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.

Role of cardiovascular magnetic resonance in the prognosis of patients with myocardial infarction with non-obstructive coronary arteries.

BACKGROUND: It is estimated that 5% to 10% of patients with myocardial infarction (MI) present with no obstructive coronary artery lesions. Until now, most studies have focused on acute coronary syndrome, including different clinical entities with a similar presentation encompassed under the term MINOCA (MI with non-obstructive coronary arteries). The aim of this study is to assess the prognosis of patients diagnosed with true infarction, confirmed by cardiovascular magnetic resonance (CMR), in the absence of significant coronary lesions. METHODS: Prospective multicenter registry study, including 120 consecutive patients with a CMR-confirmed MI without obstructive coronary artery lesions. The primary clinical outcome was major adverse cardiovascular events (MACE: death, non-fatal infarction, stroke, or cardiac readmission), assessed over three years. RESULTS: Seventy-six patients (63.3%) were admitted with a diagnosis of acute coronary syndrome, and 44 (36.6%) for other causes (mainly heart failure); the definitive diagnosis was established by CMR. Most patients (64.2%) were men, and the mean age was 58.8 ± 13.5 years. Patients presented with small infarcts: 83 (69.1%) showed late gadolinium enhancement (LGE) in one or two myocardial segments, mainly transmural (in 77.5% of patients) and with a preserved left ventricular ejection fraction (median 54.8%, interquartile range 37-62). The most frequent infarct location was inferolateral (n = 38, 31.7%). During follow-up, 43 patients (35.8%) experienced a MACE, including 9 (7.5%) who died. In multivariable analysis, LGE in two versus one myocardial segment doubled the risk of adverse cardiac events (hazard ratio [HR] 2.32, 95% confidence interval [CI] 0.97-5.83, p = 0.058). Involvement of three or more myocardial segments almost tripled the risk (HR 2.71, 95% CI 1.04-7.04, p = 0.040 respectively). CONCLUSIONS: Patients with true MI but without significant coronary artery lesions predominantly had small infarcts. Myocardial 3-segment LGE involvement is associated with a significantly higher risk of adverse cardiac events.

Quality of oral anticoagulation with vitamin K antagonists in 'real-world' patients with atrial fibrillation: a report from the prospective multicentre FANTASIIA registry.

Aims: The efficacy and safety of oral anticoagulation (OAC) using the vitamin K antagonists (VKA) are closely associated with the quality of anticoagulation, reflected by time in therapeutic range (TTR). The SAMe-TT2R2 is a risk score developed to predict the quality of anticoagulation control among VKA users. To analyse the quality of anticoagulation and its clinical determinants based on different methods in a prospective cohort of atrial fibrillation patients on VKA treatment participating in the multicentre Spanish observational registry FANTASIIA. Methods and results: Estimated TTR was calculated from Rosendaal, direct method, international normalized ratio variability, and NICE criteria. Time in therapeutic range values were compared for those patients with a SAMe-TT2R2 score 0-2 and >2. One thousand four hundred and seventy patients were analysed (56.4% male, mean age 74.1 ± 9.5 years). Mean TTR was 61.5 ± 25.1 with Rosendaal and 64.7 ± 24.2 with direct method. There was a high correlation between both methods (ρ = 0.805). The prevalence of poor anticoagulation control was 55%. Diabetes mellitus [odds ratio (OR) 1.38; P = 0.008], peripheral artery disease (PAD, OR 1.62; P = 0.048), and HAS-BLED (OR 1.13; P = 0.022) were independently associated with TTR < 70%. SAMe-TT2R2 score 0-2 had a higher mean TTR than patients with SAMe-TT2R2 >2 (P = 0.044), with a specificity of > 90% for predicting TTR < 70%. Patients with TTR < 70% had higher risk of events (21.7 vs. 16.8%; P = 0.021). Conclusion: In a multicentre prospective registry, 55% of AF patients had poor anticoagulation control with diabetes mellitus, PAD, and HAS-BLED being independently associated with TTR < 70%. A high SAMe-TT2R2 scores had a high specificity for predicting a TTR < 70% as an indicator of poor quality anticoagulation.

