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1.
J Am Heart Assoc ; 7(12)2018 06 09.
Article in English | MEDLINE | ID: mdl-29886424

ABSTRACT

BACKGROUND: Ticagrelor is a P2Y12 receptor inhibitor with superior clinical efficacy compared with clopidogrel. However, it is associated with reduced efficacy when combined with a high-dose aspirin. METHODS AND RESULTS: Patients in the acute coronary treatment and intervention outcomes network (ACTION) Registry-Get With The Guidelines (GWTG) with acute myocardial infarction from October 2013 through December 2014 were included in the study (167 455 patients; 622 sites). We evaluated temporal trends in the prescription of P2Y12 inhibitors, and identified factors associated with ticagrelor use at discharge. Among patients discharged on ticagrelor and aspirin (21 262 patients), we evaluated the temporal trends and independent factors associated with high-dose aspirin prescription at discharge. Ticagrelor prescription at discharge increased significantly from 12% to 16.7% (P<0.0001). Decreases in prasugrel and clopidogrel use at discharge (15.7%-13.9% and 54.2%-51.1%, respectively, P<0.0001) were also observed. Independent factors associated with preferential ticagrelor prescription at discharge over clopidogrel included younger age, white race, home ticagrelor use, invasive management, and in-hospital re-infarction and stroke (P<0.0001 for all), whereas older age, female sex, prior stroke, home ticagrelor use, and in-hospital stroke (P<0.0001 for all) were associated with preferential ticagrelor prescription at discharge over prasugrel. High-dose aspirin was used in 3.1% of patients discharged on ticagrelor. Independent factors associated with high-dose aspirin prescription at discharge included home aspirin use, diabetes mellitus, previous myocardial infarction, previous coronary artery bypass graft, ST-segment-elevation myocardial infarction, cardiogenic shock, and geographic region (P=0.01). CONCLUSIONS: Our contemporary analysis shows a modest but significant increase in the use of ticagrelor and a high rate of adherence to the use of low-dose aspirin at discharge.


Subject(s)
Acute Coronary Syndrome/drug therapy , Myocardial Infarction/drug therapy , Platelet Aggregation Inhibitors/therapeutic use , Practice Patterns, Physicians'/trends , Purinergic P2Y Receptor Antagonists/therapeutic use , Ticagrelor/therapeutic use , Aged , Aspirin/therapeutic use , Drug Prescriptions , Drug Therapy, Combination , Female , Guideline Adherence/trends , Humans , Male , Middle Aged , Patient Discharge/trends , Platelet Aggregation Inhibitors/adverse effects , Practice Guidelines as Topic , Purinergic P2Y Receptor Antagonists/adverse effects , Registries , Ticagrelor/adverse effects , Treatment Outcome , United States
2.
Eur Heart J Qual Care Clin Outcomes ; 3(3): 183-191, 2017 07 01.
Article in English | MEDLINE | ID: mdl-28838094

ABSTRACT

Aims: To investigate the obesity paradox and association of extreme obesity with long-term outcomes among older ST-segment elevation myocardial infarction (STEMI) patients. Methods and results: Nineteen thousand four hundred and ninety-nine patients ≥65 years with STEMI surviving to hospital discharge in NCDR ACTION Registry-GWTG linked to Centers for Medicare and Medicaid Services outcomes between 2007 and 2012 were stratified by body mass index (BMI) (kg/m2) into normal weight (18.5-24.9), overweight (25-29.9), class I (30-34.9), class II (35-39.9), and class III/extreme obese (≥40) categories. Multivariable-adjusted associations were evaluated between BMI categories and mortality by Cox proportional hazards models, and days alive and out of hospital (DAOH) by generalized estimating equations, within 3 years after discharge. Seventy percent of patients were overweight/obese and 3% extremely obese. Normal weight patients were older and more likely to smoke; while extremely obese patients were younger and more likely to be female and black, with lower socioeconomic status and more comorbidity (P ≤ 0.001). A U-shaped association was observed between BMI categories and mortality: patients with class I obesity were at lowest risk, while normal weight [hazard ratio (HR) 1.30, 95% confidence interval (CI) 1.15-1.47] and extremely obese patients (HR 1.33, 95% CI 1.02-1.74) had higher mortality. Normal weight [odds ratio (OR) 0.79, 95% CI 0.68-0.90] and extremely obese (OR 0.73, 95% CI 0.54-0.99) individuals also had lower odds of DAOH. Conclusion: Mild obesity is associated with lower long-term risk in older STEMI patients, while normal weight and extreme obesity are associated with worse outcomes. These findings highlight hazards faced by an increasing number of older individuals with normal weight or extreme obesity and cardiovascular disease.


