New Oral Anticoagulants Research Articles

The Effect of Switching From Warfarin to Novel Oral Anticoagulants on Patients' Satisfaction and the Travel Burden in a Rural Setting.

Introduction: New oral anticoagulants (NOACs) have shown comparable efficacy to warfarin in the treatment of patients with venous thromboembolism (VTE), stroke and atrial fibrillation (AF). Various studies on quality-of-life improvement in rural patients following the switch from vitamin K antagonists (VKAs) to NOACs have produced inconclusive results. The aim of the study is to assess the impact of switching from warfarin to NOACs on remotely living patients’ quality of life and the burden of travel.Methods: A questionnaire was provided to the patient by their pharmacists. The questionnaire assessed their travel burden and their level of satisfaction with their treatment.Results: The switch from warfarin to NOACs reduced the burden of travel in 75% of patients. A total of 66% of patients were hesitant about the efficacy of their warfarin treatment. The inconvenience caused due to international normalized ratio (INR) monitoring was reduced in 83% of patients; 70% and 72% of patients strongly agreed that NOACs improved their adherence and treatment satisfaction, respectively. The average number of patients’ travels for INR testing for warfarin monitoring was 7.27 trips/year. The average number of trips made by the patient to obtain their NOACs and warfarin scripts was 2.1 and 4.81 trips/year, respectively.Conclusion: The switch from warfarin, a VKA, to NOACs in patients who live in remote areas without medical services improved their quality of life, decreased their travel burden, and increased their treatment satisfaction and adherence. Switching to NOACs reduced the number of trips travelled by patients to obtain their anticoagulation scripts and/or to adjust their doses.

The relationship between self-efficacy and treatment satisfaction among patients with anticoagulant therapy: a cross-sectional study from a developing country

BackgroundThromboembolic events are a common complicated health problem. Although anticoagulants have several positive effects on these conditions, they also have several characteristics that strongly affect compliance and satisfaction. The purpose of this investigation is to explore the association between treatment satisfaction and self-efficacy in a sample of patients using anticoagulation therapy and determine the influence of sociodemographic and clinical factors on both aspects.MethodsThis was a cross-sectional exploratory study carried out in Palestine. The Arabic version of the Anti-Coagulant Treatment Satisfaction Scale (ACTS) assessed treatment satisfaction. In addition, the Arabic version of the 6-Item Self-Efficacy for Managing Chronic Diseases (SES6C) was used to assess self-efficacy.ResultsA total of 300 patients using anticoagulants (average age 51.95 and SD 17.98) were included. There is a modest correlation between treatment satisfaction and self-efficacy (r = 0.345; p < 0.001). The mean and median self-efficacy scores were 38.41 ± 9.88 and 39.00 (interquartile range: 33.00–46.00), respectively. Overall, patients reported a moderate burden and benefit score. The mean and median of the acting burden were 43.30 ± 10.45, and 43.30 (interquartile range: 36.00 to 51.00), respectively. The results showed that young age, higher education, employment, use of fewer medications, and having fewer diseases were significantly associated with higher self-efficacy behaviors. The results also showed that new oral anti-coagulants (NOACs) had a higher degree of self-efficacy and ACTS benefit scores (41.00 (33.75–47.00), p = 0.002; 13.00 (12.00–15.00), p < 0.001, respectively), than vitamin k antagonists (VKA).ConclusionsThe results demonstrated a significant relationship between treatment satisfaction and self-efficacy, and certain sociodemographic and clinical characteristics influence both. We found that there is a higher degree of self-efficacy and treatment satisfaction among patients who use NOACs than those who use UFH / VKA. Therefore, patients should be motivated to increase their knowledge about anticoagulant therapy. Healthcare providers should play an active role in educating patients, increasing their self-esteem, and awareness about anticoagulant drugs. Importantly, this study was an explanatory one, and it includes a low proportion of patients with venous thromboembolism. This encourages future research on a large scale of patients, considering the indications of anticoagulant therapy.

Risk of Stroke With Mitral Stenosis: The Underlying Mechanism, Treatment, and Prevention.

