Validation of the IMPROVE bleeding risk assessment model in surgical patients: Results from the DissolVE-2 Study.

INTRODUCTION: IMPROVE Bleeding Risk Score (BRS) is known to be validated and widely accepted in medical patients. However, its relevance in surgical patients has so far not been explored. External validation of the IMPROVE BRS on bleeding in surgical patients can hopefully improve clinical practice (for surgical patients). METHODS: Data from 6986 surgical patients were collected from the DissolVE-2 cohort. The Kaplan-Meier method was used to assess the incidences of major bleeding and any bleeding among surgical patients within 14 days of admission. A cut-off value of BRS ≥7 indicated a higher risk of bleeding. Risk factors associated with major and any bleeding were analysed by the Cox regression method. Model discrimination was evaluated by area under the receiver operator characteristic curves (AUC). Calibration curves and Hosmer-Lemeshow χ2 statistics were used to measure the difference between predicted and observed bleeding risks. RESULTS: A total of 6399 surgical patients were included in the final validation cohort. The cumulative incidence rate of any bleeding was 3.9 % (95 % confidence interval [CI], 3.4-4.5), of which the incidence rate of major bleeding was 1.2 % (95 % CI, 0.9-1.6). Among patients with a BRS of ≥7, 16.3 % reported any bleeding, and 26.3 % reported major bleeding. The IMPROVE BRS had a better discriminative power (AUC = 0.69) and excellent goodness of fit (Hosmer-Lemeshow test, P = 0.208) for the prediction of major bleeding events as compared with any bleeding (AUC = 0.55; Hosmer-Lemeshow test, P = 0.004). The calibration plot suggested a more accurate prediction for major bleeding events. Moreover, the IMPROVE BRS had a higher AUC value of 0.83 and better goodness of fit (P = 0.2616) for major bleeding in patients undergoing abdominal surgery than other surgery types. CONCLUSION: The IMPROVE BRS is a simple and practical technique that can help in predicting the risk of major bleeding in surgical patients, improving functional and safety outcomes of hospitalized patients with surgery.

Performance of the ABC-bleeding risk score for assessing major bleeding risk in Chinese patients with atrial fibrillation on oral anticoagulation therapy: A real-world study.

Objective: To evaluate performance of the ABC (Age, Biomarkers, Clinical history)-bleeding risk score in estimating major bleeding risk in Chinese patients with atrial fibrillation (AF) on oral anticoagulation (OAC) therapy in real-world practice. Methods: Data were collected from the Chinese Atrial Fibrillation Registry study (CAFR). Patients were stratified into low-, medium-, and high-risk groups based on ABC-bleeding risk score with 1-year major bleeding risk (<1%, 1-2%, and > 2%) and modified HAS-BLED score (≤1, 2, and > 2 points). Cox proportional-hazards (Cox-PH) models were used to determine the association of major bleeding incidence with bleeding scores. Harrell's C-index of the two scores were compared. Net reclassification improvement (NRI) and integrated discrimination improvement (IDI) at 1 year were employed to evaluate the reclassification capacity. The calibration curve was plotted to compare the predicted major bleeding risk using ABC-bleeding risk score with the observed annualized event rate. The decision analysis curves (DCA) were performed to show the clinical utilization of two scores in identifying major bleeding events. Results: The study included 2,892 AF patients on OAC therapy. After the follow-up of 3.0 years, 48 patients had major bleeding events; the incidence of a bleeding event in the low-, medium-, and high-risk groups according to ABC-bleeding risk score was 0.31% (reference group, HR = 1.00),0.51% (HR = 1.83, 95%CI: 0.91-3.69, P = 0.09), and 1.49% (HR = 4.92, 95%CI: 2.34-10.30, P < 0.001), respectively. Major bleeding incidence had an independent association with growth differentiation factor 15 (GDF-15) level (HR = 2.16, 95%CI: 1.27-3.68, P = 0.005) after adjusting components of the HAS-BLED score and cTnT-hs level. The ABC-bleeding score showed a Harrell's C-index of 0.67 (95%CI: 0.60-0.75) in estimating major bleeding risk, which was non-significant compared to the modified HAS-BLED score (0.67 vs. 0.63; P = 0.38). NRI and IDI also revealed comparable reclassification capacity of ABC-bleeding risk score compared with HAS-BLED score (14.6%, 95%CI: -10.2%, 39.4%, P = 0.25; 0.2%, 95%CI -0.1 to 0.9%, P = 0.64). Cross-tabulation of the two scores showed that the ABC-bleeding score outperformed the HAS-BLED score in identifying patients with a high risk of major bleeding. The calibration curve showed that the ABC-bleeding risk score overestimated the observed major bleeding risk. DCA did not show any difference in net benefit when using either of the scores. Conclusion: This study verified the value of the ABC-bleeding risk score in assessing major bleeding risk in Chinese patients with AF on OAC therapy in real-world practice. Despite the overestimation of major bleeding risk, ABC-bleeding score performed better in stratifying patients with a high risk than the modified HAS-BLED score. Combining the two scores could be a clinically practical strategy for precisely stratifying AF patients, especially those at a high risk of major bleeding, and further supporting the optimization of OAC treatment.

