Fact-Finding Survey of Information Provision and Medication Instruction on Idarucizumab for Pharmacists / 医薬品情報学

Objective: Providing patients with information and medication instruction regarding direct oral anticoagulant (DOAC)antagonists is becoming increasingly important. Comprehensive knowledge of DOAC antagonists can expedite the transportation and treatment of emergency cases, such as bleeding with antagonists, in hospitals. We investigated the awareness of idarucizumab and whether the information provided in the Risk Management Plan was reflected in the actual provision of information and medication instruction.Methods: Pharmacists in dispensing pharmacies and Kameda Medical Center were included in the survey conducted from May 2022 to June 2022. Using a web-based questionnaire, we obtained answers to questions related to idarucizumab awareness. Respondents answered a series of questions regarding idarucizumab awareness, sources of information, patient information, and medication instruction.Results: We received responses from 1,118 people. In all, 25.9% pharmacists were aware of idarucizumab, and 10.3% provided information and medication instruction on DOAC antagonists to patients. Pharmaceutical companies, books, drug information departments, workshops, and wholesalers were the sources of information on idarucizumab for 24.8, 21.0, 19.0, 10.7, and 3.1% of the pharmacists, respectively.Conclusion: Pharmacists had knowledge of DOAC antagonists and provided information and instructions to patients infrequently. Improved awareness will lead to prompt response during the occurrence of adverse events such as bleeding.

Anticoagulant effectiveness and safety of new oral anticoagulants versus warfarin after heart valve replacement ： a meta-analysis / 中国药房

OBJECTIVE To compare the anticoagulant effectiveness and safety of new oral anticoagulants （NOACs）and warfarin after heart valve replacement ，and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed，Cochrane Library ，Embase，Web of Science ，CNKI，Wanfang database and VIP ，clinical studies about the use of NOACs versus warfarin after heart valve replacement were collected during the inception to July 2021. After literature screening and data extrac tion，the quality of included randomized controlled trials （RCTs）were evaluat ed by bias risk assessment tool recommended by Cochrane system evaluator manual 5.2.0. After the quality of the included cohort studies was evaluated by Newcastle-Ottawa scale （NOS），RevMan 5.3 software was used for meta-analysis and sensitivity analysis. RESULTS A E-mail：carolmeng_0813@163.com total of 9 studies involving 4 962 patients were included ，of which 7 were RCTs and 2 were cohort studie s. Results of meta-analysis showed that after biological valve replacement/repair ，the incidence of stroke and systemic embolism （SSE）[OR＝0.71，95％CI（0.52，0.97），P＝0.03]，major bleeding [OR ＝0.40，95％CI （0.30，0.54），P＜0.000 01] and intracranial hemorrhage [OR ＝0.20，95％CI（0.04，0.95），P＝0.04] in trial group were significantly lower than warfarin group ；there was no significant difference in all-cause mortality between 2 groups [OR ＝1.25，95％CI（0.88， 1.79），P＝0.22]. After mechanical valve replacement/repair ，there were no significant difference in the incidence of SSE [OR ＝1.52， 95％CI（0.04，60.29），P＝0.82] or all-cause mortality [OR ＝0.26，95％CI（0.04，1.84），P＝0.18] between 2 groups. The results of subgroup analysis according to the follow-up time showed that after biological valve replacement/repair ，the incidence of SSE in trial group was significantly lower than that in control group when the follow-up time was ≤3 months [OR ＝0.20，95％CI（0.06， 0.74），P＝0.03]；but there was no significant difference in the incidence of major bleeding between 2 groups [OR ＝0.67，95％CI （0.19，2.38），P＝0.53]；when the follow-up time was longer than 3 months，there was no statistical significance in the incidence of SSE between 2 groups [OR ＝0.74，95％CI（0.54，1.02），P＝0.07]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.39，95％CI（0.29，0.52），P＜0.001]. Subgroup analysis by study type showed that after biological valve replacement/repair ，the incidence of SSE in the RCT in trial group was significantly lower than that in control group [OR ＝0.51，95％CI（0.29，0.92），P＝0.03]，but there was no significant difference in the incidence of major bleeding between 2 groups[OR＝0.58，95％CI（0.33，1.03），P＝0.06]. In cohort study ，there was no significant difference in the incidence of SSE between 2 groups [OR ＝1.03，95％CI（0.40，2.66），P＝0.95]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.20，95％CI（0.06，0.74），P＜0.001]. Sensitivity analysis results showed that the results of the above-mentioned meta-analysis were relatively robust. CONCLUSIONS For the patients underwent biological valve replacement/repair，the effectiveness and safety of NOACs are better than or similar to those of warfarin ；for the patients underwent mechanical valve replacement/repair ，there is no significant difference in the effectiveness and safety between NOACs and warfarin.

