Bleeding Risk Prediction Scores Research Articles

Heart failure and major haemorrhage in people with atrial fibrillation

BackgroundHeart failure (HF) is not included in atrial fibrillation (AF) bleeding risk prediction scores, reflecting uncertainty regarding its importance as a risk factor for major haemorrhage. We aimed to report...

Validation of Bleeding Risk Prediction Scores for Patients With Major Bleeding on Direct Oral Anticoagulants.

Direct oral anticoagulants (DOACs) offer many benefits over vitamin K antagonists (VKAs) but still carry a significant risk of major bleeding. Bleeding risk prediction scores such as the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, and Drugs/Alcohol (HAS-BLED), 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 (HEMORR2HAGES), Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA), Registro Informatizado Enfermedad TromboEmbólica (RIETE), and CHEST scores were validated or evaluated for use with VKAs and parenteral anticoagulants, but evidence for use with DOACs is lacking. This study aims to evaluate bleeding risk prediction scores for DOAC patients presenting with major bleeding. A retrospective analysis of patients presenting from 2015 to 2018 was performed. Patients were separated into bleed and nonbleed groups. The primary objective was to assess the diagnostic accuracy of the bleeding risk prediction scores utilizing the receiver operating characteristic (ROC) curve. A total of 126 patients were included in the analyses. The areas under the curve (AUC) for the ROC curves of the HAS-BLED, HEMORR2HAGES, ATRIA, RIETE, and CHEST scores were 0.645, 0.675, 0.580, 0.638, and 0.667, respectively. The HAS-BLED, HEMORR2HAGES, RIETE, and CHEST scores were found to have sufficient diagnostic accuracy for predicting risk of major bleeding in our study population; however, no score was identified as having an AUC greater than 0.7. Caution may be considered when utilizing these scores for patients on DOACs.

TCT-642 PARIS Risk Score Stratified Analysis of Clinical Outcomes Among Elderly Patients (Aged > 75 Years) Treated With 23-Month Ticagrelor Monotherapy Following 1-Month DAPT After PCI in the GLOBAL LEADERS Trial

Ischemic and bleeding risk prediction scores designed for guiding antiplatelet therapy after percutaneous coronary intervention (PCI) remain underused in daily clinical practice, including particularly susceptible subsets such as elderly patients. We aimed to evaluate the efficacy and safety of

D-dimer levels enhance the discriminatory capacity of bleeding risk scores for predicting in-hospital bleeding events in acute pulmonary embolism

IntroductionBleeding is a major complication of anticoagulation in acute pulmonary embolism (APE) while estimating individual bleeding risk remains challenging. Elevated D-dimer levels (DD) have been shown to predict bleeding events. Objectives(1) direct comparison of the capacity of bleeding risk prediction scores (VTE-BLEED, RIETE, HAS-BLED, HEMORR2HAGES) to prognosticate in-hospital bleeding events in the acute phase of APE in a real-life population of APE patients;(2) augmentation of the discriminative capacity of fore mentioned scores with DD. MaterialsPost-hoc analysis of a prospective observational study. DD levels were measured using the VIDAS D-dimer Exclusion test. Receiver operating characteristic curves, areas under the curve (AUC) for bleeding prediction were calculated for scores and DD. Bleeding scores+DD were compared using an established index quantifying the reclassification of patients (net reclassification index, NRI). Results310 APE patients were included. 35(11.3%) bleeding events occurred (hematomas, GI, urinary tract, retroperitoneal, uterine, CNS, respiratory tract): 17 major (MB) and 18 clinically-relevant non-major bleedings (CRNMB), none were fatal. All scores had satisfactory AUCs (0.754–0.767), except HAS-BLED (AUC = 0.512; 0.455–0.569). DD were higher in patients with bleeding events (29,911 ng/ml vs. 4805 ng/ml, p = .031), AUC 0.621(0.520–0.721), p = .02. DD = 5750 ng/ml was characterized by OR = 2.3(95%CI 1.05–5.0) for all bleeding events. Adding DD improved the discriminatory capacity of tested scores in the non-high risk of bleeding category, NRI 0.07–03. ConclusionsOf the tested scores RIETE, HEMORR2HAGES, VTE-BLEED performed best at identifying APE patients at risk of in-hospital bleeding complications. DD levels may predict in-hospital bleeding events and may improve identifying patients classified as non-high risk who experience bleeding complications.