Subject(s)
Obesity, Morbid/complications , Percutaneous Coronary Intervention , Registries , ST Elevation Myocardial Infarction/etiology , Aged , Aged, 80 and over , Body Mass Index , Female , Follow-Up Studies , Humans , Male , Obesity, Morbid/epidemiology , Risk Management , ST Elevation Myocardial Infarction/epidemiology , ST Elevation Myocardial Infarction/surgery , Survival Rate/trends , Time Factors , Treatment Outcome , United States/epidemiology
3.
Am J Cardiol ; 119(10): 1590-1595, 2017 05 15.
Article in English | MEDLINE | ID: mdl-28363354

ABSTRACT

Non-vitamin K antagonist oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the management of bleeding in contemporary, clinical use of NOACs. We aimed to assess the frequency, management, and outcomes of major bleeding in the setting of community use of NOACs. Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry, we analyzed rates of International Society on Thrombosis and Haemostasis major bleeding and subsequent outcomes in patients treated with NOACs versus warfarin. Outcomes of interest included acute and chronic bleeding management, recurrent bleeding, thromboembolic events, and death. In total, 344 patients with atrial fibrillation experienced major bleeding events over a median follow-up of 360 days follow-up: n = 273 on NOAC (3.3 per 100 patient-years) and n = 71 on warfarin (3.5 per 100 patient-years). Intracranial bleeding was uncommon but similar (0.34 per 100 patient-years for NOAC vs 0.44 for warfarin, p = 0.5), as was gastrointestinal bleeding (1.8 for NOAC vs 1.3 for warfarin, p = 0.1). Blood products and correction agents were less commonly used in NOAC patients with major bleeds compared with warfarin-treated patients (53% vs 76%, p = 0.0004 for blood products; 0% vs 1.5% for recombinant factor; p = 0.0499); no patients received pharmacologic hemostatic agents (aminocaproic acid, tranexamic acid, desmopressin, aprotinin). Within 30 days, 23 NOAC-treated patients (8.4%) died versus 5 (7.0%) on warfarin (p = 0.7). At follow-up, 126 NOAC-treated (46%) and 29 warfarin-treated patients (41%) were not receiving any anticoagulation. In conclusion, rates of major bleeding are similar in warfarin and NOAC-treated patients in clinical practice. However, NOAC-related bleeds require less blood product administration and rarely require factor replacement.


Subject(s)
Atrial Fibrillation/drug therapy , Blood Component Transfusion/methods , Disease Management , Hemorrhage/therapy , Stroke/prevention & control , Thromboembolism/prevention & control , Warfarin/administration & dosage , Administration, Oral , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Dose-Response Relationship, Drug , Female , Follow-Up Studies , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Hemostatic Techniques , Humans , Incidence , Male , Prognosis , Registries , Stroke/epidemiology , Stroke/etiology , Thromboembolism/epidemiology , Thromboembolism/etiology , Time Factors , United States/epidemiology , Vitamin K , Warfarin/adverse effects
4.
Am Heart J ; 182: 135-143, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27914493

ABSTRACT

BACKGROUND: As treatment options for atrial fibrillation (AF) increase, more attention is focused on patients' experiences and quality of life (QoL). However, little is known about the factors associated with these outcomes. METHODS: The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) is a disease-specific QoL tool for AF, with domain and summary scores ranging from 0 (the worst QoL) to 100. Using multivariable linear regression, we evaluated factors associated with baseline AFEQT Summary and Subscale Scores in ORBIT AF, a large, community-based AF registry. Independent associations were reported as coefficient estimates in scores and 95% confidence intervals (CI). RESULTS: Overall, AFEQT was assessed in 2007 AF outpatients from 99 sites. Median age (IQR) was 76 years (67-82) and 43% were female. The median AFEQT summary score was 82 (67-94). Female sex, younger age, new onset AF, higher heart rate, obstructive sleep apnea, symptomatic heart failure (HF), chronic obstructive pulmonary disease and coronary artery disease were all independently associated with reduced QoL. Female sex [Estimate -7.03, 95% CI (-9.31, -4.75)] and new onset versus permanent AF [Estimate -7.44, 95% CI (-11.03, -3.84)] were independently associated with increased symptoms. NYHA Class III or IV HF [Estimate -14.44, 95% CI (-19.46, -8.76)] and female sex [Estimate -7.91, 95% CI (-9.95, -5.88)] were most independently associated with impaired daily activities. CONCLUSIONS: QoL in patients with AF varies widely and is associated with several patient factors. Understanding patient factors independently associated with worse QoL can be a foundation for tailoring treatment.