Is the ORBIT Bleeding Risk Score Superior to the HAS-BLED Score in Anticoagulated Atrial Fibrillation Patients?

BACKGROUND: Several bleeding risk scores have been validated in patients with atrial fibrillation (AF). The ORBIT score has been recently proposed as a simple score with the best ability to predict major bleeding. The present study aimed to test the hypothesis that the ORBIT score was superior to the HAS-BLED score for predicting major bleeding and death in "real world" anticoagulated AF patients. METHODS AND RESULTS: We analyzed the predictive performance for bleeding and death of 406 AF patients who underwent 571 electrical cardioversion procedures and 1,276 patients with permanent/persistent AF from the FANTASIIA registry. In the cardioversion population, 21 patients had major bleeding events and 26 patients died. The predictive performance for major bleeding of HAS-BLED and ORBIT were not significantly different (c-statistics 0.77 (95% CI 0.66-0.88) and 0.82 (95% CI 0.77-0.93), respectively; P=0.080). For the FANTASIIA population, 46 patients had major bleeding events and 50 patients died. The predictive performances for major bleeding of HAS-BLED and ORBIT were not significantly different (c-statistics 0.63 (95% CI 0.56-0.71) and 0.70 (95% CI 0.62-0.77), respectively; P=0.116). For death, the predictive performances of HAS-BLED and ORBIT were not significantly different in both populations. The ORBIT score categorized most patients as "low risk". CONCLUSIONS: Despite the original claims in its derivation paper, the ORBIT score was not superior to HAS-BLED for predicting major bleeding and death in a "real world" oral anticoagulated AF population. (Circ J 2016; 80: 2102-2108).

[The PROPRESE trial: results of a new health care organizational model in primary care for patients with chronic coronary heart disease based on a multifactorial intervention]. / El estudio PROPRESE: resultados de un nuevo modelo organizativo en atención primaria para pacientes con cardiopatía isquémica crónica basado en una intervención multifactorial.

OBJECTIVE: Comparison of the results from the EUROASPIRE I to the EUROASPIRE III, in patients with coronary heart disease, shows that the prevalence of uncontrolled risk factors remains high. The aim of the study was to evaluate the effectiveness of a new multifactorial intervention in order to improve health care for chronic coronary heart disease patients in primary care. METHODS: In this randomized clinical trial with a 1-year follow-up period, we recruited patients with a diagnosis of coronary heart disease (145 for the intervention group and 1461 for the control group). An organizational intervention on the patient-professional relationship (centered on the Chronic Care Model, the Stanford Expert Patient Programme and the Kaiser Permanente model) and formative strategy for professionals were carried out. The main outcomes were smoking control, low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP) and diastolic blood pressure (DBP). A multivariate analysis was performed. RESULTS: The characteristics of patients were: age (68.4±11.8 years), male (71.6%), having diabetes mellitus (51.3%), dyslipidemia (68.5%), arterial hypertension (76.7%), non-smokers (76.1%); LDL-C < 100mg/dL (46.9%); SBP < 140mmHg (64.5%); DBP < 90 (91.2%). The multivariable analysis showed the risk of good control for intervention group to be: smoking, adjusted relative risk (aRR): 15.70 (95% confidence interval [95%CI], 4.2-58.7); P < .001; LDL-C, aRR: 2.98 (95%CI, 1.48-6.02); P < .002; SPB, aRR: 1.97 (95%CI, 1.21-3.23); P < .007, and DBP: aRR: 1.51 (95%CI, 0.65-3.50); P < .342. CONCLUSIONS: An intervention based on models for chronic patients focused in primary care and involving patients in medical decision making improves cardiovascular risk factors control (smoking, LDL-C and SBP). Chronic care strategies may be an efficacy tool to help clinicians to involve the patients with a diagnosis of CHD to reach better outcomes.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial.

