scholarly journals Knowledge about atrial fibrillation and direct oral anticoagulation agents in Greek patients

2021 ◽  
Vol 20 (Supplement_1) ◽  
Author(s):  
A Ioannidis ◽  
A Fragkiskou ◽  
M Paraskelidou ◽  
A Pechlevanis
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
City Hospital ◽  
Northern Greece ◽  
Funding Sources ◽  
Information Leaflets ◽  
Validated Questionnaire ◽  
Anticoagulation Agents

Abstract Funding Acknowledgements Type of funding sources: None. Background Atrial fibrillation (AF) poses significant burden to patients, physicians, and healthcare systems globally. Patient knowledge about AF and its management is often limited though it is a perquisite for patient involvement and shared decision making. Direct oral anticoagulants (DOACs) are recommended for stroke prevention. Purpose The aim of this study was to assess the knowledge about AF and anticoagulation of AF patients. Methods Patients with AF on DOACs visiting the outpatient clinics of a city hospital in northern Greece were invited to participate. The Jessa AF Knowledge Questionnaire (JAKQ) was used (as part of the validation study of the Greek translation). Results In total, 285 patients participated (female 57.9%) with mean age 65 ± 13 years. The mean JAKQ score was 57.2 ± 17.4% corresponding to medium level of knowledge. Higher scores were positively associated with more schooling years and longer AF duration. The percentage of correct answer varied among the questions. One third of the participants answered wrongly (59 patients, 20.7%) or didn’t know (38 patients, 13.3%) what atrial fibrillation means. More than half of the patients didn’t know that AF is not always accompanied by symptoms and that medication cannot prevent AF permanently (154, 54.0% and 169, 59.3% respectively). The majority of patients knew that strokes are a consequence of AF and that blood thinners are prescribed in order to prevent clot formation (222, 77.9% and 226, 79.3% correspondingly). Moreover, most patients didn’t know correctly which painkiller they should prefer (177, 62.1%) and what to do when missing a dose (172, 60.4%). As expected patients who has experienced a bleeding event (minor or major that lead to medical care) scored higher (62.3% vs. 56.2%, p < 0.05). All patients replied that they would like to be offered more information (leaflets, online site, mobile applications, etc.). Conclusions A brief and validated questionnaire could be used to assess patients" knowledge of their condition and treatment, which would reveal important gaps. Further research is needed to evaluate if such an instrument could be used as a tool for individually tailored patient education.

scholarly journals Knowledge about specific reversal agent of Greek AF patients on direct oral anticoagulants

2021 ◽  
Vol 20 (Supplement_1) ◽  
Author(s):  
A Ioannidis ◽  
A Pechlevanis ◽  
A Pechlevanis ◽  
M Paraskelidou ◽  
M Paraskelidou ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Antiplatelet Agents ◽  
City Hospital ◽  
Reversal Agent ◽  
Northern Greece ◽  
Waiting Room ◽  
Reversal Agents

Abstract Funding Acknowledgements Type of funding sources: None. Background Clinical guidelines recommend taking into account the patient’s preference when deciding on the options of direct oral anticoagulation (DOAC) therapy. Therefore, education is a prerequisite for informed, involved patients and patient-centred care. Purpose The aim of this study was to assess the patient’s awareness about the existence of the dabigatran specific reversal agent (Idarucizumab) and whether the patient was involved in the decision of the specific DOAC regimen. Methods Non-valvular atrial fibrillation (AF) patients on DOAC who visited the outpatient clinics of a city hospital in northern Greece were invited to participate. This project was part of the validation study of the Greek version of the Jessa Atrial fibrillation Knowledge Questionnaire. Analyses were performed by IBM SPSS Statistics. Results In total, there were 312 participants (168 females, 53.8%) with mean age: 64 ± 5.3 years old. The vast majority of patients (256, 82.1%) were not aware of the existence of any specific reversal agent regardless the socio-economic status (annual income, years of schooling) or the duration and type of AF. Patients that were switched from a vitamin-K antagonist (acenocoumarol) to a DOAC were more likely to be informed about specific reversal agents (31 out of 63 patients switched to DOAC, 49.2% vs. 10.0%, p < 0.05). Similarly, patients taking more than 5 pills per day were more likely to know about the reversal agent (41 of the 193 patients, 21.2% vs. 12.6%). Moreover, the majority of patients that reported any bleeding event that lead to seeking medical advice (minor or major bleeding) were informed about the specific reversal agent (35 out of 52 patients reporting bleeding event, 67.3% vs. 8.1%, p < 0.05). Inappropriately, only seven of the 38 patients (18.4%) that were also taking antiplatelet agents (mainly acetylsalicylic acid or clopidogrel) were aware of specific DOAC reversal agents. Patients with history of stoke or transient ischaemic attack were also better informed (38 out of 53 patients, 71.7% vs. 6.9%). Only about one of five patients on dabigatran (27 out of 129, 20.9%) knew about the dabigatran specific reversal agent, mainly from sources other than their doctor (e.g. journal in office waiting room). All patients agreed that they would prefer to have been informed about the current specific reversal agents when deciding on DOAC therapy. No data could be collected why patients who were informed about specific reversal agent were not prescribed dabigatran. Conclusions The sample of Greek non-valvular AF patients showed a noticeably low awareness of the existence of the specific DOAC reversal agent. It seems that DOAC prescription was a rather limited shared decision. Further research is warranted to confirm the aforementioned results.