Mitral stenosis (MS), a valvular heart disease, is defined by the narrowing of the mitral valve orifice. The common risk factors for stroke include mitral annular calcification (MAC), diabetes mellitus (DM), male gender, hypertension (HTN), hyperlipidemia, and obesity. Endothelial damage, hypercoagulability, and blood stasis in the left atrium promote the development of the thrombus. Among all the risk factors described, MAC is the independent predictor of stroke. The complicated mechanisms responsible for thromboembolism, predisposing factors for thromboembolism, the risk of cerebrovascular accident (CVA) in MS patients, advanced standardized assessment models for identifying those at risk for stroke, and the possible advantages and disadvantages of available therapies have all been discussed in this review article. We have also discussed newer oral anticoagulants (NOACs) like dabigatran, edoxaban, apixaban, and rivaroxaban. Non-pharmacological therapies are also highlighted such as left atrial appendage ligation and occlusion devices. We also conducted a thorough review of the literature on the efficacy and safety of various NOACs in reducing the risk of stroke.

Возможности защиты желудочно-кишечного тракта при применении пероральных антикоагулянтов прямого действия у пациентов с фибрилляцией предсердий

Gastrointestinal bleeding (GIB) associated with the use of direct oral anticoagulants or, as they are also called, new oral anticoagulants (NOAC) is a serious medical problem, the relevance of which will only increase taking into account the constant expansion of the use of anticoagulants. It is especially important that most of the patients receiving NOAC are elderly people with multiple concomitant pathologies, including diseases of the gastrointestinal tract (GI), which makes them classified as patients with a high risk of GIB and, therefore, in need of prescribing gastroprotectors to protect the GI mucosa and prevent GIB. Considering that one of the mechanisms of GIB development during NOAC therapy is associated with their ability to inhibit GI mucosa healing, and the NOAC themselves are factors of aggression for GI and can lead to syndrome of increased epithelial permeability, the use of gastro- and the enteroprotector of rebamipide seems appropriate and probably pathogenetically justified. The randomized REGATA trial initiated at the Russian Gerontological Research and Clinical Center will provide additional information on the use of rebamipide in patients with atrial fibrillation receiving various NOAC.

Prior intake of new oral anticoagulants adversely affects outcome following surgery for acute type A aortic dissection.

OBJECTIVESOral anticoagulation prior to emergency surgery is associated with an increased risk of perioperative bleeding, especially when this therapy cannot be discontinued or reversed in time. The goal of this study was to analyse the impact of different oral anticoagulants on the outcome of patients who underwent emergency surgery for acute type A aortic dissection (ATAAD).METHODSThis was a single-centre retrospective study of patients treated with oral anticoagulation at the time of surgery for ATAAD. Outcomes of patients on new oral anticoagulant (NOAC) therapy were compared to respective outcomes of patients on Coumadin. Additionally, a survival analysis was performed comparing these 2 groups with patients who were operated on with no prior anticoagulation.RESULTSBetween January 2013 and April 2020, a total of 437 patients (63.8 ± 11.8 years, 68.4% male) received emergency surgery for ATAAD; 35 (8%) were taking oral anticoagulation at the time of hospital admission: 20 received phenprocoumon; 14, rivaroxaban; and 1, dabigatran. Compared to Coumadin, NOAC was associated with a greater need for blood-product transfusions and haemodynamic compromise. Operative mortality was 53% in the NOAC group and 30% in the Coumadin group. A 5-year survival analysis showed no significant difference between the NOAC and the Coumadin group (P = 0.059). Compared to 402 patients treated during the study period without anticoagulation, patients taking NOAC had significantly worse survival (P = 0.001), whereas that effect was not observed in patients undergoing surgery who were taking Coumadin (P = 0.99).CONCLUSIONSEmergency surgery for ATAAD in patients taking NOAC is associated with high morbidity and mortality. NOAC are a major risk factor for uncontrollable bleeding and haemodynamic compromise. New treatment strategies must be defined to improve surgical outcomes in these high-risk patients.

Use of Anticoagulant Therapy in Patients with Acute Myocardial Infarction and Atrial Fibrillation.