Predictive performance of different bleeding risk scores in patients with atrial fibrillation and acute coronary syndrome or undergoing percutaneous coronary intervention.

This study aims to evaluate the predictive values of the HAS-BLED, ORBIT, ATRIA, REACH, PARIS, and PRECISE-DAPT scores in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) who received both anticoagulant and antiplatelet therapy. 930 patients were consecutively recruited and followed up for 1 year. The primary endpoints were BARC class ≥3 bleeding and BARC class ≥2 bleeding. BARC class ≥3 bleeding occurred in 36 patients(3.9%), while BARC class ≥2 bleeding was seen in 134 patients (14.4%). The predictive performance of the HAS-BLED score for BARC class ≥3 bleeding was unsatisfactory (c-statistic = 0.575). The discrimination of the ATRIA, ORBIT, PARIS, and PRECISE-DAPT scores was also low-to-moderate. The REACH score was useless in bleeding risk stratification for this population. Multivariable logistic regression indicated that previous bleeding events and hemoglobin were two independent predictors of BARC class ≥3 bleeding. Compared to the HAS-BLED score, the model constructed by previous bleeding events and hemoglobin displayed a significant improvement in bleeding risk prediction [c-statistics: 0.704 vs. 0.575 (p = .008), NRI = 0.662,IDI = 0.049]. In patients with AF and ACS or undergoing PCI who received anticoagulant+antiplatelet therapy, the HAS-BLED, ORBIT, ATRIA, REACH, PARIS, and PRECISE-DAPT scores displayed only low-to-moderate performance in predicting BARC class≥3 bleeding. Future studies are required to develop more reliable scoring systems for bleeding risk evaluation in this population.

An external validation study of the Utah Bleeding Risk Score.

OBJECTIVES: Gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices (CF-LVAD) impairs quality of life and increases hospitalization rate. The Utah Bleeding Risk Score (UBRS) has been created to predict gastrointestinal bleeding (GIB) in patients on left ventricular assist device. We here aimed to externally validate UBRS on our cohort of CF-LVAD patients. METHODS: Utah Bleeding Risk Score was calculated, GIB events summarized on follow-up and patients stratified into 3 risk groups. Predictive ability of UBRS was examined at 3 years and during whole support time and person time incidence rates correlated to UBRS. In a sub-analysis, single effects of UBRS variables on freedom from GIB were assessed. RESULTS: A total of 111 CF-LVAD patients were included. The median UBRS was 2 (3-1). Receiver operating characteristic curve analysis showed an area under the curve of 0.519 (P = 0.758, 95% confidence interval = 0.422-0.615) at 3 years and an area under the curve of 0.515 (P = 0.797, 95% confidence interval = 0.418-0.611) during whole support time. No significant difference was observed in UBRS between bleeders and non-bleeders (P = 0.80). No significant difference in freedom from GIB was observed (P3 years = 0.7; Psupport-time = 0.816) and no independent significance regarding the freedom from bleeding at 3 years for any variable was observed. Coronary artery disease was associated with higher risk of GIB beyond the 3rd year (P = 0.048). CONCLUSIONS: UBRS was not able to predict GIB and therefore not applicable in our cohort of patients. Coronary artery disease could lead to a higher risk for GIB during support time. An additional validation in a larger cohort is advisable.

