preclinical trials have indicated the effectiveness and safety of anticoagulant therapy as an adjuvant therapy against sepsis, there is little evidence to support its effectiveness to reduce mortality in the overall population with sepsis in clinical situations. However, several studies suggested that specific anticoagulant therapy may potentially reduce mortality in patients with sepsis-induced disseminated intravascular coagulation (DIC). We investigated whether the survival benefit of anticoagulant therapy might pertain to the coagulopathic population with sepsis. We conducted separate meta-analyses of randomized controlled trials for anticoagulant therapy in three different populations: (i) overall population with sepsis, (ii) population with sepsis-induced coagulopathy, and (iii) population with sepsis-induced DIC. We searched MEDLINE, Scopus, and the Cochrane Central Register of Controlled Trials comparing anticoagulant therapy with placebo or no intervention in sepsis patients. We measured all-cause mortality as the primary outcome and bleeding complications as the secondary outcome. We analyzed 24 trials enrolling 14 767 patients. There were no significant reductions in mortality in the overall sepsis population and the population with sepsis-induced coagulopathy. Otherwise, we observed significant reductions in mortality (risk ratio 0.72, 95% confidence interval 0.62-0.85) in the population with sepsis-induced DIC. As adverse events, bleeding complications tended to increase similarly with anticoagulant therapy in all three populations. Although associated with an increased risk of bleeding, anticoagulant therapy resulted in no survival benefits in the overall sepsis population and even the population with sepsis-induced coagulopathy; beneficial effects on mortality were observed only in the population with sepsis-induced DIC.

Anticoagulation and population risk of stroke and death in incident atrial fibrillation: a population-based cohort study.

Atrial fibrillation increases the risk of stroke and death. Anticoagulation therapy is an effective treatment for stroke prevention, but remains underused in the community. We sought to determine the effectiveness and safety of anticoagulation therapy in an inception cohort with new-onset atrial fibrillation in the province of Alberta, Canada. We conducted a population-based cohort study of atrial fibrillation using an administrative database from Alberta's publicly funded and universally available health care system. All new-onset atrial fibrillation patients from Jan. 1, 2009, to Dec. 31, 2010, were included in the cohort and followed through Dec. 31, 2013. We assessed anticoagulation status as a predictor of stroke and death using time-to-event analysis and adjusted for sex and CHADS2 (congestive heart failure, hypertension, age ≥ 75 yr, diabetes mellitus and prior stroke or transient ischemic attack) score using Cox proportional hazards modelling. We identified 10 745 patients, 7358 (68.5%) of whom received anticoagulation therapy, principally with warfarin (n = 6997, 95.1%). Anticoagulation therapy was associated with significantly decreased risk of ischemic stroke (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.58-0.82), all stroke (HR 0.77, 95% CI 0.65-0.91), all stroke and death (HR 0.70, 95% CI 0.62-0.72) and all-cause mortality (HR 0.67, 95% CI 0.62-0.72), despite an association with increased risk of hemorrhagic stroke (HR 1.92, 95% CI 1.17-3.16). There was a neutral association with subdural (HR 1.01, 95% CI 0.53-1.93) and gastrointestinal (HR 0.96, 95% CI 0.70-1.31) hemorrhage. Anticoagulation therapy is effective and safe for stroke prevention and decreases mortality in patients with incident atrial fibrillation. These population data support an aggressive approach to screening for atrial fibrillation and treatment with anticoagulant medicines to prevent stroke and death.

Anticoagulation in pregnancy and puerperium: With a focus on the benefits and risks of the applications of vitamin K antagonists on the prevention of mechanical heart valves thrombosis

