direct oral anticoagulant
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Peter A. Noseworthy ◽  
Megan E. Branda ◽  
Marleen Kunneman ◽  
Ian G. Hargraves ◽  
Angela L. Sivly ◽  

Background Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: ; Unique identifier: Identifier: NCT02905032.

2022 ◽  
pp. 174749302110577
Jonathan G Best ◽  
Liz Arram ◽  
Norin Ahmed ◽  
Maryam Balogun ◽  
Kate Bennett ◽  

Rationale Atrial fibrillation causes one-fifth of ischemic strokes, with a high risk of early recurrence. Although long-term anticoagulation is highly effective for stroke prevention in atrial fibrillation, initiation after stroke is usually delayed by concerns over intracranial hemorrhage risk. Direct oral anticoagulants offer a significantly lower risk of intracranial hemorrhage than other anticoagulants, potentially allowing earlier anticoagulation and prevention of recurrence, but the safety and efficacy of this approach has not been established. Aim Optimal timing of anticoagulation after acute ischemic stroke with atrial fibrillation (OPTIMAS) will investigate whether early treatment with a direct oral anticoagulant, within four days of stroke onset, is as effective or better than delayed initiation, 7 to 14 days from onset, in atrial fibrillation patients with acute ischemic stroke. Methods and design OPTIMAS is a multicenter randomized controlled trial with blinded outcome adjudication. Participants with acute ischemic stroke and atrial fibrillation eligible for anticoagulation with a direct oral anticoagulant are randomized 1:1 to early or delayed initiation. As of December 2021, 88 centers in the United Kingdom have opened. Study outcomes The primary outcome is a composite of recurrent stroke (ischemic stroke or symptomatic intracranial hemorrhage) and systemic arterial embolism within 90 days. Secondary outcomes include major bleeding, functional status, anticoagulant adherence, quality of life, health and social care resource use, and length of hospital stay. Sample size target A total of 3478 participants assuming event rates of 11.5% in the control arm and 8% in the intervention arm, 90% power and 5% alpha. We will follow a non-inferiority gatekeeper analysis approach with a non-inferiority margin of 2 percentage points. Discussion OPTIMAS aims to provide high-quality evidence on the safety and efficacy of early direct oral anticoagulant initiation after atrial fibrillation-associated ischemic stroke. Trial registrations: ISRCTN: 17896007; NCT03759938

Maxime Delrue ◽  
Lucie Chevillard ◽  
Alain Stépanian ◽  
Alessandra Dragoni ◽  
Laurence Camoin‐Jau ◽  

2021 ◽  
Vol 23 (Supplement_G) ◽  
Vito Maurizio Parato ◽  
Luca Di Geso ◽  
Andrea Giovanni Parato ◽  
Simona Pelliccioni

Abstract Aims Isolated pulmonic valve infective endocarditis (PV-IE) is a rare form of endocarditis. Methods and results The authors report a case of giant vegetations detected by transthoracic echocardiography on pulmonic valve in a 33 year-old patient, with drug abuse history (Figure 1). Patient underwent surgical intervention by pulmonary valved bioconduit implantation. After operation a pulmonary embolism episode was treated by a direct oral anticoagulant. The final outcome was favourable. We report a short review of this rare pathology. Conclusions The difficulty in diagnosing PV-IE is due to inability to properly visualize the pulmonic valve by echocardiography. In this case, with such large vegetations, transthoracic echocardiography (TTE) allowed a correct diagnosis and an effective surgical planning, confirming its importance as diagnostic tool.

2021 ◽  
Vol 21 (1) ◽  
Mikko Pyykönen ◽  
Miika Linna ◽  
Markku Tykkyläinen ◽  
Eric Delmelle ◽  
Tiina Laatikainen

Abstract Background Anticoagulant therapies are used to prevent atrial fibrillation-related strokes, with warfarin and direct oral anticoagulant (DOAC) the most common. In this study, we incorporate direct health care costs, drug costs, travel costs, and lost working and leisure time costs to estimate the total costs of the two therapies. Methods This retrospective study used individual-level patient data from 4000 atrial fibrillation (AF) patients from North Karelia, Finland. Real-world data on healthcare use was obtained from the regional patient information system and data on reimbursed travel costs from the database of the Social Insurance Institution of Finland. The costs of the therapies were estimated between June 2017 and May 2018. Using a Geographical Information System (GIS), we estimated travel time and costs for each journey related to anticoagulant therapies. We ultimately applied therapy and travel costs to a cost model to reflect real-world expenditures. Results The costs of anticoagulant therapies were calculated from the standpoint of patient and the healthcare service when considering all costs from AF-related healthcare visits, including major complications arising from atrial fibrillation. On average, the annual cost per patient for healthcare in the form of public expenditure was higher when using DOAC therapy than warfarin therapy (average cost = € 927 vs. € 805). Additionally, the average annual cost for patients was also higher with DOAC therapy (average cost = € 406.5 vs. € 296.7). In warfarin therapy, patients had considerable more travel and time costs due the different implementation practices of therapies. Conclusion The results indicated that DOAC therapy had higher costs over warfarin from the perspectives of the patient and healthcare service in the study area on average. Currently, the cost of the DOAC drug is the largest determinator of total therapy costs from both perspectives. Despite slightly higher costs, the patients on DOAC therapy experienced less AF-related complications during the study period.

Mohammed Shurrab ◽  
Rachel Ryu ◽  
Cynthia A. Jackevicius

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