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1.
Cardiovasc Ther ; 36(5): e12458, 2018 Oct.
Article in English | MEDLINE | ID: mdl-30007110

ABSTRACT

BACKGROUND: Intracranial hemorrhage (ICH) is the most fearful side effect of oral anticoagulant therapy. It is still unclear which risk factor is involved in ICH during vitamin K antagonists (VKAs) treatment and if commonly used bleeding risk scores are able to predict ICH. PURPOSE: Search for individual risk factors and bleeding risk scores (HAS-BLED, ATRIA and ORBIT) associated with ICHs in patients with atrial fibrillation treated with VKAs. METHODS: This is a retrospective case-control study in a single Thrombosis Center. During a 7-year period, patients with nonvalvular atrial fibrillation (NVAF) who developed ICH during VKAs were identified as cases. Four control patients matched for gender, age and length of VKAs were assigned to each case. The association between considered risk factors and ICHs was evaluated using a linear logistic regression method and expressed as odds ratio. Receiver operator characteristic (ROC) curves to assess the predictive ability of bleeding risk scores HAS-BLED, ATRIA and ORBIT were also evaluated. RESULTS: Fifty-one cases of ICH, most of whom were 80 years of age or older (72.5%), were retrieved from the Thrombosis Center's database. Compared to 204 controls, no individual risk factors were associated with ICH. Poor ability to predict ICH was also found using ROC curves (C-statistic for HAS-BLED, ATRIA, and ORBIT were 0.55, 0.53 and 0.54, respectively). CONCLUSIONS: ICHs during VKA therapy preferentially occur in very elderly patients. The risk of ICH is not predicted by the commonly used risk scores.


Subject(s)
Anticoagulants/adverse effects , Atrial Fibrillation/drug therapy , Intracranial Hemorrhages/chemically induced , Vitamin K/antagonists & inhibitors , Administration, Oral , Age Factors , Aged , Aged, 80 and over , Anticoagulants/administration & dosage , Atrial Fibrillation/diagnosis , Female , Humans , Intracranial Hemorrhages/diagnostic imaging , Italy , Male , Retrospective Studies , Risk Assessment , Risk Factors , Treatment Outcome
3.
Cardiovasc Ther ; 36(1)2018 Feb.
Article in English | MEDLINE | ID: mdl-29078033

ABSTRACT

INTRODUCTION: The issue of anticoagulation in individuals with nonvalvular atrial fibrillation (NVAF) and 1 non-gender-related (NGR) risk factor is subject to debate. The reported risk of stroke in untreated individuals is not uniform, and the rate of hemorrhage associated with anticoagulation in this group of individuals is not well defined. To this end, we assessed the rate of stroke and major hemorrhage in individuals treated with warfarin. MATERIALS AND METHODS: individuals were extracted from the START register, an observational, multicenter, dynamic inception cohort study that collects data on NVAF individuals starting anticoagulation therapy. Risk of stroke is stratified using the CHA2 DS2 VASc score upon entry into the registry. RESULTS: Overall, 431 individuals with 1 NGR risk factor were followed up for 604 person-years. One nonfatal ischemic stroke was recorded (0.17 per 100 person-years) during follow-up. On the other hand, there were 9 major bleeding events (1.49 per 100 person-years), with 4 being intracranial hemorrhage (0.66 per 100 person-years), 1 of which was fatal. No difference in patient characteristics, bleeding risk factors, and quality of treatment were found between individuals who bled versus those who did not. However, a trend toward more bleeding events was observed in individuals <65 years old. CONCLUSION: We found an elevated risk of major bleeding and intracranial hemorrhage in NVAF individuals treated with warfarin with 1 NGR risk factor for stroke. These data call for caution when treating with warfarin these individuals.


