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BACKGROUND: Some clinical characteristics and comorbidities in atrial fibrillation (AF) patients are exclusion criteria in randomized clinical trials (RCTs) investigating oral anticoagulants (OAC). However, these conditions are present also in everyday clinical practice patients. We compared the risk of adverse clinical outcomes between patients with and without RCT exclusion criteria. METHODS: The Murcia AF Project II was an observational cohort study including AF outpatients starting vitamin K antagonists (VKAs) from July 2016 to June 2018. For the selection of the exclusion criteria, the four pivotal RCTs of direct-acting OAC (DOACs) were used as reference. During 2 years, all ischemic strokes/transient ischemic attacks, major adverse cardiovascular events (MACEs), major bleeds, and all-cause deaths were recorded. RESULTS: 1050 patients (51.5% female, median age 77 years) were included, of whom 368 (35%) met at least one exclusion criterion for RCTs. During follow-up, the incidence rate ratios for major bleeding, MACE and all-cause mortality were higher among patients with exclusion criteria (all p < 0.001). Patients fulfilling at least one exclusion criterion had increased risks of major bleeding (aHR 1.48; 95% CI 1.22-1.81; p < 0.001), MACE (aHR 1.51, 95% CI 1.10-2.09, p = 0.012), and mortality (aHR 3.22, 95% CI 2.32-4.48, p < 0.001), as well as a lower event-free survival (all log-rank p < 0.001). CONCLUSIONS: In this AF cohort taking VKAs, more than one-third had at least one RCT exclusion criteria, which translates into higher risk of major bleeding, MACE, and death. These observations should be considered when translating RCTs results to AF patients for a proper and a more patient-centered management.
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Objective: This study aimed to explore the impact of a combination of hyperuricemia (HUA) and excessive high-sensitivity C-reactive protein (hs-CRP) levels on the likelihood of developing cardiac conduction block (CCB). Additionally, it sought to assess whether the influence of uric acid (UA) on CCB is mediated by hs-CRP. Methods: A prospective study was executed utilizing data from the Kailuan cohort, including 81,896 individuals initially free from CCB. The participants were categorized into four groups depending on the existence of HUA and low-grade inflammation (hs-CRP>3 mg/L). Cox regression analysis was employed to ascertain hazard ratios (HRs) and 95% confidence intervals (CIs) for the risk of incident CCB. A mediation analysis was performed to determine if hs-CRP functioned as a mediator in the connection between UA levels and the incidence of CCB. Results: During a median observation period of 11.8 years, we identified 3160 cases of newly occurring CCB. Compared with the low UA/low CRP group, the combination of HUA and low-grade inflammation elevated the CCB risks (HR:1.56, 95% CI:1.22-1.99), atrioventricular block (AVB) (HR:1.88, 95% CI:1.27-2.77), and right bundle branch block (HR:1.47, 95% CI:1.02-2.12), respectively. Mediation analysis revealed that in the HUA group, compared with the non-HUA group, the risk of CCB elevated by 14.0%, with 10.3% of the increase mediated through hs-CRP. Conclusion: HUA combined with elevated hs-CRP increased the risk of CCB, especially AVB. The connection between UA and the CCB risk was partly mediated by hs-CRP.
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AIMS: Atrial fibrillation (AF) has been associated with functional impairment. However, the role exerted by AF on the long-term trajectories of functional mobility remains to be elucidated. This study aimed to evaluate the impact of AF on functional mobility by tracing walking speed (WS) trajectories over 15 years of follow-up in a population-based cohort of individuals aged 60+ years. METHODS AND RESULTS: This population-based cohort study included 3141 community-dwelling participants (mean age 73.7 years; 63.6% women) from the Swedish National Study on Aging and Care in Kungsholmen, who were regularly examined from 2001-2004 to 2016-2019. Functional mobility was assessed by measuring WS in a standardized way. The association between AF and WS trajectories was assessed by multivariable joint models accounting for the longitudinal dropouts due to death. Stratified analyses by demographic and clinical factors were performed. The effect-modifying role of oral anticoagulant therapy (OAC), incident heart failure (HF), and incident stroke was finally investigated. At baseline, 285 (9.1%) participants were ascertained to have AF. A faster annual WS decline was observed in persons with AF than in non-AF peers (adjusted ß coefficient per year = -0.011, 95% confidence interval: -0.016 to -0.005). Incident HF and stroke were associated with greater WS decline in participants with AF. OAC use was not associated with a slower functional decline. CONCLUSION: Atrial fibrillation is associated with a faster physical function decline in older individuals. Incident HF and stroke possibly accelerate WS decline over time in AF participants.