Anticoagulation Changes Following Major and Clinically Relevant Nonmajor Bleeding Events in Non-valvular Atrial Fibrillation Patients

2021 ◽  
pp. 089719002110641
Author(s):  
Thane Feldeisen ◽  
Constantina Alexandris-Souphis ◽  
Brian Haymart ◽  
Xiaowen Kong ◽  
Eva Kline-Rogers ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Drug Class ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Bleeding Event ◽  
Bleeding Events ◽  
Anticoagulation Management ◽  
Anticoagulation Clinics ◽  
The Individual

Background Bleeding events are common complications of oral anticoagulant drugs, including both warfarin and the direct oral anticoagulants (DOACs). Some patients have their anticoagulant changed or discontinued after experiencing a bleeding event, while others continue the same treatment. Differences in anticoagulation management between warfarin- and DOAC-treated patients following a bleeding event are unknown. Methods Patients with non-valvular atrial fibrillation from six anticoagulation clinics taking warfarin or DOAC therapy who experienced an International Society of Thrombosis and Haemostasis (ISTH)-defined major or clinically relevant non-major (CRNM) bleeding event were identified between 2016 and 2020. The primary outcome was management of the anticoagulant following bleeding (discontinuation, change in drug class, and restarting of same drug class). DOAC- and warfarin-treated patients were propensity matched based on the individual elements of the CHA2DS2-VASc and HAS-BLED scores as well as the severity of the bleeding event. Results Of the 509 patients on warfarin therapy and 246 on DOAC therapy who experienced a major or CRNM bleeding event, the majority of patients continued anticoagulation therapy. The majority of warfarin (231, 62.6%) and DOAC patients (201, 81.7%) restarted their previous anticoagulation. Conclusion Following a bleeding event, most patients restarted anticoagulation therapy, most often with the same type of anticoagulant that they previously had been taking.

scholarly journals Outcomes of Direct Oral Anticoagulants with Aspirin Versus Warfarin with Aspirin for Atrial Fibrillation and/or Venous Thromboembolic Disease

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 179-179
Author(s):  
Jordan K Schaefer ◽  
Josh Errickson ◽  
Xiaowen Kong ◽  
Tina Alexandris-Souphis ◽  
Mona A Ali ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Research Funding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Thromboembolic Disease ◽  
Venous Thromboembolic Disease ◽  
Advisory Committees ◽  
Venous Thromboembolic ◽  
History Of

