Reducing bleeding risk in patients on oral anticoagulation therapy.

INTRODUCTION: Oral anticoagulation (OAC) significantly mitigates thromboembolism risks in atrial fibrillation (AF) and venous thromboembolism (VTE) patients yet concern about major bleeding events persist. In fact, clinically relevant hemorrhages can be life-threatening. Bleeding risk is dynamic and influenced by factors such as age, new comorbidities, and drug therapies, and should not be assessed solely based on static baseline factors. AREAS COVERED: We comprehensively review the bleeding risk associated with OAC therapy. Emphasizing the importance of assessing both thromboembolic and bleeding risks, we present clinical tools for estimating stroke and systemic embolism (SSE) and bleeding risk in AF and VTE patients. We also address overlapping risk factors and the dynamic nature of bleeding risk. EXPERT OPINION: The OAC management is undergoing constant transformation, motivated by the primary objective of mitigating thromboembolism and bleeding hazards, thereby amplifying patient safety throughout the course of treatment. The future of OAC embraces personalized approaches and innovative therapies, driven by advanced pathophysiological insights and technological progress. This holds promise for improving patient outcomes and revolutionizing anticoagulation practices.

Registro observacional prospectivo sobre la utilización del tratamiento antitrombótico durante el periodo perioperatorio y periprocedimiento en el «mundo real»: estudio REQXAA / Prospective observational registry of perioperative and periprocedural management of antithrombotic therapy in “real world”: the REQXAA study

Introducción y objetivos: Existe escasa evidencia acerca del impacto de las actuales recomendaciones sobre la utilización del tratamiento antitrombótico durante el periodo perioperatorio y periprocedimiento en el «mundo real». El objetivo de este estudio es analizar la utilización de los fármacos antitrombóticos en una población de pacientes que van a someterse a una cirugía/procedimiento, así como evaluar la implicación que tiene su retirada o mantenimiento en la incidencia de eventos adversos trombóticos y/o hemorrágicos. Métodos: Estudio observacional prospectivo, multicéntrico y multiespecialidad de pacientes en tratamiento antitrombótico que precisen alguna intervención. El objetivo principal fue la incidencia de eventos trombóticos y hemorrágicos a 30 días en función del uso periintervención de los fármacos antitrombóticos. Resultados: Se incluyó a un total de 1.266 pacientes (el 63,5% varones; media de edad, 72,6 años). El 48,6% de ellos se encontraban anticoagulados (la mayoría por fibrilación auricular; CHA2DS2-VASC, 3,7) y el 53,3%, antiagregados, con mayor frecuencia por cardiopatía isquémica. El 66,7% tenía un riesgo isquémico bajo y el 51,9%, un riesgo hemorrágico de la intervención bajo. El tratamiento antitrombótico periprocedimiento según las recomendaciones actuales fue idóneo únicamente en el 57,3% de los casos. Los pacientes con un uso inadecuado de los fármacos antitrombóticos periprocedimiento presentaron una incidencia de eventos adversos trombóticos y hemorrágicos significativamente mayor. Conclusiones: A pesar de las recomendaciones actuales acerca de la utilización de fármacos antitrombóticos en el periodo perioperatorio/periprocedimiento, su implementación en el «mundo real» continúa siendo baja. Un uso inadecuado se asocia con un aumento de la incidencia de eventos adversos, tanto trombóticos como hemorrágicos.(AU)

Introduction and objectives: There is scarce real-world evidence on the management of perioperative antithrombotic treatment according to current recommendations. The aim of this study was to analyze the management of antithrombotic treatment in patients undergoing surgery or another invasive intervention and to assess the consequences of this management on the occurrence thrombotic or bleeding events. Methods: This prospective, observational, multicenter and multispecialty study analyzed patients receiving antithrombotic therapy who underwent surgery or another invasive intervention. The primary endpoint was defined as the incidence of adverse (thrombotic and/or hemorrhagic) events after 30 days of follow-up with respect to management of perioperative antithrombotic drugs. Results: We included 1266 patients (male: 63.5%; mean age 72.6 years). Nearly half of the patients (48.6%) were under chronic anticoagulation therapy (mainly for atrial fibrillation; CHA2DS2-VASC: 3.7), while 53.3% of the patients were under chronic antiplatelet therapy (mainly for coronary artery disease). Low ischemic and hemorrhagic risk was found in 66.7% and 51.9%, respectively. Antithrombotic therapy management was in line with current recommendations in only 57.3% of the patients. Inappropriate management of antithrombotic therapy was an independent risk factor for both thrombotic and hemorrhagic events. Conclusions: The implementation of recommendations on the perioperative/periprocedural management of antithrombotic therapy in real-world patients is poor. Inappropriate management of antithrombotic treatment is associated with an increase in both thrombotic and hemorrhagic events.(AU)