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Fibrilación Atrial , Humanos , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/epidemiología , Fibrilación Atrial/diagnóstico , Femenino , Masculino , Anciano , Suecia/epidemiología , Estudios de Seguimiento , Persona de Mediana Edad , Velocidad al Caminar , Vida Independiente , Factores de Riesgo , Anciano de 80 o más Años , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/fisiopatología , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/epidemiología , Incidencia , Factores de Tiempo , Anticoagulantes/uso terapéuticoAsunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/complicaciones , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/tratamiento farmacológico , Hipoglucemiantes/uso terapéuticoRESUMEN
Background: While treatment interruption of non-vitamin K antagonist oral anticoagulants (NOACs) for elective surgery or procedures among patients with atrial fibrillation (AF) is becoming more prevalent, there remains insufficient evidence regarding the optimal perioperative management of NOACs, particularly procedures with minor bleeding risks. Objective: This study aims to evaluate the safety and effectiveness of a simplified, standardized protocol for perioperative management of direct factor Xa inhibitors in patients, with AF undergoing procedures associated with minor bleeding risk. Methods: This multicenter, prospective single-arm registry study plans to enroll patients undergoing procedures with minor bleeding risk who were prescribed direct factor Xa inhibitors for AF. The procedures with minor bleeding risk will include gastrointestinal endoscopy for diagnostic purposes, selected dental procedures, and ocular surgery for cataracts or glaucoma. For apixaban, patients will withhold the last evening dose and resume either from the evening dose of the procedure day or the following morning, depending on the bleeding risk of the patient. For edoxaban or rivaroxaban, patients will withhold only a single dose on the procedure day. The primary outcome is the occurrence of major bleeding events within 30 days. Secondary outcomes include systemic thromboembolism, all-cause mortality, and a composite of major and clinically relevant non-major bleeding events. Conclusion: This study has the potential to generate evidence regarding the safety of perioperative management for patients, with AF undergoing procedures associated with minor bleeding risk. Trial Registration: Clinicaltrials.gov: NCT05801068.
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Fibrilación Atrial , Inhibidores del Factor Xa , Hemorragia , Atención Perioperativa , Pirazoles , Piridonas , Sistema de Registros , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Fibrilación Atrial/mortalidad , Administración Oral , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/administración & dosificación , Estudios Prospectivos , Factores de Riesgo , Resultado del Tratamiento , Atención Perioperativa/métodos , Medición de Riesgo , Pirazoles/efectos adversos , Pirazoles/administración & dosificación , Factores de Tiempo , Piridonas/efectos adversos , Piridonas/administración & dosificación , Piridonas/uso terapéutico , Hemorragia/inducido químicamente , Piridinas/efectos adversos , Piridinas/administración & dosificación , Piridinas/uso terapéutico , Esquema de Medicación , Rivaroxabán/efectos adversos , Rivaroxabán/administración & dosificación , Estudios Multicéntricos como Asunto , Proyectos de Investigación , TiazolesRESUMEN
The effect of digoxin and beta-blockers on cardiovascular outcomes and mortality remains unclear. The study aimed to determine differences in cardiovascular (CV) outcomes and death rates among patients with atrial fibrillation (AF) who were prescribed with beta-blockers, digoxin or combination therapy. Data from phase II/III of the prospective Global Registry on Long-Term Oral Anti-thrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) were analysed. The risk of major cardiovascular events (MACE) and death among patients with different prescriptions using COX proportional hazard regression was considered. Propensity score (PS) matching and weighting were further used to adjust for potential confounders of prescription use. A total of 14,201 patients [median age: 71.0 (IQR 64.0-77.0) years; 46.2% female] were recruited. After a median follow-up of 3.0 (IQR 2.4-3.1) years, 864 MACE, and 988 all-cause deaths were recorded. The incidence rate (IR) of MACE was 22.4 (95%CI 21.0-24.0) per 1000 person-years, while the IR of all-cause death was 25.4 (95%CI 23.8-27.0) per 1000 person-years. After multivariate adjustment with Cox regression, the risk of MACE (HR 1.35, 95% CI 1.09-1.68) and the risk of all-cause death (HR 1.28, 95%CI 1.04-1.57) were significantly higher in the combination therapy group, compared to the beta-blockers alone group. The risks of MACE and all-cause death remained significant in both PS matched and PS weighted cohort Among AF patients, combination therapy of beta-blockers and digoxin was associated with higher risks of MACE and all-cause death compared to beta-blockers alone.