BACKGROUND: To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. METHODS/DESIGN: Experimental study. Randomized clinical trial. Follow-up period: one year. STUDY SETTING: primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. DISCUSSION: This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. TRIAL REGISTRATION: NCT01826929.

Trends in clinical profile and medical treatments of atrial fibrillation patients over the last 10 years.

AIM: We sought to define trends in AF prevalence and its medical management using recent data based on data from two cross-sectional studies performed in a European country in 1999 and 2009. METHODS: CARDIOTENS 1999 and CARDIOTENS 2009 were two observational, cross-sectional, multicenter studies. Patients were recruited in from primary care and cardiology outpatient clinics. A total of 32 051 and 25 137 subjects were analyzed in the two studies, 1540 and 1524 of them, respectively, diagnosed with AF. RESULTS: Over the course of the study period there was an increase in the prevalence of AF (from 4.8% to 6.1%), mainly due to the higher prevalence of AF in patients aged over 70 years (24.7% vs. 37.1%). Furthermore, patients with AF had a higher prevalence of hypertension (64.9% vs. 87.0%), diabetes (19.0% vs. 37.4%), heart failure (30.8% vs. 34.8%), coronary artery disease (23.0% vs. 25.8%) and previous stroke (1.5% vs. 8.9%). An overall increase in prescription of antithrombotic/antiplatelet therapy was observed (33.0% vs. 62.7% and 31.0% vs. 38.2% respectively); the difference observed in 1999 between prescription of oral anticoagulation by general practitioners and cardiologists was not seen in the later study. Differences in prescription of angiotensin-converting enzyme inhibitors (28.0% vs. 40.7%), angiotensin receptor blockers (10.0% vs. 40.0%), beta-blockers (14.0% vs. 41.5%) and calcium channel blockers (21.0% vs. 34.9%) were also identified. CONCLUSIONS: The number of patients with AF and a higher risk for thromboembolic events increased over the last 10 years. More aggressive antithrombotic treatment has been observed, especially in older patients.

Carotid resistive index in treated hypertensive patients: relationship with target organ damage.

AIM: The resistive index (RI) is a hemodynamic parameter that reflects local wall extensibility and related vascular resistance. We analyze the relationship between common carotid RI and target organ damage in treated hypertensive patients. METHODS: We analyzed 265 consecutive hypertensive patients. Risk factors, cardiovascular history and treatments were collected; blood test, urinary albumin excretion (UAE), echocardiography to determine left ventricular mass index (LVMI), ankle-brachial index (ABI) and carotid echo-Doppler ultrasound to calculate the carotid intima-media thickness (IMT) and RI of both common carotids arteries were performed. RESULTS: A positive correlation was found between carotid RI and age, systolic blood pressure, heart rate, carotid IMT, LVMI, UAE and a negative correlation was found with diastolic blood pressure and ABI. Subjects at the top quartile of carotid RI showed a higher prevalence of left ventricular hypertrophy and peripheral artery disease (increased IMT, carotid plaques and lower ABI) compared with those with low RI (p < 0.05). Multiple regression analysis demonstrated that age, systolic and diastolic blood pressure and LVMI independently influence carotid RI. CONCLUSION: Carotid RI is related with age, systolic-diastolic blood pressure and LVMI in hypertensive patient. This evaluation could predict the presence of early cardiovascular damage and provide an accurate estimation of overall risk in this population.

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.

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.

Pathological ankle-brachial index is equivalent of advanced age in acute coronary syndromes.