High medium-term incidence of major cardiovascular events in discharged patients with unstable angina.

The introduction of high-sensitivity troponin (hsTn) assays has reduced the diagnosis of unstable angina (UA) in favor of non-ST elevation myocardial infarction (NSTEMI) in the context of non-ST elevation acute coronary syndrome (NSTEACS). It is unclear whether the detection of these hsTn levels affects the prognosis and therefore whether a different therapeutic approach is warranted. This study aims to determine whether using hsTn results in medium-term prognostic differences in patients with UA and NSTEMI. Methods: This multicenter, prospective registry study included consecutive patients who underwent hsTn assays and were discharged with a diagnosis of NSTEACS. Patients were followed for two years. Outcomes were the occurrence of major adverse cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke), major bleeding, and all-cause mortality. Results: Patients with UA and NSTEMI did not show differences in terms of the invasive interventions received, the coronary artery disease diagnosed, the type of revascularization performed, or the proportion presenting MACE (UA 18.1% vs. NSTEMI 18.9%; p = 0.79). However, patients with NSTEMI had higher cardiovascular mortality at two years (UA 4% vs. NSTEMI 9.2%; p = 0.012), as well as, all-cause mortality (UA vs. 7.9% vs. NSTEMI 16.4%; p = 0.002). Conclusions: Medium-term incidence of MACE was similar in patients with UA and NSTEMI, but cardiovascular and all-cause mortality in NSTEMI patients was over twice that of patients with UA.

Prospective observational registry of perioperative and periprocedural management of antithrombotic therapy in "real world": the REQXAA study.

INTRODUCTION AND OBJECTIVES: There is scarce real-world evidence on the management of perioperative antithrombotic treatment according to current recommendations. The aim of this study was to analyze the management of antithrombotic treatment in patients undergoing surgery or another invasive intervention and to assess the consequences of this management on the occurrence thrombotic or bleeding events. METHODS: This prospective, observational, multicenter and multispecialty study analyzed patients receiving antithrombotic therapy who underwent surgery or another invasive intervention. The primary endpoint was defined as the incidence of adverse (thrombotic and/or hemorrhagic) events after 30 days of follow-up with respect to management of perioperative antithrombotic drugs. RESULTS: We included 1266 patients (male: 63.5%; mean age 72.6 years). Nearly half of the patients (48.6%) were under chronic anticoagulation therapy (mainly for atrial fibrillation; CHA2DS2-VASC: 3.7), while 53.3% of the patients were under chronic antiplatelet therapy (mainly for coronary artery disease). Low ischemic and hemorrhagic risk was found in 66.7% and 51.9%, respectively. Antithrombotic therapy management was in line with current recommendations in only 57.3% of the patients. Inappropriate management of antithrombotic therapy was an independent risk factor for both thrombotic and hemorrhagic events. CONCLUSIONS: The implementation of recommendations on the perioperative/periprocedural management of antithrombotic therapy in real-world patients is poor. Inappropriate management of antithrombotic treatment is associated with an increase in both thrombotic and hemorrhagic events.

Imaging in atrial fibrillation: A way to assess atrial fibrosis and remodeling to assist decision-making.

