Hypertension, Abnormal Renal/liver Function, Stroke, Bleeding History Or Predisposition Research Articles

An analysis of antithrombotic therapy in elderly patients with atrial fibrillation undergoing percutaneous coronary interventions.

As a result of large, randomized trials and updates to clinical guidelines, antithrombotic therapy following percutaneous coronary intervention (PCI) has changed in recent years for patients with nonvalvular atrial fibrillation (NVAF). The purpose of this study was to investigate the real-world data of antithrombotic regimens at discharge and their evolving trends, as well as compare the effect of different therapies on the incidence of major cardiovascular and cerebrovascular ischemic events (MACCEs) and bleeding events in elderly patients. An analysis of 6298 stent implantation patients from 2016-2018 was carried out retrospectively. AF patients aged 65 and older were divided into two groups according to the antithrombotic regimens prescribed at hospital discharge: dual antiplatelet aggregation treatment group (DAPT) and anticoagulant treatment and antiplatelet aggregation treatment group (ATT). Baseline characteristics, efficacy endpoints (MACCEs/cerebrovascular ischemic events), and safety endpoints (bleeding events) were analyzed and compared between the different antithrombotic regiments. During 2016-2018, the use of oral anticoagulants (OAC) increased from 16.3% to 54.1% (P trend < 0.01). Since the introduction of non-vitamin K antagonist oral anticoagulants (NOACs), warfarin usage has decreased from 100% to 41.7%, and NOACs have rapidly replaced warfarin. The rate of persistent AF in the ATT group was significantly higher than the rate in the DAPT group (79.6% vs. 59.7%, P = 0.01), and the ATT group used more proton pump inhibitors (PPI) than the DAPT group (23.3% vs. 11.8%, P = 0.01). A significant decrease was observed in MACCEs (10.7% vs. 26.0%, P < 0.01) and cerebrovascular ischemic events (2.9% vs. 11.8%, P = 0.01) in the ATT group compared with the DAPT group. According to the ATT subgroup analysis, there was a significant difference in the incidence of overall bleeding between the triple anticoagulant therapy group (TT) and the dual anticoagulant therapy group (DT) (18.0% vs. 2.4%, P = 0.02). MACCEs were predicted independently by ATT and CHA2DS2-VASc scores, whereas bleeding was predicted independently by PPI use and HAS-BLED scores. As a result of NOAC introduction and use, the combination of antithrombotic regimens at discharge for elderly patients with AF after PCI has changed rapidly over the past few years toward a higher use of ATTs, while patients with AF undergoing PCI still rarely receive an appropriate antithrombotic regimen. It is essential to conduct ATT in elderly patients who are undergoing PCI, and further DT may be more appropriate.

Stroke prevention of thoracoscopic left atrial appendage clipping in patients with non-valvular atrial fibrillation at high risk of stroke and bleeding: study protocol for a non-randomised controlled clinical trial

IntroductionNon-valvular atrial fibrillation (NVAF) is a high-risk factor for ischaemic stroke. The 2016 European Society of Cardiology Atrial Fibrillation Management guidelines recommend oral anticoagulants (OACs) to prevent stroke in men...

Atrial fibrillation bleeding risk and prediction while treated with direct oral anticoagulants in warfarin-naïve or warfarin-experienced patients.

BackgroundIn patients with atrial fibrillation (AF) treated with direct oral anticoagulants (DOAC), bleeding risk scores provide only modest discrimination for major or intracranial bleeding. However, warfarin experience may impact HAS‐BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (>65 years), Drugs/alcohol concomitantly) score performance in patients evaluated for DOACs, as HAS‐BLED was derived and validated in warfarin cohorts.MethodsWe performed a retrospective cohort study of patients prescribed DOAC for AF in the Veterans Health Administration between 2010 and 2017. We determined modified HAS‐BLED score discrimination and calibration for bleeding, for patients treated with DOAC, stratified by prior warfarin exposure. We also determined the association between DOAC–warfarin‐naïve status to bleeding (nonintracranial and intracranial) with DOAC–warfarin‐experienced patients as reference.ResultsThe DOAC analysis cohort included 100, 492 patients with AF (age [mean ± SD]: 72.9 ± 9.6 years; 1.7% female; 90.1% White), of which 26, 760 patients (26.6%) and 73, 732 patients (73.4%) were warfarin experienced or naïve, respectively. HAS‐BLED discrimination for bleeds was modest for patients treated with DOAC, regardless of prior warfarin experience (concordance statistics: 0.53–0.59). For DOAC–warfarin‐naïve patients, as compared to DOAC–warfarin‐experienced patients, adjusted risk of intracranial bleeding was lower, while risk of nonintracranial bleeding was higher ( intracranial bleeding propensity adjusted with inverse probability of treatment weights [IPTWs]: hazard ratio [HR]: 0.86, 95% confidence interval [CI]: 0.78–0.95, p = .0040) (nonintracranial bleeding propensity adjusted with IPTW: HR: 1.15, 95% CI: 1.11–1.19, p < .0001).ConclusionPatients’ modified HAS‐BLED score at the time of DOAC initiation, regardless of prior warfarin use, provided only modest discrimination for intracranial and nonintracranial bleeds. These data argue against maintaining DOAC eligible patients on warfarin therapy regardless of modified HAS‐BLED score.