Bleeding risk stratification in coronary artery surgery: the should-not-bleed score.

BACKGROUND: An estimated 20% of allogeneic blood transfusions in the United States are associated with cardiac surgery. It is estimated that 11% of red cell resources were used for transfusion support of patients undergoing coronary artery bypass grafting (CABG) with a documented wide variability in transfusion rate (7.8 to 92.8%). To address the issue of unnecessary transfusions within the CABG population, we developed a model to predict which patients are at low risk of bleeding for whom transfusion treatment might be considered unnecessary. Herein we present our "SHOULD-NOT-BLEED-SCORE" application developed for the Windows® software platform which is based on our previous research. METHODS: This study is aimed to develop a user-friendly application that stratifies patients with respect to bleeding risk. The statistical model we used in our previous research was focused on detection of CABG patients at low risk of bleeding. The rationale behind such an approach was to identify a CABG patient subgroup at low risk of bleeding. By identifying patients at low risk of bleeding we can define a subgroup of patients for whom transfusion treatment might be considered unnecessary. We developed a Windows platform application based on risk modelling which we previously calculated for 1426 patients undergoing elective CABG from January 2010 to January 2018. RESULTS: The SHOULD-NOT-BLEED-SCORE risk score is developed for the Windows software platform. A mathematical model that is based on multivariate analysis was used for app development. The variables that entered the scoring system were: Age; Body Mass Index; Chronic Renal Failure; Preoperative Clopidogrel Exposure; Preoperative Red Blood Cells Count; Preoperative Fibrinogen Level; Preoperative Multiplate ASPI test area under the curve (AUC) units. The SHOULD-NOT-BLEED-SCORE identifies/predicts patients without a risk for excessive bleeding with strong discriminatory performance (Receiver Operating Curve (ROC) analysis AUC 72.3%, p < 0.001). CONCLUSION: The SHOULD-NOT-BLEED risk scoring application may be useful in the preoperative risk screening process. The clinical and economic burden associated with unnecessary transfusions may be adequately addressed by a preoperative scoring system detecting patients at low risk of bleeding for whom transfusion treatment might be considered unnecessary.

Comparison of clinical performance of four gastrointestinal bleeding risk scores in Chinese patients with atrial fibrillation receiving oral anticoagulants.

Gastrointestinal bleeding is the most common bleeding complication during anticoagulant therapy. A reliable bleeding risk score can help the clinician assess risk of bleeding in individual patients and select the anticoagulant regimen. This study retrospectively analyzed the data of patients with atrial fibrillation who received anticoagulant therapy from July 2015 to December 2018 at two centers-the Fujian Medical University Union Hospital and Fuzhou Second Hospital Affiliated to Xiamen University. Demographic data, clinical findings, and laboratory results were collected from the hospital records. Patients were followed up for 6 months. The performance of four bleeding risk scores (New Score, RIETE Score, Cuschieri et al. Score, de Groot et al. Score) for prediction of gastrointestinal bleeding was assessed using the area under the curve. A total of 3462 patients (mean age, 66.3 ± 11.5 years; 59.6% males; 1055 direct oral anticoagulants users and 2407 warfarin users) were followed up for 6 months. While 99/3462 (2.9%) patients had gastrointestinal bleeding. The area under the curves for the New, RIETE, Cuschieri et al., de Groot et al. scores were 0.652 (95% CI 0.576-0.728), 0.862 (95% CI 0.809-0.914), 0.606 (95% CI 0.527-0.685), and 0.873 (95% CI 0.816-0.929), respectively. Among the four BRSs evaluated, the RIETE score and the de Groot et al. score appear to have the good predictive value, while the NEW score and the Cuschieri et al. score did not sufficiently predict gastrointestinal bleeding risk within the study Chinese population.

1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry.