The incidence of atrial fibrillation (AF) in acute coronary syndrome (ACS) ranges from 2.3–23%. This difference in the incidence of AF is explained by the different ages of the patients in different studies and the different times of application of both reperfusion and drug therapies in acute myocardial infarction (AMI). About 6–8% of patients who underwent percutaneous intervention within AMI have an indication for oral anticoagulant therapy with vitamin K antagonists or new oral anticoagulants (NOAC).The use of oral anticoagulant therapy should be consistent with individual risk of bleeding as well as ischemic risk. Both HAS-BLED and CHA2DS2VASc scores are most commonly used for risk assessment. Except in patients with mechanical valves and antiphospholipid syndrome, NOACs have an advantage over vitamin K antagonists (VKAs). One of the advantages of NOACs is the use of fixed doses, where there is no need for successive INR controls, which increases the patient’s compliance in taking these drugs. The use of triple therapy in ACS is indicated in the case of patients with AF, mechanical valves as well as venous thromboembolism. The results of the studies showed that when choosing a P2Y12 receptor blocker, less potent P2Y12 blockers such as Clopidogrel should be chosen, due to the lower risk of bleeding. It has been proven that the presence of AF within AMI is associated with a higher degree of reinfarction, more frequent stroke, high incidence of heart failure, and there is a correlation with an increased risk of sudden cardiac death. With the appearance of AF in ACS, its rapid conversion into sinus rhythm is necessary, and in the last resort, good control of heart rate in order to avoid the occurrence of adverse clinical events.

The value and limitations of new oral anticoagulant plasma level assessments.

abstractThe class of new oral anticoagulants (NOACs) has been developed to provide reliable oral anticoagulation without the need for therapeutic drug monitoring. Based on phase I and II trials and pharmacokinetic and pharmacodynamic modeling, fixed drug doses have been selected for large phase III clinical trials for each currently available NOAC. In these trials, the use of the fixed dose without plasma level assessments was shown to be at least as effective and at least as safe as vitamin K antagonists with continuous therapeutic drug monitoring. Real world evidence reaffirms that the use of a fixed NOAC dose without plasma level assessment is safe and effective in a large variety of patients. Nevertheless, measurement of NOAC plasma levels can add information that may be useful in some clinical scenarios. This review discusses the possible use cases, the limitations, and the practical implementation of measuring NOAC plasma concentrations.

POS-246 EVALUATION OF THE USE OF RIVAROXABAN IN PATIENTS WITH STAGE 4 CKD IN AF

Anticoagulant therapy is the standard for the prevention of thromboembolic complications (TEC) and, first of all, acute cerebrovascular accident (ACVA) in atrial fibrillation (AF). The combination of advanced chronic kidney disease (CKD) and AF leads to an even greater increase in the risk of TEO, but is also a risk factor for various bleeding. Clinical data on the use of new oral anticoagulants (NOACs) in this group of patients are limited, which determines the relevance of studies in comparison with vitamin K antagonists.

Real-World Data of Anticoagulant Treatment in Non-valvular Atrial Fibrillation.

AimsTo assess the impact of anticoagulant treatment on risk for stroke and all-cause mortality of patients with atrial fibrillation using real-world data (RWD).MethodsPatients with prevalent or incident atrial fibrillation were selected throughout a study period of 5 years. Stroke, transitory ischemic attack, hemorrhagic stroke, and all-cause mortality were identified in the claims of the electronic health records (EHRs). Subjects were classified according to the anticoagulant treatment in four groups: untreated, vitamin K antagonists (VKAs), New Oral Anticoagulants (NOACs), and antiplatelet (AP). Risk of events and protection with anticoagulant therapy were calculated by Cox proportional hazard models adjusted by potential confounders.ResultsFrom a total population of 3,799,884 patients older than 18,123,227 patients with incident or prevalent atrial fibrillation (AF) were identified (mean age 75.2 ± 11.5 years old; 51.9% women). In a follow-up average of 3.2 years, 17,113 patients suffered from an ischemic stroke and transitory ischemic attack (TIA), 780 hemorrhagic stroke, and 42,558 all-cause death (incidence of 46, 8, 2, and 120 per 1,000 patients/year, respectively). Among CHA2DS2, VASc Score equal or >2, 11.7% of patients did not receive any anticoagulant therapy, and a large proportion of patients, 47%, shifted from one treatment to another. Although all kinds of anticoagulant treatments were significantly protective against the events and mortality, NOAC treatment offered significantly better protection compared to the other groups.ConclusionIn the real world, the use of anticoagulant treatments is far from guidelines recommendations and is characterized by variability in their use. NOACs offered better protection compared with VKAs.