The 2020 ESC atrial fibrillation (AF) guidelines suggest the novel 4S-AF scheme for the characterization of AF. Imaging techniques could be helpful for this objective in everyday clinical practice, and information derived from these techniques reflects basic aspects of the pathophysiology of AF, which may facilitate treatment decision-making, and optimal management of AF patients. The aim of this review is to provide an overview of the mechanisms associated with atrial fibrosis and to describe imaging techniques that may help the management of AF patients in clinical practice. Transthoracic echocardiography is the most common procedure given its versatility, safety, and simplicity. Transesophageal echocardiography provides higher resolution exploration, and speckle tracking echocardiography can provide incremental functional and prognostic information over conventional echocardiographic parameters. In addition, LA deformation imaging, including LA strain and strain rate, are related to the extent of fibrosis. On the other hand, multidetector-row computed tomography and cardiac magnetic resonance provide higher resolution data and more accurate assessment of the dimensions, structure, and spatial relationships of the LA. Imaging is central when deciding on catheter ablation or cardioversion, and helps in selecting those patients who will really benefit from these procedures. Moreover, imaging enhances the understanding of the underlying mechanisms of atrial remodeling and might assists in refining the risk of stroke, which help to select the best medical therapies/interventions. In summary, evaluation of LA enlargement, LA remodeling and fibrosis with imaging techniques adds clinical and prognostic information and should be assessed as a part of routine comprehensive AF evaluation.

Contact pathway in surgical and transcatheter aortic valve replacement.

Background: Aortic valve replacement is the gold standard treatment for severe symptomatic aortic stenosis, but thrombosis of bioprosthetic valves (PVT) remains a concern. Objective: To analyze the factors involved in the contact pathway during aortic valve replacement and to assess their impact on the development of thromboembolic complications. Methods: The study was conducted in 232 consecutive patients who underwent: transcatheter aortic valve replacement (TAVR, N = 155), and surgical valve replacement (SAVR, N = 77) (MUVITAVI project). Demographic and clinical data, outcomes including a combined end point (CEP) of thrombotic events, and imaging controls were recruited. Samples were collected 24 h before and 48 h after valve replacement. FXII, FXI and (pre)kallikrein were evaluated by Western Blot and specific ELISA with nanobodies. Results: The CEP of thrombotic events was reached by 19 patients: 13 patients presented systemic embolic events and 6 patients subclinical PVT. Valve replacement did not cause FXII activation or generation of kallikrein. There was a significant reduction of FXI levels associated with the procedure, which was statistically more pronounced in SAVR than in TAVR. Cases with reductions of FXI below 80% of basal values had a lower incidence of embolic events during the procedure than patients in whom FXI increased above 150%: 2.7 vs. 16.7%; p: 0.04. Conclusion: TAVR or SAVR did not significantly activate the contact pathway. A significant reduction of FXI, was observed, particularly in SAVR, associated with lower incidence of thrombotic events. These results encourage evaluating the usefulness and safety of FXI-directed antithrombotic treatments in these patients.

A comparison of front-line oral anticoagulants for the treatment of non-valvular atrial fibrillation: effectiveness and safety of direct oral anticoagulants in the FANTASIIA registry.

INTRODUCTION: For a long time, vitamin K antagonists (VKA) were the only oral anticoagulation therapy available to reduce adverse events in atrial fibrillation (AF) patients. Direct-acting oral anticoagulants (DOAC) are at least as effective and safe as VKA with few drug interactions, rapid onset, and short half-life. Four DOACs, dabigatran, apixaban, rivaroxaban, and edoxaban, have demonstrated efficacy and safety for treatment in AF patients. AREAS COVERED: The purpose of this review article is to analyze the current evidence in clinical trials and in real-world populations and performed a new analysis with the estimated effect of those DOACs over the VKA population from the FANTASIIA registry. EXPERT OPINION: In the absence of randomized, controlled head-to-head comparisons between DOACs, high-quality observational data can provide useful information on the comparative effectiveness of DOACs. Current clinical guidelines recommend the management of oral anticoagulation in AF patients with DOACs over VKA for stroke prevention; however, many guidelines generally do not suggest a specific DOAC choice in clinical practice. The revised evidence in this manuscript and our real experience reflects that apixaban and dabigatran show the best efficacy and safety profile.