Subject(s)
Activities of Daily Living , Atrial Fibrillation/psychology , Quality of Life , Age Factors , Aged , Atrial Fibrillation/epidemiology , Atrial Fibrillation/therapy , Comorbidity , Female , Humans , Karnofsky Performance Status , Longitudinal Studies , Male , Risk Assessment/methods , Risk Factors , Sex Factors , United States/epidemiology
6.
JAMA Cardiol ; 1(3): 282-91, 2016 06 01.
Article in English | MEDLINE | ID: mdl-27438106

ABSTRACT

IMPORTANCE: Despite the frequency of atrial fibrillation (AF) in clinical practice, relatively little is known about sex differences in symptoms and quality of life and how they may affect treatment and outcomes. OBJECTIVE: To determine whether symptoms, quality of life, treatment, and outcomes differ between women and men with AF. DESIGN, SETTING, AND PARTICIPANTS: This observational cohort study included 10 135 patients with AF. The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation is a prospective, nationwide, multicenter outpatient registry of patients with incident and prevalent AF enrolled at 176 sites between June 2010 and August 2011. MAIN OUTCOMES AND MEASURES: Symptoms, quality of life as measured by Atrial Fibrillation Effects on Quality of Life scores, AF treatment, cardiovascular outcomes, stroke or non-central nervous system embolism, and all-cause mortality. RESULTS: Overall, 4293 of the cohort (42%) were female. Compared with men, women were older (77 years; interquartile range [IQR], 69-83, vs 73 years; IQR, 65-80; P < .001) and had higher median CHA2DS2-VASc scores (5; IQR, 4-6, vs 3; IQR, 2-5; P < .001), but less sleep apnea (578 [13.5%] vs 1264 [21.6%]; P < .001). Only 32.1% of women (n = 1378) were asymptomatic (European Heart Rhythm Association class I) compared with 42.5% of men (n = 2483) in unadjusted analyses (P < .001). Women had lower (more severe) unadjusted baseline overall Atrial Fibrillation Effects on Quality of Life scores (n = 2007; 80; IQR, 62-92 vs 83; IQR, 69-94; P < .001). Women had similar rates of anticoagulation and similar time in therapeutic range. In follow-up, women experienced lower risk-adjusted all-cause mortality (adjusted hazard ratio, 0.57; 95% CI, 0.49-0.67) and cardiovascular death (adjusted hazard ratio, 0.56; 95% CI, 0.44-0.72); however, they had a higher risk for stroke or non-central nervous system embolism (adjusted hazard ratio, 1.39; 95% CI, 1.05-1.84; P = .02) compared with men. CONCLUSIONS AND RELEVANCE: Women with AF have more symptoms and worse quality of life. Despite higher risk, women have lower risk-adjusted all-cause and cardiovascular death compared with men, but higher stroke rates. Future studies should focus on how treatment and interventions specifically affect AF-related quality of life and cardiovascular outcomes in women. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01165710.


Subject(s)
Atrial Fibrillation/physiopathology , Aged , Aged, 80 and over , Atrial Fibrillation/mortality , Atrial Fibrillation/therapy , Female , Humans , Male , Prospective Studies , Quality of Life , Registries , Sex Factors , Treatment Outcome
7.
Circ Cardiovasc Qual Outcomes ; 9(3): 197-205, 2016 05.
Article in English | MEDLINE | ID: mdl-27166210

ABSTRACT

BACKGROUND: Current guidelines recommend surgical revascularization (coronary artery bypass graft [CABG]) over percutaneous coronary intervention (PCI) in patients with diabetes mellitus and multivessel coronary artery disease. Few data are available describing revascularization patterns among these patients in the setting of non-ST-segment-elevation myocardial infarction. METHODS AND RESULTS: Using Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines (ACTION Registry-GWTG), we compared the in-hospital use of different revascularization strategies (PCI versus CABG versus no revascularization) in diabetes mellitus patients with non-ST-segment-elevation myocardial infarction who had angiography, demonstrating multivessel coronary artery disease between July 2008 and December 2014. Factors associated with use of CABG versus PCI were identified using logistic multivariable regression analyses. A total of 29 769 patients from 539 hospitals were included in the study, of which 10 852 (36.4%) were treated with CABG, 13 760 (46.2%) were treated with PCI, and 5157 (17.3%) were treated without revascularization. The overall use of revascularization increased over the study period with an increase in the proportion undergoing PCI (45% to 48.9%; Ptrend=0.0002) and no change in the proportion undergoing CABG (36.1% to 34.7%; ptrend=0.88). There was significant variability between participating hospitals in the use of PCI and CABG (range: 22%-100%; 0%-78%, respectively; P value <0.0001 for both). Patient-level, but not hospital-level, characteristics were statistically associated with the use of PCI versus CABG, including anatomic severity of the disease, early treatment of adenosine diphosphate receptor antagonists at presentation, older age, female sex, and history of heart failure. CONCLUSIONS: Among patients with diabetes mellitus and multivessel coronary artery disease presenting with non-ST-segment-elevation myocardial infarction, only one third undergo CABG during the index admission. Furthermore, the use of PCI, but not CABG, increased modestly over the past 6 years.