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The management of ischaemic stroke survivors is multidisciplinary, necessitating the collaboration of numerous medical professionals and rehabilitation specialists. However, due to the lack of comprehensive and holistic follow-up, their post-discharge management may be suboptimal. Achieving this holistic, patient-centred follow-up requires coordination and interaction of subspecialties, which general practitioners can provide as the first point of contact in healthcare systems. This approach can improve the management of stroke survivors by preventing recurrent stroke through an integrated post-stroke care, including appropriate Antithrombotic therapy, assisting them to have a Better functional and physiological status, early recognition and intervention of Comorbidities, and lifestyles. For such work to succeed, close interdisciplinary collaboration between primary care physicians and other medical specialists is required in a holistic or integrated way.
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There is limited information on predicting incident cardiovascular outcomes among high- to very high-risk populations such as the elderly (≥ 65 years) in the absence of prior cardiovascular disease and the presence of non-cardiovascular multi-morbidity. We hypothesized that statistical/machine learning modeling can improve risk prediction, thus helping inform care management strategies. We defined a population from the Medicare health plan, a US government-funded program mostly for the elderly and varied levels of non-cardiovascular multi-morbidity. Participants were screened for cardiovascular disease (CVD), coronary or peripheral artery disease (CAD or PAD), heart failure (HF), atrial fibrillation (AF), ischemic stroke (IS), transient ischemic attack (TIA), and myocardial infarction (MI) for a 3-yr period in the comorbid history. They were followed up for up to 45.2 months. Analyses included descriptive approaches in terms of incidence rates and density ratios, and inferential in terms of main effect statistical/complex machine learning modeling. The contemporary risk factors of interest spanned across the domains of comorbidity, lifestyle, and healthcare utilization history. The cohort consisted of 154,551 individuals (mean age 68.8 years; 62.2% female). The overall crude incidence rate of CVD events was 9.9 new cases per 100 person-years. The highest rates among its component outcomes were obtained for CAD or PAD (3.6 for each), followed by HF (2.2) and AF (1.8), then IS (1.3), and finally TIA (1.0) and MI (0.9).Model performance was modest in terms of discriminatory power (C index: 0.67, 95%CI 0.667-0.674 for training; and 0.668, 95%CI 0.663-0.673 for validation data), equal agreement between predicted and observed events for calibration purposes, and good clinical utility in terms of a net benefit of 15 true positives per 100 patients relative to the All-patient treatment strategy. Complex models based on machine learning algorithms yielded incrementally better discriminatory power and much improved goodness-of-fitness tests from those based on main effect statistical modeling. This Medicare population represents a highly vulnerable group for incident CVD events. This population would benefit from an integrated approach to their care and management, including attention to their comorbidities and lifestyle factors, as well as medication adherence.