Abstract Introduction The direct oral anticoagulants (DOACs) including apixaban, dabigatran, edoxaban, and rivaroxaban are increasingly utilized for the management of venous thromboembolic disease (VTE) and/or non-valvular atrial fibrillation (NVAF). Adding aspirin (ASA) to warfarin or DOAC therapy increases bleeding risk. Patients on combination therapy with ASA and an anticoagulant were not well represented in clinical trials comparing DOACs to warfarin. We sought to compare bleeding and thrombotic outcomes with DOACs and ASA compared to warfarin and ASA in a non-trial setting. Methods We conducted a retrospective registry-based cohort study of adults on DOAC or warfarin therapy for VTE and/or NVAF. Warfarin treated patients were followed by six anticoagulation clinics. Four out of the six clinics contributed data on their patients that were on DOACs in the Michigan Anticoagulation Quality Improvement Initiative (MAQI 2) from January 2009 to June 2021. Patients were excluded if they had a history of heart valve replacement, recent myocardial infarction, or less than 3 months of follow-up. Two propensity matched cohorts (warfarin+ASA vs DOAC+ASA) of patients were analyzed based on ASA use at the time of study enrollment. The primary outcome was any new bleeding event. Secondary outcomes included new episodes of arterial or venous thrombosis, bleeding event type (major, fatal, life threatening, central nervous system, and non-major bleeding), emergency room visits, hospitalizations, transfusions, and death. Random chart audits were done to confirm the accuracy of the abstracted data. Event rates were compared using Poisson regression. Results We identified a total of 1,139 patients on DOACs plus ASA and 4,422 patients on warfarin plus ASA. After propensity matching, we compared two groups of 1,114 matched patients. DOAC treated patients were predominately on apixaban (62.3%) and rivaroxaban (30.4%), most often at therapeutic doses (Table 1). Patients were largely (90.5%) on low dose ASA (≤ 100 mg). Patient demographics, co-morbidities, indication for anticoagulation, history of bleeding or clotting, medications, and duration of follow-up were well-balanced after matching. Patients were followed for a median of 11.7 months (interquartile range 4.4 and 34 months). Patients treated with DOAC+ASA had 2.4 thrombotic events per 100 patient years compared to 2.2 thrombotic events per 100 patient years with warfarin+ASA (P=0.78). There were no significant differences observed between groups by thrombotic subtype (stroke, transient ischemic attack, pulmonary embolism, deep vein thrombosis, table 1). Bleeding was also similar with 30.1 bleeding events per 100 patient years with DOAC+ASA compared to 27.8 bleeds per 100 patient years with warfarin+ASA (P=0.24). There were no significant differences by bleeding subtype (table 1). Hospitalizations for clotting occurred less frequently with DOAC+ASA (0.9 hospitalizations per 100 patient years) compared to warfarin+ASA (1.7 hospitalizations per 100 patient years, P=0.03). Mortality, transfusions, and healthcare utilization were otherwise similar between the two groups. Conclusions For patients on a DOAC versus warfarin with ASA for atrial fibrillation and/or venous thromboembolic disease without a recent myocardial infarction or heart valve replacement, bleeding and thrombotic outcomes were similar. Figure 1 Figure 1. Disclosures Kaatz: Gilead: Consultancy; CSL Behring: Consultancy; Novartis: Consultancy; Bristol Myer Squibb: Consultancy, Research Funding; Pfizer: Consultancy; Alexion: Consultancy; Janssen: Consultancy, Research Funding; Osmosis Research: Research Funding. Kline-Rogers: Janssen: Consultancy; American College of Physicians: Consultancy. Sood: Bayer: Consultancy. Froehlich: Merck: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Boehringer-Ingelheim: Consultancy; Pfizer: Consultancy; Blue Cross Blue Shield of Michigan: Research Funding; Fibromuscular Disease Society of America: Research Funding. Barnes: National Certification Board of Anticoagulation Providers: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy; Acelis: Consultancy; AMAG Pharmaceuticals: Consultancy; Connected Health: Consultancy; Blue Cross Blue Shield of Michigan: Research Funding; AC Forum: Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy; Bristol-Myers Squibb: Consultancy.

scholarly journals Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Klaus K. Witte ◽  
Georgios Tsivgoulis ◽  
Matthew R. Reynolds ◽  
Stelios I. Tsintzos ◽  
Simon Eggington ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Recurrent Stroke ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Cost Savings ◽  
Embolic Stroke ◽  
Bleeding Events ◽  
Event Rates

