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BACKGROUND: Vitamin K antagonists (VKA) represent an important therapeutic strategy offered by the Brazilian Unified Public Health System to patients with atrial fibrillation (AF). However, predictors of relevant clinical outcomes are understudied in the real world. OBJECTIVE: To determine the incidence and independent predictors of clinical outcomes in patients with valvular and nonvalvular AF treated with VKA. METHODS: This prospective cohort included patients with valvular and nonvalvular AF receiving VKA for ≥ 1 year. The primary outcomes were cardiovascular death, thromboembolic events, and major and clinically relevant non-major bleeding, separately and as a composite outcome. The outcomes were independently adjudicated. P values < 0.05 were considered statistically significant. RESULTS: The study included 1,350 patients, with a mean age of 69.2 (± 11.8) years, 53.6% female, followed up for 17 (15 - 19) months. The annual incidence of thromboembolic events and cardiovascular death was 4.4%, and predictors were prior thromboembolism (hazard ratio [HR] 2.12; 95% confidence interval [CI] 1.22 - 3.67), time in therapeutic range (TTR) < 50% (HR 1.98; 95% CI 1.16 - 3.37), and glomerular filtration rate (GFR) < 45 mL/min/1.73 m2 (HR 2.76; 95% CI 4.82 - 1.58). The rate of major and clinically relevant non-major bleeding was 3.24% per year (95% CI 2.47 - 4.14), and predictors were prior bleeding (HR 2.60; 95% CI 1.47 - 4.61) and mechanical prosthesis (HR 1.91; 95% CI 1.15 - 3.15). The composite outcome was 8.7% per year, and predictors were prior bleeding (HR 1.70; 95% CI 1.07 - 2.70), TTR < 41% (HR 1.79; 95% CI 1.11 - 2.86), and left atrial diameter > 44 mm (HR 1.97; 95% CI 3.26 - 1.19). CONCLUSIONS: Prior thromboembolism or bleeding, reduced GFR and TTR levels, and enlarged left atrium were predictors of clinical outcomes in patients with AF treated with VKA.

FUNDAMENTO: Antagonistas da vitamina K (AVK) representam uma importante estratégia terapêutica oferecida pelo Sistema Único de Saúde no Brasil aos pacientes com fibrilação atrial (FA). Entretanto, os preditores de desfechos clínicos relevantes são pouco estudados no mundo real. OBJETIVO: Determinar a incidência e os preditores independentes de desfechos clínicos em pacientes com FA valvar e não valvar tratados com AVK. MÉTODOS: Coorte prospectivo de pacientes com FA valvar e não valvar em uso ≥ 1 ano de AVK. Desfechos primários foram morte cardiovascular, eventos tromboembólicos, sangramento maior e não maior clinicamente relevante, separadamente e como desfecho composto, e adjudicados de modo independente. Valores de p < 0,05 foram considerados estatisticamente significantes. RESULTADOS: Incluídos 1.350 pacientes, idade média de 69,2 (± 11.8) anos e 53,6% do sexo feminino, seguidos por 17 (15 - 19) meses. Incidência anual de eventos tromboembólicos e morte cardiovascular foi 4,4% e preditores foram tromboembolismo prévio (hazard ratio [HR] 2,12; intervalo de confiança [IC] de 95% 1,22 - 3,67), tempo na faixa terapêutica (TFT) < 50% (HR 1,98; IC95% 1,16 - 3,37), e taxa de filtração glomerular (TFG) < 45 mL/min/1.73 m2 (HR 2,76; IC95% 4,82 - 1,58). Taxa de sangramento maior e não maior clinicamente relevante foram 3,24% por ano (IC95% 2,47 - 4,14) e preditores foram sangramento prévio (HR 2,60; IC95% 1,47 - 4,61) e prótese mecânica (HR 1,91; IC95% 1,15 - 3,15). O desfecho composto foi 8,7% por ano e preditores foram sangramento prévio (HR 1,70; IC95% 1,07 - 2,70), TFT < 41% (HR 1,79; IC95% 1,11 - 2,86) e diâmetro do átrio esquerdo > 44 mm (HR 1,97; IC95% 3,26 - 1,19). CONCLUSÕES: Tromboembolismo ou sangramento prévios, TFG e TFT reduzidos e átrio esquerdo aumentado foram preditores de desfechos clínicos em pacientes com FA tratados com AVK.