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Fibrilación Atrial , Enfermedades Cardiovasculares , Enfermedad de la Arteria Coronaria , Insuficiencia Cardíaca , Ataque Isquémico Transitorio , Infarto del Miocardio , Enfermedad Arterial Periférica , Humanos , Femenino , Anciano , Estados Unidos/epidemiología , Masculino , Enfermedades Cardiovasculares/epidemiología , Ataque Isquémico Transitorio/epidemiología , Medicare , Factores de Riesgo , Infarto del Miocardio/epidemiología , Fibrilación Atrial/epidemiología , Algoritmos , Aprendizaje AutomáticoRESUMEN
This study aims to determine the frequency and impact of concomitant cerebral infarction and acute myocardial infarction (AMI) and association with in-hospital outcomes. We analyzed the nationally representative data from National Inpatient Sample between 2016 and 2019. We used multiple logistic regressions to determine the impact of sustaining a cerebral infarction or AMI on in-hospital mortality and linear regression to evaluate length of stay and hospitalization costs. A total of 2,396,450 admissions for cerebral infarction, 4,098,904 admissions for AMI and 130,635 admissions for both conditions were identified. The in-hospital mortality was 7.2% overall: 5.6% for patients with cerebral infarction, 7.7% for patients with AMI and 19.9% for patients with both conditions (p < 0.001). The median length of stay was 4 days, 3 days and 7 days for cerebral infarction, AMI and when both occurred together, respectively (p < 0.001). The median total healthcare cost for cerebral infarction, AMI and when both occurred was US$10,647, $15,735 and $23,290, respectively (p < 0.001). After adjustments for potential confounders, in-hospital mortality [adjusted odds ratio (aOR) 4.07, 95% CI 3.93-4.21], length of stay (aOR 3.95 95% CI 3.85-4.04), and hospitalization cost (regression coefficient 15,480 95% CI 15,135-15,825) were greater for patients with AMI and cerebral infarction compared to admission for cerebral infarction only. Cerebral infarction and AMI during the same hospitalization occurs in 5% of admissions with cerebral infarction and 3% of admission with AMI and is associated with significant increase in mortality, length of stay and cost compared to admissions with either condition alone.
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Pacientes Internos , Infarto del Miocardio , Humanos , Estados Unidos/epidemiología , Infarto del Miocardio/epidemiología , Infarto del Miocardio/terapia , Hospitalización , Infarto Cerebral/epidemiología , Modelos Logísticos , Mortalidad HospitalariaRESUMEN
BACKGROUND: An association with aortic aneurysm has been reported among patients with atrial fibrillation (AF). The aims of this study were to investigate the prevalence of thoracic aorta aneurysm (TAA) among patients with AF and to assess whether the co-presence of TAA is associated with a higher risk of adverse clinical outcomes. METHODS AND RESULTS: Using TriNetX, a global federated health research network of anonymised electronic medical records, all adult patients with AF, were categorised into two groups based on the presence of AF and TAA or AF alone. Between 1 January 2017 and 1 January 2019, 874,212 people aged ≥ 18 years with AF were identified. Of these 17,806 (2.04%) had a TAA. After propensity score matching (PSM), 17,805 patients were included in each of the two cohorts. During the 3 years of follow-up, 3079 (17.3%) AF patients with TAA and 2772 (15.6%) patients with AF alone, developed an ischemic stroke or transient ischemic attack (TIA). The risk of ischemic stroke/TIA was significantly higher in patients with AF and TAA (HR 1.09, 95% CI 1.04-1.15; log-rank p value < 0.001) The risk of major bleeding was higher in patients with AF and TAA (OR 1.07, 95% CI 1.01-1.14), but not significant in time-dependent analysis (HR 1.04, 95% CI 0.98-1.10; log-rank p value = 0.187), CONCLUSION: This retrospective analysis reports a clinical concomitance of the two medical conditions, and shows in a PSM analysis an increased risk of ischemic events in patients affected by TAA and AF compared to AF alone.