The Predictive Role of Cardiac Troponin in Non-cardiac Surgery: A Study in the Greek Population

IntroductionThe incidence of postoperative myocardial ischemia (POMI) remains uncertain and underdiagnosed despite significant morbidity and mortality rates.MethodsThis study included patients who underwent non-cardiac surgery. Troponin T (TnT) was measured on the first three postoperative days. The revised cardiac risk index, HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio (INR), elderly, drugs/alcohol concomitantly) bleeding score, and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score were combined. The receiver operating characteristic (ROC) curve was used to estimate the discriminative ability of preoperative troponin for myocardial ischemia (MI).ResultsOf 105 patients with a mean age of 69.1 years, 32.4% had MI. Hypertension, diabetes mellitus, and dyslipidemia were the main risk factors. A ROC analysis indicated that a preoperative value of 17.2 pg/ml or higher of troponin was significantly associated with MI. Moreover, a higher CHA2DS2-VASc score was associated with POMI.ConclusionsPOMI is associated with high mortality and a long stay in the intensive care unit. Routine use of different scores before surgery can be very useful.

Effectiveness and Safety of Apixaban Versus Warfarin in Obese Patients with Nonvalvular Atrial Fibrillation Enrolled in Medicare and Veteran Affairs

Real-world studies have evaluated the use of anticoagulants in obese patients with nonvalvular atrial fibrillation (NVAF), but they have been limited by sample size or the use of diagnosis codes on claims to define obesity. This retrospective study used body weight data of ≥100 kg or a body mass index of ≥30 kg/m2 to identify elderly (aged ≥65 years) NVAF patients with obesity in dually enrolled Veterans Affairs and fee-for-service Medicare patients. It evaluated the risk of stroke/systemic embolism (SE) and major bleeding (MB) in patients that initiated apixaban versus warfarin. Stabilized inverse probability treatment weighting was used to balance the baseline characteristics between patients prescribed apixaban and warfarin in obese patients. Cox models were used to evaluate the relative risk of stroke/SE and MB. Overall, 35.9% (n = 26,522) of the NVAF population were obese, of which 13,604 apixaban and 12,918 warfarin patients were included. After inverse probability treatment weighting, patient characteristics were balanced. The mean age was 75 years, the mean CHA2DS2-VASc score (Congestive Heart Failure, Hypertension, Age ≥75 [Doubled], Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack [Doubled], Vascular Disease, Age 65-74, Female) was 3.8, the mean HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) Score was ∼2.6, and >98% of patients were males. Obese apixaban patients were associated with a similar risk of stroke/SE (hazard ratio: 0.82; 95% confidence interval: 0.66 to 1.03) and a significantly lower risk of MB (hazard ratio: 0.62; 95% confidence interval: 0.54 to 0.70) versus warfarin. No significant interaction was observed between treatment and obesity status (nonobese, obese/nonmorbid, obese/morbid) for stroke/SE (interaction p = 0.602) or MB (interaction p = 0.385). In obese patients with NVAF, apixaban was associated with a similar risk of stroke/SE and a significantly lower risk of MB versus warfarin.

Available Bleeding Scoring Systems Poorly Predict Major Bleeding in the Acute Phase of Pulmonary Embolism.

