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.

Relation of Renal Dysfunction to Quality of Anticoagulation Control in Patients with Atrial Fibrillation: The FANTASIIA Registry.

BACKGROUND: One-third of atrial fibrillation (AF) patients have chronic kidney disease (CKD), a condition that itself increases thromboembolic and major bleeding risks, especially in patients with severe CKD. Bleeding would be accentuated by suboptimal anticoagulation control with vitamin K antagonists (VKA). PURPOSE: This article aimed to investigate the incidence of cardiovascular events, mortality and quality of anticoagulation in relation to CKD in a 'real-world' prospective cohort of AF patients included in the FANTASIIA registry. METHODS: We analysed consecutive AF patients who were prospectively recruited with a year of follow-up. The quality of anticoagulation was estimated by time in therapeutic range (TTR). The annual incidence of events was analysed. RESULTS: We studied 1,936 patients (male: 55.7%, mean: 73.8 ± 9.4 years): 445 (22.9%) had normal function, 698 (36.1%) had mild CKD, 713 (36.8%) had moderate CKD and 80 (4.2%) had severe CKD. Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (severe CKD) had lower TTR (53.3 ± 25.6% vs. 61.8 ± 25.1%, p = 0.007) and higher proportion of poor TTR (67.2 vs. 51.8%; p = 0.014) than patients with eGFR ≥30 mL/min/1.73 m2. Severe CKD was significantly associated with cardiovascular mortality (hazard ratio [HR]: 9.33; p = 0.002), major bleeding (HR: 2.94; p = 0.036) and major adverse cardiovascular events (MACE) (HR: 4.93; p = 0.004). Importantly, 375 patients (21.1%) showed a deteriorating eGFR of ≥10 mL/min during the follow-up, with significantly higher mortality and cardiovascular events. CONCLUSION: In a prospective and real-world AF registry, approximately 67% of patients with severe CKD had poor anticoagulation control while taking VKA. The presence of severe CKD was an independent factor for cardiovascular mortality, MACE and major bleeding. Worsening eGFR of only ≥10 mL/min during follow-up was significantly associated with mortality and major bleeding.

Inappropriate doses of direct oral anticoagulants in real-world clinical practice: prevalence and associated factors. A subanalysis of the FANTASIIA Registry.

Aims: To describe the prevalence and associated factors of inappropriate doses of direct oral anticoagulants (DOAC) in a national registry of patients of real clinical practice. Methods and results: Five hundred and thirty outpatients with atrial fibrillation treated with DOAC were included in a prospective, national, multicentre study. The appropriateness of the doses of DOAC was defined according to the recommendations of the European Heart Rhythm Association. Mean age was 73 ± 9 years, with a 46% of women. Two hundred and sixty-seven patients were prescribed dabigatran, 190 rivaroxaban, and 73 apixaban. A total of 172 patients (32%) did not receive the appropriate dose: 93 patients received a lower dose (18%) and 79 patients a higher dose (15%). In the comparisons among the subgroups of inappropriately low, appropriate, and inappropriately high dose, we observed significant trends to older age (69 ± 8 years vs. 73 ± 10 years vs. 77 ± 6 years), more frequent female sex (37% vs. 46% vs. 59%), antiplatelet drugs (5% vs. 8% vs. 25%), rivaroxaban (14% vs. 38% vs. 53%), and apixaban use (5% vs. 15% vs. 19%), higher CHAD2DS2-VASc (3.00 ± 1.38 vs. 3.58 ± 1.67 vs. 4.59 ± 1.44) and HAS-BLED scores (1.83 ± 0.87 vs. 1.92 ± 1.07 vs. 2.47 ± 1.13), lower body mass index (30 ± 6 kg/m2 vs. 29 ± 4 kg/m2 vs. 28 ± 4 kg/m2) and glomerular filtration rate (74 ± 27 mL/min vs. 70 ± 22 mL/min vs. 63 ± 16 mL/min), and lower frequency of dabigatran use (81% vs. 47% vs. 28%) (all comparisons P ≤ 0.01). Conclusion: In this real-life study, 32% of patients received an inappropriate dose of DOAC. Several clinical factors can identify patients at risk of this situation.

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.

Usefulness of the 2MACE Score to Predicts Adverse Cardiovascular Events in Patients With Atrial Fibrillation.

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.