Subject(s)
Anticoagulants/adverse effects , Atrial Fibrillation/drug therapy , Blood Coagulation/drug effects , Decision Support Techniques , Hemorrhage/chemically induced , Stroke/prevention & control , Warfarin/adverse effects , Aged , Atrial Fibrillation/blood , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Drug Prescriptions , Female , Humans , Intracranial Hemorrhages/chemically induced , Male , Middle Aged , Predictive Value of Tests , Registries , Risk Assessment , Risk Factors , Stroke/blood , Stroke/diagnosis , Stroke/etiology , Time Factors , Treatment Outcome
4.
Int J Cardiol ; 249: 198-203, 2017 Dec 15.
Article in English | MEDLINE | ID: mdl-28935464

ABSTRACT

BACKGROUND: The global real-life impact of non-vitamin K antagonist oral anticoagulants (NOACs) introduction in the healthcare system in a setting of well-managed vitamin K antagonist (VKA) therapy has not been specifically addressed. METHODS: We did a population-based retrospective cohort study in naïve patients initiating oral anticoagulants for stroke prevention in atrial fibrillation in a region with a well-managed VKA therapy. NOAC and VKA cohorts were identified using Anatomical Therapeutic Chemical (ATC) codes, while excluding other indications for anticoagulation therapy using ICD-9CM codes. Propensity score was conducted using two different approaches: stratification and 1:1 matching. Event-rates were assessed using both an intention to treat (ITT) and as treated analyses. RESULTS: Of the 137,800 selected patients, 40,411 (6923 treated with NOACs and 33,488 with VKAs) were identified (June 2013-December 2015). Overall ischaemic stroke and major bleeding risk did not significantly differ between the groups both in the ITT and as treated analyses. Noteworthy, intracranial bleeding risk was lower with NOACs (stratified model HR=0.69; 95%CI 0.48-0.99; 1:1 matched model HR=0.73; 95%CI 0.47-1.13) reaching statistical significance in the as treated analysis in both stratified and 1:1 matched models (HR=0.51; 95%CI 0.32-0.80 and HR=0.52; 95%CI 0.30-0.90, respectively). CONCLUSION: Despite well-managed anticoagulation with VKAs, NOACs' introduction has a positive global impact in the public healthcare system in terms of effectiveness and safety especially by lowering intracranial bleeding.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Disease Management , Propensity Score , Vitamin K/antagonists & inhibitors , Administration, Oral , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Atrial Fibrillation/physiopathology , Cohort Studies , Female , Hemorrhage/chemically induced , Hemorrhage/diagnosis , Hemorrhage/prevention & control , Humans , Male , Middle Aged , Retrospective Studies , Treatment Outcome
7.
PLoS One ; 10(12): e0145318, 2015.
Article in English | MEDLINE | ID: mdl-26710337

ABSTRACT

UNLABELLED: Genotype-guided warfarin dosing have been proposed to improve patient's management. This study is aimed to determine whether a CYP2C9- VKORC1- CYP4F2-based pharmacogenetic algorithm is superior to a standard, clinically adopted, pharmacodynamic method. Two-hundred naïve patients with non-valvular atrial fibrillation were randomized to trial arms and 180 completed the study. No significant differences were found in the number of out-of-range INRs (INR<2.0 or >3.0) (p = 0.79) and in the mean percentage of time spent in the therapeutic range (TTR) after 19 days in the pharmacogenetic (51.9%) and in the control arm (53.2%, p = 0.71). The percentage of time spent at INR>4.0 was significantly lower in the pharmacogenetic (0.7%) than in the control arm (1.8%) (p = 0.02). Genotype-guided warfarin dosing is not superior in overall anticoagulation control when compared to accurate clinical standard of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01178034.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Drug Monitoring/methods , Warfarin/pharmacokinetics , Adult , Aged , Aged, 80 and over , Algorithms , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Cytochrome P-450 CYP2C9/metabolism , Cytochrome P-450 Enzyme System/metabolism , Cytochrome P450 Family 4 , Female , Humans , International Normalized Ratio/methods , Male , Middle Aged , Pharmacogenetics/methods , Polymorphism, Single Nucleotide , Stroke/prevention & control , Treatment Outcome , Vitamin K Epoxide Reductases/metabolism , Warfarin/adverse effects , Warfarin/therapeutic use
8.
Expert Opin Drug Saf ; 14(5): 683-95, 2015 May.
Article in English | MEDLINE | ID: mdl-25803739