New Oral Anticoagulants for Venous Thromboembolism Prophylaxis in Total Hip and Knee Arthroplasty: A Systematic Review and Network Meta-Analysis.

Background: There is controversy over whether use of new oral anticoagulants (NOACs) associates with increased hemorrhage risk compared with non-NOAC. Meanwhile, determining which NOAC to use remains unclear. We aimed to summarize the evidence about NOACs in venous thromboembolism (VTE) prevention for patients with total hip and knee arthroplasty (THA and TKA). Methods: We searched RCTs assessing NOACs for VTE prophylaxis in adults undergoing THA and TKA in Medline, Embase, and Cochrane up to May 2021. Primary outcomes were VTE [included deep vein thrombosis (DVT) and pulmonary embolism (PE)], major VTE, and major bleeding. The rank probabilities of each treatment were summarized by the surface under the cumulative ranking curve area (SUCRA). Results: 25 RCTs with 42,994 patients were included. Compared with non-NOAC, NOACs were associated with a decreased risk of VTE (RR 0.68; 95% CI 0.55–0.84) and major VTE (RR = 0.52; 95% CI 0.35–0.76). Additionally, rivaroxaban, apixaban, and edoxaban but not dabigatran and betrixaban, did confer a higher efficacy compared with non-NOAC. None of the individual NOACs increased the risk of bleeding, while apixaban and betrixaban were even associated with a decreased risk of bleeding. In the comparison of different NOACs, rivaroxaban was associated with the greatest benefits in VTE (SUCRA = 79.6), DVT (SUCRA = 88.8), and major VTE (SUCRA = 89.9) prevention. Furthermore, subgroup analysis confirmed that NOACs associated with a higher efficacy tendency in patients with follow-up duration <60 days than follow-up duration ≥60 days. Conclusion: Evidence suggests that NOACs exert more benefits on VTE prophylaxis, and none of the individual NOACs increased hemorrhage compared with non-NOAC. Among various NOACs, rivaroxaban is recommended in patients with lower bleeding risk, and apixaban is recommended in patients with higher bleeding risk. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/], identifier [CRD42021266890].

Safety and efficacy of different anticoagulation regimens after left atrial appendage occlusion

This study examined the safety and efficacy of different anticoagulation regimens in patients with atrial fibrillation (AF) after left atrial appendage occlusion (LAAC) using the Watchman closure device. AF patients who underwent LAAC using the Watchman closure device in the Department of Cardiology, Jiangsu Taizhou People's Hospital between March 2018 and November 2019 were retrospectively enrolled in this study. Patients were divided into two groups according to different postoperative anticoagulant regimens. One group was treated with anticoagulant therapy alone [oral anticoagulant (OAC)/new OAC (NOAC) group] and the other was given NOACs combined with single antiplatelet therapy (SPAT) (NOAC + SAPT group). The incidences of ischemic stroke/transient ischemic attack (TIA), major bleeding events, all-cause mortality, and device-related thrombosis (DRT) were recorded. Furthermore, multivariate regression was used to analyze the factors associated with the occurrence of early DRT. A total of 160 patients, including 42 (51%) females, with a mean age of 69.13±6.14 years were enrolled in this study. The mean CHA2DS2-VASc score was 3.66±1.11 and the mean HAS-BLED score was 4.16±0.82. During the postoperative follow-up period, there were no significant differences in the incidence of ischemic stroke/TIA [hazard ratio (HR) =0.616; 95% confidence interval (CI): 0.056 to 6.818; P=0.693], major bleeding events (HR =0.520; 95% CI: 0.047 to 5.764; P=0.594) nor all-cause mortality (HR =0.579; 95% CI: 0.052 to 6.394; P=0.656) between the two groups. However, the incidence of early DRT was higher in the OAC/NOAC group compared to the NOAC + SAPT group [odds ratio (OR) =0.120; 95% CI: 0.015 to 0.984; P=0.048]. Multivariate regression confirmed that atrial blood stasis (OR =11.367; 95% CI: 1.394 to 92.687; P=0.023) and peri-device leak (OR =9.337; 95% CI: 1.623 to 53.727; P=0.012) were independent predictors of early DRT. Short-term NOAC + SAPT after LAAC did not significantly increase the incidence of major bleeding events, ischemic stroke/TIA, nor all-cause mortality compared to OAC/NOAC therapy. Not only was NOAC + SAPT therapy found to be safe and effective in short-term follow-up, but it also lowered the risk of early DRT.