Efficacy of the Checksheet for Appropriate Prescription of DOAC / 医薬品情報学

Objective: The use of direct oral anticoagulants (DOACs) has increased because they have some advantages over warfarin, such as fewer interactions and no requirement for coagulation monitoring in principle. DOACs have dose adjustment requirement based on renal function and other complex criteria that differ depending on specific DOAC preparations and indications. At the Nagoya City East Medical Center, DOAC dose‒related decisions previously depended on the knowledge and discretion of individual pharmacists. However, a dose checking sheet for DOACs (the Checking Sheet) was prepared and used on our electronic medical record system since September 2016 to increase the reliability of prescription checking, eliminate improper prescriptions, and ensure electronic documentation of pharmaceutical inquiries. In this study, we compared percentages of proper prescriptions before and after the introduction of the Checking Sheet to assess the effectiveness of its use, which has not been reported previously.Method: The percentage of proper DOAC prescriptions was used as a measure to assess the effectiveness of the Checking Sheet. We investigated DOAC prescriptions from March 2017, when the Checking Sheet system had been established, and compared those with prescriptions from March 2016 (before the Checking Sheet was introduced). Prescriptions of rivaroxaban, apixaban, edoxaban, and dabigatran for nonvalvular atrial fibrillation or venous thromboembolism were included; prescriptions dispensed outside the hospital were excluded.Result: DOAC prescriptions before and after the Checking Sheet introduction were similar in number. The percentage of proper prescriptions increased significantly from 82.4 to 94.3%. Among specific DOAC preparations, the number of improper prescriptions decreased significantly for apixaban and showed a tendency to decrease for rivaroxaban.Conclusion: The increases in the number of proper DOAC prescriptions observed after introducing the Checking Sheet showed that the Checking Sheet helped ensure a certain level of prescription checking, suggesting its usefulness for promoting proper DOAC use.

Clinical application of clot waveform analysis / 中华检验医学杂志

Bleeding and thrombotic diseases are closely related to various clinical departments. Laboratory-related tests play an important role in disease diagnosis and differential diagnosis, risk assessment, cause finding, and efficacy monitoring. Clot waveform analysis (CWA), as an automated coagulation detection technology, can provide more valuable information about the entire coagulation process of a plasma sample. A large number of studies have showed that CWA has certain value in the evaluation of coagulation status of COVID-19 patients, the judgment of clinical phenotype of hemophilia A (HA) patients, and the monitoring of direct oral anticoagulant drugs (DOAC). In-depth interpretation and application of CWA in different clinical settings can provide more laboratory information for diagnosis and treatment of bleeding and thrombotic diseases.