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OBJECTIVE: Acute Pulmonary Embolism (APE) is a disease with increasing incidence worldwide. Antithrombotics are the cornerstone of the treatment. Bleeding is an adverse event related to this therapy. The objective was to evaluate the prevalence of bleeding in a sample of Brazilian patients hospitalized with APE and the impact of this complication on mortality. Additionally, the performance of some bleeding predictive scores was evaluated in this sample. METHODS: A retrospective cohort study was carried out on patients hospitalized with APE from January 2009 through August 2017. The medical records of these patients were reviewed, and the bleeding recorded during hospital stay was classified according to the "Thrombolysis in Myocardial Infarction (TIMI) bleeding risk." Five different predictive scores for bleeding after APE (RIETE, PE-SARD, VTE-BLEED, Kuijer, and ATRIA) were applied. Overall mortality at 30 days and one year were assessed. RESULTS: One hundred fifty-nine patients were included. The prevalence of any bleeding was 36/159 (23 %), major bleeding was 10/159 (06 %), minor bleeding was 11/159 (07 %), and bleeding requiring attention was 15/159 (10 %). Only major bleeding was associated with higher mortality at one-year follow-up with a Relative Risk (RR) of 2.00 (95 % CI 1.16-3.57; p = 0.044). All bleeding predictive scores evaluated showed low accuracy in identifying patients at higher risk of bleeding. CONCLUSION: Patients hospitalized with APE in Brazil had a high prevalence of bleeding. The major bleeding increased the one-year mortality. The bleeding predictive scores assessed showed limited accuracy in identifying patients at high risk of bleeding.

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BACKGROUND: In hospitalized patients undergoing therapeutic plasma exchange (TPE), it is not known how TPE-associated bleeding risk is impacted by a prior bleeding episode. Therefore, to assess the prevalence and predictors of bleeding recurrence, we analyzed data from the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). MATERIALS AND METHODS: Using a retrospective cross-sectional analysis of REDS-III public use files, we identified hospitalized adults who had a major bleeding episode prior to their first TPE procedure. Patients were classified into two cohorts based on bleeding recurrence (no-recurrence vs recurrence). After identifying potential predictors, we used multiple imputation by chained equations to impute variables with <30% missing data. Variable selection was optimized using a 10-fold cross validated least absolute shrinkage and selection operator. Final predictors were identified by fitting a logistic regression model. RESULTS: In 310 patients with major bleeding prior to TPE initiation, bleeding recurred in 121 (39.0%). We identified the following seven unique predictors: 1) >10 TPE procedures (OR 2.23); 2) intensive care unit stay (OR 1.35); 3) thrombocytopenia (OR 1.26); 4) surgery (OR 1.22); 5) hepatic disease (OR 1.21); 6) 6-10 TPE procedures (OR 1.04); and 7) Asian race (OR 1.01). We also identified the following five interactions: 1) surgery and therapeutic anticoagulation (OR 1.50); 2) 6-10 TPE procedures and therapeutic anticoagulation (OR 1.05); 3) 6-10 TPE procedures and antiplatelets (OR 1.02); 4) >10 TPE procedures and antiplatelets (OR 1.00); and 5) albumin-only TPE and antiplatelets (OR 0.53). When assessed for adjusted performance, the prediction model had a C-statistic of 0.617 (95% CI 0.613-0.619) and Brier Score of 0.342 (95% CI 0.340-0.347). DISCUSSION: In this study assessing predictors of bleeding recurrence among hospitalized patients undergoing TPE, we identified seven variables and five interactions. These findings should be validated in future studies.

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BACKGROUND: The optimal antithrombotic regimen for patients with atrial fibrillation (AF) who had an acute coronary syndrome (ACS) or have undergone percutaneous coronary intervention (PCI) is not known. OBJECTIVES: The authors sought to determine which antithrombotic regimen best balances safety and efficacy. METHODS: AUGUSTUS, a multicenter 2 × 2 factorial design randomized trial compared apixaban with vitamin K antagonist (VKA) and aspirin with placebo in patients with AF with recent ACS and/or PCI treated with a P2Y12 inhibitor. We conducted a 4-way analysis comparing safety and efficacy outcomes in the 4 randomized groups. The primary outcome was a composite of all-cause death, major or clinically relevant nonmajor bleeding, or hospitalization for cardiovascular causes over 6-month follow-up. Secondary outcomes included individual components of the primary endpoint. RESULTS: A total of 4,614 patients were enrolled. All patients were treated with a P2Y12 inhibitor. The primary endpoint occurred in 21.9% of patients randomized to apixaban plus placebo, 27.3% randomized to apixaban plus aspirin, 28.0% randomized to VKA plus placebo, and 33.3% randomized to VKA plus aspirin. Rates of major or clinically relevant nonmajor bleeding and hospitalization for cardiovascular causes were lower with apixaban and placebo compared with the other 3 antithrombotic strategies. There was no difference between the 4 randomized groups with respect to all-cause death. CONCLUSIONS: In patients with AF and a recent ACS and/or PCI, an antithrombotic regimen that included a P2Y12 inhibitor and apixaban without aspirin resulted in a lower incidence of the composite of death, bleeding, or cardiovascular hospitalization than regimens including VKA, aspirin, or both. (An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention; NCT02415400).