Subject(s)
Coronary Artery Bypass/trends , Coronary Artery Disease/therapy , Diabetes Mellitus/epidemiology , Guideline Adherence/trends , Non-ST Elevated Myocardial Infarction/therapy , Percutaneous Coronary Intervention/trends , Practice Patterns, Physicians'/trends , Aged , Chi-Square Distribution , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/mortality , Coronary Artery Bypass/statistics & numerical data , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Diabetes Mellitus/diagnosis , Diabetes Mellitus/mortality , Female , Humans , Linear Models , Logistic Models , Male , Middle Aged , Multivariate Analysis , Non-ST Elevated Myocardial Infarction/diagnostic imaging , Non-ST Elevated Myocardial Infarction/mortality , Patient Admission/trends , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Percutaneous Coronary Intervention/statistics & numerical data , Practice Guidelines as Topic , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States
8.
Am Heart J ; 174: 29-36, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26995367

ABSTRACT

BACKGROUND: Significant racial/ethnic differences exist in the incidence of atrial fibrillation (AF). However, less is known about racial/ethnic differences in quality of life (QoL), treatment, and outcomes associated with AF. METHODS: Using data from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation, we compared clinical characteristics, QoL, management strategies, and long-term outcomes associated with AF among various racial/ethnic groups. RESULTS: We analyzed 9,542 participants with AF (mean age 74 ± 11 years, 43% women, 91% white, 5% black, 4% Hispanic) from 174 centers. Compared with AF patients identified as white race, patients identified as Hispanic ethnicity and those identified as black race were younger, were more often women, and had more cardiac and noncardiac comorbidities. Black patients were more symptomatic with worse QoL and were less likely to be treated with a rhythm control strategy than other racial/ethnic groups. There were no significant racial/ethnic differences in CHA2DS2-VASc stroke or ATRIA bleeding risk scores and rates of oral anticoagulation use were similar. However, racial and ethnic minority populations treated with warfarin spent a lower median time in therapeutic range of international normalized ratio (59% blacks vs 68% whites vs 62% Hispanics, P < .0001). There was no difference in long-term outcomes associated with AF between the 3 groups at a median follow-up of 2.1 years. CONCLUSION: Relative to white and Hispanic patients, black patients with AF had more symptoms, were less likely to receive rhythm control interventions, and had lower quality of warfarin management. Despite these differences, clinical events at 2 years were similar by race and ethnicity.


Subject(s)
Atrial Fibrillation/ethnology , Cardiac Resynchronization Therapy/methods , Disease Management , Ethnicity , Quality of Life , Racial Groups , Registries , Aged , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/therapy , Embolism/ethnology , Embolism/etiology , Female , Follow-Up Studies , Humans , Incidence , Male , Prognosis , Stroke/ethnology , Stroke/etiology , Survival Rate/trends , Time Factors , United States/epidemiology
9.
Am J Med ; 129(6): 592-599.e1, 2016 06.
Article in English | MEDLINE | ID: mdl-26797080