Knowledge gaps about Oral Anticoagulant in Saudi Patients

Patients with atrial fibrillation (AF) are at a higher risk of thrombotic stroke. Therefore treatment with an oralanticoagulant (OAC) has been proven to prevent stroke, however, the bleeding side effect of OAC is the concernfor both physicians and patients. Patients’ knowledge of the stroke and bleeding related to AF is lacking inSaudi Arabia. We conducted this study to assess the knowledge of patients on AF related to stroke and bleedingfrom OAC. Method: this is a cross-sectional study conducted in a tertiary care university center in Riyadh SaudiArabia. A validated questioner provided to patients or patients’ relatives who were diagnosed as permanent AFon OAC, 15 years of age or older who consented to participate in answering the questionnaire. Results: Of 229patients analyzed 46% were male and 54% were female; 58.8% in the age of 56-75 years. They were obese andhad a sedentary lifestyle. 42% knew AF symptoms, 28.9% knew AF can cause stroke, 39% knew bleeding sideeffect of OAC and there were no gender differences. Conclusion: This study revealed poor knowledge about AF,stroke, and bleeding side effects, and this mandate urgent strategy for patients’ education in Saudi Arabia.

Performance Evaluation of the CS-5100 Coagulation Analyzer for Special Coagulation Parameters

Pacientes con fibrilación auricular no valvular tratados con antivitamina K o anticoagulantes directos: perfil de paciente y efectos a largo plazo / Patients with non-valvular atrial fibrillation on vitamin k antagonists or direct-acting oral anticoagulants: patients profile and long-term follow up outcomes

Resumen Introducción: La llegada de los anticoagulantes directos (ACD) ha supuesto un cambio en el tratamiento de la fibrilación auricular no valvular (FANV) en los últimos años. Los objetivos de este estudio son determinar el grado de control de la anticoagulación con antivitamina K (AVK) y su posible implicación en efectos cardiovasculares adversos mayores (ECAM) y evaluar las diferencias entre el grupo en tratamiento con AVK respecto del grupo con ACD. Pacientes y métodos: Estudio de cohorte prospectivo que incluyó a pacientes consecutivos diagnosticados con FANV valorados en el Servicio de Cardiología con un seguimiento de 18 meses. Se analizaron diferencias demográficas, clínicas y analíticas entre grupos, incluido el grado de control de la anticoagulación del grupo AVK y su posible relación con ECAM. Resultados: Se incluyó a 273 pacientes: 46.5% tratados con AVK, 42.5% con ACD y 11% sin tratamiento anticoagulante. El control de la anticoagulación con AVK fue del 62.1%, sin diferencias en ECAM en función de control. El grupo ACD presentó menos ECAM que el grupo de AVK (13.4 vs. 4.3%; HR, 0.90; 0.83-0.98; p = 0.01), con una menor mortalidad cardiovascular (0.0 vs. 5.5%; HR, 0.94; 0.90-0.98; p = 0.01) y total (0.9 vs. 12.6%; HR, 0.88; 0.82-0.94; p menor que 0,01), aunque sin diferencias significativas en eventos hemorrágicos (0.9 vs. 4.7%; p = 0.07) ni isquémicos (2.6 vs. 0.8%; p = 0.27). Discusión: Los pacientes con AVK poseen un perfil clínico diferente en comparación con los que reciben ACD. El control de anticoagulación del grupo de AVK fue inadecuado en casi la mitad de los casos. El grupo de AVK presentó más ECAM que el grupo de ACD.