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The role of aspirin in cardiovascular primary prevention remains controversial. There are physiological reasons to explore its potential benefits in patients with high levels of lipoprotein(a) [Lp(a)], mainly due to its antifibrinolytic properties and interactions with platelets. The primary objective of this systematic review was to evaluate the cardiovascular benefits and bleeding risks associated with aspirin use in patients who have elevated Lp(a) levels but no history of cardiovascular disease. This systematic review was conducted following PRISMA guidelines. We performed a literature search to identify studies assessing the cardiovascular benefits and bleeding risks of aspirin use in patients with elevated Lp(a) levels (or a related genetic variant) who have no history of cardiovascular disease. Five studies (49,871 individuals) were considered for this systematic review. Three studies assessed the impact of aspirin use in relation to genetic variants associated with elevated Lp(a) levels (SNP rs379822), while the remaining two studies directly measured plasma levels of Lp(a). The endpoints evaluated varied among the studies. Overall, the findings consistently show that carriers of the apolipoprotein(a) variant or patients with Lp(a) levels > 50 mg/dL experience a reduction in cardiovascular risk with aspirin use. No significant bleeding issues were observed, although such events were reported in only two studies. This systematic review suggests that aspirin use in patients with elevated Lp(a) levels and no prior cardiovascular history may reduce cardiovascular risk. The available data on bleeding risk is insufficient.

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The efficacy and safety of direct oral anticoagulants (DOAC) in patients with embolic stroke of undetermined source (ESUS) remains unclear. We systematically searched PubMed, Embase, and Cochrane Library for randomized controlled trials (RCT) comparing DOACs versus aspirin in patients with ESUS. Risk ratios (RR) and 95% confidence intervals (CI) were computed for binary endpoints. Four RCTs comprising 13,970 patients were included. Compared with aspirin, DOACs showed no significant reduction of recurrent stroke (RR 0.95; 95% CI 0.84-1.09; p = 0.50; I2 = 0%), ischemic stroke or systemic embolism (RR 0.97; 95% CI 0.80-1.17; p = 0.72; I2 = 0%), ischemic stroke (RR 0.92; 95% CI 0.79-1.06; p = 0.23; I2 = 0%), and all-cause mortality (RR 1.11; 95% CI 0.87-1.42; p = 0.39; I2 = 0%). DOACs increased the risk of clinically relevant non-major bleeding (CRNB) (RR 1.52; 95% CI 1.20-1.93; p < 0.01; I2 = 7%) compared with aspirin, while no significant difference was observed in major bleeding between groups (RR 1.57; 95% CI 0.87-2.83; p = 0.14; I2 = 63%). In a subanalysis of patients with non-major risk factors for cardioembolism, there is no difference in recurrent stroke (RR 0.98; 95% CI 0.67-1.42; p = 0.90; I2 = 0%), all-cause mortality (RR 1.24; 95% CI 0.58-2.66; p = 0.57; I2 = 0%), and major bleeding (RR 1.00, 95% CI 0.32-3.08; p = 1.00; I2 = 0%) between groups. In patients with ESUS, DOACs did not reduce the risk of recurrent stroke, ischemic stroke or systemic embolism, or all-cause mortality. Although there was a significant increase in clinically relevant non-major bleeding, major bleeding was similar between DOACs and aspirin.

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Central nervous system (CNS) malignant neoplasms may lead to venous thromboembolism (VTE) and bleeding, which result in rehospitalization, morbidity and mortality. We aimed to assess the incidence of VTE and bleeding in this population. METHODS: This systematic review and meta-analysis (PROSPERO CRD42023423949) were based on a standardized search of PubMed, Virtual Health Library and Cochrane (n = 1653) in July 2023. After duplicate removal, data screening and collection were conducted by independent reviewers. The combined rates and 95% confidence intervals for the incidence of VTE and bleeding were calculated using the random effects model with double arcsine transformation. Subgroup analyses were performed based on sex, age, income, and type of tumor. Heterogeneity was calculated using Cochran's Q test and I2 statistics. Egger's test and funnel graphs were used to assess publication bias. RESULTS: Only 36 studies were included, mainly retrospective cohorts (n = 30, 83.3%) from North America (n = 20). Most studies included were published in high-income countries. The sample size of studies varied between 34 and 21,384 adult patients, mostly based on gliomas (n = 30,045). For overall malignant primary CNS neoplasm, the pooled incidence was 13.68% (95%CI 9.79; 18.79) and 11.60% (95%CI 6.16; 18.41) for VTE and bleeding, respectively. The subgroup with elderly people aged 60 or over had the highest incidence of VTE (32.27% - 95%CI 14.40;53.31). The studies presented few biases, being mostly high quality. Despite some variability among the studies, we observed consistent results by performing sensitivity analysis, which highlight the robustness of our findings. CONCLUSIONS: Our study showed variability in the pooled incidence for both overall events and subgroup analyses. It was highlighted that individuals over 60 years old or diagnosed with GBM had a higher pooled incidence of VTE among those with overall CNS malignancies. It is important to note that the results of this meta-analysis refer mainly to studies carried out in high-income countries. This highlights the need for additional research in Latin America, and low- and middle-income countries.