Outcomes and predictive value of the 2MACE score in patients with atrial fibrillation treated with rivaroxaban in a prospective, multicenter observational study: The EMIR study.

BACKGROUND: The aim of the study was to evaluate the performance of the 2MACE in patients with atrial fibrillation (AF) treated with rivaroxaban and to improve the accuracy of 2MACE. METHODS: This was a post-authorization and observational study of AF adults treated with rivaroxaban for ≥ 6 months. The primary endpoint was any of the major adverse cardiac events (MACE), namely, cardiovascular death, non-fatal myocardial infarction, and myocardial revascularization. The area under the curve (AUC) was calculated to evaluate the performance of 2MACE, and a new score, 2MACER to predict MACE. RESULTS: A total of 1433 patients were included (74.2 ± 9.7 years, CHA2DS2-VASc 3.5 ± 1.5, 26.9% 2MACE ≥ 3). The annual event rates (follow-up 2.5 years) were 1.07% for MACE, 0.66% for thromboembolic events and 1.04% for major bleeding. Patients with 2MACE ≥ 3 (vs. < 3) had higher risk of stroke/systemic embolism/transient ischemic attack (odds ratio [OR] 5.270; 95% CI 2.216-12.532), major bleeding (OR 4.624; 95% CI 2.163-9.882), MACE (OR 3.202; 95% CI 1.548-6.626) and cardiovascular death (OR 3.395; 95% CI 1.396-8.259). 2MACE was recalculated giving 1 more point to patients with baseline a glomerular filtration rate < 50 mL/min/1.73 m² (2MACER); 2MACER vs. 2MACE: IDI 0.1%, p = 0.126; NRI 23.9%, p = 0.125; AUC: 0.651 (95% CI 0.547-0.755) vs. 0.638 (95% CI 0.534-0.742), respectively; p = 0.361. CONCLUSIONS: In clinical practice, AF patients anticoagulated with rivaroxaban exhibit a low risk of events. 2MACE score acts as a modest predictor of a higher risk of adverse outcomes in this population. 2MACER did not significantly increase the ability of 2MACE to predict MACE.

Impact of Integrated Care Management on Clinical Outcomes in Atrial Fibrillation Patients: A Report From the FANTASIIA Registry.

Background: An integrated and holistic approach is increasingly advocated in patients with atrial fibrillation (AF), based on the "Atrial fibrillation Better Care (ABC) pathway: A, Avoid stroke with anticoagulation; B, better symptom management; C, cardiovascular and comorbidity risk management." The aim of this study was to examine the prevalence of adherence to each component of the ABC pathway and to analyze its impact on long-term prognosis in the "real-world" cohort of AF patients from the FANTASIIA registry. Methods: This prospective study included consecutive AF outpatients anticoagulated with direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA) from June 2013 to October 2014. From the ABC pathway, adherence to the "A criterion" was defined by a time in the therapeutic range (TTR) ≥ 70% or correct dose with DOAC; "B criterion" adherence was defined by a European Heart Rhythm Association (EHRA) Symptom Scale I-II; and "C criterion" adherence was defined as optimized risk factors and comorbidity management. Baseline features and embolic events, severe bleeding, and all-cause and cardiovascular mortality rates up to 3 years of follow-up were analyzed, and a Cox multivariate analysis was performed to investigate the role of each component of the ABC pathway in predicting major events. Results: A total of 1,955 AF patients (age: 74.4 ± 9.4 years; 43.2% female patients) were included in this study: adherence to A criterion was observed in 920 (47.1%) patients; adherence to B criterion was observed in 1,791 (91.6%) patients; and adherence to C criterion was observed in 682 (34.8%) patients. Only 394 (20.2%) of the whole population had good control of AF according to the ABC pathway. After a median follow-up of 1,078 days (IQR: 766-1,113), adherence to A criterion was independently associated with reduced cardiovascular mortality [HR: 0.67, 95%CI (0.45-0.99); p = 0.048] compared with non-adherence. Adherence to the B criterion was independently associated with reduced stroke [HR: 0.28, 95%CI (0.14-0.59); p < 0.001], all-cause mortality [HR: 0.49, 95%CI (0.35-0.69); p < 0.001], cardiovascular mortality [HR: 0.39, 95%CI (0.25-0.62); p < 0.001], and major adverse cardiovascular events (MACE) [HR: 0.41, 95%CI (0.28-0.62); p < 0.001] compared with non-adherence. AF patients with C criterion adherence had a significantly lower risk of myocardial infarction [HR: 0.31, 95%CI (0.15-0.66); p < 0.001]. Fully adherent ABC patients had a significant reduction in MACE [HR: 0.64, 95%CI (0.42-0.99); p = 0.042]. Conclusion: In real-world anticoagulated AF patients from FANTASIIA registry, we observed a lack of adherence to integrated care management of AF following the ABC pathway. AF managed according to the ABC pathway was associated with a significant reduction in adverse outcomes during long follow-up, suggesting the benefit of a holistic and integrated approach to AF management.