BACKGROUND: Age is one the factors associated with poor prognosis in acute coronary syndromes (ACS) and elderly patients are a high-risk collective with few parameters for mid-term cardiovascular stratification. We aimed to assess the predictive value of ankle-brachial index (ABI) in patients (> 75 years) for 1-year mortality after an ACS. MATERIALS AND METHODS: Prospective, observational and multicentre study of ACS patients in whom ABI was assessed during hospitalization. RESULTS: A total of 1·054 patients were included, mean age 66·6 (11·7) years from whom 26·6% were > 75 years. Elderly patients showed more history of cardiovascular disease and higher prevalence of all risk factors, except current smoking. Angiography and revascularization were performed less frequently in the elderly. Patients > 75 years showed higher presence of three vessel coronary disease and received fewer guideline-recommended treatments. Patients who died through the follow-up, mean time 387·9 ± 7·2 days, had lower ABI (0·73 ± 0·24 vs. 0·92 ± 0·22; P < 0·01), also in the elderly patients (0·73 ± 0·24 vs. 0·86 ± 0·23; P < 0·01). Cox regression analysis identified age > 75 years (HR: 2·30; IC 95% 1·26-4·18; P < 0·01) and ABI < 0·90 (HR: 3·58; IC 95% 1·80-7·15; P < 0·01) as risk factors for to 1-year mortality. Mortality was similar in elderly patients with ABI > 0·90 and young patients with ABI < 0·90; the worst prognosis was observed in elderly patients with ABI < 0·90 (HR: 10·01; 95% CI 3·74-27·15). CONCLUSIONS: Elderly patients represent a relevant collective of patients with ACS and are treated less optimally. ABI predicts 1-year mortality after an ACS in elderly patients.

Clinical effectiveness of a cardiology outpatient management plan to reduce inefficiency in consultations.

Objectives: Longer delays in carrying out complementary tests in cardiology services have resulted in patients arriving for consultation without these tests being performed (inefficient consultations). To ameliorate this situation, a management-based intervention was designed, optimizing the available resources and modifying the appointment system. Therefore, our objective was to determine the effectiveness of this intervention to reduce the number of inefficient consultations and improve the clinical care process.Methods: A non-randomized experimental study comparing two periods (pre- and post-intervention) was designed, analyzing a total of 473 outpatients attending cardiology consultations in a Spanish region in February 2014 (pre-intervention) and 441 patients attending cardiology consultations in November 2014 (post-intervention). The outcome of management measures aimed at optimizing coordination in outpatient care to reduce inefficient consultations was analyzed. After the visit, treatment modifications, requests for new examinations or tests, outpatient discharges, and new diagnoses were evaluated.Results: In the pre-intervention period, 37.2% of the patients had not had the tests performed, while in the post-intervention period, this figure dropped to 10.7% (p < 0.001). When the patients had all the tests completed, there was an increase in the number of new examinations (p < 0.001), outpatient discharges (p < 0.001) and new diagnoses (p = 0.004). Treatment modifications were not significant (p = 0.223).Conclusions: The intervention proved effective, clinically relevant, and statistically significant in reducing the proportion of inefficient consultations, thereby enabling continuation of the clinical care process.

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.

A simple score to select patients for manual thrombectomy in emergent percutaneous coronary interventions: the DDTA score.

BACKGROUND: The objective of manual thrombectomy is the removal of occlusive thrombus to improve the results of primary angioplasty. The better understanding of the factors associated with successful manual thrombectomy may provide relevant information regarding thrombus formation and resolution. METHODS: Observational study of all consecutive patients remitted for emergent percutaneous coronary intervention (PCI) in a single centre. Successful manual thrombectomy was considered when TIMI 3 was achieved after using the device and a score to predict successful manual thrombectomy was designed. RESULTS: We included 618 patients, 65.1% treated with manual thrombectomy. No relevant differences in clinical features or time delays were observed between patients treated with vs. without manual thrombectomy, but manual thrombectomy treated patients received more often dual antiplatelet treatment (DAPT) before PCI. Final TIMI flow 3 was achieved in most patients and more frequently in manual thrombectomy treated patients (94.8 vs. 86.6%; P < 0.01). The successful manual thrombectomy rate was 81.3% and it was higher in patients pretreated with DAPT (89.0 vs. 73.3%; P < 0.01). The time delay to first medical contact was not related to the final TIMI 3, but it was significantly and negatively related to successful manual thrombectomy. According to the multivariate analysis, we designed the DDTA score: DAPT pretreatment (2), delay less than 2 h (3) or 2-4 h (2), TIMI flow improvement after wiring the lesion (2) and age less than 55 years (3). Patients with DDTA score at least 4 had lower no-reflow, mortality and major cardiovascular complications incidence. CONCLUSION: The DDTA score (DAPT pretreatment, time delays, TIMI flow improvement after wiring the lesion and age) identifies patients who benefit mostly from manual thrombectomy.