ABSTRACT

INTRODUCTION: Oral anticoagulation (OAC) is given for ischemic stroke prevention in patients with nonvalvular atrial fibrillation. OAC's most serious complications are major bleeding and, in particular, hemorrhagic stroke. Together with vitamin K antagonists (VKAs), direct oral anticoagulants (DOAC) are now available which have a more rapid onset/offset of action and more predictable anticoagulant effect. The advent of DOAC has given to the clinician an opportunity to tailor OAC therapy in order to maximize advantages and minimize complications. AREAS COVERED: This review covers data published in literature regarding the risk of hemorrhagic stroke in patients taking OAC. Bleeding risk assessment is discussed and different bleeding risk factors are presented. The paper will also review clinical studies comparing DOAC against standard anticoagulation, in regard to the risk of hemorrhagic stroke. EXPERT OPINION: Bleeding assessment is mandatory in order to select patients at high hemorrhagic risk who will benefit the most from close monitoring. Blood pressure, alcohol intake, concomitant medication and comorbidities should be constantly evaluated and treated accordingly. During VKA therapy, adherence and intensity of anticoagulation must be strictly monitored. DOAC are associated with lower risk of hemorrhagic stroke than VKA. However, periodic hepatic and renal checks as well as careful evaluation of time adherence are necessary to reduce the risk of bleeding.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Stroke/chemically induced , Administration, Oral , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Drug Monitoring/methods , Hemorrhage/chemically induced , Hemorrhage/prevention & control , Humans , Intracranial Hemorrhages/chemically induced , Intracranial Hemorrhages/prevention & control , Medication Adherence , Risk Assessment , Risk Factors , Stroke/prevention & control
9.
Rev. esp. cardiol. (Ed. impr.) ; 67(8): 651-658, ago. 2014. ilus, tab
Article in Spanish | IBECS | ID: ibc-125425

ABSTRACT

Introducción y objetivos La ecocardiografía con speckle tracking bidimensional es un nuevo instrumento para evaluar la función del miocardio. El objetivo de este estudio fue evaluar los parámetros de rotación ystrain del ventrículo izquierdo mediante la ecocardiografía con speckle tracking bidimensional en un gran grupo de adultos sanos de una amplia gama de edades, con objeto de establecer los valores de referencia de dichos parámetros y determinar la influencia de la edad, el sexo y los factores hemodinámicos.MétodosSe realizaron ecocardiografías transtorácicas a 247 voluntarios sanos (139 mujeres; media de edad, 44 ± 16 [intervalo, 18-80] años). Efectuamos determinaciones de los valores de strainsistólico máximo longitudinal, circunferencial y radial, así como de la rotación y el giro del ventrículo izquierdo.ResultadosLos valores medios de strain total longitudinal, radial y circunferencial fueron -21,5% ± 2,0%, 40,1 ± 11,8% y -22,2 ± 3,4%, respectivamente. El strain longitudinal fue significativamente más negativo en las mujeres, mientras que el strain radial y el circunferencial y los parámetros rotacionales fueron similares en ambos sexos. En consecuencia, los límites inferiores de la normalidad para los componentes del strain fueron -16,9% en los varones y -18,5% en las mujeres para el strain longitudinal, -15,4% para el strain circunferencial y 24,6% para el strain radial, con independencia del sexo. Los valores de strain longitudinal fueron más negativos en la base que en los segmentos apicales. Los valores medios de la rotación fueron–6,9 ± 3,5° en la base, 13,0 ± 6,5° para la rotación apical y 20,0 ± 7,3° para el giro neto. Conclusiones Presentamos una evaluación detallada de la deformación normal del miocardio y la mecánica rotacional en una cohorte amplia de voluntarios sanos. Observamos que las mujeres presentan un strain longitudinal más negativo, lo cual explica su mayor fracción de eyección del ventrículo izquierdo. La disponibilidad de valores de referencia de esos parámetros puede facilitar su aplicación en la práctica clínica habitual