Clinical implications of diabetes mellitus in patients with acute coronary syndrome: Prognostic role and use of new P2Y12 receptor inhibitors.

AIMS: We investigated the impact of diabetes mellitus (DM) in acute coronary syndrome (ACS) patients, and the 2-year prognosis based on antiplatelet therapy. METHODS: This is a prospective and multicenter registry including hospitalized ACS patients. Clinical management and antiplatelet therapy at discharge were recorded. Bleeding events, all-cause mortality and major adverse cardiovascular events (MACEs) were recorded during 2-years and compared according to DM and the P2Y12 receptor inhibitor. RESULTS: From 1717 ACS patients, 653 (38%) had DM. Diabetic patients were older, more commonly females, with higher prevalence of comorbidities and more conservative management. After excluding antiplatelet monotherapy or oral anticoagulation, clopidogrel was prescribed in 59.6% of DM patients. Cox regression analysis showed that DM was an independent risk factor for MACE (aHR 1.39, 95% CI 1.05-1.83). The use of clopidogrel instead of ticagrelor/prasugrel was also independently associated with MACE (aHR 1.71, 95% CI 1.11-2.63), and all-cause mortality (aHR 2.47, 95% CI 1.23-4.96) in diabetic patients (log-rank p-values < 0.001). CONCLUSIONS: In ACS patients, DM was associated with higher risk of MACE. In such patients, the use of ticagrelor/prasugrel reduced MACE and mortality compared to clopidogrel. Novel P2Y12 receptor inhibitors might be used as the first therapeutic choice in these high-risk patients.

Practical Decision Algorithms for the Use of the Cardiovascular Polypill in Secondary Prevention in Europe.

The main objective of cardiovascular disease (CVD) prevention is to reduce morbidity and mortality. Despite recommendations on evidence-based pharmacological treatment and lifestyle changes, the control of CV risk factors such as hypertension or dyslipidaemia is not optimal. The use of a CV polypill, including guideline-recommended drugs, as a baseline therapy, may contribute to improving risk factors control either by improving the treatment adherence or by the synergistic effect of its components. The CNIC-Polypill is the first CV polypill approved in Europe as an effective strategy for secondary prevention, which contains acetylsalicylic acid, atorvastatin (in two optional doses), and ramipril (in three optional doses) in a single pill. The present practical clinical document aims to provide a guide for patient management after an acute coronary syndrome (ACS) or with chronic CVD (CCVD) with a strategy based on the CNIC-Polypill, also considering the need to add other therapies for a personalized treatment. The most suitable clinical scenarios for the CNIC-Polypill use are discussed: (a) in patients after an ACS at discharge, (b) in patients with CCVD (chronic coronary syndrome, stroke, or peripheral artery disease) with uncontrolled low-density lipoprotein cholesterol (LDL-c) and/or blood pressure levels and (c) in patients with CCVD with well-controlled risk factors to simplify treatment and reduce polypharmacy in the context of CCVD prevention.

Antithrombotic Therapy in Patients with Peripheral Artery Disease: A Focused Review on Oral Anticoagulation.