Abstract Objective Prevention of recurrent stroke in patients with embolic stroke of undetermined source (ESUS) is challenging. The advent of safer anticoagulation in the form of direct oral anticoagulants (DOACs) has prompted exploration of prophylactic anticoagulation for all ESUS patients, rather than anticoagulating just those with documented atrial fibrillation (AF). However, recent trials have failed to demonstrate a clinical benefit, while observing increased bleeding. We modeled the economic impact of anticoagulating ESUS patients without documented AF across multiple geographies. Methods CRYSTAL-AF trial data were used to assess ischaemic stroke event rates in ESUS patients confirmed AF-free after long-term monitoring. Anticipated bleeding event rates (including both minor and major bleeds) with aspirin, dabigatran 150 mg, and rivaroxaban 20 mg were sourced from published meta-analyses, whilst a 30% ischaemic stroke reduction for both DOACs was assumed. Cost data for clinical events and pharmaceuticals were collected from the local payer perspective. Results Compared with aspirin, dabigatran and rivaroxaban resulted in 17.9 and 29.9 additional bleeding events per 100 patients over a patient’s lifetime, respectively. Despite incorporating into our model the proposed 30% reduction in ischaemic stroke risk, both DOACs were cost-additive over patient lifetime, as the costs of bleeding events and pharmaceuticals outweighed cost savings associated with the reduction in ischaemic strokes. DOACs added £5953–£7018 per patient (UK), €6683–€7368 (Netherlands), €4933–€9378 (Spain), AUD$5353–6539 (Australia) and $26,768–$32,259 (US) of payer cost depending on the agent prescribed. Additionally, in the U.S. patient pharmacy co-payments ranged from $2468–$12,844 depending on agent and patient plan. In all settings, cost-savings could not be demonstrated even when the modelling assumed 100% protection from recurrent ischaemic strokes, due to the very low underlying risk of recurrent ischaemic stroke in this population (1.27 per 100 patient-years). Conclusions Anticoagulation of non-AF patients may cause excess bleeds and add substantial costs for uncertain benefits, suggesting a personalised approach to anticoagulation in ESUS patients.

scholarly journals Predictors of inappropriate dosing of direct oral anticoagulants in nonagenarian patients with atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Dominguez Erquicia ◽  
S Raposeiras-Roubin ◽  
E Abu-Asi ◽  
M Cespon-Fernandez ◽  
D Alonso Rodriguez ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Kidney Function ◽  
Older Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Information Criterion ◽  
Disease Epidemiology ◽  
Funding Sources ◽  
Suboptimal Dose

Abstract Background Direct oral anticoagulants (DOACs) are presented as a good option for older patients owing to their safety profile. However, the dosing can become challenging especially in this population. Objective Our aim is to evaluate the predictors of inappropriate dosing of DOACs. Methods The authors analyzed the use of DOACs in 726 patients aged ≥90 years with a diagnosis of atrial fibrillation (AF) from a retrospective multicenter registry from 3 health areas in Spain. We studied the dosing, differentiating between appropriate dose, underdosing or overdosing. To evaluate the best predictive model, the Akaike information criterion (AIC) was used. Results Follow-up was 27.7±18.3 months. Mean age was 93.0±5.2 years, and 60.1% of patients were female. 339 patients received rivaroxaban (47.3%), 237 apixaban (33.1%), 105 dabigatran (14.7%) and 35 edoxaban (4.9%). An important proportion of patients received a suboptimal dose (41.5%, n=297): 35.3% underdosed and 6.1% overdosed. The rate of suboptimal dosing was higher for apixaban and lower for dabigatran (Figure 1A). In our registry we found as a predictors of inappropriate dosing: kidney function (Chronic Kidney Disease Epidemiology Collaboration), odds Ratio (OR) 1.04; 95% CI: 1.03–1.05, P<0.001; weight measured in kilograms, OR 1.04; 95% CI: 1.01–1.07, P=0.012; and high blood pressure (HBP), OR 1.61; 95% CI: 1.02–2.53, P=0.041 (Figure 1B). Other variables such as HASBLED, CHADSVASc, anemia, prior bleeding, or concomitant use of antiplatelet therapy, were not significantly associated. Conclusions We want to highlight that the use of an inappropriate dose of DOAC in older patients is common, about 40% in our study. Apixaban was the most frequently underdosed DOAC. HBP, weight, and kidney function were associated with an inappropriate dosing prescription. Therefore, it is important to carefully evaluate the characteristics of the patient to prescribe the appropriate dose that guarantees a correct action. FUNDunding Acknowledgement Type of funding sources: None. Dosing of DOACs Predictors of inappropriate dosing

Off-label underdosed apixaban use in Asian patients with non-valvular atrial fibrillation

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
SR Lee ◽  
EK Choi ◽  
SH Park ◽  
JH Jung ◽  
KD Han ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Clinical Outcome ◽  
Dose Reduction ◽  
Standard Dose ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label ◽  
Funding Sources ◽  
Asian Patients

