Background There is limited prospective real-world evidence of patients with atrial fibrillation (AF) in Latin America. Methods The rationale and design of the study were previously published (1). Briefly, RECALL was the first nationwide prospective study of patients in Brazil with known atrial fibrillation. A total of 4,585 patients were included among 89 sites from April 2012 to August 2019. All patients were followed for one year by the protocol. Patient characteristics, medications under use and clinical outcomes during the follow-up were collected. Results From the total of patients enrolled, 41 were excluded from the analysis since they did not have a confirmed diagnosis of atrial fibrillation. The median age was 70 (61–78) years, 46% were women and the majority of the cases were permanent AF (53,8%). The mean CHA2DS2VASc was 3.2±1.6 and the median HASBLED was 2 [2–3]. The most common risk factor was arterial hypertension (77.9%). The median heart rate was 74 [65–85] and the mean ejection fraction was 52.2±2.6 (%). Only 4.4% of patients had history of previous ablation and 30.4% were using anti-arrhythmic. At baseline, 22.0% did not use anticoagulants (Figure 1) and 9.1% did not use any antithrombotic therapy. The most common anticoagulant was vitamin K antagonist – VKA (62.6%) while the remaining 37.4% were direct oral anticoagulants. The main reasons for not using an oral anticoagulant were physician judgment's (low risk of stroke – 24.6%) and difficult to control (14.7%) or perform INR (9.9%) while patient preference and adverse event represented respectively 5.3% and 4.1%, respectively. Only 42.5% of the INRs at baseline were between 2 and 3. During follow-up, the use of anticoagulants and INR in the therapeutic range increased to 87.1% and 59.1%, respectively. In one year, 17.8% of patients were hospitalized due to atrial fibrillation. At 1 year, the rates of death, stroke, systemic embolism and major bleeding were 5.76 [5.12–6.47], 2.77 [2.32–3.32] 1.01 [0.75–1.36], 2.21 [1.81–2.70], respectively. Among VKA users, the rate of mortality and bleeding was higher in the group with time in therapeutic range below 60% (Figure 2). Conclusion RECALL represents the largest prospective registry of patients with atrial fibrillation in Latin America. Our findings highlight important gaps in the treatment of patients which can inform clinical practice and help to guide future interventions to improve the care of these patients. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Brazilian Society of Cardiology
Background In the ACTION trial, therapeutic anticoagulation did not show benefit on mortality, days of hospitalization and oxygens therapy at 30 days among patients with COVID19. However, this strategy was associated with higher rate of bleeding and a potential reduction in the rate of clinical thrombotic events. The current analysis evaluated which variables were independently associated with both outcomes in order to help the identification of the risk for thrombotic and hemorrhagic events among patients with COVID19. Methods A total of 615 patients hospitalized with COVID-19 and elevated D-dimer levels were randomly assigned to prophylactic anticoagulation (mainly in-hospital heparin) or a therapeutic strategy that used in-hospital rivaroxaban 20 mg daily for stable patients, or enoxaparin 1 mg/kg twice daily for unstable patients, followed by rivaroxaban through 30 days. One patient withdrew consent and was not included in the analysis. The current analysis tested baseline clinical characteristics and laboratorial exams one by one with independent logistic regressions for the composite of bleeding (major bleeding and clinically relevant nonmajor bleeding) and thrombotic events (venous thromboembolism, myocardial infarction, stroke, systemic embolism, and major adverse limb events). Significant variables (p<0.05) were selected to adjust several multiple logistic models. Final models were chosen based on Akaike information criterion and therapeutic anticoagulation was included in the final model based on the primary results of the trial. Results The model for bleeding events showed an accuracy of area under the curve (AUC) of 0.635 (table 1) while the model for thrombotic events had an AUC of 0.725 (table 2). Level of respiratory support (especially invasive ventilation) was associated with both outcomes in the multivariable analysis (tables 1 and 2). Beyond respiratory support, level of creatinine and history of coronary disease were also independently associated to the risk of thrombotic events. When the utilization of therapeutic anticoagulation (mainly with rivaroxaban) was included in the multivariable analysis, this variable was strongly associated with higher risk of bleeding (model AUC of 0.718) but was not associated with lower rate of thrombotic events (Tables 1 and 2). Conclusion Since the variables associated with higher risk of thrombotic events are similar to the variables associated to bleeding complications, the selection of patients with better balance of risk vs. benefit to use therapeutic anticoagulation in COVID-19 still a challenging decision. Coronary disease and creatine may help to identify patients at higher risk of thrombotic complications while the use of therapeutic dose of direct oral anticoagulant increased the risk of bleeding in almost 4 times among patients hospitalized due to COVID19. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Investigator initiated research with financial support of Bayer
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