Peripheral artery disease (PAD) is a major cause of morbidity and mortality but it is usually underdiagnosed and undertreated. Patients with PAD present dysregulated procoagulant, anticoagulant, and fibrinolytic pathways leading to arterial and venous thrombosis. The risk of several ischemic-related complications could be mitigated with appropriate antithrombotic therapy, which plays a central role in all types of PAD. For years, antiplatelets have been indicated in patients with symptomatic PAD or those who have undergone revascularization. Unfortunately, a non-negligible proportion of patients with PAD will suffer from adverse events during the follow-up, even despite proper medical therapies for the prevention of PAD complications. Thus, there is room for improving clinical outcomes in these patients. Given the implication of both, primary and secondary hemostasis in arterial thrombosis and the pathophysiology of PAD, the combination of antiplatelets and anticoagulants has emerged as a potential antithrombotic alternative to antiplatelets alone. In this narrative review article, we have highlighted the most recent evidence about antithrombotic therapy in PAD patients, with a special focus on oral anticoagulation. Certainly, COMPASS and VOYAGER PAD trials have shown promising results. Thus, rivaroxaban in combination with aspirin seem to reduce cardiovascular outcomes with a similar bleeding risk compared to aspirin alone. Nevertheless, results from real-world studies are needed to confirm these observations, and other trials will provide novel evidence about the safety and efficacy of emerging anticoagulant agents.

Relationship between multimorbidity and outcomes in atrial fibrillation.

BACKGROUND: Multimorbidity is common in atrial fibrillation (AF) patients. Charlson comorbidity index (CCI) is used to evaluate multimorbidity in the general population. Limited long-term data are available on the relationship between CCI and AF. We examined the association between CCI, anticoagulation control and outcomes in AF patients. METHODS: We studied 1956 from the FANTASIIA registry, an observational Spanish nationwide study on anticoagulated AF patients. Time in therapeutic range (TTR) was used to evaluate anticoagulation control. Stroke/TIA, major bleeding, cardiovascular (CV) death and all-cause death were study outcomes. RESULTS: Mean ± SD CCI was 1.1 ± 1.2. Based on CCI quartiles, patients were categorised in four groups: 676 (34.6%) in Q1 (CCI 0); 683 (34.9%) in Q2 (CCI 1); 345 (17.6%) in Q3 (CCI 2); and 252 (12.9%) in Q4 (CCI ≥3). In vitamin K antagonist treated patients, the highest CCI quartile was inversely associated with TTR >70% (odds ratio:0.67, 95% confidence interval (CI):0.45-0.99). During observation, a progressively higher rate of major bleeding, CV death and all-cause death was found across the quartiles (all p < 0.001). The final Cox multivariable regression analysis showed an association with increasing risk for major bleeding occurrence in Q3 and Q4 (hazard ratio (HR):1.69, 95%CI:1.00-2.87 and HR:1.92, 95%CI:1.08-3.41). An increasing risk for all-cause death and CV death was found across CCI quartiles. CONCLUSIONS: In a nationwide contemporary cohort of AF anticoagulated patients, multimorbidity was inversely associated with good anticoagulation control. A progressively higher risk for major bleeding, CV death and all-cause death was found across CCI quartiles.

Comparison of Aortic Gradient and Ventricular Mass after Valve Replacement for Aortic Stenosis with Rapid Deployment, Sutureless, and Conventional Bioprostheses.

BACKGROUND: The use of rapid deployment and sutureless aortic prostheses is increasing. Previous reports have shown promising results on haemodynamic performance and mortality rates. However, the impact of these bioprostheses on left ventricular mass (LVM) regression remains unknown. We decided to study the changes in remodelling and LVM regression in isolated severe aortic stenosis treated with conventional or Perceval® or Intuity® valves. METHOD AND RESULTS: From January 2011 to January 2016, 324 bioprostheses were implanted in our centre. The collected characteristics were divided into 3 groups: conventional valves, Perceval®, and Intuity®, and they were analysed after 12 months. There were 183 conventional valves (56%), 72 Perceval® (22%), and 69 Intuity® (21.2%). The statistical analysis showed significant differences in transprosthetic postoperative peak gradient (23 [18-29] mm Hg vs. 21 [16-29] mm Hg and 18 [14-24] mm Hg, p < 0.001), ventricular mass electrical criteria regression (Sokolow and Cornell products), and 1-year survival (90 vs. 93% and 97%, log rank p value = 0.04) in conventional, Perceval®, and Intuity® groups. CONCLUSIONS: We observed differences in haemodynamic, electrocardiographic, and echocardiographic parameters related to the different types of prosthesis. Patients with the Intuity® prosthesis had the highest reduction in peak aortic gradient and the higher ventricular mass regression. Besides, patients with the Intuity® prosthesis had less risk of mortality during follow-up than the other two groups. Further studies are needed to confirm these findings.