Relationship of adverse events to quality of anticoagulation control in atrial fibrillation patients with diabetes: real-world data from the FANTASIIA Registry.

BACKGROUND: Atrial fibrillation (AF) patients with diabetes (DM) have high risk of cardiovascular events. PURPOSE: To compare clinical characteristics, adverse outcomes and quality of anticoagulation in AF patients regarding DM status. METHODS: AF patients from FANTASIIA registry were included. Baseline characteristics and comorbidities were recorded. After 2-years follow-up, the association between adverse events and DM was evaluated. RESULTS: 1956 patients (mean age 73.8 ± 9.5 years, 56% male) were analyzed; 574 (29.3%) had DM. Diabetic patients had also high prevalence of hypertension (90.6% vs 76.1%; p < .001) or renal disease (21.4% vs 15.9%; p < .001). After median follow-up of 1077 days (IQR 766-1113 days), diabetic patients had high total mortality (16.9%/year vs 11.4%/year; p < .001), cardiovascular mortality (9.1%/year vs 3.9%/year; p < .001) and MACE (12.9%/year vs 6.8%/year; p < .001). DM patients had poor anticoagulation control (time in therapeutic range: 58.52 ± 24.37% vs 62.68 ± 25.31%; p = .002). DM with lower TTR showed higher cardiovascular death and MACE. Multivariate analysis showed an independent association between DM and cardiovascular mortality [HR 1.73 (IC95% 1.07-2.80); p = .024]. CONCLUSION: AF Diabetic patients have higher comorbidities and poorer TTR than nondiabetic patients. Low TTR was associated with adverse events. The risk of cardiovascular outcomes was higher in DM patients, with independent association between DM and mortality risk.

Association of Body Mass Index With Clinical Outcomes in Patients With Atrial Fibrillation: A Report From the FANTASIIA Registry.

Background Obesity and atrial fibrillation (AF) frequently coexist and independently increase mortality. We sought to assess the association between obesity and adverse events in patients receiving oral anticoagulants for AF. Methods and Results Consecutive AF outpatients receiving anticoagulant agents (both vitamin K antagonists and direct oral anticoagulants) were recruited into the FANTASIIA (Atrial fibrillation: influence of the level and type of anticoagulation on the incidence of ischemic and hemorrhagic stroke) registry. This observational, multicenter, and prospective registry of AF patients analyzes the quality of anticoagulation, incidence of events, and differences between oral anticoagulant therapies. We analyzed baseline patient characteristics according to body mass index, normal: <25 kg/m2, overweight: 25-30 kg/m2, and obese: ≥30 kg/m2), assessing all-cause mortality, stroke, major bleeding and major adverse cardiovascular events (a composite of ischemic stroke, myocardial infarction, and total mortality) at 3 years' follow-up. In this secondary prespecified substudy, the association of weight on prognosis was evaluated. We recruited 1956 patients (56% men, mean age 73.8±9.4 years): 358 (18.3%) had normal body mass index, 871 (44.5%) were overweight, and 727 (37.2%) were obese. Obese patients were younger (P<0.01) and had more comorbidities. Mean time in the therapeutic range was similar across body mass index categories (P=0.42). After a median follow-up of 1070 days, 255 patients died (13%), 45 had a stroke (2.3%), 146 a major bleeding episode (7.5%) and 168 a major adverse cardiovascular event (8.6%). Event rates were similar between groups for total mortality (P=0.29), stroke (P=0.90), major bleeding (P=0.31), and major adverse cardiovascular events (P=0.24). On multivariate Cox analysis, body mass index was not independently associated with all-cause mortality, cardiovascular mortality, stroke, major bleeding, or major adverse cardiovascular events. Conclusions In this prospective cohort of patients anticoagulated for AF, obesity was highly prevalent and was associated with more comorbidities, but not with poor prognosis.

Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study.

INTRODUCTION AND OBJECTIVES: To compare the long-term results of direct oral anticoagulants (DOAC) vs vitamin K antagonists (VKA) in real-world-patients with nonvalvular atrial fibrillation (NVAF) in a nationwide, prospective study. METHODS: The FANTASIIA registry prospectively included outpatients with AF anticoagulated with DOAC or VKA (per protocol, proportion of VKA and DOAC 4:1), consecutively recruited from June 2013 to October 2014 in Spain. The incidence of major events was analyzed and compared according to the anticoagulant treatment received. RESULTS: A total of 2178 patients were included in the study (mean age 73.8±9.4 years), and 43.8% were women. Of these, 533 (24.5%) received DOAC and 1645 (75.5%) VKA. After a median follow up of 32.4 months, patients receiving DOAC vs those receiving VKA had lower rates of stroke-0.40 (95%CI, 0.17-0.97) vs 1.07 (95%CI,0.79-1.46) patients/y, P=.032-, severe bleedings-2.13 (95%CI, 1.45-3.13) vs 3.28 (95%CI, 2.75-3.93) patients/y; P = .044-, cardiovascular death-1.20 (95%CI, 0.72-1.99) vs 2.45 (95%CI, 2.00-3.00) patients/y; P = .009-, and all-cause death-3.77 (95%CI, 2.83-5.01) vs 5.54 (95%CI, 4.83-6.34) patients/y; P = .016-. In a modified Cox regression model by the Andersen-Gill method for multiple events, hazard ratios for patients receiving DOAC were: 0.42 (0.16-1.07) for stroke; 0.47 (0.20-1.16) for total embolisms; 0.76 (0.50-1.15) for severe bleedings; 0.67 (0.39-1.18) for cardiovascular death; 0.86 (0.62-1.19) for all-cause death, and 0.82 (0.64-1.05) for the combined event consisting of stroke, embolism, severe bleeding, and all-cause death. CONCLUSIONS: Compared with VKA, DOAC is associated with a trend to a lower incidence of all major events, including death, in patients with NVAF in Spain.

Influence of sex on long-term prognosis in patients with atrial fibrillation treated with oral anticoagulants. Results from the prospective, nationwide FANTASIIA study.

BACKGROUND: While many risk factors for Atrial Fibrillation (AF) have been identified, there are important differences in their relative impact between sexes. The aim of our study was to investigate the influence of sex as a long-term predictor of adverse events in "real world" AF patients treated with direct oral anticoagulants. METHODS: The FANTASIIA registry is a prospective, national and multicentric study including outpatients with anticoagulated AF patients. Baseline characteristics and adverse events at 3 years of follow-up were collected and classified by sex. Cox multivariate analysis was performed to investigate the role of sex in major events and composite outcomes. RESULTS: A total of 1956 patients were included in the study. 43.9% of them were women, with a mean age of 73.8 ± 9.4 years (women were older 76.5 ± 7.9 vs 71.7 ± 10.1, p<0.001). Women had higher rate of cardiovascular risk factors and higher mean of CHA2DS2-VASc (4.4 ± 1.4 vs 3.7 ± 1.6, p<0.001) and HAS-BLED (2.1 ± 1.0 vs 1.9 ± 1.1, p<0.001) than men. After 3 years of follow-up, rates of major events were similar in both groups with limit difference for all-cause mortality (4.4%/year in women vs 5.6%/year in men; p = 0.056). However, all the composite events were more frequent in women. We observed in the non-adjusted adverse events lower rate of all-cause mortality (HR 0.62, 95%CI 0.47-0.81; p<0.001), composite 1 outcomes (HR 0.80, 95%CI 0.65-0.98; p = 0.029) and composite 2 (HR 0.77, 95%CI 0.64-0.94; p = 0.010) in women compared with men. In multivariate Cox regression analysis observed that female sex was an independently protector factor for all-cause mortality and for the composite outcomes 1 and 2. CONCLUSIONS: In this "real world" study of anticoagulated AF patients, women could have a protective role against development of adverse events, mainly on all-cause mortality and combined events.