We aimed to compare six available bleeding scores, in a real-life cohort, for prediction of major bleeding in the early phase of pulmonary embolism (PE). We recorded in-hospital characteristics of 2754 PE patients in a prospective observational multicenter cohort contributing 18,028 person-days follow-up. The VTE-BLEED (Venous Thrombo-Embolism Bleed), RIETE (Registro informatizado de la enfermedad tromboembólica en España; Computerized Registry of Patients with Venous Thromboembolism), ORBIT (Outcomes Registry for Better Informed Treatment), HEMORR2HAGES (Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke), ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol) scores were assessed at baseline. International Society on Thrombosis and Haemostasis (ISTH)-defined bleeding events were independently adjudicated. Accuracy of the overall original 3-level and newly defined optimal 2-level outcome of the scores were evaluated and compared. We observed 82 first early major bleedings (3.0% (95% CI, 2.4–3.7)). The predictive power of bleeding scores was poor (Harrel’s C-index from 0.57 to 0.69). The RIETE score had numerically higher model fit and discrimination capacity but without reaching statistical significance versus the ORBIT, HEMORR2HAGES, and ATRIA scores. The VTE-BLEED and HAS-BLED scores had significantly lower C-index, integrated discrimination improvement, and net reclassification improvement compared to the others. The rate of observed early major bleeding in score-defined low-risk patients was high, between 15% and 34%. Current available scoring systems have insufficient accuracy to predict early major bleeding in patients with acute PE. The development of acute-PE-specific risk scores is needed to optimally target bleeding prevention strategies.

The Risk of Falling and Consequences of Falling in Patients with Atrial Fibrillation Receiving Different Types of Anticoagulant.

Our objective was to investigate the predictors of falls requiring a visit to the emergency department in patients with nonvalvular atrial fibrillation (AF) receiving different types of anticoagulants and to investigate the clinical consequences of falling in the same population. A total of 1217 patients with nonvalvular AF from two institutions were retrospectively evaluated. Each patient underwent a physical examination, and clinical histories and medication profiles were taken from each patient at baseline. The median age of our cohort was 71 years; 52.3% were males, and 86.1% of patients were receiving anticoagulation at study baseline. The 5-year freedom-from-falling rate was 81.6%. The use and type of anticoagulation was not significantly associated with the risk of falling (P = 0.222), whereas higher Morse Fall Scale (MFS), CHA2DS2-VASC (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65-74 years, sex category), and HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly [> 65 years], drugs/alcohol concomitantly) scores were significantly associated with a higher hazard of the first fall in univariate analyses. In the multivariate Cox regression model, MFS, older age, osteoporosis, higher levels of high-density lipoprotein cholesterol, higher diastolic blood pressure, and use of amiodarone, diuretics, or short- and medium-acting benzodiazepines were mutually independent predictors of the first fall. Of 163 patients, 93 (57%) had a bone fracture during the fall. Type of anticoagulation significantly affected survival after the first fall (P < 0.001): patients inadequately anticoagulated with warfarin had worse survival rates, and patients receiving apixaban and dabigatran had the best survival rates after the first fall. Older patients who had comorbidities and were taking amiodarone, diuretics, or short- or medium-acting benzodiazepines had the highest risk of falls. The type and quality of anticoagulation did not seem to affect the risk of falling but did significantly affect survival after the first fall.

Thromboembolism, mortality, and bleeding in 2,435,541 atrial fibrillation patients with and without cancer: A nationwide cohort study.