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Aneurisma de la Aorta Torácica , Fibrilación Atrial , Ataque Isquémico Transitorio , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Adulto , Humanos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/epidemiología , Ataque Isquémico Transitorio/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/complicaciones , Aneurisma de la Aorta Torácica/complicaciones , Accidente Cerebrovascular Isquémico/complicacionesRESUMEN
Background The association between cancer types and specific bleeding events in patients with atrial fibrillation has been scarcely investigated. Also, the performance of bleeding risk scores in this high-risk subgroup of patients is unclear. We investigated the rate of any bleeding, intracranial hemorrhage, major bleeding, and gastrointestinal bleeding according to cancer types in patients with atrial fibrillation. We also tested the predictive value of HAS-BLED, ATRIA, and ORBIT bleeding risk scores. Methods and Results Observational retrospective cohort study including hospitalized patients with atrial fibrillation and cancer from the French National Hospital Discharge Database (Programme de Medicalisation des Systemes d'Information) from January 2010 to December 2019. Major bleeding was defined according to Bleeding Academic Research Consortium definitions. Patients with HAS-BLED ≥3, ATRIA ≥5, or ORBIT ≥4 were classified as at high bleeding risk. Receiver operating characteristic analysis for each score against any bleeding, major bleeding, gastrointestinal bleeding, and intracranial hemorrhage was performed. Areas under the curve (AUCs) were then compared. We included 399 344 patients. Mean age was 77.9±10.2 years, and 63.2% were men. The highest intracranial hemorrhage rates were found in leukemia (1.89%/year), myeloma (1.52%/year), lymphoma and liver (1.45%/year), and pancreas cancer (1.41%/year). Receiver operating characteristic analysis showed that ORBIT score predicted best for any bleeding. In addition, ORBIT score ≥4 had the highest predictivity for major bleeding (AUC, 0.805), followed by HAS-BLED ≥3 and ATRIA ≥5 (AUCs, 0.716 and 0.700, respectively). HAS-BLED and ORBIT performed best for intracranial hemorrhage (AUCs, 0.744 and 0.742 for continuous scores, respectively), better than ATRIA (AUC, 0.635). For gastrointestinal bleeding, ORBIT ≥4 had the highest predictivity (AUC, 0.756), followed by the HAS-BLED ≥3 (AUC, 0.702) and ATRIA ≥5 (AUC, 0.662). Conclusions Some cancer types carry a greater bleeding risk in patients with atrial fibrillation. The identification and management of modifiable bleeding risk factors is crucial in these patients, as well as to flag up high bleeding risk patients for early review and follow-up.
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Fibrilación Atrial , Neoplasias Orbitales , Anciano , Anciano de 80 o más Años , Humanos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Hemorragia Gastrointestinal/inducido químicamente , Hemorragia Gastrointestinal/epidemiología , Hospitales , Hemorragias Intracraneales/inducido químicamente , Hemorragias Intracraneales/diagnóstico , Hemorragias Intracraneales/epidemiología , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Background: Atrial fibrillation (AF) is associated with an increased risk of stroke and the combination of AF and mitral stenosis (MS) is associated with a higher risk. In developed nations, degenerative mitral stenosis (DMS) constitutes a sizeable proportion of patients with MS. Current international guidelines do not offer recommendations regarding anticoagulation in these patients. The objective of this study was to describe the incidence of stroke or systemic embolism in patients with DMS with or without prevalent AF. Methods: A cohort study of DMS patients from 1997 to 2018, using data from the Danish health registries. The cohort was stratified based on AF prevalence and prior ischemic stroke. The primary outcome was a diagnosis of ischemic stroke or systemic embolism after 1 year of follow-up from time of DMS diagnosis. Results: The study included 1162 patients with DMS, of which 421 had prevalent AF. The incidence rate of stroke or systemic embolism after 1 year of follow-up was highest in the DMS without AF group (7.58 vs. 6.63 per 100 person-years). In both groups, DMS without AF and DMS with AF, the incidence rate was highest in patients with prior thromboembolic events (29.61 vs. 5.15 and 19.53 vs. 5.15, respectively). Conclusions: The incidence rate of stroke or systemic embolism was highest in DMS patients without AF. Current Danish guidelines recommend DMS patients should be treated with anticoagulation only with concurrent AF, yet our results call for additional research to establish if DMS patients without AF could benefit from stroke prevention therapy.