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BACKGROUND: Effective treatment of non-ST-segment elevation acute coronary syndromes (NSTEACS) requires careful assessment of both ischaemic and bleeding risks. We aimed to analyse risk distribution and evaluate antiplatelet prescription behaviours in real-life settings. METHODS: Data from 1100 NSTEACS patients in Buenos Aires, Argentina, from the Buenos Aires I Registry, with a 15-month follow-up, were analysed. In-hospital and 6-month GRACE scores, CRUSADE, and Precise DAPT scores were calculated. RESULTS: The mean age was 65.4 ± 11.5 years with a majority being male (77.2%). In-hospital mortality was 2.7%, primarily due to cardiovascular causes (1.8%). Bleeding events occurred in 20.9% of patients, with 4.9% classified as ≥ BARC 3. Predominance of low bleeding (71.3%) and ischaemic (55.8%) risks on admission was observed. At 6 months, the low-risk Precise category (70.9%) and GRACE (44.1%) categories prevailed. Linear correlation analysis showed a moderately positive correlation (r = 0.61, p < .05) between ischaemic-haemorrhagic risks. Regarding the prescription of antiplatelet agents, in the low ischaemic-haemorrhagic risk group, there was a predominance of aspirin + clopidogrel (41.2%) over other high-potency antiplatelet regimens (aspirin + ticagrelor or prasugrel). In the low ischaemic and high haemorrhagic risk group, aspirin and clopidogrel were also predominant (58%). CONCLUSIONS: Our analysis underscores the significant relationship between ischaemic and haemorrhagic risks during NSTEACS hospitalisation. Despite the majority of patients falling into the low-intermediate risk category, the prescription of P2Y12 inhibitors in real-life settings does not consistently align with these risks.

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BACKGROUND: Cancer survivors are at increased risk for atrial fibrillation (AF). However, data on the efficacy and safety of catheter ablation (CA) in this population remain limited. Therefore, we aimed to perform a systematic review and meta-analysis comparing outcomes after CA for AF in patients with versus without prior or active cancer. METHODS: We systematically searched PubMed, Cochrane Library, and Embase from inception to April 2023 for studies comparing the safety and efficacy of CA for AF in cancer survivors. Outcomes of interest were bleeding events, late AF recurrence, and need for repeat ablation. Statistical analyses were performed using Review Manager 5.4.1. We pooled odds ratios (OR) with 95% confidence intervals (CI) for binary endpoints. RESULTS: We included 5 retrospective cohort studies comprising 998 patients, of whom 41.4% had a history of cancer. Cancer survivors were at significantly higher risk of clinically relevant bleeding (OR 2.17; 95% CI 1.17-4.0; p=0.01) as compared with those without cancer. The efficacy of CA for AF was similar between groups. Late AF recurrence at 12 months was not significantly different between patients with vs. without a history of cancer (OR 1.29; 95% CI 0.78-2.13; p=0.32). Similar findings were observed in the outcome of repeat ablations (OR 0.71; 95% CI 0.37-1.37; p=0.31). CONCLUSIONS: These findings suggest that cancer survivors have an increased risk of bleeding after CA for AF relative to patients without cancer, with no significant difference in the efficacy of CA for maintenance of sinus rhythm between groups. STUDY REGISTRATION: This systematic review is registered in the International Prospective Register of Systematic Reviews (PROSPERO) under registration number CRD42023394538.

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Aim: The present study aimed to investigate if cannabis use can be associated with gingival bleeding and caries experience among Brazilian students. Methods: A cross-sectional study was performed in 2016 with first-semester university students in Pelotas. Data was collected via a self-administered questionnaire. Self-reported gingival bleeding and caries experienced were collected. Cannabis use was assessed using a modified version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). We define cannabis users as individuals who report using cannabis at least once a month. A Poisson regression model with robust variance was used to analyze the data. Results: A total of 2,058 (64.5% of eligible students) students were assessed. The prevalence of caries experience was 68.2% and gingival bleeding was 50.8%. The prevalence of cannabis use was 11.7%. After controlling (sex, skin color, age, family income, depressive symptoms, oral health self-perception tobacco use), individuals who use cannabis present a prevalence of gingival bleeding 2.51 (CI95%[1.42­4;53]) higher than individuals who did not use cannabis. The association was maintained even when the individuals who used tobacco were excluded from the sample (PR=2.24, CI95%[1.16 ­ 4.31]). Cannabis use did not show an association with the experience of dental caries in both crude (PR 0.91 CI95%[0.82 ­ 1.01]) and adjusted models (PR 0.93 CI 95%[0.83 ­ 1.05]). Conclusion: Cannabis use was associated with the presence of gingival bleeding among the students of a public university in the south of Brazil. However, the experience of dental caries did not present an association with cannabis use