Abstract Funding Acknowledgements Type of funding sources: None. Background In Asian patients with atrial fibrillation (AF), off-label underdosed prescriptions of direct oral anticoagulants (DOACs) are common Purpose We aimed to compare the effectiveness and safety of off-label underdosed apixaban with on-label standard dose apixaban in Asian patients with AF. Methods Using the Korean nationwide claims database, we identified patients who prescribed apixaban and did not fulfill the dose reduction criteria of apixaban between January 2015 and December 2017. Multivariable Cox hazard regression model was performed and hazard ratios (HRs) for ischemic stroke, major bleeding (MB), all-cause death, and the composite clinical outcome were analyzed. Results Compared to patients prescribed on-label standard dose apixaban (n = 4,194), patients prescribed off-label underdosed apixaban (n = 2,890) were associated with higher risks of ischemic stroke (adjusted HR [aHR] 1.38, 95% confidence interval [CI] 1.06-1.81), all-cause death (aHR 1.19, 95% CI 1.01-1.39) and the composite clinical outcome (aHR 1.17, 95% CI 1.03-1.34), but with no significant differences in MB between the two groups (Figure). In patients without any dose reduction criteria, off-label underdosed apixaban use was associated with a significantly higher risk of ischemic stroke than on-label standard dose apixaban use (aHR 1.85, 95% 1.25-2.73); however, in patients who had single dose reduction criteria (age ≥80 years, serum creatinine ≥1.5mg/dL, or bodyweight ≤60 kg), off-label underdosed apixaban use did not show a significant overall benefit in the composite clinical outcome compared with on-label standard dose apixaban, but was associated with a higher risk of all-cause death (aHR 1.32, 95% CI 1.07-1.64). Conclusion Off-label underdosed apixaban use was associated with higher risks of ischemic stroke, all-cause death, and composite clinical outcome and comparable risk of MB compared with on-label standard dose apixaban use. Label-adherence of apixaban dosing should be emphasized to achieve the best clinical outcome for Asian patients with non-valvular AF, especially in those without any dose reduction criteria. Abstract Figure.

scholarly journals Clinical significances of prothrombin time-international normalized ratio and activated partial thromboplastin time in patients with atrial fibrillation treated with direct oral anticoagulants

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Randomized Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
International Normalized Ratio ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Factors Associated ◽  
Funding Sources

Abstract Background Although the measurements of PT-INR or aPTT were not performed for patients with atrial fibrillation (AF) taking direct oral anticoagulants (DOACs) in randomized trials, these tests were commonly used and familiar to clinical physicians. We aimed to test whether there is an association between PT-INR or aPTT ratio and risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding among AF patients taking rivaroxaban or dabigatran, respectively. Methods This multi-center cohort study included 3,192 AF patients taking rivaroxaban and 958 patients taking dabigatran for stroke prevention whose data about PT-INR and aPTT were available. Results For patients treated with rivaroxaban, a higher INR level was not associated with a higher risk of major bleeding compared to an INR level <1.1. The risk of IS/SE was lower for patients having an INR ≥1.5 compared to those with an INR <1.1 (aHR: 0.57; [95% CI: 0.37–0.87]; P=0.0088) (Figure). On-label dosing of rivaroxaban and use of digoxin were independent factors associated with an INR ≥1.5 after taking rivaroxaban. For patients taking dabigatran, a higher aPTT ratio was not associated with a higher risk of major bleeding. The risk of IS/SE was lower for patients having an aPTT ratio of 1.1–1.2 and 1.3–1.4 than those with an aPTT ratio <1.1. Conclusions In Asian AF patients, PT-INR or aPTT ratios were not associated with the occurrences of bleeding events for rivaroxaban or dabigatran. Patients taking rivaroxaban with an INR ≥1.5 were associated with a lower risk of IS/SE. Appropriate dosages of DOACs and the compliances of patients should be confirmed for patients taking rivaroxaban with an INR <1.5. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Direct oral anticoagulants vs warfarin in non-valvular atrial fibrillation. Meta-analysis, includes all published trials

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
C Arreaga-Perez ◽  
D Evangelista-Barragan ◽  
A Zarate-Zapata ◽  
E Penaherrera ◽  
J J Zuniga-Bohorquez ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Hemorrhagic Stroke ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Cardiovascular Death ◽  
Phase Iii ◽  
Funding Sources ◽  
Selection Of