The number of patients with atrial fibrillation (AF) and cancer is rapidly increasing in clinical practice. The impact of cancer on clinical outcomes in this patient population is unclear, as is the performance of the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol) and CHA2 DS2 -VASc (Congestive Heart Failure, Hypertension, Age ≥ 75 years, Diabetes Mellitus, Stroke or Transient Ischemic Attack, Vascular Disease, Age 65 to 74 Years, Sex Category) scores. This was an observational, retrospective cohort study including 2,435,541 adults hospitalized with AF. The authors investigated the incidence rates (IRs) of all-cause and cardiovascular mortality, ischemic stroke, major bleeding, and intracranial hemorrhage (ICH) according to the presence of cancer and cancer types. Overall, 399,344 (16.4%) had cancer, with the most common cancers being metastatic, prostatic, colorectal, lung, breast, and bladder. During a mean follow-up of 2.0 years, cancer increased all-cause mortality (hazard ratio [HR], 2.00; 95% confidence interval [CI], 1.99-2.01). The IR of ischemic stroke was higher with pancreatic cancer (2.8%/y), uterine cancer (2.6%/y), and breast cancer (2.6%/y), whereas it was lower with liver/lung cancer (1.9%/y) and leukemia/myeloma (2.0%/y), in comparison with noncancer patients (2.4%/y). Cancer increased the risk of major bleeding (HR, 1.27; 95% CI, 1.26-1.28) and ICH (HR, 1.07; 95% CI, 1.05-1.10). Leukemia, liver cancer, myeloma, and metastatic cancers showed the highest IRs for major bleeding/ICH. Major bleeding and ICH rates progressively increased with the HAS-BLED score, which showed generally good predictivity with C indexes > 0.70 for all cancer types. The CHA2 DS2 -VASc score's predictivity was slightly lower in AF patients with cancer. Cancer increased all-cause mortality, major bleeding, and ICH risk in AF patients. The association between cancer and ischemic stroke differed among cancer types, and in some types, the risk of bleeding seemed to exceed the thromboembolic risk.

Oral Anticoagulants for Atrial Fibrillation: Benefits Outweigh Risks for Older Adults

Oral Anticoagulants for Atrial Fibrillation: Benefits Outweigh Risks for Older Adults

The Extended Utility of CHA2DS2VASc and HAS-BLED Scores in the Selection for Transcutaneous Left Atrial Appendage Closure.

Background and purpose: Left atrial appendage closure (LAAC) is an option for stroke prevention in atrial fibrillation patients. Randomized studies have demonstrated the effectiveness and safety of LAAC but included patients with an average risk of stroke and bleeding complications. The current study aimed to assess the extended utility of CHA2DS2VASc (congestive heart failure; hypertension; age ≥75 years [doubled]; type 2 diabetes; previous stroke, transient ischemic attack, or thromboembolism [doubled]; vascular disease; age 65 to 75 years; and sex category) and HAS-BLED (hypertension; abnormal renal/liver function; stroke; bleeding history or predisposition; labile INR, elderly, drugs/alcohol concomitantly) scores for qualification and prognosis after LAAC. Methods: The study population comprised 270 patients aged 72.8 ± 8.78 years. The occluders used were the Amplatzer Amulet (N = 205), Amplatzer Cardiac Plug (N = 53), and Watchman device (N = 12). The prognosis after LAAC was analyzed for different cohorts of patients distinguished based on different CHA2DS2VASc and HAS-BLED scores. The mean duration of follow-up was 21.6 ± 10.3 months. Results: The observed rates of ischemic stroke and bleeding were much lower than that expected (2.2% vs. 5.6%, and 0.76% vs. 6.05%, respectively). The mortality rate did not differ concerning the CHA2DS2CVASc score. It was significantly lower (8.3%) for HAS-BLED < 3, and it raised to 17.9% for HAS-BLED = 3 and to 25.9% for HAS-BLED > 3. Significant differences (p = 0.003) occurred for Kaplan–Meier curves for extreme HAS-BLED subgroups. A composite endpoint was most often found in high/very high risk of bleeding patients. Conclusions: HAS-BLED, but not CHA2DS2CVASc score, may be a useful tool to predict the prognosis of patients after LAAC. Qualification for LAAC based on the risk of stroke should not differ from qualification for anticoagulation. Despite the worse prognosis of patients with the highest bleeding risk, this group is likely to experience the greatest benefit from reducing the bleeding risk from LAAC.

Utility of HAS-BLED and CHA2DS2-VASc Scores Among Patients With Atrial Fibrillation and Imaging Evidence of Cerebral Amyloid Angiopathy