ABSTRACT

BACKGROUND: The role of triple antithrombotic therapy vs dual antithrombotic therapy in patients with both atrial fibrillation and coronary artery disease remains unclear. This study explores the differences in treatment practices and outcomes between triple antithrombotic therapy and dual antithrombotic therapy in patients with atrial fibrillation and coronary artery disease. METHODS: Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (n = 10,135), we analyzed outcomes in patients with coronary artery disease (n = 1827) according to treatment with triple antithrombotic therapy (defined as concurrent therapy with an oral anticoagulant, a thienopyridine, and aspirin) or dual antithrombotic therapy (comprising either an oral anticoagulant and one antiplatelet agent [OAC plus AA] or 2 antiplatelet drugs and no anticoagulant [DAP]). RESULTS: The use of triple antithrombotic therapy, OAC plus AA, and DAP at baseline was 8.5% (n = 155), 80.4% (n = 1468), and 11.2% (n = 204), respectively. Among patients treated with OAC plus AA, aspirin was the most common antiplatelet agent used (90%), followed by clopidogrel (10%) and prasugrel (0.1%). The use of triple antithrombotic therapy was not affected by patient risk of either stroke or bleeding. Patients treated with triple antithrombotic therapy at baseline were hospitalized for all causes (including cardiovascular) more often than patients on OAC plus AA (adjusted hazard ratio 1.75; 95% confidence interval, 1.35-2.26; P <.0001) or DAP (hazard ratio 1.82; 95% confidence interval, 1.25-2.65; P = .0018). Rates of major bleeding or a combined cardiovascular outcome were not significantly different by treatment group. CONCLUSIONS: Choice of antithrombotic therapy in patients with atrial fibrillation and coronary artery disease was not affected by patient stroke or bleeding risks. Triple antithrombotic therapy-treated patients were more likely to be hospitalized for all causes than those on OAC plus AA or on DAP.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Coronary Artery Disease/drug therapy , Fibrinolytic Agents/administration & dosage , Myocardial Infarction/prevention & control , Outcome and Process Assessment, Health Care/statistics & numerical data , Platelet Aggregation Inhibitors/administration & dosage , Stroke/prevention & control , Administration, Oral , Aged , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Aspirin/administration & dosage , Aspirin/adverse effects , Aspirin/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/epidemiology , Clopidogrel , Comorbidity , Coronary Artery Disease/complications , Coronary Artery Disease/epidemiology , Drug Therapy, Combination/adverse effects , Drug Therapy, Combination/methods , Drug Therapy, Combination/statistics & numerical data , Female , Fibrinolytic Agents/therapeutic use , Hospitalization/statistics & numerical data , Humans , Male , Markov Chains , Monte Carlo Method , Myocardial Infarction/etiology , Percutaneous Coronary Intervention/statistics & numerical data , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Proportional Hazards Models , Pyridines/administration & dosage , Pyridines/adverse effects , Pyridines/therapeutic use , Registries , Stroke/etiology , Ticlopidine/administration & dosage , Ticlopidine/analogs & derivatives , Ticlopidine/therapeutic use , Warfarin/administration & dosage , Warfarin/therapeutic use
10.
Circ Cardiovasc Qual Outcomes ; 8(6): 576-85, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26487739

ABSTRACT

BACKGROUND: In 2009, national legislation promoted wide-spread adoption of electronic health records (EHRs) across US hospitals; however, the association of EHR use with quality of care and outcomes after acute myocardial infarction (AMI) remains unclear. METHODS AND RESULTS: Data on EHR use were collected from the American Hospital Association Annual Surveys (2007-2010) and data on AMI care and outcomes from the National Cardiovascular Data Registry Acute Coronary Treatment and Interventions Outcomes Network Registry-Get With The Guidelines. Comparisons were made between patients treated at hospitals with fully implemented EHR (n=43 527), partially implemented EHR (n=72 029), and no EHR (n=9270). Overall EHR use increased from 82.1% (183/223) hospitals in 2007 to 99.3% (275/277) hospitals in 2010. Patients treated at hospitals with fully implemented EHRs had fewer heparin overdosing errors (45.7% versus 72.8%; P<0.01) and a higher likelihood of guideline-recommended care (adjusted odds ratio, 1.40 [confidence interval, 1.07-1.84]) compared with patients treated at hospitals with no EHR. In non-ST-segment-elevation AMI, fully implemented EHR use was associated with lower risk of major bleeding (adjusted odds ratio, 0.78 [confidence interval, 0.67-0.91]) and mortality (adjusted odds ratio, 0.82 [confidence interval, 0.69-0.97]) compared with no EHR. In ST-segment-elevation MI, outcomes did not significantly differ by EHR status. CONCLUSIONS: EHR use has risen to high levels among hospitals in the National Cardiovascular Data Registry. EHR use was associated with less frequent heparin overdosing and modestly greater adherence to acute MI guideline-recommended therapies. In non-ST-segment-elevation MI, slightly lower adjusted risk of major bleeding and mortality were seen in hospitals implemented with full EHRs; however, in ST-segment-elevation MI, differences in outcomes were not seen.