Abstract Introduction Warfarin, despite its limitations, is still used as standard treatment in patients with Atrial Fibrillation, but it has been demonstrated that Direct Oral Anticoagulants (DOAC) offer many advantages over warfarin in the prevention of strokes. Purpose The goal was to determinate the safety and effectiveness in reducing systemic thromboembolism, ischemic stroke, hemorrhagic stroke, cerebral hemorrhage and cardiovascular mortalityof the direct oral anticoagulants (DOACs) over warfarin in patients with non-valvular atrial fibrillation, conducting an analysis of the studies of DOACs, including the ENGAGE study on the use of edoxaban, affirming its safety including the pivotal essays available. Method A systematic search of PubMed's bibliographic database was made for the selection of the articles.Clinical essays from less than 10 years, in phase III and multicentric studies were selected. Results The main objective was the significant reduction in the incidence of stroke/systemic thromboembolism with the use of DOACs vs. Warfarin (2,73% vs. 3,24%), the reduction of hemorrhagic stroke was (0.41% vs. 0.94%), ischemic stroke (3.12% vs. 3.5%), cardiovascular death with DOACs was 6.02% vs. Warfarin 6.84%, (compared with previous studies that demonstrated effectiveness with max doses affirming safety and effectiveness). Conclusion Our meta-analysis is the first to date to evaluate all the pivotal trials published,we include the ENGAGE trial. In non-valvular atrial fibrillation, the use of DOACs, in comparison with Warfarin, significantly reduced the risk of stroke/systemic thromboembolism by 16.3%, ischemic stroke by 11.1%, hemorrhagic stroke by 54.6%, cardiovascular mortality by 12.9%. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Burden of Oral Anticoagulation in Embolic Stroke of Undetermined Source without Atrial Fibrillation

2021 ◽  
Author(s):  
Klaus Witte ◽  
Georgios Tsivgoulis ◽  
Matthew Reynolds ◽  
Stelios Tsintzos ◽  
Simon Eggington ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Recurrent Stroke ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Cost Savings ◽  
Embolic Stroke ◽  
Bleeding Events ◽  
Event Rates

Abstract Objective: Prevention of recurrent stroke in patients with embolic stroke of undetermined source (ESUS) is challenging. The advent of safer anticoagulation in the form of direct oral anticoagulants (DOACs) has prompted exploration of prophylactic anticoagulation for all ESUS patients, rather than anticoagulating just those with documented atrial fibrillation (AF). However, recent trials have failed to demonstrate a clinical benefit, while observing increased bleeding. We modeled the economic impact of anticoagulating ESUS patients without documented AF across multiple geographies.Methods: CRYSTAL-AF trial data were used to assess ischaemic stroke event rates in ESUS patients confirmed AF-free after long-term monitoring. Anticipated bleeding event rates (including both minor and major bleeds) with aspirin, dabigatran 150 mg, and rivaroxaban 20 mg were sourced from published meta-analyses, whilst a 30% ischaemic stroke reduction for both DOACs was assumed. Cost data for clinical events and pharmaceuticals were collected from the local payer perspective.Results: Compared with aspirin, dabigatran and rivaroxaban resulted in 17.9 and 29.9 additional bleeding events per 100 patients over a patient’s lifetime, respectively. Despite incorporating into our model the proposed 30% reduction in ischaemic stroke risk, both DOACs were cost-additive over patient lifetime, as the costs of bleeding events and pharmaceuticals outweighed cost savings associated with the reduction in ischaemic strokes. DOACs added £5,953-£7,018 per patient (UK), €6,683-€7,368 (Netherlands), €4,933-€9,378 (Spain), AUD$5,353-6,539 (Australia) and $26,768-$32,259 (US) of payer cost depending on the agent prescribed. Additionally, in the U.S. patient pharmacy co-payments ranged from $1,716-$12,473 depending on agent and patient plan. In all settings, cost-savings could not be demonstrated even when the modelling assumed 100% protection from recurrent ischaemic strokes, due to the very low underlying risk of recurrent ischaemic stroke in this population (1.27 per 100 patient-years).Conclusions: Anticoagulation of non-AF patients may cause excess bleeds and add substantial costs for uncertain benefits, suggesting a personalised approach to anticoagulation in ESUS patients.

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