Ximelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V)

2003 ◽  
Vol 146 (3) ◽  
pp. 431-438 ◽  
Author(s):  
Jonathan L Halperin
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Studies ◽  
Patient Characteristics ◽  
Nonvalvular Atrial Fibrillation

scholarly journals Anticoagulant Utilization and Direct Oral Anticoagulant Prescribing in Patients with Nonvalvular Atrial Fibrillation

2019 ◽  
Vol 72 (6) ◽  
Author(s):  
Priscilla Shum ◽  
Gordon Klammer ◽  
Dale Toews ◽  
Arden Barry
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulant ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Renal Dialysis ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Nonvalvular Atrial Fibrillation ◽  
Patients Âgés ◽  
Fibrillation Auriculaire

ABSTRACTBackground: Direct oral anticoagulants (DOACs) are indicated for prevention of stroke and embolism in patients with nonvalvular atrial fibrillation (NVAF). These agents have been shown to be non-inferior to warfarin in terms of efficacy and safety. However, their uptake in practice has been variable, and prescribed dosages may be inconsistent with manufacturer recommendations.Objectives: To evaluate patterns of oral anticoagulant use in patients with NVAF, including determination of patient characteristics associated with the prescribing of warfarin or DOACs and whether prescribed dosages of DOACs were concordant with manufacturer recommendations.Methods: This retrospective chart review was conducted from April to September 2017 at Abbotsford Regional Hospital, Abbotsford, British Columbia. Patients at least 18 years of age with NVAF and CHADS-65 score of 1 or higher were included. Patients with contraindications to oral anticoagulants, those with reversible atrial fibrillation, and those undergoing renal dialysis were excluded. The dosage of DOACs was categorized as too low, too high, or correct in relation to manufacturer recommendations for the Canadian product. Results: A total of 120 patients were included. At discharge, 83 (69%) of the patients had a prescription for DOAC, 25 (21%) had a prescription for warfarin, and 12 (10%) had no prescription for an oral anticoagulant. There were no statistically significant differences between the warfarin and DOAC groups with respect to patient characteristics. Among the 56 patients for whom a full DOAC dose was indicated, 7 (13%) received a dose that was too low. Among the 23 patients for whom a full DOAC dose was not indicated, 4 (17%) received a dose that was too high. Conclusions: At the study hospital, most patients with NVAF and CHADS-65 score of at least 1 had a discharge prescription for DOAC. Patient characteristics appeared to be similar between the warfarin and DOAC groups. For a notable proportion of patients who received a DOAC, the dosage was incorrect. Appropriate prescribing of oral anticoagulants could be further improved by education for prescribers and involvement of hospital pharmacists.RÉSUMÉContexte : Les anticoagulants oraux directs (AOD) sont indiqués pour prévenir les AVC et les embolies parmi les patients atteints de fibrillation auriculaire non valvulaire (FANV). Il a été démontré que l’efficacité et l’innocuité de ces agents n’étaient pas inférieures à la warfarine. Cependant, leur adoption dans la pratique est inégale, et les doses prescrites peuvent être contraires aux recommandations des fabricants.Objectifs : Évaluation des habitudes d’utilisation des anticoagulants oraux pour les patients atteints de FANV, y compris la définition des caractéristiques des patients associées à la prescription de la warfarine ou des AOD, ainsi que de la conformité des doses prescrites de ces derniers aux recommandations des fabricants.Méthodes : Cet examen rétrospectif des dossiers a été mené d’avril à septembre 2017 à l’Hôpital régional d’Abbotsford à Abbotsford, en Colombie-Britannique. Des patients âgés d’au moins 18 ans, atteints de FANV et ayant un score CHADS-65 d’au moins 1, ont été inclus dans l’étude. Les patients présentant une contre-indication aux anticoagulants oraux, ceux atteints de fibrillation auriculaire réversible et ceux soumis à une dialyse rénale en ont été exclus. La dose d’AOD destinés au marché canadien a été catégorisée comme trop faible, trop élevée ou correcte par rapport aux recommandations du fabricant.Résultats : Cent-vingt patients au total ont participé à l’étude. Au moment du congé, 83 (69 %) d’entre eux avaient une prescription d’AOD, 25 (21 %) avaient une prescription de warfarine et 12 (10 %) n’avaient pas de prescription d’anticoagulant oral. En ce qui concerne les caractéristiques des patients, il n’y avait aucune différence statistique notable entre les groupes ayant reçu une prescription de warfarine et ceux ayant reçu une prescription d’AOD. Des 56 patients qui avaient reçu une indication de dose complète d’AOD, sept (13 %) ont reçu une dose trop faible. Des 23 patients qui n’avaient pas reçu d’indication de dose complète d’AOD, quatre (17 %) ont reçu une dose trop élevée.Conclusions : À l’hôpital où s’est déroulée l’étude, la plupart des patients atteints de FANV et ceux ayant un score CHADS-65 d’au moins 1 recevaient une prescription d’AOD au moment du congé. Les caractéris-tiques des patients semblaient similaires entre les groupes ayant reçu une prescription de warfarine et ceux ayant reçu une prescription d’AOD. La dose d’AOD reçue par une proportion notable de patients était incorrecte. La prescription appropriée d’anticoagulants oraux pourrait encore être améliorée si on sensibilisait les prescripteurs avec la collaboration des pharmaciens d’hôpitaux.   