Impact of frailty and atrial fibrillation in elderly patients with acute coronary syndromes.

BACKGROUND: There is scarce information on the prognostic role of frailty and atrial fibrillation (AF) in elderly patients with acute coronary syndrome (ACS). METHODS: The aim was to analyse the management of elderly patients with frailty and AF who suffered an ACS using data of the prospective multicentre LONGEVO-SCA registry. We evaluated the predictive performance of FRAIL, Charlson scores and AF status for adverse events at 6-month follow-up. RESULTS: A total of 531 unselected patients with ACS and above 80 years old [mean age 84.4 (SD = 3.6) years; 322 (60.6%) male] were enrolled, of whom 128 (24.1%) with AF and 145 (27.3%) with frailty. Mutually exclusive number of patients were as follows: non-frail and sinus rhythm (SR) 304 (57.2%); frail and SR 99 (18.6%); non-frail and AF 82 (15.4%); and frail and AF 46 (8.7%). Frail and AF patients compared with non-frail and SR patients had higher risk of all-cause mortality [HR 2.61, (95% CI 1.28-5.31; P = .008)], readmissions [HR 2.28, (95%CI 1.37-3.80); P = .002)] and its composite [HR 2.28, (95% CI 1.44-3.60); P < .001)]. After multivariate adjustment, FRAIL score [HR 1.41, (95% CI 1.02-1.97); P = .040] and Charlson index [HR 1.32, (95% CI 1.09-1.59); P = .003] were significantly associated with mortality. AF status was not independently related with adverse events. CONCLUSIONS: Frailty but not AF status was independently associated with follow-up adverse events. Frailty status and high Charlson index were independent conditions associated with adverse events during the follow-up. The impact of functional status has a bigger prognostic role over AF status in elderly patients with ACS.

Stroke and Thromboembolism in Warfarin-Treated Patients with Atrial Fibrillation: Comparing the CHA2DS2-VASc and GARFIELD-AF Risk Scores.

BACKGROUND: Evaluation of thromboembolic risk is essential in anticoagulated atrial fibrillation (AF) patients. The CHA2DS2-VASc score is largely validated and recommended by most guidelines. The GARFIELD-AF Stroke score has been proposed as an alternative risk score. METHODS: We analyzed warfarin-treated patients from SPORTIF III and V studies. Any thromboembolic event (TE) was an adjudicated study outcome. We compared the two scores' capacity in predicting any TE occurrence. RESULTS: A total of 3,665 patients (median [interquartile range] age: 72 [66-77] years; 30.5% female) were included in this analysis. After a mean (standard deviation) follow-up of 566.3 (142.5) days, 148 (4.03%) TEs were recorded. Both continuous CHA2DS2-VASc and GARFIELD-AF were associated with TE (hazard ratio [HR]: 1.37, 95% confidence interval [CI]: 1.22-1.53 and HR: 2.43, 95% CI: 1.72-3.42), with modest predictive ability (c-indexes: 0.63, 95% CI: 0.59-0.68 and 0.61, 95% CI: 0.56-0.66, respectively), with no differences. CHA2DS2-VASc quartiles showed an increasing cumulative risk, while in GARFIELD-AF only the highest quartile (Q4) demonstrated an increased TE risk. On multivariate Cox regression analysis, CHA2DS2-VASc quartiles were associated with increasing risk of TE, whereas for GARFIELD-AF only Q4 showed an association with TE. Discrimination analysis showed that GARFIELD-AF quartiles were associated with a 48.7% reduction in discriminatory ability. Using decision curve analysis, CHA2DS2-VASc was associated with improved clinical usefulness and net clinical benefit, compared with GARFIELD-AF. CONCLUSION: In a warfarin-treated trial cohort of AF patients, both CHA2DS2-VASc and GARFIELD-AF Stroke scores were associated with adjudicated TE events, with modest predictive capacity. The simpler CHA2DS2-VASc score improved discriminatory capacity compared with the more complex GARFIELD-AF score, demonstrating improved clinical usefulness and net clinical benefit.