ObjectiveTo determine the utility of the HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly, Drugs/alcohol concomitantly) and CHA2DS2-VASc (Congestive heart failure, Hypertension, Age, Diabetes, previous Stroke/transient ischemic attack–VAScular disease) scores among patients on anticoagulation (AC) therapy for atrial fibrillation (AF) who have evidence of cerebral amyloid angiopathy (CAA). Patients and MethodsPatients older than 55 years with a diagnosis of AF who had a nontraumatic intracerebral hemorrhage (ICH) while on AC therapy between 1995 and 2016 were identified using the Rochester Epidemiology Project Database. Medical records were reviewed, including imaging of the brain, to identify baseline characteristics, AC use, and outcomes. ResultsA total of 65 patients were identified (mean age, 81.3 years); 35 (53.8%) had evidence of possible/probable CAA. Mean HAS-BLED score in the CAA group was significantly lower (2.1) than that of the non-CAA group (2.9; P<.001). Mortality after ICH, adjusted for HAS-BLED scores, was not significantly different among patients with and without CAA. Sixteen patients restarted on AC therapy after ICH; CHA2DS2-VASc scores were no different between this group and those who were not restarted. Among patients with CAA, the overall rate of ICH recurrence was 8.6% over 93.5 person-years of follow-up. Among patients with CAA, the rate of ICH recurrence was 3.2 per 100 patient-years, higher than their HAS-BLED scores would predict (1.9 bleeds/100 patient-years). ConclusionHAS-BLED scores were lower in patients who had evidence of CAA compared with those without, suggesting underestimation of ICH risk in patients with CAA. CHA2DS2-VASc scores did not affect resumption of AC therapy. ICH recurrence was higher in patients with CAA than their HAS-BLED scores predicted. Current risk assessment scoring systems do not accurately account for CAA in patients with AF on AC.

The NCDR Left Atrial Appendage Occlusion Registry

BackgroundLeft atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited. ObjectivesThe purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years. MethodsThe authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates. ResultsA total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare. ConclusionsThe LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.

Correlation between frailty status and anticoagulation therapy in elderly patients with atrial fibrillation

Objective To investigate the correlation between frailty status and anticoagulation therapy in elderly patients with atrial fibrillation. Methods A total of 131 atrial fibrillation inpatients in our hospital aged 70 years and over with a mean age of(77.4±6.4)years were enrolled from January 2017 to June 2018 in this retrospective study.According to the state of anticoagulation therapy at discharge, patients were divided into the anticoagulation group(n=67)and the non-anticoagulation group(n=64). Data including gender, age, N-terminal pro-brain natriuretic peptide(NT-proBNP), glomerular filtration rate(eGFR), the type of medication, HAS-BLED(Hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly), CHA2DS2-VASc scores, Charlson comorbidity index and clinical frailty scores(CFS)were recorded and compared between the two groups.Spearman correlation was used to analyze the correlation between frailty degrees and program of anticoagulant therapy.Two-class Logistic regression models were used to analyze the related factors for programs of anticoagulant therapy. Results The incidence of the frailty syndrome was 56.49% in 131 elderly patients with atrial fibrillation.Compared with the anticoagulation group, non-anticoagulation group showed that the CFS score[(5.73±1.85)vs.(3.69±2.07), P 0.05). The correlation analysis showed that there was a negative correlation between the application of anticoagulants and CFS grade in elderly patients with atrial fibrillation(r=-0.138, P<0.05). Multivariate Logistic regression analysis showed that age, CFS score and the incidence of frailty state were risk factors in elderly atrial fibrillation patients without the anticoagulant therapy(P<0.05). Conclusions The incidence of frailty state in elderly patients with atrial fibrillation is high, and the proportion of patients receiving the anticoagulant therapy is low.Age and frailty may be the most important influencing factors for anticoagulant therapy.Therefore, it is of great significance to incorporate frailty assessment into the management of anticoagulant therapy in elderly patients with atrial fibrillation. Key words: Frailty; Atrial fibrillation; Anticoagulation

P4791Performance of the HAS-BLED, ATRIA, and PRECISE-DAPT Bleeding Risk Scores in Atrial Fibrillation Patients Using Antiplatelet Agents or Oral Anticoagulants