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BACKGROUND: Major bleeding in patients undergoing therapeutic plasma exchange (TPE) has been studied in large databases; but without standardizing bleeding definitions. Therefore, we used standardized definitions to evaluate major bleeding in hospitalized patients undergoing TPE using public use data files from the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). STUDY DESIGN AND METHODS: In a retrospective cross-sectional analysis, we identified TPE-treated adults in a first inpatient encounter. We evaluated major bleeding prevalence using (1) International Classification of Diseases (ICD) or Current Procedural Terminology (CPT) codes, (2) packed red blood cell (PRBC) transfusion, or (3) hemoglobin (Hgb) decline. Patients with major bleeding prior to their first TPE were excluded from the analysis. RESULTS: Among 779 patients undergoing TPE, major bleeding by at least one of the three bleeding definitions occurred in 135 patients (17.3%). For each of the ICD/CPT, PRBC, and Hgb definitions, the prevalence of major bleeding was 2.8% (n = 31), 7.4% (n = 81), and 5.4% (n = 59), respectively. Only 3.7% of bleeds (5/135) were captured by all three definitions and 19.3% (26/135) exclusively by any two pairwise definitions. The addition of PRBC transfusion and Hgb decline to ICD/CPT code definitions increased bleeding prevalence threefold. CONCLUSION: Among hospitalized adults undergoing TPE in the REDS-III study, the prevalence of major bleeding was 17.3%. The addition of PRBC and Hgb decline to ICD codes increased bleeding prevalence threefold. Future studies are needed to develop validated models that identify patients at risk for major bleeding during TPE.

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BACKGROUND: Heart valve replacement surgery with mechanical or biological prostheses entails a risk of thromboembolism and bleeding complications. OBJECTIVE: To determine the complications related to complementary anticoagulation therapy and the probability of risk. METHODS: One-hundred and sixty-three patients who underwent heart valve replacement between 2002 and 2016 with either mechanical or biological prostheses, and who received vitamin K antagonists after hospital discharge, were studied. Anticoagulation therapy was categorized into optimal and non-optimal according to INR values prior to the development of complications. Patients with comorbidities and other risk factors for thrombosis and/or bleeding were excluded. RESULTS: In total, 68.7 % of patients received mechanical prostheses, and 31.3 %, biological prostheses (p ≤ 0.001); 25.2 % experienced the complications that motivated the study (p ≤ 0.001), which were hemorrhagic in 48.8 %, thromboembolic in 26.8 %, and of both types in 24.4 % (relative risk = 4.229). Among the patients with complications, 95.1 % received mechanical prostheses, and 4.9 %, biological (p = 0.005); non-optimal INR was identified in 49.7 % (p ≤ 0.001). CONCLUSIONS: Given the high risk of thromboembolic and hemorrhagic complications, valve prostheses must be carefully chosen, and care priorities should include prevention and follow-up, especially in those patients who require anticoagulation therapy.

ANTECEDENTES: El reemplazo valvular por prótesis mecánicas o biológicas implica riesgo de tromboembolismo y complicaciones hemorrágicas. OBJETIVO: Determinar las complicaciones relacionadas con la terapia de anticoagulación complementaria y la probabilidad de riesgo en pacientes portadores de prótesis valvulares del corazón. MÉTODOS: Se estudiaron 163 pacientes entre 2002 y 2016, portadores de prótesis mecánicas y biológicas, quienes recibieron antagonistas de la vitamina K posterior al egreso hospitalario. La terapia de anticoagulación se categorizó en óptima y no óptima conforme a los valores de INR previos a las complicaciones. Fueron excluidos los pacientes con comorbilidades y otros factores de riesgo de trombosis y/o sangrado. RESULTADOS: a 68.7 % de los pacientes se les colocó prótesis mecánica y a 31.3 %, biológica (p ≤ 0.001); 25.2 % presentó las complicaciones motivo de estudio (p ≤ 0.001), hemorrágicas en 48.8 %, tromboembólicas en 26.8 % y de ambos tipos en 24.4 % (riesgo relativo = 4.229); a 95.1 % de los pacientes con complicaciones se les colocó prótesis mecánica y a 4.9 %, biológica (p = 0.005); 49.7 % presentó INR no óptimo (p ≤ 0.001). CONCLUSIONES: Ante riesgo alto de complicaciones tromboembólicas y hemorrágicas, la elección de las prótesis valvulares, la prevención y el seguimiento son prioridades, principalmente en quienes requieren terapia de anticoagulación.