Subject(s)
Delivery of Health Care , Electronic Health Records/statistics & numerical data , Hospitals , Myocardial Infarction/therapy , Process Assessment, Health Care , Quality Improvement , Quality Indicators, Health Care , Aged , Anticoagulants/adverse effects , Delivery of Health Care/standards , Drug Overdose/prevention & control , Electronic Health Records/standards , Female , Guideline Adherence , Health Care Surveys , Heparin/adverse effects , Hospitals/standards , Humans , Logistic Models , Male , Medication Errors/prevention & control , Middle Aged , Multivariate Analysis , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Odds Ratio , Practice Guidelines as Topic , Process Assessment, Health Care/standards , Quality Improvement/standards , Quality Indicators, Health Care/standards , Registries , Treatment Outcome , United States/epidemiology
11.
Eur Heart J ; 36(46): 3258-64, 2015 Dec 07.
Article in English | MEDLINE | ID: mdl-26424865

ABSTRACT

BACKGROUND: Therapeutic decisions in atrial fibrillation (AF) are often influenced by assessment of bleeding risk. However, existing bleeding risk scores have limitations. OBJECTIVES: We sought to develop and validate a novel bleeding risk score using routinely available clinical information to predict major bleeding in a large, community-based AF population. METHODS: We analysed data from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), a prospective registry that enrolled incident and prevalent AF patients at 176 US sites. Using Cox proportional hazards regression, we identified factors independently associated with major bleeding among patients taking oral anticoagulation (OAC) over a median follow-up of 2 years (interquartile range = 1.6-2.5). We also created a numerical bedside risk score that included the five most predictive risk factors weighted according to their strength of association with major bleeding. The predictive performance of the full model, the simple five-item score, and two existing risk scores (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drugs/alcohol concomitantly, HAS-BLED, and anticoagulation and risk factors in atrial fibrillation, ATRIA) were then assessed in both the ORBIT-AF cohort and a separate clinical trial population, Rivaroxaban Once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET-AF). RESULTS: Among 7411 ORBIT-AF patients taking OAC, the rate of major bleeding was 4.0/100 person-years. The full continuous model (12 variables) and five-factor ORBIT risk score (older age [75+ years], reduced haemoglobin/haematocrit/history of anaemia, bleeding history, insufficient kidney function, and treatment with antiplatelet) both had good ability to identify those who bled vs. not (C-index 0.69 and 0.67, respectively). These scores both had similar discrimination, but markedly better calibration when compared with the HAS-BLED and ATRIA scores in an external validation population from the ROCKET-AF trial. CONCLUSIONS: The five-element ORBIT bleeding risk score had better ability to predict major bleeding in AF patients when compared with HAS-BLED and ATRIA risk scores. The ORBIT risk score can provide a simple, easily remembered tool to support clinical decision making.


Subject(s)
Anticoagulants/adverse effects , Atrial Fibrillation/drug therapy , Hemorrhage/chemically induced , Point-of-Care Systems , Aged , Aged, 80 and over , Female , Hemorrhage/prevention & control , Humans , Male , Middle Aged , Prospective Studies , Registries , Risk Assessment/methods , Risk Factors , Stroke/prevention & control
12.
J Am Coll Cardiol ; 65(25): 2691-8, 2015 Jun 30.
Article in English | MEDLINE | ID: mdl-26112191

ABSTRACT

BACKGROUND: Although digoxin has long been used to treat atrial fibrillation (AF) and heart failure (HF), its safety remains controversial. OBJECTIVES: This study sought to describe digoxin use over time in patients with AF who were stratified by the presence or absence of HF, to characterize the predictors of digoxin use and initiation, and to correlate digoxin use with outcomes. METHODS: Longitudinal patterns of digoxin use and its association with a variety of outcomes were assessed in a prospective outpatient registry conducted at 174 U.S. sites with enrollment from June 2010 to August 2011. RESULTS: Among 9,619 patients with AF and serial follow-up every 6 months for up to 3 years, 2,267 (23.6%) received digoxin at study enrollment, 681 (7.1%) were initiated on digoxin during follow-up, and 6,671 (69.4%) were never prescribed digoxin. After adjusting for other medications, heart rate was 72.9 beats/min among digoxin users and 71.5 beats/min among nonusers (p < 0.0001). Prevalent digoxin use at registry enrollment was not associated with subsequent onset of symptoms, hospitalization, or mortality (in patients with HF, adjusted hazard ratio [HR] for death: 1.04; without HF, HR: 1.22). Incident digoxin use during follow-up was not associated with subsequent death in patients with HF (propensity adjusted HR: 1.05), but was associated with subsequent death in those without HF (propensity adjusted HR: 1.99). CONCLUSIONS: After adjustment for detailed clinical factors, digoxin use in registry patients with AF had a neutral association with outcomes under most circumstances. Because of the multiple conflicting observational reports about digoxin's safety and possible concerns in specific clinical situations, a large pragmatic trial of digoxin therapy in AF is needed.