Introduction and objectives Two-dimensional speckle-tracking echocardiography is a novel tool to assess myocardial function. The purpose of this study was to evaluate left ventricular myocardial strain and rotation parameters by two-dimensional speckle-tracking echocardiography in a large group of healthy adults across a wide age range to establish their reference values and to assess the influence of age, sex, and hemodynamic factors.MethodsTransthoracic echocardiograms were acquired in 247 healthy volunteers (139 women, 44 years [standard deviation, 16 years old] (range, 18-80 years). We measured longitudinal, circumferential, and radial peak systolic strain values, and left ventricular rotation and twist.ResultsAverage values of global longitudinal, radial, and circumferential strain were -21.5% (standard deviation, 2.0%), 40.1% (standard deviation, 11.8%) and -22.2% (standard deviation, 3.4%), respectively. Longitudinal strain was significantly more negative in women, whereas radial and circumferential strain and rotational parameters were similar in both sexes. Accordingly, lower limits of normality for the strain components were -16.9% in men and -18.5% in women for longitudinal strain, and -15.4% for circumferential and 24.6% for radial strain, irrespective of sex. Longitudinal strain values were more negative at the base than at apical segments. Mean rotational values were -6.9° (standard deviation, 3.5°) for the base, 13.0° (standard deviation, 6.5°) for apical rotation, and 20.0° (standard deviation, 7.3°) for net twist. Conclusions: We report the comprehensive assessment of normal myocardial deformation and rotational mechanics in a large cohort of healthy volunteers. We found that women have more negative longitudinal strain, accounting for their higher left ventricular ejection fraction. Availability of reference values for these parameters may foster their implementation in the clinical routine


Subject(s)
Humans , Male , Female , Adult , Ventricular Function, Left/physiology , Echocardiography, Doppler/methods , Heart/physiology , Reference Values , Age and Sex Distribution , Heart/anatomy & histology
10.
Rev Esp Cardiol (Engl Ed) ; 67(8): 651-8, 2014 Aug.
Article in English | MEDLINE | ID: mdl-25037544

ABSTRACT

INTRODUCTION AND OBJECTIVES: Two-dimensional speckle-tracking echocardiography is a novel tool to assess myocardial function. The purpose of this study was to evaluate left ventricular myocardial strain and rotation parameters by two-dimensional speckle-tracking echocardiography in a large group of healthy adults across a wide age range to establish their reference values and to assess the influence of age, sex, and hemodynamic factors. METHODS: Transthoracic echocardiograms were acquired in 247 healthy volunteers (139 women, 44 years [standard deviation, 16 years old] (range, 18-80 years). We measured longitudinal, circumferential, and radial peak systolic strain values, and left ventricular rotation and twist. RESULTS: Average values of global longitudinal, radial, and circumferential strain were -21.5% (standard deviation, 2.0%), 40.1% (standard deviation, 11.8%) and -22.2% (standard deviation, 3.4%), respectively. Longitudinal strain was significantly more negative in women, whereas radial and circumferential strain and rotational parameters were similar in both sexes. Accordingly, lower limits of normality for the strain components were -16.9% in men and -18.5% in women for longitudinal strain, and -15.4% for circumferential and 24.6% for radial strain, irrespective of sex. Longitudinal strain values were more negative at the base than at apical segments. Mean rotational values were -6.9° (standard deviation, 3.5°) for the base, 13.0° (standard deviation, 6.5°) for apical rotation, and 20.0° (standard deviation, 7.3°) for net twist. CONCLUSIONS: We report the comprehensive assessment of normal myocardial deformation and rotational mechanics in a large cohort of healthy volunteers. We found that women have more negative longitudinal strain, accounting for their higher left ventricular ejection fraction. Availability of reference values for these parameters may foster their implementation in the clinical routine.


Subject(s)
Echocardiography/methods , Heart Ventricles/diagnostic imaging , Ventricular Function, Left/physiology , Adolescent , Adult , Aged , Aged, 80 and over , Female , Healthy Volunteers , Humans , Male , Middle Aged , Reference Values , Young Adult
11.
J Am Soc Echocardiogr ; 27(8): 858-871.e1, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24975996