Meta-Analysis of Bleeding Risk Prediction Scores in Patients After Percutaneous Coronary Intervention on Dual Antiplatelet Therapy

The duration and type of dual antiplatelet therapy (DAPT) prescribed to patients after percutaneous coronary intervention (PCI) involves carefully balancing reduced ischemia and increased bleeding risk for individual patients. Whereas multiple bleeding risk scores exist, the performance of these models to predict long-term bleeding in the setting of DAPT across different settings and populations is unclear. Therefore, we performed a systematic review and meta-analysis to compare the performance of current bleeding risk prediction scores for predicting major long-term bleeding events in patients on DAPT post-PCI. Based on a search of MEDLINE (January 1, 1946 to March 3, 2017) and EMBASE (January 1, 1974 to March 3, 2017) for studies published in the English language, we identified 10 published studies of 11 risk unique risk prediction models across a wide variety of settings. Area under the receiver operating characteristic curve (AUC) was used to measure discrimination, when available. Our findings reveal that the prediction models created to date demonstrate only modest accuracy, with the reported AUCs ranging from 0.54 to 0.89; aggregated AUC 0.68 (95% confidence intervals 0.65 to 0.72). Although only 5 studies (50%) reported measures of calibration, the reported models were reasonably well calibrated. Only 3 models (33%) were externally validated. Meta-regression demonstrated lack of influence by age (p = 0.99) or length of follow up (p = 0.42). Sensitivity analysis did not significantly change the results. Novel prediction models are warranted to aid in maximizing the benefit of DAPT after PCI while minimizing harm.

P3836The prognostic accuracy of bleeding risk prediction scores in patients with atrial fibrillation: a systematic review and meta-analysis

P3836The prognostic accuracy of bleeding risk prediction scores in patients with atrial fibrillation: a systematic review and meta-analysis

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.

Assessing the Appropriateness of Oral Anticoagulation for Atrial Fibrillation in Advanced Frailty: Use of Stroke and Bleeding Risk-Prediction Models.

Atrial fibrillation (AF) is common among frail older adults. Oral anticoagulation (OAC) is particularly challenging for these due to overlapping stroke and bleeding risk factor profiles. To compare the utility of stroke and haemorrhage risk-prediction instruments in the treatment of AF among frail older adults. Cross-sectional study. Frail residents in four nursing homes with a Clinical Frailty Scale score ≥5 (median 7±0). The prevalence of AF was assessed by ECG and chart review. Stroke (CHADS2 and CHA2DS2-VASc) and bleeding (HASBLED and HEMORR2HAGES) risk-prediction scores were then applied. A validated, risk-based, colour-coded decision support tool, incorporating these instruments, was then used to create a risk matrix and assess the appropriateness of OAC. In total, 225 patients were included. The distribution of CFS scores was similar irrespective of AF status. In all, 86/225 (38%) had any history of AF. Of these, only 15/86 (17%) were prescribed OAC. All those in AF scored ≥2 on the CHA2DS2-VASc. One-third also scored high-risk of bleeding using HAS-BLED or HEMORR2HAGES. Risk-prediction scores were similar between those with 'known' (documented) and occult (only on ECG) AF. The colour-coded decision tree suggested that OAC would be recommended for the majority in AF when HAS-BLED (60/86, 70%) was used as the bleeding risk-prediction instrument. Despite this, only 12/60 (20%) were anticoagulated. When HEMORR2HAGES was incorporated instead, one patient was advised OAC, the remainder no treatment (57%) or an antiplatelet (42%). Stroke risk was high and bleeding risk levels comparatively low, suggesting that the balance of risk may favor OAC for AF in this cohort of patients with advanced frailty. Despite this and the high prevalence of AF, OAC prescription rates were low. The decision-support tool used showed mixed results, depending on the bleeding-risk score incorporated, suggesting that while useful, they should not replace clinical judgement.

Evaluation of the HAS-BLED, ATRIA, and ORBIT Bleeding Risk Scores in Patients with Atrial Fibrillation Taking Warfarin

ObjectivesVarious bleeding risk prediction schemes, such as the Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized Ratio, Elderly, Drugs/alcohol (HAS-BLED), Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA), and Outcomes Registry for Better Informed Treatment (ORBIT) scores, have been proposed in patients with atrial fibrillation. We compared the relative predictive values of these bleeding risk scores for clinically relevant bleeding and the relationship of ATRIA and ORBIT scores to the quality of anticoagulation control on warfarin, as reflected by time in therapeutic range. MethodsWe conducted a post hoc ancillary analysis of clinically relevant bleeding and major bleeding events among 2293 patients receiving warfarin therapy in the AMADEUS trial. ResultsOnly HAS-BLED was significantly predictive for clinically relevant bleeding, and all 3 risk scores were predictive for major bleeding. The predictive performance of HAS-BLED was modest, as reflected by c-indexes of 0.59 (P < .001) and 0.65 (P < .002) for clinically relevant bleeding and major bleeding, respectively. The HAS-BLED score performed better than the ATRIA (P = .002) or ORBIT (P = .001) score in predicting any clinically relevant bleeding. Only the HAS-BLED score was significantly associated with the risk for both bleeding outcomes on Cox regression analysis (any clinically relevant bleeding: hazard ratio, 1.85; 95% confidence interval, 1.43-2.40, P < .001; major bleeding: hazard ratio, 2.40; 95% confidence interval, 1.28-4.52; P = .007). There were strong inverse correlations of ATRIA and ORBIT scores to time in therapeutic range as a continuous variable (low risk ATRIA, r = −0.96; P = .003; ORBIT, r = −0.96; P = .003). Improvement in the predictive performance for both ATRIA and ORBIT scores for any clinically relevant bleeding was achieved by adding time in therapeutic range to both scores, with significant differences in c-indexes (P = .001 and P = .002, respectively), net reclassification improvement, and integrated discriminant improvement (both P < .001). ConclusionsAll 3 bleeding risk prediction scores demonstrated modest predictive ability for bleeding outcomes, although the HAS-BLED score performed better than the ATRIA or ORBIT score. Significant improvements in both ATRIA and ORBIT score prediction performances were achieved by adding time in therapeutic range to both scores.