New oral anti coagulants – A guide for Plastic Surgeons

With the advent of new oral anticoagulants (NOACs), it is a challenge for a plastic surgeon to stay updated with the myriad of new medications, and their associated mechanisms of action, laboratory monitoring, adverse events and potential reversal agents. The limitations of warfarin therapy include varying pharmacokinetic profiles, multitude of food and drug interactions, hypersensitivity, resistance, therapy failure and frequent laboratory monitoring)1. Hence there are an increasing number of patients who are presenting to their plastic surgeon on alterative antithrombotic agents. The aim of this paper is to educate Plastic Surgeons regarding NOAC's, and their management in the operative setting.

Mycotic coronary aneurysm: A rare complication of percutaneous coronary intervention

Coronary artery aneurysms are extremely rare, major causative factors associated with this condition are atherosclerosis, trauma, connective tissue disorders, vasculitis, idiopathic, mycotic, and congenital. We present a case of a 49-year-old male who underwent primary angioplasty for acute ST-elevation myocardial infarction and presented with chest pain, fresh ST elevation, and fever after 10 days of the index procedure. The patient was suspected to have subacute stent thrombosis along with some infective pathology. However, work up did not reveal any systemic localization, and blood cultures were negative. Coronary angiogram showed aneurysm of the left anterior descending artery (LAD) with Grade 3 thrombus in the proximal part of stent with thrombolysis in myocardial infarction (TIMI) II antegrade flow. A two-dimensional echo revealed mild left ventricular dysfunction with moderate pericardial effusion. Cardiac positron emission tomography scan confirmed the suspicion of a stent-related mycotic aneurysm. Therefore, the patient was managed with intravenous antibiotics, antiplatelets, and low-molecular-weight heparin, followed by newer oral anticoagulants.

Efficacy and Safety of Non-recommended Dose of New Oral Anticoagulants in Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis

Introduction: The real-world treatment of atrial fibrillation (AF) often involves the prescription of new oral anticoagulants (NOACs) using dosing both lower and higher than recommended guidelines. Our study aimed to evaluate the efficacy and safety of non-recommended dosage of NOACs in AF patients.Methods: A systematic search was performed for relevant studies across multiple electronic databases (PubMed, Embase, Cochrane Library, Clinical Trials Registry) from inception to May 1, 2021. Multicenter randomized trials and observational studies were selected with key reporting measures for inclusion involved efficacy outcomes including stroke or systemic thromboembolism along with safety endpoints assessing major or clinically relevant bleeding events.Results: A total of 11 eligible studies were included involving 48,648 patients receiving recommended dose of NOACs and 50,116 patients receiving non-recommended dosage. Compared to AF patients treated with recommended dose regimens, administration of low dose of NOACs was associated with higher risk of stroke/systemic embolism (RR = 1.24, 95% CI 1.14–1.35, P < 0.00001), but without reducing bleeding risk (RR = 1.18, 95% CI 0.91–1.53, P = 0.21) and a higher risk of all-cause mortality (RR = 1.58, 95% CI 1.25–1.99, P = 0.0001). Moreover, high dose of NOACs was associated with higher risk of stroke and systemic embolism efficacy (RR = 1.71, 95% CI 1.06–2.76, P = 0.03) and a non-significant trend to a greater risk of major or clinically relevant bleeding (RR = 1.57, 95% CI 0.96–2.58, P = 0.07).Conclusions: AF patients treated with low dose of NOACs showed equivalent safety but with worse efficacy compared with recommended dose. High dose of NOACs was not superior to recommended dose regimens in preventing stroke/systemic embolism outcomes in AF patients.