BACKGROUND: The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. OBJECTIVE: We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. METHODS: MASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score ≤ 3 and intermediate-to-high (IHBR) for score > 3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. RESULTS: The study included 56% (n = 1270) LBR and 44% (n = 1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p = 0.047) driven by cardiac death (1.7% vs. 0.7%, p = 0.029) with similar rates of MI (1.8% vs. 1.1%, p = 0.17), TLR (1.5% vs. 1.6%, p = 0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p = 0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p = 0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p < 0.01), driven by physician-guided discontinuation. CONCLUSIONS: Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

Validation of the IMPROVE bleeding risk score in Chinese medical patients during hospitalization: Findings from the dissolve-2 study.

BACKGROUND: Venous thromboembolism (VTE) prophylaxis remains suboptimal in China due to the bleeding risk associated with pharmacologic prophylaxis. We used data from the DissolVE-2 study to report the risk factors for bleeding and validated the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) bleeding risk score (BRS). METHODS: In-hospital major bleeding incidence in medical patients from the DissolVE-2 study were assessed by Kaplan-Meier method. Risk factors associated with clinically relevant bleeding (CRB) were analysed using Cox regression model. Sensitivity, specificity, positive predictive value, negative predictive value and receiver-operating characteristic (ROC) curve was used to compute the diagnostic accuracy of IMPROVE BRS in the study cohort. FINDINGS: Of the 6623 medical patients, 5076 patients with all relevant clinical details were included for the validation cohort. Overall, 127 CRB events (38 major and 89 clinically relevant non-major bleeding events) occurred in this cohort, with a cumulative incidence rate of 2.6% (95% confidence interval [CI], 2.3-3.4). Application of IMPROVE BRS revealed significantly higher hazards of CRB (hazard ratio [HR]: 7.17, 95% CI, 5.05-10.18) and major bleeding (HR: 13.95, 95% CI, 7.28-26.73) in patients with IMPROVE BRS ≥7. Comparison of predictive parameters revealed higher sensitivity (44.1 vs 35.9) and positive predictive value (10.9 vs 2.6) for CRB in our study than the IMPROVE study, which was substantiated by the area under the curve (0.73, p<0.0001) from the ROC curve analysis. INTERPRETATION: IMPROVE BRS is a simple model for estimating bleeding risk in Chinese medical patients and could be used in conjunction with VTE risk assessment models to decide prophylactic treatment for VTE. FUNDING: This study and the additional data analysis were funded by Sanofi (Beijing) Pharmaceutical Co, Ltd by the Fund of The National Key Research and Development Program of China [Grant 2016YFC0905600] and by CAMS Innovation Fund for Medical Sciences (CIFMS) (No.2018-I2M-1-003).

Comparison of prediction value of four bleeding risk scores for pulmonary embolism with anticoagulation: A real-world study in Chinese patients.

BACKGROUND: Major bleeding (MB) and clinically relevant bleeding (CRB) are the most common seen complications associated with anticoagulation treatment for pulmonary embolism (PE) patients. A bleeding risk score (BRS) may help to accurately determine the risk of bleeding and make better decisions for patients in clinical practice. METHODS: Patients diagnosed as acute PE and who met the inclusion criteria in Beijing Chao-Yang Hospital from January 2009 to September 2013 were consecutively enrolled. Baseline data were collected. Four BRS (Kuijer score, RIETE score, Kearon score and Nieuwenhuis score) were assessed and compared using the area under the receiver operating characteristic curve (AUC). RESULTS: A total number of 563 patients were included in the study. Of which, 16 had MB and 89 had CRB within three months of anticoagulation treatment. Three months' cumulative incidence for MB and CRB events was 0.03 (95% CI 0.01-0.05) and 0.17 (95% CI 0.12-0.21), respectively. In our study population, the AUCs for Kuijer, RIETE, Kearon and Nieuwenhuis scores were 0.57 (95% CI 0.44~0.68), 0.56 (95% CI 0.45-0.71), 0.75 (95% CI 0.60~0.89) and 0.59 (95% CI 0.41~0.74), respectively. In addition, the AUCs of four BRS for CRB were all poor, with values less than 0.65. CONCLUSIONS: Only the Kearon score appeared to have more accuracy in predicting the risk of MB. Further large prospective studies are needed to externally validate a BRS for CRB.