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Purpose: The aim was to analyze the characteristics, treatment patterns, and clinical outcomes of Colombian patients with non-valvular atrial fibrillation (NVAF) under treatment with oral anticoagulants (OAs). Patients and Methods: Retrospective cohort in patients with NVAF identified from a drug dispensing database, aged ≥18 years, with first prescription of an OA (index) between January/2013 and June/2018, and a follow-up until June/2019. Data from the clinical history, pharmacological variables, and outcomes were searched. International Classification of Diseases-10 codes were used to identify the patient sample and outcomes. Patients were followed until a general composite outcome of effectiveness (thrombotic events), bleeding/safety or persistence (switch/discontinuation of anticoagulant) events. Descriptive and multivariate analyzes (Cox regressions comparing warfarin and direct oral anticoagulants-DOACs) were carried out. Results: A total of 2076 patients with NVAF were included. The 57.0% of patients were women and the mean age was 73.3±10.4 years. Patients were followed for a mean of 2.3±1.6 years. 8.7% received warfarin before the index date. The most frequent OA was rivaroxaban (n=950; 45.8%), followed by warfarin (n=459; 22.1%) and apixaban (n=405; 19.5%). Hypertension was present in 87.5% and diabetes mellitus in 22.6%. The mean CHA2DS2-VASc Score was 3.6±1.5. The 71.0% (n=326/459) of the warfarin patients presented the general composite outcome, and 24.6% of those with DOACs (n=397/1617). The main effectiveness and safety outcomes were stroke (3.1%) and gastrointestinal bleeding (2.0%) respectively. There were no significant differences between patients with warfarin and DOACs regarding thrombotic events (HR: 1.28; 95% CI: 0.68-2.42), but warfarin was associated with higher bleeding/safety events (HR: 4.29; 95% CI: 2.82-6.52) and persistence events (HR: 4.51; 95% CI: 3.81 -5.33). Conclusion: The patients with NVAF in this study were mainly older adults with multiple comorbidities. Compared to warfarin, DOACs were found to be equally effective, but safer and had a lower probability of discontinuation or switch.

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The PRECISE-DAPT score predicts the bleeding risk in patients treated with dual antiplatelet treatment after PCI. We asess the prediction power of the score in patients suffering from non-ST elevation acute coronary syndromes. Our cohort included 862 patients from Buenos Aires 1 registry. The PRECISE-DAPT score was calculated upon admission and the follow up period was 15 months. The score as a continuous variable had low to moderate ability to predict bleeding events BARC 2, 3 or 5 (c-statistics 0.58 [95% CI, 0.52-0.61]); moderate at BARC 3 or 5 (c-statistics 0.72 [95% CI, 0.64-0.78]), and poor for MACE (c-statistics 0.49 [95% CI, 0,45-0.51]). PRECISE-DAPT score as a dichotomous variable (≥25, n= 210 [24%]) was associated with very high risk of bleeding (HR 2.1) and ischemic events (HR 1.9, 95% CI 1.8-2.1). As conclusion, PRECISE-DAPT score ≥25 was able to identify a subgroup of patients with high bleeding, and thrombotic events.

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INTRODUCTION: A clear assessment of the bleeding risk score in patients presenting with myocardial infarction (MI) is crucial because of its impact on prognosis. The Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA score is a validated risk score to predict bleeding risk in atrial fibrillation (AF), but its predictive value in predicting bleeding after percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) patients receiving antithrombotic therapy is unknown. Our aim was to investigate the predictive performance of the ATRIA bleeding score in STEMI and NSTEMI patients in comparison to the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the American College of Cardiology/American Heart Association Guidelines) and ACUITY-HORIZONS (Acute Catheterization and Urgent Intervention Triage strategY-Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) bleeding scores. METHODS: A total of 830 consecutive STEMI and NSTEMI patients who underwent PCI were evaluated retrospectively. The ATRIA, CRUSADE, and ACUITY-HORIZONS risk scores of the patients were calculated. Discrimination of the three risk models was evaluated using C-statistics. RESULTS: Major bleeding occurred in 52 (6.3%) of 830 patients during hospitalization. Bleeding scores were significantly higher in the bleeding patients than in non-bleeding patients (all P<0.001). The discriminatory ability of the ATRIA, CRUSADE, and ACUITY-HORIZONS bleeding scores for bleeding events was similar (C-statistics 0.810, 0.832, and 0.909, respectively). The good predictive value of all three scores for predicting the risk of bleeding was observed in NSTEMI and STEMI patients as well (C-statistics: 0.820, 0.793, and 0.921 and 0.809, 0.854, and 0.905, respectively). CONCLUSION: This study demonstrated that the ATRIA bleeding score is a useful risk score for predicting major in-hospital bleeding in MI patients. This good predictive value was also present in STEMI and NSTEMI patient subgroups.

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OBJECTIVES: Most evidence for anticoagulation (AC) in aortic bioprosthesis is centred on embolic events, bleeding and reintervention risk. The effect of AC on haemodynamics has not been previously assessed. Our hypothesis was that patients with early AC after aortic valve replacement (AVR) with porcine bioprosthesis have better haemodynamics at 1 year of follow-up. METHODS: Prospective, randomized, open-label trial conducted at 2 cardiac surgery centres. All patients undergoing AVR with porcine bioprosthesis were consecutively recruited. The anticoagulated group received warfarin + aspirin and the non-anticoagulated (control) only aspirin. The primary outcome was mean gradient after 1 year of AVR and change in New York Heart Association class. Secondary outcomes were major and minor bleeding, embolic events and prosthetic leak. RESULTS: Of 140 participants in the study, 71 were assigned to the anticoagulated group and 69 to the control group. The mean age of the overall population was 72.4 (SD: 7.1) years. Global EuroSCORE was 7.65 (SD: 5.73). At 1 year, the mean gradient was similar between both groups [18.6 (SD: 1.1 mmHg) and 18.1 (SD: 1.0 mmHg) in the control and anticoagulated groups, respectively, P = 0.701]. No differences in functional class at 3 months or 1 year were found among groups. No differences were found among groups in the secondary outcomes. CONCLUSIONS: The addition of 3 months of oral AC to anti-aggregation treatment was not detected to affect bioprosthetic haemodynamics nor functional class at 1 year after AVR. Likewise, AC does not lead to the higher incidence of complications.