Incidence and predictors of stroke in patients discharged with the diagnosis of acute coronary syndrome.

BACKGROUND: Stroke is one the most feared cardiovascular disease due to its high risk of disability and its incidence after an acute coronary syndrome (ACS) is not uncommon. METHODS: Retrospective study of all consecutive patients admitted for an ACS in two hospitals. Competing risk regression, taking all-cause mortality as a competing event, was used for the assessment of stroke incidence. RESULTS: We included 8771 patients, AF prevalence 12.4%. AF patients were older and presented higher prevalence of cardiovascular risk factors, previous cardiovascular disease, and lower glomerular filtration rate. Less than half of AF patients were receiving oral anticoagulation before admission. In-hospital mortality was 5.1% and it was more than two-fold higher in AF patients (10.2% vs. 4.4%; p < 0.01). Relevant differences on medical treatments were observed at discharge and oral anticoagulation was roughly <50% in AF patients. During a median follow-up was 58.7 months, 313 patients experienced at least one stroke (incidence 3.8%, 95% CI 3.4-4.2,) and it was 2-fold higher in patients with AF: 7.8% vs. 3.3% (p < 0.01). Median time to first stroke was 33.0 (30.1) months and it was shorter for AF patients compared to non-AF patients (28.2 ±â€¯22.3 vs. 34.6 ±â€¯31.1; p < 0.01). The adjusted competing risk regression identified AF, previous stroke and CHA2DS2-VASc score = 2 or ≥3 as independent predictors of stroke; CHA2DS2-VASc score = 2 was associated to higher risk of stroke only in AF patients. CONCLUSIONS: The long-term incidence of stroke after an ACS was 3.8%, 7.8% in AF-patients and 3.3% in patients without any diagnosis of AF.

Prognosis and lipid profile improvement by a specialized outpatient clinic for acute coronary syndrome patients.

BACKGROUND AND AIMS: Prognosis variations in patients discharged after an acute coronary syndrome (ACS) according to the professionals involved has not been clearly outlined. The aim of our study was to assess the impact on a specific outpatient clinic (SOC). METHODS: We included all consecutive patients admitted for an ACS in a single center. We performed a propensity score matching with all patients discharged from hospital according to whether they were referred to the SOC or not. RESULTS: From the 1822 patients discharged, 260 couples of well-balanced ACS patients were obtained after propensity score matching. Median follow-up was 43.3 months and cardiovascular mortality rate was 10.4%, all-cause mortality was 13.9% and any MACE 38.2%. Patients attended the SOC had significantly lower rates at all three endpoints. Multivariate analysis results showed how the follow-up in the SOC was associated with significantly lower risk at all endpoints. SOC patients also had significantly lower rate at hospital readmissions and the multivariate analysis identified a negative association between the first cardiovascular readmission and SOC (sHR: 0.26 95%CI 0.18-0.367; p < 0.01). Mean LDLc levels at the time of ACS admission was 99.0 (36.7) mg/dl and no difference was observed in patients referred to SOC vs. non-referred. Patients followed at the SOC achieved significantly lower LDLc and higher percentage of LDLc <70 mg/dl (56.7% vs. 36.7%; p < 0.01). SOC follow-up was associated with 44% higher probability of final LDLc <70 mg/dl. CONCLUSIONS: An SOC for ACS patients was independently associated with higher LDLc control and long-term survival.