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In-Hospital Bleeding Outcomes of Myocardial Infarction in the Era of Warfarin and Direct Oral Anticoagulants for Atrial Fibrillation in the United States: A Report From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry.

ABSTRACT: Background We sought to examine patient characteristics, peri-infarction invasive and pharmacologic management, and in-hospital major bleeding in myocardial infarction patients with atrial fibrillation or flutter, based on home anticoagulant use. Methods and Results We stratified patients by home anticoagulant: (1) no anticoagulant, (2) warfarin, and (3) direct oral anticoagulants ( DOAC s) among ST-segment-elevation myocardial infarction ( STEMI ) and non-STEMI (NSTEMI) patients with atrial fibrillation or flutter treated at 761 US hospitals in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry from January 2015 to December 2016. The primary outcome of our study was in-hospital major bleeding. Multivariable logistic regression was used to examine the independent association between home anticoagulant and in-hospital major bleeding. Among 6471 STEMI patients with atrial fibrillation or flutter, 15.7% were on warfarin and 13.0% on DOAC s; among 19 954 NSTEMI patients, 22.8% were on warfarin and 15.4% on DOAC s. In STEMI , door-to-balloon times were slightly higher in those on anticoagulant, with similar rates of angiography within 24 hours in the 3 groups. NSTEMI patients on anticoagulant were less likely to undergo angiography (49.3% no anticoagulant, 33.4% on warfarin, 36.4% on DOAC s; P<0.01) or percutaneous coronary intervention within 24 hours (21.1% no anticoagulant, 14.3% on warfarin, 15.9% on DOAC s; P<0.01). After multivariate adjustment, use of home warfarin (odds ratio: 1.00 [95% CI , 0.79-1.27] in STEMI and 1.13 [95% CI , 0.97-1.30] in NSTEMI ) or DOAC (odds ratio: 0.93 [95% CI , 0.73-1.20] in STEMI and 0.97 [95% CI , 0.81-1.16] in NSTEMI ) was not associated with increased in-hospital major bleeding compared with no anticoagulant. Conclusions In routine clinical practice, home warfarin or DOAC therapy is not associated with an increased risk of in-hospital bleeding compared with no anticoagulant.

SUBMITTER: Feldman DN

PROVIDER: S-EPMC6507194 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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In-Hospital Bleeding Outcomes of Myocardial Infarction in the Era of Warfarin and Direct Oral Anticoagulants for Atrial Fibrillation in the United States: A Report From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry.

Feldman Dmitriy N DN Wang Tracy Y TY Chen Anita Y AY Swaminathan Rajesh V RV Kim Luke K LK Wong S Chiu SC Minutello Robert M RM Bergman Geoffrey G Singh Harsimran S HS Madias Christopher C

Journal of the American Heart Association 20190401 8

Background We sought to examine patient characteristics, peri-infarction invasive and pharmacologic management, and in-hospital major bleeding in myocardial infarction patients with atrial fibrillation or flutter, based on home anticoagulant use. Methods and Results We stratified patients by home anticoagulant: (1) no anticoagulant, (2) warfarin, and (3) direct oral anticoagulants ( DOAC s) among ST-segment-elevation myocardial infarction ( STEMI ) and non-STEMI (NSTEMI) patients with atrial fib ...[more]

PMID: 30955406

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Project description:ImportanceBleeding and thrombotic events (eg, stroke and systemic embolism) are common in patients with atrial fibrillation (AF) taking warfarin sodium despite a well-established therapeutic range.ObjectiveTo evaluate whether history of therapeutic warfarin control in patients with AF is independently associated with subsequent bleeding or thrombotic events.Design, setting, and participantsIn this multicenter cohort study of 176 primary care, cardiology, and electrophysiology clinics in the United States, data were obtained during 51 830 visits among 10 137 patients with AF in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry; 5545 patients treated with warfarin were included in the bleeding analysis, and 5635 patients were included in the thrombotic event analysis. Patient follow-up was performed from June 29, 2010, to November 30, 2014. Data analysis was performed from August 4, 2016, to February 15, 2019.ExposuresMultiple measures of warfarin control within the preceding 6 months were analyzed: time in therapeutic range of 2.0 to 3.0, most recent international normalized ratio (INR), percentage of time that a patient had interpolated INR values less than 2.0 or greater than 3.0, INR variance, INR range, and percentage of INR values in therapeutic range.Main outcomes and measuresAssociation of INR measures, alone or in combination, with clinical factors and risk for thrombotic events and bleeding during the subsequent 6 months was assessed post hoc using logistic regression models.ResultsA total of 5545 patients (mean [SD] age, 74.5 [9.8] years; 3184 [57.4%] male) with AF were included in the major bleeding analysis and 5635 patients (mean [SD] age, 74.5 [9.8] years; 3236 [57.4%] male) in the thrombotic event analysis. During a median follow-up of 1.5 years (interquartile range, 1.0-2.5 years), there were 339 major bleeds (6.1%) and 51 strokes (0.9%). Multiple metrics of warfarin control were individually associated with subsequent bleeding. After adjustment for clinical bleeding risk, 3 measures-time in therapeutic range (per 1-SD increase ≤55: adjusted odds ratio [aOR], 1.16; 95% CI, 1.02-1.32), variation in INR values (aOR, 1.32; 95% CI, 1.19-1.47), and maximum INR (aOR, 1.20; 95% CI, 1.10-1.31)-remained associated with bleeding risk. Adding INR variance to a clinical risk model slightly increased the C statistic from 0.68 to 0.69 and had a net reclassification improvement index of 0.028 (95% CI, -0.029 to 0.067). No INR measures were associated with subsequent stroke risk.Conclusions and relevanceThree metrics of prior warfarin control were associated with bleeding risk but only marginally more so than traditional clinical factors. This study did not identify any measures of INR control that were significantly associated with stroke risk.