Abstract Introduction: The arrival of direct-acting oral anticoagulants (DOACs) has led to a change in the management of non-valvular atrial fibrillation (NVAF) in recent years. The objectives of this study are to determine the level of therapeutic control of anticoagulation with vitamin K antagonists (VKA) and its possible involvement in major adverse cardiovascular events (MACE) and to evaluate differences between the group on VKA with respect to the group on DOACs. Patients and methods: Prospective cohort study that included consecutive patients diagnosed with NVAF in Cardiology Consultations with a clinical follow-up of 18 months. Demographic, clinical and analytical differences between groups were analyzed, including the level of therapeutic control of anticoagulation on the VKA group and its association with MACE. Results: Overall, 273 patients were included: 46.5% on VKA, 42.5% on DOACs, 11% without antithrombotic treatment. Patients on VKA spent 62.1% of their time within therapeutic range (TTR by the Rosendaal formule). There were no differences in MACE depending on anticoagulation control. The DOACs group presented lesser MACE rate than the VKA group (13.4 vs. 4.3%; 0.90; HR 0.90; 0.83-0.98 p = 0.01) with lower cardiovascular mortality (0.0 vs. 5.5%; HR, 0.94; 0.90-0.98; p = 0.01) and total mortality (0.9 vs. 12.6%; HR, 0.88; 0.82-0.94; p less 0.01) although without significant differences in hemorrhagic (0.9 vs. 4.7 %; p = 0.07), or ischemic events (2.6 vs. 0.8%, p = 0.27). Conclusions: Patients on VKA have a different clinical profile than those who receive DOACs. Patients on VKA have an inadequate control of the anticoagulation in quite the half of the cases. The VKA group presented more MACE than the DOACs group.

Cirugía herniaria electiva en pacientes portadores de tratamiento anticoagulante / Elective hernia surgery in patients with anticoagulant treatment

Resumen Introducción: Diversas patologías requieren de tratamiento anticoagulante oral (TACO). Algunos de estos pacientes requieren resolución quirúrgica. El manejo perioperatorio de estos pacientes es variable dependiendo del centro. Objetivos: Evaluar la morbilidad y mortalidad del protocolo de manejo de patología herniaria en TACO, atendidos en nuestro hospital. Material y Métodos: Estudio descriptivo prospectivo de 37 pacientes sometidos a cirugía herniaria en TACO entre 2008-2016. Los datos fueron obtenidos de la base de datos computacional del Equipo de Hernias, con un seguimiento mínimo de 1 mes. Se evaluaron las características clínicas, quirúrgicas y la morbimortalidad postoperatoria. El traslape consistió en hospitalizar al paciente tres días previos a la cirugía, suspendiéndose el TACO e iniciando heparina de bajo peso molecular (HBPM) en dosis terapéuticas, que se suspende 24 h previas a la cirugía. Se reinicia la HPBM a las 12 a 24 h postoperatorias, y se inicia el traslape a TACO a las 24-48 h. Los datos fueron analizados con Stata v14. Resultados: De los 37 pacientes estudiados, veintiséis pacientes fueron hombres (70,2%), la media de edad fue de 67,3 años. El 48,7% tenían fibrilación auricular. El 100% consumía acenocumarol como TACO. La media en el inicio del traslape a la anticoagulación oral fue de 1,4 días. El promedio de INR al momento del alta fue de 2,04. Dos pacientes fueron dados de alta con dalteparina. Un paciente (2,7%), presentó dolor en el postoperatorio inmediato y uno (2,7%), equimosis del sitio quirúrgico. Conclusiones: El protocolo de trabajo utilizado, demostró ser seguro, con una mínima morbilidad postoperatoria.

Introduction: Various pathologies require oral anticoagulant treatment (TACO). Some of these patients present pathologies of surgical resolution. The perioperative management of these patients is variable depending on the center. Aim: To evaluate the morbidity and mortality of patients attended with hernia pathology and TACO, assisted in our hospital. Materials and Method: Prospective, descriptive study of 37 patients submmited to hernia surgery in TACO between 2008-2016. The data was obtained from the computer database of the Hernia Team, with a minimum follow-up of 1 month. Clinical, surgical characteristics and postoperative morbidity and mortality were evaluated. The treatment overlap from TACO to Low Molecular Weight Heparin (LMWH) in therapeutic doses, was initiated three days before surgery. LMWH was suspended 24 hours prior to surgery, and reinitiated 12 to 24 hours post operation. 48 to 72 hours TACO was resumed. The data was analyzed with Stata v14. Results: Twenty-six patients were men, the mean age was 67.3 years. 48.7% had atrial fibrillation. 100% consumed acenocoumarol as TACO. The mean time for resuming TACO after surgery was 1.4 days. The average INR at the time of discharge was 2.04. Two patients were discharged with dalteparin. One patient (2.7%) presented pain in the immediate postoperative period and one showed ecchymosis of the surgical site (2.7%). Conclusions: The work protocol used, proved to be safe, with minimal postoperative morbidity.