Warfarin adherence and anticoagulation control in atrial fibrillation patients: a systematic review.

This paper aims to review the literature systematically on warfarin adherence in patients with atrial fibrillation and to assess the anticoagulation control focused on patient clinical outcomes. Atrial Fibrillation (AF) is a cardiac disease defined by abnormal heart rhythm, which significantly impacts a patient's health status, quality of life, and heart output, and thus a greater risk of stroke and hospitalization. Most AF patients should be managed with long-term anticoagulation, either with vitamin K antagonists such as warfarin or new oral anticoagulants (NOACs). Anticoagulants have been a core in treating AF and weighing the consequences of thrombosis with the risk of bleeding. This systematic review aimed to assess the impact of warfarin adherence on AF patients. A systematic search of the literature was conducted on electronic databases of PubMed/MEDLINE, EBSCO, Cochrane library, Google, and Google Scholar from January 2011 to April 2021 to determine studies that reported warfarin adherence on patients with atrial fibrillation. Out of 1429 titles and abstracts were retrieved, 12 studies fulfilled and met the inclusion criteria. From the included studies, two were carried out in Brazil and one from the following nations: Libya, Jordan, Iran, KSA, Canada, Malaysia, Bahrain, UAE, Singapore, and the USA. The study designs identified were cross-section, retrospective, and prospective studies. Warfarin adherence was influenced by multiple causes, including pharmaceutical services, the number of medications, and warfarin knowledge regarding anticoagulation control. Warfarin adherence illustrates its positive association with TTR and INR as a measure of anticoagulation control. While the available evidence is limited, this systematic review demonstrated a positive finding of the association between warfarin adherence and anticoagulation control in patients with AF.

An Observational Study Comparing the Safety and Efficacy of Conventional Anticoagulation Versus New Oral Anticoagulants in the Management of Cerebral Venous Sinus Thrombosis.

Objective: To compare the safety and efficacy of conventional anticoagulants with new oral anticoagulants (NOACs) for management of cerebral venous sinus thrombosis (CVST).Methods: This was a retrospective, prospective cohort study of patients who presented with CVST to a tertiary stroke center in the Middle East from January 2012 to October 2019. Patients with a diagnosis of CVST were identified, and data were analyzed for demographic characteristics. Specific consideration was given to compare the efficacy and safety of different anticoagulation treatments.Results: A total of 36 patients were included in the final analysis, with 15 (41%) men and 21 (59%) women and a male to female ratio of 1:1.4. Most of the patients (n = 22, 61%) were Saudi. Their ages ranged between 15 and 82 years (mean ± SD age of 34.22 ± 13.16 years). Headache was the most common feature, present in 22 (61%) of the patients, followed by unilateral weakness in 15 (41%) and cranial nerve palsies in 11 (30%). The most common etiology was prothrombotic state (both hereditary and acquired thrombophilia: n = 16, 45%). Other etiologies were postpartum state/oral contraceptive pill usage in 7 (19%), infections in 7 (19%), and trauma in 3 (8%). Most of the patients (n = 24, 67%) still received conventional anticoagulation (warfarin/low molecular weight heparin), but 9 (25%) of the patients consented to start NOACs. Efficacy (as measured by clinical improvement plus rate of recanalization of previously thrombosed venous sinuses) showed no statistically significant difference, although it proved to be better tolerated, as none of the patients stopped the treatment due to adverse events and risk of major bleeding was significantly low in the NOAC group. Nine patients in the warfarin group stopped medication, while none in the NOAC group did so (P = .034).Conclusion: NOACs were found to be at least as good as conventional anticoagulation for the management of CVST. However, efficacy was almost similar, a finding that is consistent with most of the published case series and the few recently published prospective studies. Larger prospective and population-based studies are needed to clarify our preliminary results.