Introduction: The current number of women in the reproductive phase (from 15 to 45 years) in Europe is estimated at about 105 million, with about 5 million children annually born in average. About 1% of pregnancies among women in Europe are complicated by heart disease, the risk of cardiovascular disease in pregnant women being further increased by the fact that ever older women are giving birth. Methods: Preparing this paper is based on a systematic PubMed search of existing professional databases and accessible medical journals and textbooks dealing with this subject matter. Topic: Being certainly drugs with the best anticoagulant effect in situations of high risk for thrombosis, especially in patients with mechanical prosthetic heart valves during pregnancy, vitamin K antagonists (VKA) on the other hand also entail a well-known dose-related risk of embryo toxicity, genotoxicity, and hemorrhage in the fetus and in the mother. The choice of appropriate anticoagulant depends on the stage of pregnancy. In accordance with the North-American guidelines (American College of Chest Physicians - ACCP) for women already on oral vitamin K antagonists actively trying to conceive frequent pregnancy tests, and substitution of VKA with heparin drugs when pregnant are recommended rather than VKA replacement with low molecular weight heparin (Low Molecular Weight Heparin - LMWH) when planning a pregnancy. Heparin derivatives have no embryo toxic and fetotoxic characteristic effects of VKA but they are less effective at preventing valve thrombosis, due to which they have recently been superseded by improved techniques for monitoring effects of heparin, with a mentioned made that low molecular weight heparin used in high therapeutic doses requires obligatory (on a weekly basis) monitoring of anti-factor Xa coagulation activities. Conclusion: Adequate anticoagulant therapy during pregnancy requires an analysis of risk factors for thrombosis, hemorrhage risk, consideration of comorbidities in pregnant women, especially renal function, especially taking into account the gestational age. Though it must be admitted that there is no absolutely safe anticoagulant therapy during pregnancy, a choice of the safest option regarding the stated risks for the mother and the child is of paramount importance.

Feasibility Study of a Mobile Health Intervention for Older Adults on Oral Anticoagulation Therapy.

Background: Oral anticoagulation treatment (OAT) such as warfarin therapy is recommended for older adults with atrial fibrillation, heart failure, or who are at risk for venous thromboembolism. Despite its proven benefits, older adults report both dissatisfaction with OAT and reduced quality of life that can potentially lead to low adherence to OAT and decreased treatment efficacy. Objective: To test the feasibility of Mobile Applications for Seniors to enhance Safe anticoagulation therapy (MASS), a mobile-based health technology intervention designed to promote independence and self-care. Methods: This pilot study used a single-arm experimental pre–post design to test the feasibility of a 3-month intervention using MASS in 18 older adults (male: n = 14; White: n = 9; Hispanic: n = 7; Other: n = 2; M age = 67). MASS was available in English or Spanish. Participants completed surveys about their OAT knowledge, attitudes, quality of life with OAT, and adherence at baseline and at a 3-month follow-up. Satisfaction with the MASS intervention was also assessed at follow-up. Results: Anticoagulation knowledge significantly improved from baseline to follow-up (Mbase = 12.5 ± 5.51, Mfollow-up = 14.78 ± 3.93, p = .007). Other outcomes were not different, pre- and post-tests. Participants reported they were generally satisfied with MASS, its ease of use and its usefulness. Conclusion: The results showed use of MASS improved older adults’ knowledge of OAT. Using mHealth apps may enhance self-care among older adults with chronic conditions who are also taking oral anticoagulants.

PRACTICAL CONCERNS OF ANTICOAGULATION IN NONVALVULAR ATRIAL FIBRILLATION: A UNIVERSITY CLINICS REGISTRY

Aim. To evaluate the possibility to increase the effectiveness and safety of anticoagulation therapy in nonvalvular atrial fibrillation (AF) under the circumstances of an office for anticoagulation control located at the University Clinics. Material and methods. Observational prospective study (registry), included 325 patients with nonvalvular AF, taking various anticoagulation drugs for the prevention of thromboembolic complications (TEC). Mean duration of follow-up is 24±12 months. Results. At the current moment about 95% of patients continue taking anticoagulants and follow-up in the office of anticoagulation control. Totally there were 37 bleedings marked, of those 19 minor and 18 major. By the general quantity of bleeding cases there is no significance in the difference between warfarin and “novel” anticoagulants (NOAC) (p>0,05). Major bleedings significantly more common in warfarin group than in NOAC (p<0,05), and absolute number of minor is lower in warfarin group (p<0,05). By the total number of bleedings anticoagulants ranged as following: dabigatran (in 5,13% of patients), warfarin with time in target INR more than 40% (10,34%), rivaroxaban (14,3%), apixaban (26,9%). Higher rate in apixaban can be explained by older mean age of the patients taking it (p<0,05), that is itself a risk factor for hemorrhagic complications. It should be marked that by the rate of major bleedings warfarin was significantly worse, than any NOAC. During follow-up time thromboembolic complications were found just in 3% (0,9% of all taking anticoagulants). Conclusion. Anticoagulation control under the conditions of specialized office is effective and safe for the patients with nonvalvular AF. On vitamin K antagonists (even in good INR control) there are significantly more common major (potentially life-threatening) bleedings, though in NOAC treatment there are more minor bleedings that require only short interruption of drug intake.