Resolution of Primary Aortic Thrombosis after Dabigatran therapy—A New Hope for the Rare and Old Disease

The primary aortic thrombosis (PAT) is an uncommon noncardiac cause of distal peripheral embolization to lower extremities. Also, this condition develops in the absence of extensive atherosclerosis of aorta or abnormal dilatation like aneurysm of the aorta. In most of the cases, there was either no or minimal atherosclerosis of the aorta. The disease can involve any part of the aorta, but in most of the cases, the thoracic aorta below the origin of the left subclavian artery followed by the infrarenal portion of the abdominal aorta was the most common site of involvement. In our case, there was extensive thrombosis starting from the lower part of the thoracic aorta extending across both the renal arteries up to the aortic bifurcation without any underlying aortic pathology or hypercoagulable disease. There are no guidelines for the management of the PAT, but our experience is based on few case series, case reports, and meta-analysis where there are variable success rate using conservative medical management, endovascular procedure, or surgical thrombectomy. Vitamin K antagonist was the drug of choice in all the cases as a part of conservative medical management or used to prevent recurrence after the endovascular or surgical procedure. We present a case of PAT where the use of dabigatran leads to complete resolution and prevented the recurrence of the disease during two-year follow-up, which is the first and unique case report of the literature.

A national audit on the utilisation and documentation of dabigatran checklist for patients initiated on dabigatran

@#Background: Direct oral anticoagulants (DOACs) especially dabigatran, have gain popularity for their efficacy, fixed dosing and favourable safety profile. A dabigatran prescribing checklist has been prepared by the Ministry of Health, Malaysia (MOH) to ensure rational and safe prescribing of dabigatran. This study therefore aimed to audit the utilization and documentation of this checklist and use of dabigatran in the government healthcare facilities. Methods: This is a nationwide retrospective audit on the documentation of Dabigatran Prescribing and Dispensing Checklist for a period of two years from January 2013 till December 2014. Data from these Dabigatran Checklists (indication, dose, duration, renal function and adverse drug reactions encountered) were extracted by the pharmacist at MOH healthcare facilities. Results: A total of 52 out of 56 (92.9%) of MOH facilities complied to usage of checklist at their centres involving a total of 582 patients of which 569 (97.7%) patients were initiated on dabigatran for the approved indications. The recommended dose of dabigatran was used correctly in 501 (99.6%) of patients. Reason for switching to DOACs use was only documented in 76.7% (131/171) of patients. The most common reason for switching from warfarin was poor INR control (n=39), history of bleeding/overwarfarinisation (n=22) and unable to attend regular INR clinic (n=21). There were 75 cases of adverse events reported. The most common adverse event reported were abdominal discomfort (n=10) followed by gum bleeding (n=9) and dizziness (n=5). Conclusions: Compliance to the dabigatran check list was high with 70% of patients prescribed the appropriate dosing.

Antithrombotic Strategy in Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention

Choosing antithrombotic regimens for patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) with stent placement is challenging. Until recently, the guidelines recommended warfarin-based triple therapy, which causes frequent major bleeding events in up to 12% of patients during the first year of treatment. The WOEST trial, however, revealed that dual therapy, by without aspirin, resulted in significantly lower bleeding risks with similar thromboembolic events to triple therapy. Subsequently, efforts to seek the optimal dual therapy regimens, especially with the combination of a non-vitamin K antagonist oral anticoagulant (NOAC), were initiated. This review highlights the evidence for dual therapy using an NOAC for patients with AF who underwent PCI, with an emphasis on reduced bleeding risk.