Peripheral artery disease and clinical outcomes in patients with atrial fibrillation: A report from the FANTASIIA registry.

BACKGROUND: Atrial fibrillation (AF) and peripheral artery disease (PAD) are common conditions that increase cardiovascular risk. We determined the association between PAD and prognosis in a cohort of real-world patients receiving oral anticoagulant therapy for nonvalvular AF. METHODS: We prospectively included 1956 patients (mean age 73.8 ± 9.5 years, 44.0% women) receiving oral anticoagulant therapy for AF. Clinical characteristics were collected at baseline. Patients were followed for a period of 3 years. Survival analysis and multivariable regression analyses were performed to assess variables related to death, stroke, bleeding, myocardial infarction and major adverse cardiovascular events (MACE). RESULTS: Patients with PAD (n = 118; 6%) exhibited higher rates of cardiovascular risk factors and cardiovascular diseases. After 3 years of follow-up, there were a total of 255 deaths (no PAD 233, vs PAD 22), 45 strokes (43 vs 2), 146 major bleedings (136 vs 10) and 168 MACE (148 vs 20). On univariate analysis, there was a higher risk of cardiovascular mortality (2.02%/year no PAD vs 4.08%/year PAD, P = .02), myocardial infarction (0.99%/year no PAD vs 2.43%/year PAD, P = .02) and MACE (3.18%/year no PAD vs 6.99%/year PAD, P < .01). There was no statistically significant association with these events after multivariable adjustment. CONCLUSIONS: In a large cohort of anticoagulated patients with AF, the presence of PAD represents a higher risk subgroup and is associated with worse crude outcomes. The exact contribution of the PAD independently of other cardiovascular diseases or risk factors requires further investigation.

Recomendaciones sobre el tratamiento antitrombótico durante la pandemia COVID-19. Posicionamiento del Grupo de Trabajo de Trombosis Cardiovascular de la Sociedad Española de Cardiología / Recommendations on antithrombotic treatment during the COVID-19 pandemic. Position statement of the Working Group on Cardiovascular Thrombosis of the Spanish Society of Cardiology

La pandemia producida por la infección del nuevo coronavirus SARS-CoV-2, que da lugar a una enfermedad altamente contagiosa (COVID-19), ha producido un colapso de los sistemas sanitarios de todo el mundo. Se ha descrito que estos pacientes sufren un estado inflamatorio que condiciona un alto riesgo trombótico. Sin embargo, apenas hay información sobre cómo abordar el riesgo trombótico, la coagulopatía y el tratamiento anticoagulante de estos pacientes. Por otra parte, incluso los pacientes no infectados por COVID-19 sufren una tremenda influencia en su abordaje habitual por la situación sanitaria actual. El objetivo del presente documento, elaborado por el Grupo de Trabajo de Trombosis Cardiovascular de la Sociedad Española de Cardiología, es presentar la información disponible y dar unas pautas sencillas de tratamiento con fármacos antitrombóticos

The new coronavirus SARS-CoV-2, which gives rise to the highly contagious COVID-19 disease, has caused a pandemic that is overwhelming health care systems worldwide. Affected patients have been reported to have a heightened inflammatory state that increases their thrombotic risk. However, there is very scarce information on the management of thrombotic risk, coagulation disorders, and anticoagulant therapy. In addition, the situation has also greatly influenced usual care in patients not infected with COVID-19. This article by the Working Group on Cardiovascular Thrombosis of the Spanish Society of Cardiology aims to summarize the available information and to provide a practical approach to the management of antithrombotic therapy