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Patients with atrial fibrillation (AF) have an increased risk of coronary artery disease (CAD) compared to patients without. Angiographic characteristics, clinical presentation and severity of CAD according to the presence of AF have been poorly described. We performed a retrospective study of 303 consecutive patients (mean age 69.6 ± 10.8 years; 23.1% women) with and without AF undergoing percutaneous coronary intervention. Data on (1) type of CAD presentation, (2) coronary involvement, and (3) number of diseased coronary vessels (≥70%/luminal narrowing) were collected. CHA2DS2-VASc and 2 major adverse cardiac event (MACE) scores were calculated. Presentation of CAD was ST-segment elevation myocardial infarction (STEMI) in 37.6% of patients, non-STEMI- unstable angina in 55.1%, and other in 7.3%. Non-STEMI-unstable angina was more common in AF (69.6% vs 46.6%, p <0.001), while STEMI was more in the non-AF (22.3% vs 46.6%, p <0.001) group. Left anterior descending artery (LAD) was the most common diseased vessel (70.6%) followed by right coronary artery (RCA, 56.4%) and obtuse marginal artery (36.6%). Patients with AF had a significantly lower RCA involvement (47.3% vs 61.8%, pâ¯=â¯0.016), with a trend for LAD (64.3% vs 74.3%, pâ¯=â¯0.069). At multivariable logistic regression analysis, AF remained inversely associated with RCA involvement (odds ratio [OR] 0.541, 95% confidence interval [CI] 0.335 to 0.874, pâ¯=â¯0.012) and with ≥3 vessel CAD (OR 0.470, 95% CI 0.272 to 0.810, pâ¯=â¯0.007). The 2MACE score was associated with diseased LAD (OR 1.301, 95% CI 1.103 to 1.535, pâ¯=â¯0.002) and with ≥3 vessel CAD (OR 1.330, 95% CI 1.330 to 1.140, p <0.001). In conclusion, patients with AF show lower RCA involvement and generally less severe CAD compared to non-AF ones. The 2MACE score was higher in LAD obstruction and identified patients with severe CAD.
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Angina Inestable/fisiopatología , Fibrilación Atrial/complicaciones , Enfermedad de la Arteria Coronaria/fisiopatología , Infarto del Miocardio sin Elevación del ST/fisiopatología , Infarto del Miocardio con Elevación del ST/fisiopatología , Anciano , Anciano de 80 o más Años , Angina Inestable/etiología , Angina Inestable/cirugía , Estudios de Casos y Controles , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Infarto del Miocardio sin Elevación del ST/etiología , Infarto del Miocardio sin Elevación del ST/cirugía , Intervención Coronaria Percutánea , Estudios Retrospectivos , Infarto del Miocardio con Elevación del ST/etiología , Infarto del Miocardio con Elevación del ST/cirugía , Índice de Severidad de la EnfermedadRESUMEN
Introduction: Atrial fibrillation (AF) is associated with high morbidity and mortality rates due to thromboembolic complications, and anticoagulation is central to the management of this common arrhythmia to prevent acute thromboembolic events. The traditional anticoagulants: heparin, fondaparinux, and vitamin K antagonists (VKA, e.g. warfarin, acenocoumarol or phenprocoumin) have long served as pharmacotherapy for ischemic stroke prophylaxis. Areas covered: In this review article, the authors provide an overview on current and emerging pharmacotherapy for ischemic stroke prevention. Furthermore, they review the data from novel therapeutic targets in the coagulation cascade, and investigational anticoagulant drugs currently assessed in preclinical and clinical studies. Expert opinion: The introduction of nonvitamin K antagonist oral anticoagulants (NOACs) was an important milestone, as these drugs show relative efficacy, safety, and convenience compared to the VKAs. Nevertheless, their clinical use still has some limitations with, for example, patients with severe renal impairment and those with mechanical heart valves, high bleeding risks, lack of standard laboratory monitoring and (some) reversal agents. To overcome some of these limitations, various attempts are now underway to discover new strategies and targets via the hemostatic pathway in order to develop new coagulation inhibiting drugs.