Perioperative Venous Thromboembolism (VTE) Prophylaxis in Thoracic Cancer Patients: Chinese Experts Consensus - Interpretation of Application Prospect of Direct Oral Anticoagulant / 中国肺癌杂志

Venous thromboembolism (VTE) is a preventable perioperative complication of malignant tumor in thoracic surgery. At present, low molecular weight heparin anticoagulants are the first choices for perioperative drug prevention of malignant tumors, and direct oral anticoagulants are not recommended for perioperative use of malignant tumors in thoracic surgery, but their application in other related fields is relatively mature. This article will introduce direct oral anticoagulants and analyze the prospect of their perioperative application in patients with thoracic malignant tumors. It is helpful to better understand the relevant contents of "perioperative VTE prophylaxis in thoracic cancer patients: Chinese experts consensus (2018 edition)".

The Role of Novel Oral Anticoagulants and Antiplatelet Therapy after Percutaneous Coronary Intervention: Individualizing Therapy to Optimize Outcomes

The number of patients undergoing percutaneous coronary intervention (PCI) who mandate additional oral anticoagulant therapy has been increasing. Dual antiplatelet therapy (DAPT) is associated with reduced ischemic events including stent thrombosis, myocardial infarction and stroke following PCI. However, the tradeoff is an increased risk for bleeding while on DAPT. The addition of a novel oral anticoagulant (NOAC) further increases the likelihood of bleeding while on antiplatelet therapy. Thus, the overall risks and benefits for each patient undergoing PCI on NOAC must be assessed and therapy individualized to ensure optimal therapy for each unique situation. Patients on NOAC undergoing PCI should undergo routine assessment with intravascular imaging as the role of high-risk lesion-related features have increased importance prior to determining optimal duration of treatment with DAPT. We review the best practices for the pharmacologic management of patients requiring anticoagulation with NOAC who are treated with PCI and require antiplatelet therapy.

Reducing Stroke Risk in Atrial Fibrillation: Adherence to Guidelines Has Improved, but Patient Persistence with Anticoagulant Therapy Remains Suboptimal

Atrial fibrillation (AF) is a significant risk factor for avoidable stroke. Among high-risk patients with AF, stroke risk can be mitigated using oral anticoagulants (OACs), however reduction is largely contingent on physician prescription and patient persistence with OAC therapy. Over the past decade significant advances have occurred, with revisions to clinical practice guidelines relating to management of stroke risk in AF in several countries, and the introduction of non-vitamin K antagonist OACs (NOACs). This paper summarises the evolving body of research examining guideline-based clinician prescription over the past decade, and patient-level factors associated with OAC persistence. The review shows clinicians' management over the past decade has increasingly reflected guideline recommendations, with an increasing proportion of high-risk patients receiving OACs, driven by an upswing in NOACs. However, a treatment gap remains, as 25–35% of high-risk patients still do not receive OAC treatment, with great variation between countries. Reduction in stroke risk directly relates to level of OAC prescription and therapy persistence. Persistence and adherence to OAC thromboprophylaxis remains an ongoing issue, with 2-year persistence as low as 50%, again with wide variation between countries and practice settings. Multiple patient-level factors contribute to poor persistence, in addition to concerns about bleeding. Considered review of individual patient's factors and circumstances will assist clinicians to implement appropriate strategies to address poor persistence. This review highlights the interplay of both clinician's awareness of guideline recommendations and understanding of individual patient-level factors which impact adherence and persistence, which are required to reduce the incidence of preventable stroke attributable to AF.

Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation

PURPOSE: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. MATERIALS AND METHODS: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on- or off-label use according to Korea Food and Drug Regulations. RESULTS: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA₂DS₂-VASc score was 3.3±1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. CONCLUSION: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.