Performance of HAS-BLED, ORBIT, PRECISE-DAPT, and PARIS risk score for predicting long-term bleeding events in patients taking an oral anticoagulant undergoing percutaneous coronary intervention.

BACKGROUND: No standardized tool exists for weighting bleeding risk before selecting an antithrombotic regimen in patients undergoing percutaneous coronary intervention (PCI) who require both oral anticoagulant (OAC) and antiplatelet agents. METHODS: We performed PCI in 3718 consecutive patients between April 2011 and March 2017, 302 of whom were treated with both OAC and antiplatelet agents. We retrospectively evaluated the predictive performance of four major bleeding risk scores (HAS-BLED, ORBIT, PRECISE-DAPT, and PARIS score). Patients were followed for up to 3 years for bleeding events, defined as a composite of major and minor bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) criteria and the Bleeding Academic Research Consortium (BARC) criteria. RESULTS: TIMI significant bleedings (major, minor, and requiring medical attention) were seen in 90 patients (29.8%); whereas the BARC class ≥3 bleedings were seen in 53 patients (17.5%). Regarding TIMI significant bleedings, HAS-BLED, ORBIT, and PRECISE-DAPT scores equally categorized high-risk patients, but the PARIS score could not [high-risk versus non-high-risk: hazard ratio (HR), 1.74; 95% confidence interval (CI), 1.15-2.64; p=0.01; HR, 1.63; 95% CI, 1.08-2.48; p=0.02; HR, 1.62; 95% CI, 1.06-2.51; p=0.03; HR, 1.05; 95% CI, 0.70-1.63; p=0.79, respectively); regarding BARC class ≥3 bleeding, all four scores could stratify high-risk patients (high-risk versus non-high-risk: HR, 2.23; 95% CI, 1.30-3.88; p=0.004; HR, 2.25; 95% CI, 1.31-3.96; p=0.003; HR, 3.87; 95% CI, 2.06-7.91; p<0.0001; HR, 1.85; 95% CI, 1.04-3.47; p=0.04, respectively). CONCLUSIONS: In patients taking an OAC undergoing PCI, HAS-BLED, ORBIT, and PRECISE-DAPT scores predicted TIMI significant bleeding events better than the PARIS score; whereas all four scores could predict BARC class ≥3 bleeding events.

Biomarkers Associated with Bleeding Risk in the Setting of Atrial Fibrillation.

BACKGROUND: Prevention of thromboembolic disease, mainly stroke, with oral anticoagulants remains a major therapeutic goal in patients with atrial fibrillation. Unfortunately, despite the high efficacy, anticoagulant therapy is associated with a significant risk of, frequently catastrophic, and hemorrhagic complications. Among different clinical and laboratory parameters related to an increased risk of bleeding, several biological markers have been recognized and various risk scores for bleeding have been developed. OBJECTIVES/METHODS: The aim of the present study is to review current evidence regarding the different biomarkers associated with raised bleeding risk in atrial fibrillation. RESULTS: Data originating from large cohorts or the recent large-scale trials of atrial fibrillation have linked numerous individual biomarkers to an increased bleeding risk. Such a relation was revealed for markers of cardiac physiology, such as troponin, BNP and NT-proBNP, markers of renal function, such as GFR and Cystatin or hepatic function, markers involving the system of coagulation, such as D-dimer and Von Willebrand factor, hematologic markers, such as low haemoglobin or low platelets, inflammatory markers, such as interleukin-6, other factors such as GDF-15 and vitamin-E and finally genetic polymorphisms. Many such biomarkers are incorporated in the bleeding risk schemata developed for the prediction of the hemorrhagic risk. CONCLUSIONS: Biomarkers were introduced in clinical practice in order to better estimate the potential risk of haemorrhage in these patients and increase the prognostic impact of clinical risk scores. In the last years this concept is gaining significant importance.

CRUSADE bleeding score as a predictor of bleeding events in patients with acute coronary syndrome in Zagazig University Hospital.