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Fibrilación Atrial/tratamiento farmacológico , Isquemia Encefálica/prevención & control , Accidente Cerebrovascular/prevención & control , Administración Oral , Anticoagulantes/uso terapéutico , Fibrilación Atrial/complicaciones , Isquemia Encefálica/etiología , Hemorragia/inducido químicamente , Humanos , Accidente Cerebrovascular/etiología , Tromboembolia/prevención & control , Vitamina K/antagonistas & inhibidores , Warfarina/uso terapéuticoRESUMEN
In the original publication, one of the ARAPACIS collaborators Dr. "Leonardo Di Gennaro" name has been erroneously mentioned as "Leonardo De Gennaro".
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Prescription of non-vitamin K antagonist oral anticoagulants (NOACs) requires an assessment of renal function (RF) and the Cockcroft-Gault (CG) equation is traditionally recommended. The objective of the study was to evaluate the potential changes in NOACs management using different equations for estimating RF. In a post hoc analysis of a prospective cohort of patients with atrial fibrillation, we considered different equations: (1) CG for creatinine clearance (CrCl), (2) modification of diet in renal disease (MDRD), (3) CKD-EPI, (4) Berlin Initiative Study 1 (BIS-1) and (5) full age spectrum (FAS), for glomerular filtration rate (GFR). RF was classified according to CrCl in three categories: severely depressed (SD-RF) < 30 ml/min; moderately depressed (MD-RF) 30-49 ml/min; preserved/mildly depressed (P-RF) ≥ 50 ml/min. Concordances in the assignments were analyzed. A population of 402 patients (61.2% males, age 72 ± 11) was categorized according to CrCl: 12 patients (2.9%) as SD-RF, 81 (20.1%) as MD-RF, 309 (76.8%) as P-RF. A potential change in NOACs management could occur using GFR equations rather than CrCl in 16.9% of patients using MDRD formula, in 11.7% using BIS-1, in 14.7% using CKD-EPI and in 12.9% using the FAS equation. Important changes in RF estimates were more frequent in patients aged ≥ 75, but also BMI had a meaningful impact. Use of equations estimating GFR instead of the Cockcroft-Gault equation may result in changes in NOACs management in 12-17% of patients. In the elderly ≥ 75, more pronounced changes in RF classification are detectable according to different equations and NOACs dosing should be further investigated.
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Anticoagulantes/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Pruebas de Función Renal , Administración Oral , Anciano , Anciano de 80 o más Años , Creatinina/orina , Dieta , Femenino , Tasa de Filtración Glomerular , Humanos , Masculino , Estudios Prospectivos , Sistema de Registros , Estudios RetrospectivosRESUMEN
Chronic obstructive pulmonary disease (COPD) increases the risk of mortality in non-valvular atrial fibrillation (NVAF) patients. Data on the relationship of COPD to major cardiovascular events (MACE) in AF have not been defined. The aim of the study is to assess the predictive value of COPD on incident MACE in NVAF patients over a 3-year follow-up. In the Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study (ARAPACIS) cohort, we evaluate the impact of COPD on the following clinical endpoints: MACE (including vascular death, fatal/non-fatal MI and stroke/TIA), cardiovascular (CV) death and all-cause mortality. Among 2027 NVAF patients, patients with COPD (9%) are more commonly male, elderly and at higher thromboembolic risk. During a median 36.0 months follow-up, 186 patients experienced MACE: vascular death (n = 72), MI (n = 57), stroke/TIA (n = 57). All major outcomes (including stroke/TIA, MI, vascular death, and all-cause death) are centrally adjudicated. Kaplan-Meier curves show that NVAF patients with COPD are at higher risk for MACE (p < 0.001), CV death (p < 0.001) and all-cause death (p < 0.001). On Cox proportional hazard analysis, COPD is an independent predictor of MACE (Hazard ratio [HR] 1.77, 95% Confidence Intervals [CI] 1.20-2.61; p = 0.004), CV death (HR 2.73, 95% CI 1.76-4.23; p < 0.0001) and all-cause death (HR 2.16, 95% CI 1.48-3.16; p < 0.0001). COPD is an independent predictor of MACE, CV death and all-cause death during a long-term follow-up of NVAF patients.