Treatment efficacy and risk of bleeding among cancer patients treated for Venous Thromboembolism with Dabigatran Compared to Warfarin

Introduction@#The special needs of cancer patients offer unique challenges in treating them for venous thromboembolism (VTE). Dabigatran is a novel oral anticoagulant (NOAC) that may be comparable to warfarin in clinical benefit and risks of bleeding. A meta-analysis and systematic review was performed to compare efficacy of prevention of VTE recurrence and risks of bleeding with dabigatran compared to warfarin. @*Methods@#Randomized-controlled trials (RCTs) from various sources comparing dabigatran with warfarin for the prevention of recurrence of VTE were then retrieved and analyzed. The efficacy outcomes looked into was recurrence of VTE and mortality related to VTE while the primary safety outcome looked into was major bleeding. @*Results@#This meta-analysis, which included the studies, RECOVER I, RECOVER II, REMEDY showed that VTE and VTErelated deaths occurred in six out of 174 (3.4%) of cancer patients treated with dabigatran while four out of 166 (3.6%) cancer patients treated with warfarin with a relative risk of 1.44 with a 95% CI of 0.41, 5.03 showing no significant difference between dabigatran and warfarin. The REMEDY trial included a total of 60 cancer patients from a total of 1,430 patients in the dabigatran group versus 59 cancer patients from a total of 1,426 patients in the warfarin group. Under the outcome of major bleeding event, among all patients who received dabigatran, 13 patients had major bleeding events, while among those who received warfarin, 25 patients had major bleeding events with a hazard ratio of 0.52 and 95% CI of 0.27-1.02. With the RECOVER I, and RECOVER II, among cancer patients analysed, four patients of the 105 who received dabigatran had major bleeding; while three of the 100 patients who received warfarin had major bleeding with a HR of 1.23 (95% CI of 0.28-5.5). @*Conclusion@#The authors conclude that dabigatran is comparable to warfarin in the prevention of recurrence of VTE among cancer patients in terms of both benefits and risks.

Ambulant treatment for a very elderly patient with acute deep vein thrombosis in a rural area: A case report / Journal of Rural Medicine

<p>Acute symptomatic deep vein thrombosis (DVT) is usually managed by intravenous heparin and oral warfarin. Recently, direct oral anticoagulants (DOAC) have been introduced for the treatment of acute DVT. DOAC may be useful for very elderly patients who live in rural areas, where medical resources are limited. An 83-year-old woman presented to our clinic with left leg edema. Contrast enhanced computed tomography showed massive deep vein thrombosis in her left internal iliac vein. We diagnosed her with acute deep vein thrombosis. Since she refused to be hospitalized, we treated her with rivaroxaban as an outpatient. She had a good clinical course without hospitalization or an adverse event. DOAC may be useful for very elderly patients in rural areas.</p>

Meta-analysis of Efficacy and Safety of New Oral Anticoagulants in Non-valvular Atrial Fibrillation / 中国药学杂志

OBJECTIVE: To evaluate the efficacy and safety of new oral anticoagulants (dabigatran etexilate, rivaroxaban, apixaban, edoxaban) in the treatment of non-valvular atrial fibrillation. METHODS: The randomized controlled trials about new oral anticoagulants in the treatment of non-valvular atrial fibrillation, which had been published from the time of library foundation to March 2016 were collected from Pubmed, Embase, Medline, Cochrane, ClinicalTrials.gov, Web of Science, CNKI, Wanfang database, VIP database according to the following criterias. At the same time quality of the trials was evaluated and the results of studies were analyzed using Rev Man 5.3 software and Stata 13.1 software. RESULTS: Seventeen randomized controlled trials were included, involving 83 561 patients. Network Meta-analysis showed that in the prevention of all-cause mortality, the optimal sorting order of new oral anticoagulants was rivaroxaban, apixaban, edoxaban, dabigatran etexilate; in the prevention of the incidence of stroke and systemic embolism, the optimal sorting order of new oral anticoagulants was rivaroxaban, dabigatran etexilate, apixaban, edoxaban; in the prevention of the incidence of ischemic stroke, the optimal sorting order of new oral anticoagulants was rivaroxaban, apixaban, dabigatran etexilate, edoxaban; the incidence of major bleeding for the optimal sorting order of new oral anticoagulants was edoxaban, apixaban, dabigatran etexilate, rivaroxaban; the incidence of intracranial bleeding for the optimal sorting order of new oral anticoagulants was dabigatran etexilate, edoxaban, apixaban, rivaroxaban; the incidence of myocardial infarction for the optimal sorting order of new oral anticoagulants was rivaroxaban, apixaban, edoxaban, dabigatran etexilate. The inconsistency of all the outcomes indicated that there was no significant difference between direct comparison and indirect comparison. In addition, there was no statistical heterogeneity among studies. CONCLUSION: Through analysis the effectiveness, safety and economy of new oral anticoagulants, apixaban has the best sort and should be used in preference.