Performance of Bleeding Risk-Prediction Scores in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

The hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, and drugs/alcohol (HAS-BLED); anticoagulation and risk factors in atrial fibrillation (ATRIA); modified Outpatient Bleeding Risk Index (mOBRI); and reduction of atherothrombosis for continued health (REACH) schemes are validated bleeding risk-prediction tools, but their predictive performance in patients with AF receiving multiple antithrombotic drugs after percutaneous coronary intervention (PCI) is unknown. We sought to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation (AF) undergoing PCI. Management of patients with AF undergoing coronary artery stenting is a multicenter European prospective registry enrolling patients with AF undergoing PCI. We calculated HAS-BLED, ATRIA, mOBRI, and REACH bleeding risk-prediction scores and assessed the rate of bleeding complications as defined by Bleeding Academic Research Consortium at 12 months follow-up in 929 consecutive patients undergoing PCI. Increasing age, femoral access site, and previous peptic ulcer were independent determinants of bleeding. Low bleeding risk scores as determined by HAS-BLED 0 to 2, ATRIA 0 to 3, mOBRI 0, and REACH 0 to 10 were detected in 23.7%, 73.0%, 7.8%, and 5.7% of patients of the cohort, respectively. No significant differences were detected in the rates of any bleeding or major bleeding events for low versus intermediate/high scores with each risk-prediction tool. In conclusion, the performance of ATRIA, HAS-BLED, mOBRI, and REACH scores in predicting bleeding complications in this high-risk patient subset was useless.

Performance of bleeding risk-prediction scores in patients with atrial fibrillation undergoing percutaneous coronary intervention

Performance of bleeding risk-prediction scores in patients with atrial fibrillation undergoing percutaneous coronary intervention

The Analysis of Bleeding Risk–Prediction Scores Should Include All Major Bleeds

The study by Apostolakis et al. ([1][1]) compares the performance of bleeding risk–prediction scores in AMADEUS participants randomized to receive a vitamin K antagonist but excludes the 2,283 participants who were randomized to receive idraparinux. Because most of the bleeds in AMADEUS occurred

Performance of the HEMORR2HAGES, ATRIA, and HAS-BLED Bleeding Risk–Prediction Scores in Nonwarfarin Anticoagulated Atrial Fibrillation Patients

To the Editor: Estimation of bleeding risk is a crucial step in the management of patients with atrial fibrillation (AF). Three bleeding risk–prediction schemes have been derived and validated exclusively in AF populations: HEMORR2HAGES, HAS-BLED, and ATRIA ([1,2][1]). In the present analysis,

Performance of the HEMORR2HAGES, ATRIA, and HAS-BLED Bleeding Risk–Prediction Scores in Patients With Atrial Fibrillation Undergoing Anticoagulation: The AMADEUS (Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation) Study

The objective of this study was to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation (AF) undergoing anticoagulation. Three bleeding risk-prediction schemes have been derived for and validated in patients with AF: HEMORR(2)HAGES (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). Τhe relative predictive values of these bleeding scores have not previously been compared. We analyzed the dataset from the AMADEUS (Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation) trial, a multicenter, randomized, open-label noninferiority study that compared fixed-dose idraparinux with adjustable-dose oral vitamin K antagonist therapy in patients with AF. The principal safety outcome was any clinically relevant bleeding event, which was a composite of major bleeding plus clinically relevant nonmajor bleeding. The HAS-BLED score performed best in predicting any clinically relevant bleeding, reflected both in net reclassification improvement (10.3% and 13% improvement compared with HEMORR(2)HAGES and ATRIA, respectively) and receiver-operating characteristic (ROC) analyses (c-indexes: 0.60 vs. 0.55 and 0.50 for HAS-BLED vs. HEMORR(2)AGES and ATRIA, respectively). Using decision-curve analysis, the HAS-BLED score demonstrated superior performance compared with ATRIA and HEMORR(2)HAGES at any threshold probability for clinically relevant bleeding. HAS-BLED was the only score that demonstrated a significant predictive performance for intracranial hemorrhage (c-index: 0.75; p = 0.03). An ATRIA score >3 was not significantly associated with the risk for any clinically relevant bleeding on Cox regression or on ROC analysis (c-index: 0.50; p = 0.87). All 3 tested bleeding risk-prediction scores demonstrated only modest performance in predicting any clinically relevant bleeding, although the HAS-BLED score performed better than the HEMORR(2)HAGES and ATRIA scores, as reflected by ROC analysis, reclassification analysis, and decision-curve analysis. Only HAS-BLED demonstrated a significant predictive performance for intracranial hemorrhage. Given its simplicity, the HAS-BLED score may be an attractive method for the estimation of oral anticoagulant-related bleeding risk for use in clinical practice, supporting recommendations in international guidelines.