Subject(s)
Atrial Fibrillation/drug therapy , Digoxin/therapeutic use , Aged , Aged, 80 and over , Digoxin/adverse effects , Female , Heart Failure/complications , Heart Rate/drug effects , Humans , Male , Prospective Studies , Quality of Life , Registries , Time Factors , Treatment Outcome
13.
Am Heart J ; 170(1): 141-8, 148.e1, 2015 Jul.
Article in English | MEDLINE | ID: mdl-26093875

ABSTRACT

BACKGROUND: Time in therapeutic range (TTR) of international normalized ratio (INR) of 2.0 to 3.0 is important for the safety and effectiveness of warfarin anticoagulation. There are few data on TTR among patients with atrial fibrillation (AF) in community-based clinical practice. METHODS: Using the US Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), we examined TTR (using a modified Rosendaal method) among 5,210 patients with AF on warfarin and treated at 155 sites. Patients were grouped into quartiles based on TTR data. Multivariable logistic regression modeling with generalized estimating equations was used to determine patient and provider factors associated with the lowest (worst) TTR. RESULTS: Overall, 59% of the measured INR values were between 2.0 and 3.0, with an overall mean and median TTR of 65% ± 20% and 68% (interquartile range [IQR] 53%-79%). The median times below and above the therapeutic range were 17% (IQR 8%-29%) and 10% (IQR 3%-19%), respectively. Patients with renal dysfunction, advanced heart failure, frailty, prior valve surgery, and higher risk for bleeding (ATRIA score) or stroke (CHA2DS2-VASc score) had significantly lower TTR (P < .0001 for all). Patients treated at anticoagulation clinics had only slightly higher median TTR (69%) than those not (66%) (P < .0001). CONCLUSIONS: Among patients with AF in US clinical practices, TTR on warfarin is suboptimal, and those at highest predicted risks for stroke and bleeding were least likely to be in therapeutic range.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , International Normalized Ratio , Registries , Stroke/prevention & control , Warfarin/therapeutic use , Aged , Aged, 80 and over , Atrial Fibrillation/complications , Atrial Fibrillation/epidemiology , Female , Frail Elderly , Heart Failure/epidemiology , Heart Valve Prosthesis Implantation/statistics & numerical data , Hemorrhage/epidemiology , Humans , Logistic Models , Male , Middle Aged , Renal Insufficiency, Chronic/epidemiology , Risk Factors , Stroke/etiology , Time Factors , Treatment Outcome , United States
14.
Circ Cardiovasc Qual Outcomes ; 8(4): 393-402, 2015 Jul.
Article in English | MEDLINE | ID: mdl-26058720

ABSTRACT

BACKGROUND: Instruments to assess symptom burden and quality of life among patients with atrial fibrillation (AF) have not been well evaluated in community practice or associated with patient outcomes. METHODS AND RESULTS: Using data from 10 087 AF patients in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF), symptom severity was evaluated using the European Heart Rhythm Association (EHRA) classification system, and quality of life was assessed using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire. The association between AF-related symptoms, quality of life, and outcomes was assessed using Cox regression. The majority of AF patients (61.8%) were symptomatic (EHRA >2) and 16.5% had severe or disabling symptoms (EHRA 3-4). EHRA symptom class was well correlated with the AFEQT score (Spearman correlation coefficient -0.39). Over 1.8 years of follow-up, AF symptoms were associated with a higher risk of hospitalization (adjusted hazard ratio for EHRA ≥2 versus EHRA 1 1.23, 95% confidence interval, 1.15-1.31) and a borderline higher risk of major bleeding. Lower quality of life was associated with a higher risk of hospitalization (adjusted hazard ratio for lowest quartile of AFEQT versus highest 1.49, 95% confidence interval, 1.2-1.84), but not other major adverse events, including death. CONCLUSIONS: In a community-based study, most patients with AF were symptomatic and had impaired quality of life. Quality of life measured by the AFEQT correlated closely with symptom severity measured by the EHRA class. AF symptoms and lower quality of life were associated with higher risk of hospitalization but not mortality during follow-up.