Abstract TP399: Incremental Healthcare Burden Associated with Dyspepsia Among Nonvalvular Atrial Fibrillation Patients: Implications for Anticoagulation Therapy

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Michael H Kim ◽  
Kelly F Bell ◽  
Dinara Makenbaeva ◽  
Daniel Daniel Wiederkehr ◽  
Jay Lin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Insurance Coverage ◽  
Anticoagulation Therapy ◽  
Patient Characteristics ◽  
Nonvalvular Atrial Fibrillation ◽  
Chads2 Score ◽  
Entire Study ◽  
Healthcare Burden ◽  
Gi Bleed

Background: Dyspepsia is common among nonvalvular atrial fibrillation (NVAF) patients and may influence stroke preventative medication choice, such as warfarin and dabigatran, especially when bleeding is a concern. This study evaluated the incremental healthcare burden associated with dyspepsia among NVAF patients. Methods: NVAF patients ≥18 years of age with continuous insurance coverage were identified (1/1/2007-12/31/2009) from the MarketScan® Commercial and Medicare Research Databases. Patients with at least 1 inpatient or 2 outpatient dyspepsia diagnoses within 12 months following any NVAF diagnosis were categorized as dyspepsia cohort, with patients without any dyspepsia diagnosis during the entire study period categorized as non-dyspepsia cohort. Of the overall dyspepsia/non-dyspepsia cohorts, patients were matched by key patient characteristics. Healthcare usage and costs were measured in a 12-month follow-up period. Results: Among NVAF patients, 10.2% had dyspepsia. For the dyspepsia cohort (n=14,556) vs. unmatched non-dyspepsia cohort (n= 127,766), mean CCI (2.4 vs. 1.6, p<0.0001), CHADS2 score (1.8 vs. 1.6, p<0.0001), hospitalizations (dyspepsia-related, GI-related, GI-bleed related, any cause), associated inpatient costs, outpatient usage and costs, as well as pharmacy usage and costs were greater. After matching, a lesser proportion of patients in the dyspepsia cohort used warfarin (49% vs. 57%, p<0.0001) and had significantly higher healthcare resource usage and costs vs. the non-dyspepsia cohort during the follow-up period (Table). Conclusions: The incremental healthcare burden associated with dyspepsia among NVAF patients is significant and appears associated with less warfarin usage. Further data on dyspepsia as a barrier to anticoagulation in NVAF are needed.

scholarly journals Impact of Co-morbidities and Patient Characteristics on International Normalized Ratio Control Over Time in Patients With Nonvalvular Atrial Fibrillation

2013 ◽  
Vol 112 (4) ◽  
pp. 509-512 ◽  
Author(s):  
Winnie W. Nelson ◽  
Jiyoon C. Choi ◽  
Julie Vanderpoel ◽  
Chandrasekharra V. Damaraju ◽  
Peter Wildgoose ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Patient Characteristics ◽  
International Normalized Ratio ◽  
Nonvalvular Atrial Fibrillation ◽  
Over Time

scholarly journals Patient characteristics and stroke and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban and vitamin K antagonists: a Spanish real-world study

2019 ◽  
Vol 8 (14) ◽  
pp. 1201-1212 ◽  
Author(s):  
Sreeram V Ramagopalan ◽  
Antoni Sicras-Mainar ◽  
Carlos Polanco-Sanchez ◽  
Robert Carroll ◽  
Jaime F de Bobadilla
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Medical Records ◽  
Vitamin K Antagonists ◽  
Patient Characteristics ◽  
Minor Bleeding ◽  
Thromboembolic Events ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation

Aim: To compare the risk of stroke, systemic thromboembolism and bleeding, in patients initiating apixaban or acenocoumarol for the treatment of nonvalvular atrial fibrillation. Methods: An observational, retrospective study was performed using medical records of patients who initiated apixaban or acenocoumarol between 2015 and 2017. Propensity score matching was used to match patients; stroke, systemic thromboembolism, major and minor bleeding events were compared between the matched patients. Results: Patients who were prescribed apixaban had a lower rate of systemic embolism/stroke (hazard ratio [HR] = 0.54; 95% CI: 0.38–0.78; p = 0.001), minor bleeding (HR = 0.64; 95% CI: 0.52–0.79; p < 0.001) and major bleeding (HR = 0.51; 95% CI: 0.37–0.72; p < 0.001). Conclusion: Patients prescribed apixaban for the treatment of nonvalvular atrial fibrillation had lower rates of thromboembolic events and minor/major bleeding than patients on acenocoumarol.