Abstract Background Various bleeding risk scores have been proposed to assess the risk of bleeding in atrial fibrillation (AF) patients undergoing anticoagulation. PRECISE DAPT score has been developed to assess the out-of hospital bleeding risk in patients receiving dual antiplatelet therapy (DAPT). Our objective was to compare the predictive performance between the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol), ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), and PRECISE-DAPT (Predicting Bleeding Complication in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet therapy) score in AF patients using antiplatelet agents or anticoagulants Methods We recruited 1,114 consecutive AF patients (51% male; median age, 71 years) receiving antiplatelet agents or oral anticoagulants from January 2014 through December 2018. Major bleeding was defined as according to the Bleeding Academic Research Consortium (BARC) criteria (type 3 or 5: hemodynamic instability, need for transfusion, drop in hemoglobin ≥3 g, and intracranial, intraocular or fatal bleeding). The performance of risk scores were assessed by C-statistic. Results Bleeding events occurred in 135 patients (12.1%) during 30 days, and 72 patients (6.5%) from 30 days till 1-year follow-up. Based on the C-statistic, PRECISE-DAPT score (AUC: 0.72, 95% CI: 0.69–0.75) had a good performance, significantly better than HAS-BLED (AUC: 0.64, 95% CI: 0.61–0.67) (p=0.008) or ATRIA scores (AUC: 0.57, 95% CI: 0.54–0.60) (p&lt;0.001) for 30-days bleeding prediction. Also, PRECISE-DAPT score had a good C-statistic (AUC: 0.72, 95% CI: 0.69–0.75) for 1-year bleeding events compared with HAS-BLED (AUC: 0.64, 95% CI: 0.60–0.67) (p=0.02) or ATRIA (AUC: 0.61, 95% CI: 0.58–0.65) (p=0.01). ROC curve for bleeding Conclusions The PRECISE-DAPT score has been used for assessing bleeding events during DAPT. Also, the PRECISE-DAPT score predicted bleedings better than HAS-BLED or ATRIA scores in AF patients. So, the PRECISE-DAPT score may be considered as bleeding risk score during DAPT or oral anticoagulation in clinical practice.

Patients with Heart Failure and Preserved Ejection Fraction Are at Risk of Gastrointestinal Bleeding.

Aims. Two thirds of patients with heart failure and preserved ejection fraction (HFpEF) have an indication for oral anticoagulation (OAC) to prevent thromboembolic events. However, evidence regarding the safety of OAC in HFpEF is limited. Therefore, our aim was to describe bleeding events and to find predictors of bleeding in a large HFpEF cohort. Methods and Results. We recorded bleeding events in a prospective HFpEF cohort. Out of 328 patients (median age 71 years (interquartile range (IQR) 67–77)), 64.6% (n = 212) were treated with OAC. Of those, 65.1% (n = 138) received vitamin-K-antagonists (VKA) and 34.9% (n = 72) non-vitamin K oral anticoagulants (NOACs). During a median follow-up time of 42 (IQR 17–63) months, a total of 54 bleeding events occurred. Patients on OAC experienced more bleeding events (n = 49 (23.1%) versus n = 5 (4.3%), p < 0.001). Major drivers of events were gastrointestinal (GI) bleeding (n = 18 (36.7%)]. HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score (hazard ratios (HR) of 2.15 (95% confidence interval (CI) 1.65–2.79, p < 0.001)) was the strongest independent predictor for overall bleeding. In the subgroup of GI bleeding, mean right atrial pressure (mRAP: HR of 1.13 (95% CI 1.03–1.25, p = 0.013)) and HAS-BLED score (HR of 1.74 (95% CI 1.15–2.64, p = 0.009)] remained significantly associatiated with bleeding events after adjustment. mRAP provided additional prognostic value beyond the HAS-BLED score with an improvement from 0.63 to 0.71 (95% CI 0.58–0.84, p for comparison 0.032), by C-statistic. This additional prognostic value was confirmed by significant improvements in net reclassification index (61.3%, p = 0.019) and integrated discrimination improvement (3.4%, p = 0.015). Conclusion. OAC-treated HFpEF patients are at high risk of GI bleeding. High mRAP as an indicator of advanced stage of disease was predictive for GI bleeding events and provided additional risk stratification information beyond that obtained by HAS-BLED score.

TRIPLE THERAPY - WALKING ON A TIGHT ROPE!