Subject(s)
Atrial Fibrillation/psychology , Hospitalization/trends , Outpatients/psychology , Quality of Life , Registries , Aged , Aged, 80 and over , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Electrocardiography , Female , Follow-Up Studies , Humans , Male , Prognosis , Prospective Studies , Severity of Illness Index , Surveys and Questionnaires
15.
Am J Cardiol ; 115(12): 1655-60, 2015 Jun 15.
Article in English | MEDLINE | ID: mdl-25888303

ABSTRACT

Elevated low-density lipoprotein cholesterol (LDL-C) is associated with increased risk of myocardial infarction and is a target for disease prevention. The association between initial LDL-C and statin treatment in patients with non-ST-segment elevation myocardial infarction (NSTEMI)/unstable angina pectoris (UAP) has not been well characterized. We explored detailed LDL-C levels and statin treatment in 22,938 patients with NSTEMI/UAP enrolled in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines Registry (2003 to 2006). Patients reporting home statin use or previous cardiovascular disease were excluded. We examined statin receipt at discharge across 4 categories of baseline LDL-C: very low (<70 mg/dl), low (70 to 99 mg/dl), high (100 to 129 mg/dl), and very high (≥130 mg/dl). The largest proportion of patients had LDL-C ≥130 mg/dl (32.6%), followed by LDL-C 100 to 129 mg/dl (32.1%), LDL-C 70 to 99 mg/dl (24.9%), and LDL-C <70 mg/dl (10.4%). Compared with high LDL-C categories, patients in the lowest LDL-C category had their first NSTEMI/UAP event at a significantly older age and had higher rates of other cardiovascular risk factors (including hypertension and diabetes) but were less likely to have a family history of coronary artery disease. Overall, 80.3% of eligible patients with NSTEMI/UAP received statins at discharge, ranging from 63.8% in those with very low LDL-C (<70 mg/dl) to 88.1% in those with very high LDL-C (>130 mg/dl). In conclusion, >1/3 of patients with NSTEMI/UAP had an LDL-C level <100. Those with low LDL-C were older, had more co-morbidities, and were less likely to be prescribed a statin at discharge than those with higher LDL-C.


Subject(s)
Angina, Unstable/blood , Angina, Unstable/drug therapy , Cholesterol, LDL/blood , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Myocardial Infarction/blood , Myocardial Infarction/drug therapy , Aged , Comorbidity , Female , Humans , Male , Middle Aged , Registries , Risk Factors , Treatment Outcome , United States
16.
Am Heart J ; 168(4): 487-94, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25262258

ABSTRACT

BACKGROUND: Warfarin reduces thromboembolic risks in atrial fibrillation (AF), but therapeutic durability remains a concern. METHODS: We used clinical data from ORBIT-AF, a nationwide outpatient AF registry conducted at 176 sites with follow-up data at 6 and 12 months, to examine longitudinal patterns of warfarin discontinuation. We estimated associations between patient and provider characteristics and report of any warfarin discontinuation using discrete time proportional odds models. RESULTS: Of 10,132 AF patients enrolled in ORBIT-AF from June 2010 to August 2011, 6,110 (60.3%) were prescribed warfarin, had follow-up data, and were not switched to an alternative oral anticoagulant enrolled from June 2010 to August 2011. Over 1 year, 617 patients (10.1% of baseline warfarin users) discontinued warfarin therapy. Among incident warfarin users (starting therapy within 1 year of baseline survey), warfarin discontinuation rates rose to 17.1%. The most commonly reported reasons for warfarin discontinuation were physician preference (47.7%), patient refusal/preference (21.1%), bleeding event (20.2%), frequent falls/frailty (10.8%), high bleeding risk (9.8%), and patient inability to adhere to/monitor therapy (4.7%). In multivariable analysis, the factors most strongly associated with warfarin discontinuation were bleeding hospitalization during follow-up (odds ratio 10.91, 95% CI 7.91-15.03), prior catheter ablation (1.83, 1.37-2.45), noncardiovascular/nonbleeding hospitalization (1.77, 1.40-2.24), cardiovascular hospitalization (1.64, 1.33-2.03), and permanent AF (0.25, 0.17-0.36). CONCLUSIONS: Discontinuation of warfarin is common among patients with AF, particularly among incident users. Warfarin is most commonly discontinued because of physician preference, patient refusal, and bleeding events.


Subject(s)
Atrial Fibrillation/therapy , Registries , Thromboembolism/prevention & control , Warfarin/therapeutic use , Withholding Treatment , Aged , Aged, 80 and over , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Catheter Ablation , Female , Follow-Up Studies , Hospitalization/statistics & numerical data , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Risk Factors , Thromboembolism/epidemiology , Thromboembolism/etiology , Treatment Outcome
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