Cost-effectiveness of anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation in mainland China.

With the high cost, the long-term persistence of new oral anticoagulants (NOACs) was lower than that of warfarin in Chinese patients with non-valvular atrial fibrillation (NVAF) for a long time. The prices of NOACs (apixaban, rivaroxaban and dabigatran) decreased significantly over the past year in mainland China. The objective of this study was to evaluate the cost-effectiveness of NOACs versus warfarin for preventing stroke in patients with NVAF from a Chinese healthcare system perspective. A decision tree and Markov model were used to assess the treatment strategies of four NOACs versus warfarin over a lifetime horizon. For each treatment strategy, the total lifetime cost, quality-adjusted life-years (QALY) and incremental cost-effectiveness ratio (ICER) were calculated. The impact of parameter uncertainties on base-case analysis results was evaluated using sensitivity analyses. In the base-case analysis, compared with warfarin, apixaban had a decreased total lifetime cost of USD 389 and rivaroxaban of USD 1482, while low-dose dabigatran had an increased total lifetime cost of USD 925 and high-dose dabigatran of USD 6641, with QALY increasing by 0.53, 1.32, 0.92 and 1.83, respectively. The ICER of low-dose dabigatran versus warfarin was USD 1005 per QALY gain, while those of apixaban (-USD 734 per QALY gain) and rivaroxaban (-USD 1123 per QALY gain) were negative. One-way and probabilistic sensitivity analyses indicated that the base-case results were robust by applying certain varying parameters to the model. These four NOAC (apixaban, rivaroxaban, low-dose dabigatran and high-dose dabigatran) treatment strategies were cost-effective compared with warfarin and recommended as substitutes for warfarin treatment for preventing stroke in patients with NVAF in the healthcare system of China, which might be driven by large drug price reductions in the past year.

Primary Non-adherence to Treatment with New Oral Anticoagulants: The Results of a Prospective Observational Study «ANTEY»

Aim: To assess the main characteristics of patients with non-valvular Atrial Fibrillation (AF) who are initially non-adherent to New Oral Anticoagulants (NOAC), and to identify factors associated with this version of non-adherence. Materials and Methods: The ANTEY study included 201 patients with non-valvular AF, who had indications and without contraindications for NOAC treatment. The patients had previously been advised to take oral anticoagulants but they did not comply with all medical recommendations. The observation period was 1 year, during which 2 in-person visits were performed: an inclusion visit (V0) and a visit (V1), as well as 1 telephone contact/follow up (FU); the interval between contacts was 6 months. All patients were recommended to take the NOAC by decision of the physician. During the V0, V1 and FU visits, the “National Society for Evidence-Based Pharmacotherapy (NSEPh) Adherence Scale” questionnaire was used to assess overall adherence and associated factors. 15 (7.5%) patients had not started NOAC therapy by the end of the study (primary non-adherent patients). Their characteristics are analysed in this work. Results: The main reasons for primary non-adherence to NOAC were high cost (33.3%), fears of adverse effects (AE) (33.3%), doubts about the need for treatment (13.3%) and the complex therapy regimen (13.3%). In the group of primary non-adherent patients in comparison with the rest of the patients there were significantly more patients with 1 point according to CHADS2VASc (20% and 2.2%, respectively, p = 0.029) and patients with 3 points according to HAS-BLED (33.3% and 9.1%, respectively, p = 0.006); they took antiplatelet drugs more often 73.3% versus 21.5%, respectively (p = 0.001). Full employment at work (OR = 5.2; CI95% [1.5; 18.1], p = 0.009), history of quitting smoking (OR = 5.1; CI95% [1.5; 17.0], p = 0,008), the presence of any pharmacotherapy AE (OR = 4.0; CI95% [1.01; 16.0], p = 0.048) increased the chance of primary non-adherence to NOAC by 4-5 times. Conclusion: The most vulnerable in relation to initiation of NOAC therapy for the prevention of thromboembolic complications in AF are those patients who continue to work or have any pharmacotherapy AE. The leading factors preventing the initiation of NOAC administration are their high cost, fear of the development of AE from the therapy, and patients’ doubts about the need for treatment with these drugs. The clinical trial registration number is NCT 03790917.