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INTRODUCTION: In current European guidelines for the management of myocardial infarction after coronary stent placement, there is no consensus on dual antiplatelet therapy (DAPT) ideal duration to prevent stent thrombosis-restenosis without significantly increasing the bleeding risk. OBJECTIVE: To report the percentage of major bleeding and presence of major cardiovascular events associated with prolonged DAPT in patients recruited at the National Institute of Cardiology, treated with primary percutaneous coronary intervention and stent. METHODS: A longitudinal, prospective, observational, non-experimental, descriptive study was carried out. Patients were recruited from November 2016 to December 2017. RESULTS: One hundred and thirty-five patients with a mean age of 57 ± 10 years who completed the three-year follow-up were selected. Obesity and hypertension stood out as the main risk factors. After using DAPT for three years, 3.7% of mortality, 1.48% of major bleeding, and 4.4% of thrombosis-restenosis were recorded. CONCLUSIONS: Prolonged use of DAPT would be justified by the high incidence of thrombosis-restenosis, without a significant increase in bleeding risk, as well as a decrease in major cardiovascular events.

INTRODUCCIÓN: En las guías actuales europeas para el manejo del infarto de miocardio posterior a la colocación de endoprótesis coronaria (stent), no existe consenso sobre la duración ideal de la terapia antiagregante plaquetaria dual (DAPT, dual antiplatelet therapy) para prevenir la trombosis-reestenosis del stent sin aumentar el riesgo significativo de sangrado. OBJETIVO: Reportar el porcentaje de sangrado mayor y de eventos cardiovasculares mayores asociados a la DAPT prolongada en pacientes atendidos en el Instituto Nacional de Cardiología y tratados con intervención coronaria percutánea primaria y stent. MÉTODOS: Se realizó un estudio longitudinal, prospectivo observacional y descriptivo no experimental. Los pacientes fueron captados de noviembre de 2016 a diciembre de 2017. RESULTADOS: Fueron seleccionados 135 pacientes con una media de edad de 57 ± 10 años, quienes cumplieron un seguimiento clínico por tres años. La obesidad y la hipertensión destacaron como principales factores de riesgo. Posterior al uso de DAPT durante tres años, se registró 3.7 % de mortalidad, 1.48 % de sangrado mayor y 4.4 % de trombosis-reestenosis. CONCLUSIONES: El uso prolongado de DAPT estaría justificado por la alta incidencia de trombosis-reestenosis, sin incremento significativo en el riesgo de sangrado y con disminución de los eventos cardiovasculares mayores.

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Importance: Data are limited regarding the risk of cerebrovascular ischemic events and major bleeding in patients with atrial fibrillation (AF) and recent acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI). Objective: Determine the efficacy and safety of apixaban or vitamin K antagonists (VKA) and aspirin or placebo according to prior stroke, transient ischemic attack (TIA), or thromboembolism (TE). Design, Setting, and Participants: In this prospective, multicenter, 2-by-2 factorial, randomized clinical trial, post hoc parallel analyses were performed to compare randomized treatment regimens according to presence or absence of prior stroke/TIA/TE using Cox proportional hazards models. Patients with AF, recent ACS or PCI, and planned use of P2Y12 inhibitors for 6 months or longer were included; 33 patients with missing data about prior stroke/TIA/TE were excluded. Interventions: Apixaban (5 mg or 2.5 mg twice daily) or VKA and aspirin or placebo. Main Outcomes and Measures: Major or clinically relevant nonmajor (CRNM) bleeding. Results: Of 4581 patients included, 633 (13.8%) had prior stroke/TIA/TE. Patients with vs without prior stroke/TIA/TE were older; had higher CHA2DS2-VASC and HAS-BLED scores; and more frequently had prior bleeding, heart failure, diabetes, and prior oral anticoagulant use. Apixaban was associated with lower rates of major or CRNM bleeding and death or hospitalization than VKA in patients with (hazard ratio [HR], 0.69; 95% CI, 0.46-1.03) and without (HR, 0.68; 95% CI, 0.57-0.82) prior stroke/TIA/TE. Patients without prior stroke/TIA/TE receiving aspirin vs placebo had higher rates of bleeding; this difference appeared less substantial among patients with prior stroke/TIA/TE (P = .01 for interaction). Aspirin was associated with numerically lower rates of death or ischemic events than placebo in patients with (HR, 0.71; 95% CI, 0.42-1.20) and without (HR, 0.93; 95% CI, 0.72-1.21) prior stroke/TIA/TE (not statistically significant). Conclusions and Relevance: The safety and efficacy of apixaban compared with VKA was consistent with the AUGUSTUS findings, irrespective of prior stroke/TIA/TE. Aspirin increased major or CRNM bleeding, particularly in patients without prior stroke/TIA/TE. Although aspirin may have some benefit in patients with prior stroke, our findings support the use of apixaban and a P2Y12 inhibitor without aspirin for the majority of patients with AF and ACS and/or PCI, regardless of prior stroke/TIA/TE status. Trial Registration: ClinicalTrials.gov Identifier: NCT02415400.