Project description:Background:Given the lack of clear indications for the use of warfarin in the treatment of atrial fibrillation (AF) in patients on hemodialysis and the potential risks that accompany warfarin use in these patients, we systematically reviewed stroke and bleeding outcomes in hemodialysis patients treated with warfarin for AF. Objective:To systematically review the stroke and bleeding outcomes associated with warfarin use in the hemodialysis population to treat AF. Design:Systematic review. Setting:All adult hemodialysis patients. Patients:Patients on hemodialysis receiving warfarin for the management of AF. Measurements:Any type of stroke and/or bleeding outcomes. Methods:MEDLINE(R) In-Process & Other Non-Indexed Citations and MEDLINE(R) via OVID (1946 to January 11, 2017), and EMBASE via OVID (1974 to January 11, 2017) were searched for relevant literature. Inclusion criteria were randomized controlled trials, observational studies, and case series in English that examined stroke and bleeding outcomes in adult population of patients (over 18 years old) who are on hemodialysis and taking warfarin for AF. Studies with less than 10 subjects, case reports, review articles, and editorials were excluded. Quality of selected articles was assessed using Newcastle-Ottawa Scale (NOS). Results:Of the 2340 titles and abstracts screened, 7 met the inclusion criteria. Two studies showed an association between warfarin use and an increased risk of stroke (Hazard Ratio: 1.93-3.36) but no association with an increased risk of bleed (HR: 0.85-1.04), while 4 studies showed no association between warfarin and stroke outcomes (HR: 0.12-1.17) but identified an association between warfarin and increased bleeding outcome (HR: 1.41-3.96). And 1 study reported neither beneficial nor harmful effects associated with warfarin use. Limitations:The major limitation to this review is that the 7 included studies were observational cohort studies, and thus the outcome measures were not specified and predetermined in a research protocol. Conclusion:Our systematic review demonstrated that for patients with AF who are on hemodialysis, warfarin was not associated with reduced outcomes of stroke but was rather associated with increased bleeding events.

Project description:Atrial fibrillation (AF) is the most common cardiac rhythm disorder with a significant health burden. The aim of this study was to characterise patients with recently diagnosed AF and to estimate the rates of comorbidities and outcome events requiring hospitalisation in routine clinical practice.Pharmacoepidemiological cohort study using observational data.This study included 16 513 patients with a first diagnosis of AF between 1 January 2005 and 28 February 2010 (newly diagnosed patients) using data from the UK Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) and the Office for National Statistics mortality data. Exposure was stratified by vitamin K antagonist (VKA) exposure (non-use, current, recent and past exposure) based on prescriptions and/or international normalised ratio measurements, and followed for outcome events of interest based on diagnosis codes in the databases, that is, vascular outcomes, bleeding events and others. The main focus of the study was on outcome events requiring hospitalisation using the HES data.The incidence of vascular outcome hospitalisations (myocardial infarction (MI), stroke or systemic arterial peripheral embolism) was 3.8 (95% CI 3.5 to 4.0)/100 patient-years. The incidence of stroke was 0.9 (0.8 to 1.1) during current VKA exposure, 2.2 (1.6 to 2.9) for recent, 2.4 (1.9 to 2.9) for past and 3.4 (3.1 to 3.7) during non-use. MI incidence was 0.7 (0.6 to 0.9) for current VKA exposure, 0.7 (0.4 to 1.2) for recent, 1.1 (0.8 to 1.5) for past and 1.9 (1.7 to 2.1) during non-use. The incidence of bleeding event hospitalisations was 3.8 (3.4 to 4.2) for current VKA exposure, 4.5 (3.7 to 5.5) for recent, 2.7 (2.2 to 3.3) for past and 2.9 (2.6 to 3.2) during non-use; 38% of intracranial bleeds and 6% of gastrointestinal bleeds were fatal.This population-based study from recent years provides a comprehensive characterisation of newly diagnosed patients with AF and incidence estimates of common outcomes with a focus on hospitalised events stratified by VKA exposure. This study will help to place future data on new oral anticoagulants into perspective.

Dataset Information

In-Hospital Bleeding Outcomes of Myocardial Infarction in the Era of Warfarin and Direct Oral Anticoagulants for Atrial Fibrillation in the United States: A Report From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry.

Publications

In-Hospital Bleeding Outcomes of Myocardial Infarction in the Era of Warfarin and Direct Oral Anticoagulants for Atrial Fibrillation in the United States: A Report From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry.

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