Managing patients with atrial fibrillation (AF) requiring percutaneous interventionor those on anticoagulant therapy needing an intervention is an act of greatbalancing like walking on a tight rope. The premise revolves around three basicconsiderations - the risk of embolism and stroke due to AF, the possibility ofthrombosis due to underlying coronary obstructive disease and interventionsand more importantly the hazard of bleeding in combining different therapeuticagents. Risk of thromboembolic stroke is determined by a host of factors. CHA DS VASC score is well-validated risk score based onage, gender and comorbidities. It identifies patients at higher risk of thromboembolism who require anticoagulants to preventstroke. HASBLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile internationalnormalized ratio [INR], elderly [>65 years], drugs/alcohol concomitantly) has been recommended as a bleeding risk score forpatients with AF, with scores Ý3 considered high risk. Both scores have to be used with a grain of common sense andconsidering patient as a whole, though the HAS-BLED score has been credited to predict bleeding significantly; thediscriminating value is overall limited and similar to CHA DS VASC score. A brief period of washout from the anticoagulant effect of OAC is preferable whenever possible in elective and non-emergentprocedures. In patients on Vit K antagonists, those being subjected to radial approach, INR should be preferably U2.0 and iffemoral approach is used INR has to be U 1.5. In patients on NOAC, irrespective of vascular access site, treatment may bewithheld for 24 hours (or 48 hours for patients with impaired renal function with dabigatran). Although in stable CAD patientsbridging with parenteral anticoagulation can be omitted yet this should be considered for patients presenting with an ACS. To conclude, treating patients with triple therapy in the setting of AF and PCI is like walking on a tight rope. Three importantconsiderations for all decisions making are risk of thrombo-embolism and stroke, risk for thrombotic complications and risk ofbleeding. Meticulous management is recommended pre, intra and post procedure. This entails selecting patients usingappropriate criteria, employing radial approach, using latest generation DES, starting triple therapy and then changing over toSAPT earlier or later balancing thrombotic versus bleeding risks.

New predictive model for acute gastrointestinal bleeding in patients taking oral anticoagulants: A cohort study

The study developed a predictive model of long-term gastrointestinal (GI) bleeding risk in patients receiving oral anticoagulants and compared it with the HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratios, Elderly, Drugs/alcohol concomitantly) score. The study periodically followed a cohort of 508 patients taking oral anticoagulants (66 direct oral anticoagulants users and 442 warfarin users). Absence of GI bleeding at an initial examination and any subsequent GI bleeding were confirmed endoscopically. The bleeding model was developed by multivariate survival analysis and evaluated by Harrell's c-index. During a median follow-up of 31.4months, 42 GI bleeds (8.3%) occurred: 42.8% in the upper GI tract, 50.0% in the lower GI tract, and 7.1% in the middle GI tract. The cumulative 5 and 10-year probability of GI bleeding was 12.6% and 18.5%, respectively. Patients who bled had a significantly higher cumulative incidence of all-cause mortality (hazard ratio 2.9, P<0.001). Multivariate analysis revealed that absence of proton pump inhibitor therapy, chronic kidney disease, chronic obstructive pulmonary disease, history of peptic ulcer disease, and liver cirrhosis predicted GI bleeding. The c-statistic for the new predictive model using these five factors was 0.65 (P<0.001), higher than the HAS-BLED score of 0.57 (P=0.145). Gastrointestinal bleeding increased the risk of subsequent mortality during follow-up of anticoagulated patients, highlighting the importance of prevention. The study developed a new scoring model for acute GI bleeding risk based on five factors (no-proton pump inhibitor use, chronic kidney disease, chronic obstructive pulmonary disease, history of peptic ulcer disease, and liver cirrhosis), which was superior to the HAS-BLED score.

Predicting Major Bleeding in Ischemic Stroke Patients With Atrial Fibrillation.

Performance of risk scores for major bleeding in patients with atrial fibrillation and a previous transient ischemic attack or ischemic stroke is not well established. We aimed to validate risk scores for major bleeding in patients with atrial fibrillation treated with oral anticoagulants after cerebral ischemia and explore the net benefit of oral anticoagulants among bleeding risk categories. We analyzed 3623 patients with a history of transient ischemic attack or stroke included in the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). We assessed performance of HEMORR2HAGES (hepatic or renal disease, ethanol abuse, malignancy, older age, reduced platelet count or function, hypertension [uncontrolled], anemia, genetic factors, excessive fall risk, and stroke), Shireman, HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly), ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), and ORBIT scores (older age, reduced haemoglobin/haematocrit/history of anaemia, bleeding history, insufficient kidney function, and treatment with antiplatelet) with C statistics and calibration plots. Net benefit of oral anticoagulants was explored by comparing risk reduction in ischemic stroke with risk increase in major bleedings on warfarin. During 6922 person-years of follow-up, 266 patients experienced a major bleed (3.8 per 100 person-years). C statistics ranged from 0.62 (Shireman) to 0.67 (ATRIA). Calibration was poor for ATRIA and moderate for other models. The reduction in recurrent ischemic strokes on warfarin was larger than the increase in major bleeding risk, irrespective of bleeding risk category. Performance of prediction models for major bleeding in patients with cerebral ischemia and atrial fibrillation is modest but comparable with performance in patients with only atrial fibrillation. Bleeding risk scores cannot guide treatment decisions for oral anticoagulants but may still be useful to identify modifiable risk factors for bleeding. Clinical usefulness may be best for ORBIT, which is based on a limited number of easily obtainable variables and showed reasonable performance.