AIM: To examine the value of CRUSADE bleeding score in predicting bleeding events in our local patients with acute coronary syndrome (ACS) in Zagazig University Hospitals. METHODS: Our study included 240 patients with ACS. They underwent history and clinical examination; 12-lead electrocardiography; echocardiography; troponin I, hematocrit value; estimated glomerular filtration rate (eGFR); application of CRUSADE score; and follow-up of the hospital stay and documentations of events. Patients were classified into two groups: Group I: patients with major bleeding, and Group II: patients without major bleeding. RESULTS: Patients with major bleeding were significantly older, with more diabetic and hypertensive patients, more prior vascular disease, heart failure, and less patients with unstable angina, higher heart rate and systolic blood, lower eGFR, and higher CRUSADE risk score. CRUSADE bleeding score was the strongest predictor of major bleeding. Sensitivity of CRUSADE score ≥33 in prediction of major bleeding in the whole study group was 80%, specificity was 73.4%, positive predictive value was 26.9%, negative predictive value was 96.9%, overall accuracy was 74.1%. Sensitivity of CRUSADE score ≥38.5 in prediction of major bleeding in the STEMI patients was 70%, specificity was 84.8%, positive predictive value was 50%, negative predictive value was 92.9%, and overall accuracy was 82.1%. CONCLUSION: CRUSADE score is a good predictor for major bleeding in Egyptian patients with ACS. It is applicable in UA/NSTEMI as well as in STEMI patients and in women as well as in men.

Incremental Value of the CRUSADE, ACUITY, and HAS-BLED Risk Scores for the Prediction of Hemorrhagic Events After Coronary Stent Implantation in Patients Undergoing Long or Short Duration of Dual Antiplatelet Therapy.

BACKGROUND: Multiple scores have been proposed to stratify bleeding risk, but their value to guide dual antiplatelet therapy duration has never been appraised. We compared the performance of the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) scores in 1946 patients recruited in the Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) and assessed hemorrhagic and ischemic events in the 24- and 6-month dual antiplatelet therapy groups. METHODS AND RESULTS: Bleeding score performance was assessed with a Cox regression model and C statistics. Discriminative and reclassification power was assessed with net reclassification improvement and integrated discrimination improvement. The C statistic was similar between the CRUSADE score (area under the curve 0.71) and ACUITY (area under the curve 0.68), and higher than HAS-BLED (area under the curve 0.63). CRUSADE, but not ACUITY, improved reclassification (net reclassification index 0.39, P=0.005) and discrimination (integrated discrimination improvement index 0.0083, P=0.021) of major bleeding compared with HAS-BLED. Major bleeding and transfusions were higher in the 24- versus 6-month dual antiplatelet therapy groups in patients with a CRUSADE score >40 (hazard ratio for bleeding 2.69, P=0.035; hazard ratio for transfusions 4.65, P=0.009) but not in those with CRUSADE score ≤40 (hazard ratio for bleeding 1.50, P=0.25; hazard ratio for transfusions 1.37, P=0.44), with positive interaction (Pint=0.05 and Pint=0.01, respectively). The number of patients with high CRUSADE scores needed to treat for harm for major bleeding and transfusion were 17 and 15, respectively, with 24-month rather than 6-month dual antiplatelet therapy; corresponding figures in the overall population were 67 and 71, respectively. CONCLUSIONS: Our analysis suggests that the CRUSADE score predicts major bleeding similarly to ACUITY and better than HAS BLED in an all-comer population with percutaneous coronary intervention and potentially identifies patients at higher risk of hemorrhagic complications when treated with a long-term dual antiplatelet therapy regimen. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00611286.

A quality study to improve prophylactic antithrombotic therapy prescribed to patients with atrial fibrillation.