Asunto(s)
Fibrilación Atrial/complicaciones , Enfermedades Cardiovasculares/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Anciano , Enfermedades Cardiovasculares/mortalidad , Causas de Muerte , Determinación de Punto Final , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Italia/epidemiología , Masculino , Valor Predictivo de las Pruebas , Prevalencia , Estudios Prospectivos , Sistema de Registros , Factores de RiesgoRESUMEN
We investigated the incidence of nonembolic adverse events in 2 cohorts of patients with atrial fibrillation (AF) and validated the 2MACE score ([metabolic syndrome, age ≥75] [doubled]; [myocardial infarction or revascularization, congestive heart failure {HF}, and stroke, transient ischemic attack or thromboembolism]) as predictor of major adverse cardiovascular events (MACEs). We recruited 2,630 patients with AF from 2 different cohorts (Murcia AF and FANTASIIA). The 2MACE score was calculated, and during a median of 7.2 years (Murcia AF cohort) and 1.01 years (FANTASIIA) of follow-up, we recorded all nonembolic adverse events and MACEs (composite of nonfatal myocardial infarction or revascularization and cardiovascular death). Receiver operating characteristic curves comparison, reclassification and discriminatory analyses, and decision curve analyses were performed to compare predictive ability and clinical usefulness of the 2MACE score against CHA2DS2-VASc. During follow-up, there were 65 MACEs in the Murcia cohort and 60 in the FANTASIIA cohort. Events rates were higher in the high-risk category (score ≥3) (1.94%/year vs 0.81%/year in the Murcia cohort; 6.01%/year vs 1.71%/year, in FANTASIIA, both p <0.001). The predictive performance of 2MACE according to the receiver operating characteristic curve was significantly higher than that of CHA2DS2-VASc (0.662 vs 0.618, p = 0.008 in the Murcia cohort; 0.656 vs 0.565, p = 0.003 in FANTASIIA). Decision curve analyses demonstrated improved clinical usefulness of the 2MACE compared with the CHA2DS2-VASc score. In conclusion, in "real-world" patients with AF, the 2MACE score is a good predictor of MACEs. A score ≥3 should be used to categorize patients at "high risk," in identifying patients at risk of MACE.
Asunto(s)
Fibrilación Atrial/complicaciones , Ataque Isquémico Transitorio/epidemiología , Medición de Riesgo , Tromboembolia/epidemiología , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/diagnóstico , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Ataque Isquémico Transitorio/etiología , Masculino , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , España/epidemiología , Tromboembolia/etiologíaRESUMEN
Recent findings suggest that patients with non-valvular atrial fibrillation (AF), in addition to having a high risk for ischemic stroke, are also at risk for myocardial infarction (MI). The aim of the study was to combine factors predicting Major Adverse Cardiovascular Events (MACE) in AF patients, including fatal/nonfatal MI, cardiac revascularization, and cardiovascular death, into a simple risk score. Predictors of MACE were obtained from a prospective observational cohort study, including 1019 AF patients taking vitamin K antagonists from the Atherothrombosis Center, of Sapienza University of Rome. Thus, we derived the 2MACE score [2 points for Metabolic Syndrome and Age ≥75, 1 point for MI/revascularization, Congestive heart failure (ejection fraction ≤40 %), thrombo-Embolism (stroke/transient ischemic attack)], ranging from 0 to 7 points. To evaluate the 2MACE score, we included an external validation cohort of 1089 anticoagulated AF patients from the Thrombosis Centre of Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy. At follow-up, 111 AF patients in the internal and 68 in the external cohort experienced a MACE. The 2MACE score showed a good ability in discriminating AF patients experiencing MACE both in the internal derivation cohort, with a c-index of 0.79 [95 % Confidence Interval (CI) 0.71-0.90, p < 0.001] and in the external validation cohort (c-index 0.66, 95 % CI 0.60-0.73, p < 0.001). The overall Hazard Ratio (HR) was 1.61 (95 % CI 1.40-1.85, p < 0.001) for each additional point. A 2MACE score ≥3 had the best combination of specificity and sensitivity, with an HR of 3.92 (95 % CI 2.41-6.40, p < 0.001). The new simple 2MACE score may help identifying AF patients at risk for cardiovascular events.