Role of Rivaroxaban in Patients with Cerebral Venous Thrombosis

Objective: Cerebral venous thrombosis is a common neurological disease. It has been treated so far with Warfarin that needs continuous monitoring of PT (prothrombin time) and INR (International Normalization Ratio) with potential complications due to this problem. Newer oral anticoagulants have been recommended for other thromboembolic events like pulmonary embolism and can be a good alternative treatment of CVT. We determined the effectiveness of new oral anticoagulant Rivaroxaban in patients with cerebral venous thrombosis.&#x0D; Material and Methods: The study was conducted in the indoor department of Neurology, Punjab Institute of neurosciences for 1year. Magnetic cerebral venography (MRV) Brain was done at the start of Rivaroxaban, at 3 months and at 6 months where needed. The bias effect was removed by getting MRV done and reported from the same department.&#x0D; Results: A total of 18 patients were enrolled in the study. One patient was lost to followup. Mean age of our patient data was 28.66 ± 6.66. 16 (88%) patients were females and 2 (11%) were males. 9 patients (50%) had clinical and radiological recovery based on MRV brain at 3 months.7 patients (38%) had recovery based on clinical and radiological parameters at 6 months. Only 1 patient had partial recanalization but that also improved clinically.&#x0D; Conclusion: Rivaroxabancan is a very effective alternative for warfarin in cerebral venous sinus thrombosis which will avoid concerns commonly encountered with warfarin.

THE INFLUENCE OF ANTIPLATELET MEDICATIONS ON INTRAOPERATIVE PATIENT BLOOD MANAGEMENT DURING ADULT CARDIAC SURGERY

Introduction Cardiac surgery is inherently associated with increased bleeding and transfusion requirements. The increased risk of bleeding is due to multiple factors; pharmacological (Intravenous heparin and Dual Antiplatelet Therapy-DAPT), patient (advanced age, preoperative anaemia, and female gender) and surgical (Emergency and redo surgery)1. This study aimed to determine if preoperative antiplatelet medication influenced intraoperative blood and blood products requirements during elective adult Isolated Coronary Artery Bypass Graft (CABG) and valve surgery. Methods Methodology: A Prospective observational study carried out between September to November 2020, MMUH Ethical committee approval ref: CA20-064 on 12/10/2020. Perioperative data were collected from fifty patients. This included demographic data, preoperative laboratories, pre-Cardiopulmonary Bypass (CPB) heparin dose, Activated Clotting Time (ACT) at baseline, post heparin and post protamine, blood products transfused and estimated blood loss (EBL). The inclusion criteria applied was isolated CABG, single valve surgery and elective operation. A one-paired Student t-test performed to detect a statistical difference between the two groups (Isolated CABG Vs Single valve Surgery) Results 31 patients met the inclusion criteria. 19 patients excluded because of the following reasons: emergency surgery n=3, redo surgery n=1, New Oral Anticoagulants (NOACS) medication n= 4, combined CABG & valve surgery/other n=12. 20 patients underwent an isolated CABG, and 11 patients underwent a single valve operation. DAPT was prescribed in 30% n=6/20 and 9% n=1/11 in the CABG and Valve group respectively. There was no statistical difference in the EBL at the end of the procedure between the two groups (CABG-624 ml Vs Valve-507 ml, p= 0.13). Intraoperative red cells transfusion between the two groups were similar, however Octaplasma, fibrinogen and platelets transfusion were higher in the valve group. Discussion DAPT were more frequently prescribed pre-operatively in patients undergoing elective CABG in comparison to single valve surgery. Pre & postoperative haemoglobin and EBL were similar between the two groups. Despite this, in the single valve surgery group (only 1 patient out of 9 received DAPT, n=1/9) received more blood products during the intraoperative period. This was statistically significant for the use of Octaplasma, Platelets and fibrinogen. Blood transfusion was not directed using ROTEM in any patients in either group. We, therefore, recommend the intraoperative use of ROTEM to guide blood transfusion for patients undergoing isolated single valve surgery.