Comparison of HAS-BLED and HAS-BED Versus CHADS2 and CHA2DS2VASC Stroke and Bleeding Scores in Patients With Atrial Fibrillation

Anticoagulation is recommended in patients with atrial fibrillation (AF) for stroke prevention, and the bleeding risk associated suggests the need for a bleeding risk stratification. HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio (INR), elderly >65years, drugs/alcohol concomitantly) score includes "labile INR" referred to quality of anticoagulation. However, in naïve patients, this item is not available. In addition, stroke and bleeding risk prediction scores shared several risk factors. The aims of our study were as follows: (1) to evaluate if the HAS-BLED score in its refined form excluding "labile INR" (HAS-BED [hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, elderly, drugs/alcohol]) is still associated with bleeding risk and (2) to evaluate the predictive ability for bleeding of both stroke and bleeding prediction models. We followed an inception cohort of 4,579 patients with AF enrolled in the Survey on anticoagulaTed pAtients RegisTer (NCT02219984). Major bleeds were recorded. During follow-up (7,014 patient-years), 115 patients experienced a major bleeding (MB; rate 1.6× 100 patient-years). Patients at high risk were better identified by HAS-BLED and HAS-BED scores with respect to CHADS2 (congestive heart failure, hypertension, age >75years, diabetes, previous stroke or transient ischemic attack) and CHA2DS2VASc (congestive heart, failure, hypertension, age [>75years], diabetes, stroke/transient ischemic attack, vascular disease, age [65 to 74years], female gender). HAS-BLED has a slightly higher c value in comparison to CHADS2 and CHA2DS2VASc. However, among naïve patients, the predictive ability for hemorrhage of HAS-BED score is overlapping with CHADS2 and CHA2DS2VASc. In low stroke risk patients (CHA2DS2VASc= 0 to 1), only 6 patients are at high bleeding risk, and none of them experienced MB. In conclusion, in our prospective cohort of patients with AF, we found that HAS-BLED and HAS-BED scores identify patients at high bleeding risk. However, the predictive value for MB of HAS-BED used in naïve patients is similar to CHADS2 or CHA2DS2VASc, suggesting that stroke stratification scores could be sufficient for tailoring treatment.

Oral anticoagulation in octogenarians with atrial fibrillation

BackgroundVitamin K antagonists (VKAs) are still largely employed, even in nonvalvular atrial fibrillation (AF). Our aim was to study the clinical profile of octogenarians treated with oral anticoagulation and to study the effect of age on the quality of VKAs anticoagulation. MethodsData are from a prospective national registry in an adult Spanish population of nonvalvular AF. We included 1637 patients who had been receiving VKAs for at least 6months before enrolment. ResultsMean age was 73.8±9.4years. Patients aged >80years (N=429) had a high risk profile with higher risk of stroke and bleeding than younger patients; CHA2DS2-VASc (Cardiac failure, Hypertension, Age>74, Diabetes, Stroke, Vascular disease, Age 65–74years, and Sex category) 4.5±1.3 vs. 3.5±1.6, p<0.001, HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (>64years), Drugs/alcohol concomitantly) 2.4±0.9 vs. 1.9±1.1, p<0.001. Creatinine clearance was lower in octogenarians than in younger patients (54.3±16.1ml/min vs. 69.5±23.7ml/min, p<0.001) and severe renal disease with creatinine clearance <30ml/min was more frequent in octogenarians (5.2% vs. 2.2%, p<0.001). In patients treated with VKAs (N=1637), the international normalized ratio values of the 6months previous to enrollment were similar in all age quartiles, as was the time in the therapeutic range. ConclusionIn this large registry octogenarians with nonvalvular AF had high risk of stroke and bleeding and frequent renal disease. VKAs anticoagulation quality was similar in octogenarians and in younger patients.