Retrospective Analysis on Anticoagulant Therapy with Rivaroxaban in Atrial Fibrillation Patients after Ra-diofrequency Catheter Ablation / 中国药师

Objective:To evaluate the effectiveness and safety of anticoagulant therapy with rivaroxaban in atrial fibrillation( AF) pa-tients after radiofrequency catheter ablation( RFCA) . Methods:A retrospective analysis was performed in the study. Totally 141 AF pa-tients with RFCA in our hospital were enrolled from January 2014 to October 2015. The patients were divided into rivaroxaban group(70 patients)and warfarin group (71 patients). In rivaroxaban group,rivaroxaban(10 mg, po,qd)was given for at least 3 months after RFCA. In warfarin group,low molecular heparin (100 IU·kg-1,ih) was given before RFCA, and standard dose of warfarin (3-5 mg,po,qd) was given for at least 3 months by adjusting the INR within the range of 2. 0-3. 0 after RFCA as bridging therapy. The death rate, throm-boem bolism events and bleeding events between the groups were evaluated and companed groups. Results: There were no significant differences in baseline characteristics between the groups except the diastolic pressure. There were no significant differences in the death and thromboembolism events(transient cerebral ischemia , ischemic encephalopathy, 2/70 vs 4/71,P>0. 05)between the groups. There were no TIMI major bleeding events in both groups. There were no significant differences in minor bleeding events between the groups (3/70 vs 4/71,P>0. 05). Conclusion: Compared with those of warfarin,the effectiveness and safety of rivaroxaban show the similar effect in AF patients after RFCA. Rivaroxaban can be safely and effectively used in AF patients with low or middle risk of thromboembo-lism after RFCA.

Hemorrhagic pericarditis associated with rivaroxaban in an atrial fibrillation patient with pacemaker

Rivaroxaban is a new oral anticoagulant used for the prevention of stroke in patients with atrial fibrillation. Hemorrhagic pericarditis is known to occur with rivaroxaban; however, only a few case reports in the literature describe such events. Recently, we experienced hemorrhagic pericarditis that treated with rivaroxaban for anticoagulation of newly diagnosed, non valvular AF patients with pacemaker. An 83 year old male with permanent pacemaker receiving rivaroxaban 20 mg daily once for 3 months presented at our emergency department complaining of exertional dyspnea. ECG showed intermittent atrial pacing failure and echocardiography showed large amount of pericardial effusion. After urgent pericardiocentesis, which resulted in removal of 500cc bloody fluid, there was an immediate and dramatic improvement in the patient's clinical state. He was discharged without anticoagulation therapy due to concern for further bleeding. This case highlight the potential for bleeding complications associated with novel anticoagulants. Rivaroxaban is being used with increasing frequently in outpatient care. However, no available laboratory test specifically measures the anticoagulant effect of rivaroxaban. Also, in the events of serious bleeding, no specific antidotes, reversal agents were available. Clinicians should be aware of the possibility of hemopericardium in patients treated with anticoagulants, including rivaroxaban who presented with cardiomegaly.