Abstract 505: Incidence of Major Bleeding in a Real-World Population of 57,070 Nonvalvular Atrial Fibrillation Patients Treated With Rivaroxaban

2017 ◽  
Vol 37 (suppl_1) ◽  
Author(s):  
Frank Peacock ◽  
Manesh Patel ◽  
Zhong Yuan ◽  
Nicholas Sicignano ◽  
Kathleen Hopf ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Factor Xa ◽  
Patient Characteristics ◽  
World Population ◽  
Nonvalvular Atrial Fibrillation ◽  
Military Health ◽  
Bleeding Management ◽  
Fatal Bleeding ◽  
Registration Trial

Introduction: Rivaroxaban, a direct factor Xa inhibitor approved in 2011, reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Phase 3 results from the registration trial showed a major bleeding (MB) rate of 3.6 per 100 person-years. Objective: To evaluate MB incidence among NVAF patients taking rivaroxaban in a post-approval clinical setting. Methods: From January 1, 2013 to June 30, 2016, over 10 million electronic medical records from the Department of Defense Military Health System were queried. A validated MB case-finding algorithm (Cunningham) was used to identify MB-related hospitalizations. Major bleeding incidence, patient characteristics, comorbid conditions, concomitant medications, bleeding management, and fatal bleeds were assessed. Results: Of 57,070 rivaroxaban users with NVAF, 1,914 experienced a MB event, with incidence of 2.60 (95% CI 2.49-2.72) per 100 person-years. Patient characteristics and subgroup bleeding rates are displayed in Table 1. There were 62 patients who experienced fatal bleeding, and the mean (SD) age at time of death was 79.3 (7.6) years. Among those who died, 74.2% had intracranial hemorrhage, 22.6% had gastrointestinal hemorrhage, and 3.2% had bleeding in other sites. Conclusion: The incidence, pattern, and management of MB in rivaroxaban users with NVAF in a large and diverse population were generally consistent with the findings from the registration trial. Fatal bleeding was rare.

Effect of Fixed Minidose Warfarin, Conventional Dose Warfarin and Aspirin on INR and Prothrombin Fragment 1 + 2 in Patients with Atrial Fibrillation

1997 ◽  
Vol 77 (05) ◽  
pp. 0845-0848 ◽  
Author(s):  
B G Koefoed ◽  
C Feddersen ◽  
A L Gulløv ◽  
P Petersen
Keyword(s):  
Atrial Fibrillation ◽  
International Normalized Ratio ◽  
Coagulation System ◽  
Nonvalvular Atrial Fibrillation ◽  
Treatment Groups ◽  
Prothrombin Fragment ◽  
Conventional Dose ◽  
Dose Warfarin ◽  
Significant Difference ◽  
Changes Over Time

SummaryThe efficacy of conventional dose adjusted oral anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation is well- documented but not considered ideal as primary antithrombotic treatment in elderly patients. The antithrombotic effect of fixed minidose warfarin 1.25 mg/day alone or in combination with aspirin 300 mg/day, of conventional dose adjusted warfarin (INR 2.0-3.0), and of aspirin 300 mg/day have been investigated in outpatients with chronic nonvalvular atrial fibrillation in the second Copenhagen Atrial Fibrillation, Aspirin and Anticoagulant Therapy Study (AFASAK 2). In order to investigate the effect on the coagulation system of the treatments, the International Normalized Ratio of the prothrombin time (INR) and prothrombin fragment 1 + 2 (F1 +2) were monitored at baseline and after three months of treatment in 100 patients consecutively included in the trial. At baseline no differences in INR and F1+2 between the four treatment groups were present. After three months of therapy the level of INR increased significantly from baseline in patients receiving warfarin in any dose and the level of F1+2 decreased significantly by combined minidose warfarin-aspirin and by dose adjusted warfarin. When comparing the changes over time in FI +2 (three-month value minus baseline value) during therapy with fixed minidose warfarin, combined minidose warfarin-aspirin and aspirin alone no significant difference between the groups was found. In conclusion, INR was changed by all three warfarin regimens but only dose adjusted warfarin (INR 2.0-3.0) had a marked effect on F1+2.

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