ABSTRACT

BACKGROUND: Despite growing interest in applying three-dimensional (3D) speckle-tracking echocardiography (STE) to measure left ventricular (LV) myocardial deformation in various diseases, normative values for 3D speckle-tracking echocardiographic parameters and the effects of demographic, hemodynamic, and technical factors on these values are unknown. METHODS: In 265 healthy volunteers (age range, 18-76; 57% women), longitudinal strain (3DLε), circumferential strain (3DCε), radial strain (3DRε), and area strain (3DAε) were measured by using vendor-specific (Vsp) 3D speckle-tracking echocardiographic equipment. LV strain was also measured by using Vsp two-dimensional (2D) and vendor-independent 3D speckle-tracking echocardiographic software packages, for comparison. RESULTS: Reference values (lower limit of normality) for Vsp 3D STE were -17% to -21% (-15%) for 3DLε, -17% to -20% (-14%) for 3DCε, -31% to -36% (-26%) for 3DAε, and 47% to 59% (38%) for 3DRε. Three-dimensional longitudinal strain decreased, whereas 3DCε increased, with aging (P < .003), with different trends in men and women. Men had lower 3DLε, 3DRε, 3DAε, and 2D longitudinal strain than women (P < .02). LV 3D strain parameters were also influenced by LV volumes and mass, image quality, and temporal resolution (P < .02). Reference values obtained by Vsp 2D STE were -20% to -23% (-18%) for 2D longitudinal strain, -20% to -24% (-17%) for 2D circumferential strain, and 39% to 54% (28%) for 2D radial strain (P < .001 vs Vsp 3D STE). Significantly different 3DCε and 3DRε values were obtained with vendor-independent versus Vsp 3D STE (P < .001). CONCLUSIONS: In healthy subjects, reference values of LV 3D strain parameters were significantly influenced by demographic, cardiac, and technical factors. Limits of normality of LV strain by Vsp 3D STE should not be used interchangeably with Vsp 2D STE or with Vin 3D STE software.


Subject(s)
Echocardiography, Three-Dimensional/methods , Heart Ventricles/diagnostic imaging , Ventricular Function, Left/physiology , Adolescent , Adult , Aged , Elastic Modulus , Female , Healthy Volunteers , Humans , Male , Middle Aged , Prospective Studies , Reproducibility of Results , Young Adult
13.
Blood ; 118(17): 4714-8, 2011 Oct 27.
Article in English | MEDLINE | ID: mdl-21765019

ABSTRACT

Persistent antiphospholipid (aPL) antibodies are occasionally found in subjects without prior history of thromboembolic events (TEs), raising the dilemma of whether to initiate or not a primary thromboprophylaxis. A first TE is considered rare in aPL carriers, but previous studies did not consider the aPL profile nor was the test positivity confirmed in a reference laboratory. In this study, 104 subjects with high-risk aPL profile (positive lupus anticoagulant, anticardiolipin, and anti-ß(2)-glycoprotein I antibodies, triple positivity) confirmed in a reference laboratory, were followed up for a mean of 4.5 years. There were 25 first TEs (5.3% per year): the cumulative incidence after 10 years was 37.1% (95% confidence interval [CI], 19.9%-54.3%). On multivariate analysis, male sex (hazard ratio = 4.4; 95% CI, 1.5-13.1, P = .007) and risk factors for venous thromboembolism (hazard ratio = 3.3; 95% CI, 1.3-8.5, P = .01) were independent predictors for TEs. Aspirin did not significantly affect the incidence of TE. In conclusion, the occurrence of a first TE in carriers of high-risk aPL profile is considerable; it is more frequent among male subjects and in the presence of additional risk factors for venous TE. These data can help in the decision to initiate primary thromboprophylaxis in these subjects.


Subject(s)
Antibodies, Antiphospholipid/blood , Antiphospholipid Syndrome/complications , Antiphospholipid Syndrome/diagnosis , Thromboembolism/diagnosis , Thromboembolism/etiology , Adolescent , Adult , Aged , Antibodies, Antiphospholipid/metabolism , Antiphospholipid Syndrome/blood , Antiphospholipid Syndrome/epidemiology , Disease Susceptibility/blood , Disease Susceptibility/diagnosis , Disease Susceptibility/etiology , Early Diagnosis , Female , Follow-Up Studies , Humans , Incidence , Male , Middle Aged , Prospective Studies , Risk Factors , Thromboembolism/epidemiology , Young Adult
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