INTRODUCTION: Atrial fibrillation is the most common cardiac arrhythmia and has important clinical repercussions, increasing thromboembolic events and mortality. The CHA2DS2-VASc and HAS-BLED scores assist the clinician in assessing the benefits and risks of antithrombotic therapy. OBJECTIVE: The aim of this study was to assess and improve the quality of prophylactic antithrombotic therapy prescribed to patients with atrial fibrillation. METHODS: This was a quality study, based on a cycle of assessment and improvement, applied to the population of a family health unit, consisting of an initial assessment, an educational intervention and a second assessment. Both scores were calculated for all patients. Whenever the CHA2DS2-VASc score recommended initiation of anticoagulation, the risk was calculated by the HAS-BLED score; it was thus possible to determine for each patient if the prescribed therapy was appropriate. RESULTS: The first assessment included 105 patients, of whom 49.5% had appropriate prophylactic therapy according to their scores. In the second assessment, four months after the educational intervention, 60.0% had been prescribed appropriate therapy, which represented a 21.2% improvement. CONCLUSIONS: In both assessments, inappropriate treatment was due to non-prescription of prophylactic oral anticoagulation. This quality cycle serves as a tool for continuous assessment in the pursuit of improved care for patients with atrial fibrillation.

CRUSADE bleeding risk score validation for ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

INTRODUCTION: The CRUSADE bleeding risk score (CBRS) accurately predicts major bleeding in non-ST segment elevation myocardial infarction NSTEMI patients. However, little information exists about its application in ST segment elevation myocardial infarction STEMI. We aimed to assess the ability of CBRS to predict in-hospital major bleeding in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). MATERIALS AND METHODS: We prospectively analyzed consecutive STEMI patients undergoing PPCI. Baseline characteristics, in-hospital complications and mid term mortality were recorded. Major bleeding was defined by the CRUSADE definition. Predictive ability of the CBRS was assessed by logistic regression method and the area under the ROC curve (AUC). RESULTS: We included 1064 patients (mean age 63years). Mean CBRS value was 24. Most of patients (740/1064 (69.6%)) were in the two lowest risk quintiles of CBRS. Incidence of in-hospital major bleeding was 33/1064 (3.1%). The rates of in-hospital bleeding across the quintiles of risk groups were 0.4% (very low risk), 2.6% (low), 4.6% (moderate), 7.2% (high), and 13.4% (very high) (p 0.001). AUC was 0.80 (95% CI 0.73-0.87 p 0.001). In patients with radial access angiography (n=621) AUC was 0.81 (95% CI: 0.65-0.97). Mean follow up was 344days. Patients with bleeding events had higher mortality during follow up (HR 6.91; 95% CI 3.72-12.82; p 0.001). CONCLUSIONS: Our patients had a significantly lower bleeding risk as compared to CRUSADE NSTEMI population. CBRS accurately predicted major in-hospital bleeding in this different clinical scenario, including patients with radial artery approach.

Comparative assessment of the HAS-BLED score with other published bleeding risk scoring schemes, for intracranial haemorrhage risk in a non-atrial fibrillation population: the Chin-Shan Community Cohort Study.

BACKGROUND: The HAS-BLED score is a validated bleeding risk model for predicting major bleeding events in anticoagulated individuals with atrial fibrillation (AF). It remains uncertain whether the HAS-BLED score could identify non-AF individuals at risk of developing intracranial haemorrhage (ICH), which is the most intractable and devastating major bleeding complication. METHODS: We assessed the predictive value of a modified HAS-BLED and other bleeding risk scoring models to predict the risk for ICH in the Chin-Shan Community Cohort, which followed 1899 women and 1703 men, aged >35 years, for a median of 15.9 years. ICH events (including haemorrhagic strokes) were ascertained according to questionnaires and the national register database. RESULTS: Of 3524 individuals without baseline AF, 54 ICH events occurred during follow-up. The risk for ICH was raised with increasing HAS-BLED scores, and was significantly associated with uncontrolled hypertension and older age (Odds Ratios [95% confidence interval (CI)], 4.2[2.3-7.6] and 1.9[1.1-3.4], respectively). Among the five bleeding risk scoring schemes tested, HAS-BLED had highest general discrimination performance (c-statistic [95% CI], 0.72 [0.67-0.78]), and better ability to discriminate between those who were at risk for ICH and who were not (NRI, net reclassification improvement, all p<0.05, compared to other four scoring schemes). CONCLUSION: The HAS-BLED score had the highest general discrimination performance and best ability to discriminate risk for ICH. This score may be of clinical use in predicting the risk for occurrence of ICH among non-AF individuals.