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BACKGROUND: Pulmonary embolism (PE) is a common life-threatening cardiovascular condition, with an incidence of 23 to 69 new cases per 100,000 people each year. For selected low-risk patients with acute PE, outpatient treatment might provide several advantages over traditional inpatient treatment, such as reduction of hospitalisations, substantial cost savings, and improvements in health-related quality of life. This is an update of an earlier Cochrane Review. OBJECTIVES: To assess the effects of outpatient versus inpatient treatment in low-risk patients with acute PE. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 31 May 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of outpatient versus inpatient treatment of adults (aged 18 years and over) diagnosed with low-risk acute PE. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were short- and long-term all-cause mortality. Secondary outcomes were bleeding, adverse effects, recurrence of PE, and patient satisfaction. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We did not identify any new studies for this update. We included a total of two RCTs involving 453 participants. Both trials discharged participants randomised to the outpatient group within 36 hours of initial triage, and both followed participants for 90 days. One study compared the same treatment regimens in both outpatient and inpatient groups, and the other study used different treatment regimens. There was no clear difference in treatment effect for the outcomes of mortality at 30 days (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.01 to 7.98; 2 studies, 453 participants; low-certainty evidence), mortality at 90 days (RR 0.98, 95% CI 0.06 to 15.58; 2 studies, 451 participants; low-certainty evidence), major bleeding at 14 days (RR 4.91, 95% CI 0.24 to 101.57; 2 studies, 445 participants; low-certainty evidence) and at 90 days (RR 6.88, 95% CI 0.36 to 132.14; 2 studies, 445 participants; low-certainty evidence), minor bleeding (RR 1.08, 95% CI 0.07 to 16.79; 1 study, 106 participants; low-certainty evidence), recurrent PE within 90 days (RR 2.95, 95% CI 0.12 to 71.85; 2 studies, 445 participants; low-certainty evidence), and patient satisfaction (RR 0.97, 95% CI 0.90 to 1.04; 2 studies, 444 participants; moderate-certainty evidence). We downgraded the certainty of the evidence because the CIs were wide and included treatment effects in both directions, the sample sizes and numbers of events were small, and it was not possible to determine the effect of missing data or the presence of publication bias. The included studies did not assess PE-related mortality or adverse effects, such as haemodynamic instability, or adherence to treatment. AUTHORS' CONCLUSIONS: Currently, only low-certainty evidence is available from two published randomised controlled trials on outpatient versus inpatient treatment in low-risk patients with acute PE. The studies did not provide evidence of any clear difference between the interventions in overall mortality, bleeding, or recurrence of PE.

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BACKGROUND: Although therapeutic plasma exchange (TPE) is associated with hemostatic abnormalities, its impact on bleeding outcomes is unknown. Therefore, the main study objective was to determine bleeding outcomes of inpatients treated with TPE. STUDY DESIGN AND METHODS: In a cross-sectional analysis of the National Inpatient Sample (NIS), discharges were identified with 10 common TPE-treated conditions. A 1:3 propensity-matched analysis of TPE- to non-TPE-treated discharges was performed. The primary outcome was major bleeding and secondary outcomes were packed red blood cell (PRBC) transfusion, mortality, disposition, hospital length of stay (LOS), and charges. Multivariable regression analyses were used to examine the association between TPE and study outcomes. RESULTS: The study population was 15,964 discharges, of which 3991 were TPE- treated. The prevalence of major bleeding was low (5.4%). When compared to non-TPE discharges, TPE had a significant and positive association with major bleeding (OR = 1.37, 95% CI: 1.16-1.63, p = .0003). TPE was also associated with PRBC transfusion (OR = 1.66, 95% CI: 1.42-1.94, p < .0001), in-hospital mortality (OR = 1.45, 95% CI: 1.10-1.90, p = .0008), hospital length of stay (12.45 [95% CI: 11.95-12.97] vs. 7.38 [95% CI: 7.12-7.65] days, p < .0001) and total charges, ($125,123 [95% CI: $119,220-$131,317] vs. $61,953 [95% CI: $59,391-$64,625], p < .0001), and disposition to non-self-care (OR = 1.29, 95% CI: 1.19-1.39, p < .0001). DISCUSSION: The use of TPE in the inpatient setting is positively associated with bleeding; however, with low prevalence. Future studies should address risk factors that predispose patients to TPE-associated bleeding.