Outcomes Registry For Better Informed Treatment Research Articles

Oral anticoagulant safety in family practice: prognostic accuracy of Bleeding Risk Scores (from the CACAO study).

To assess bleeding risk of patients treated by oral anticoagulants, several scores have been constructed to assist physicians in the evaluation of the benefit risk. Most of these scores lack a strong enough level of evidence for use in family practice. To assess the predictive prognostic accuracy of 13 scores designed to assess the risk of major or clinically relevant non-major (CRNM) bleeding events in a French ambulatory cohort receiving Vitamin-K antagonists (VKA) or direct oral anticoagulants (DOACs) in a family practice setting. CACAO (Comparison of Accidents and their Circumstances with Oral Anticoagulants) was a multicentre prospective cohort of ambulatory patients prescribed oral anticoagulants. We selected patients from the cohort who had received an oral anticoagulant because of non-valvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE) to be followed during one year by their GP. The following scores were calculated: mOBRI, Shireman, Kuijer, HEMORR2HAGES, ATRIA, HAS-BLED, RIETE, VTE-BLEED, ACCP score, Rutherford, ABH-Score, GARFIEL-AF, and Outcomes Registry for Better InformedTreatment of Atrial Fibrillation (ORBIT). Prognostic accuracy was assessed by using receiver operating characteristic curves and c-statistics. During 1 year, 3,082 patients were followed. All of the scores demonstrated only poor to moderate ability to predict major bleeding or CRNM in NVAF patients on DOACs (c-statistic: 0.41-0.66 and 0.45-0.58), respectively. The results were only slightly better for patients prescribed VKA (0.47-0.66 and 0.5-0.55, respectively) in this indication. The results were also unsatisfactory in patients treated for VTE. None of the scores demonstrated satisfactory discriminatory ability when used in family practice. ClinicalTrials.gov NCT02376777.

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.

Correlation of the ORBIT Score With 30-Day Mortality in Patients With ST-Segment Elevation Myocardial Infarction.

A new scoring system Outcomes Registry for Better Informed Treatment (ORBIT) score is used to assess the bleeding risk in anticoagulated patients with atrial fibrillation (AF). Our aim is to investigate the possible correlations of the ORBIT score with 30-day mortality in patients with ST-segment elevation myocardial infarction (STEMI). A total of 639 patients with STEMI were enrolled in this study. The ORBIT, HAS-BLED, and TIMI scores were recorded during admission. After 30 days’ follow-up, 639 patients were divided into 2 groups: the survival group and the nonsurvival group. Different clinical parameters were compared. The predictive values of the ORBIT, HAS-BLED, and TIMI scores for 30-day mortality were assessed from receiver operating characteristic (ROC) analyses. The univariate and multivariate Cox proportional hazards analyses were applied to evaluate the relationships between variables and 30-day mortality. Sixty-seven deaths occurred after a 30-day follow-up. The ORBIT, HAS-BLED, and TIMI scores in the death group were higher than those in the survival group (P < .05). The areas under the ROC curve for the ORBIT, HAS-BLED, and TIMI scores to predict the occurrence of 30-day mortality were 0.811 (95% CI: 0.779-0.841, P < .0001), 0.717 (95% CI: 0.680-0.752, P < .0001), and 0.844 (95% CI: 0.813-0.871, P < .0001), respectively. In multivariate Cox proportional hazards modeling, the high ORBIT score was positively associated with 30-day mortality (hazard ratio: 1.309, 95% CI: 1.101-1.556, P = .013) after adjustment. A graded relation is found in the elevated ORBIT score and 30-day mortality in patients with STEMI. Thus, the ORBIT score can be an independent predictor of 30-day mortality in patients with STEMI.

HAS-BLED score as a predictor of bleeding complications from catheter ablation of atrial fibrillation: A subanalysis of the Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registries

BackgroundThe ATRIA, Outcomes Registry for Better Informed Treatment (ORBIT), and modified (m) HAS-BLED (excluding a labile international normalized ratio element from the HAS-BLED score) scores are currently used to predict the bleeding risk in atrial fibrillation (AF) patients receiving oral anticoagulant treatment. We assessed the usefulness of these scores in estimating the catheter ablation (CA)-related bleeding risk in AF patients from the Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry (JACRE). MethodsWe investigated 1322 consecutive patients enrolled in the prospective, multicenter JACRE registry of AF patients receiving CA. The patients also received rivaroxaban (n=1118) or warfarin (n=204) during the perioperative period and complications were monitored for 30 days post-surgery. ResultsPeriprocedural bleeding complications occurred in 42 patients (3.2%) and were significantly associated with the mHAS-BLED [hazard ratio=1.46, 95% confidence interval (1.06–2.01)], ATRIA [1.16 (1.00–1.35)], and ORBIT [1.29 (1.06–1.57)] scores. However, only the mHAS-BLED score predicted a significantly greater bleeding prevalence in the high-score group than in the low-score group stratified by a threshold maximizing the sensitivity and specificity (threshold=3, p<0.001). The incidence of all bleeding complications was significantly lower in the rivaroxaban cohort in patients with a mHAS-BLED score ≥3 (rivaroxaban vs. warfarin cohort, 5.56% vs. 25%, p=0.028). ConclusionsAll three common bleeding scores were associated with a periprocedural risk of CA-related bleeding in AF patients and a mHAS-BLED score ≥3 best distinguished high-risk patients from low-risk patients.

Relationship of the ORBIT and HAS-BLED scores with Killip class 3-4 in patients with ST-segment elevation myocardial infarction.

Heart failure (HF) complicating ST-segment elevation myocardial infarction (STEMI) is recognized as an ominous complication. The HAS-BLED and Outcomes Registry for Better Informed Treatment (ORBIT) scores are used to assess the bleeding risk in patients with anticoagulated atrial fibrillation. This study aimed to investigate the relationship of the ORBIT and HAS-BLED scores with Killip class 3-4 in patients with STEMI.639 patients with STEMI were enrolled in this study. The ORBIT and HAS-BLED scores were recorded after admission, and all patients were divided into 2 groups: the Killip class 1-2 and Killip class 3-4 groups. Different clinical parameters were compared. The predictive values of the ORBIT and HAS-BLED scores for Killip classes 3 to 4 were assessed using receiver-operating characteristic (ROC) analyses. Univariate and multivariate logistic analyses were used to evaluate the relationships between variables and Killip class 3-4.The ORBIT and HAS-BLED scores were higher in the Killip class 3-4 group than in the Killip class 1-2 group (P < .05). The areas under the ROC curve of the ORBIT and HAS-BLED scores for predicting the higher Killip classification were 0.818 (95% CI: 0.786–0.847, P < .0001) and 0.674 (95% CI: 0.636–0.710, P < .0001), respectively. In multivariate logistic analysis, the high ORBIT score was positively associated with Killip classes 3 to 4 after adjustment (odds ratio: 2.306, 95% CI: 1.084–4.911, P = .012).A graded relationship was found in the elevated ORBIT and HAS-BLED scores and Killip classes 3 to 4 in patients with STEMI. The ORBIT score is independently associated with the Killip 3-4 in patients with STEMI.

Performance of bleeding risk scores in dialysis patients.

Bleeding risk scores have been created to identify patients with an increased bleeding risk, which could also be useful in dialysis patients. However, the predictive performances of these bleeding risk scores in dialysis patients are unknown. Therefore, the aim of this study was to validate existing bleeding risk scores in dialysis patients. A cohort of 1745 incident dialysis patients was prospectively followed for 3 years during which bleeding events were registered. We evaluated the discriminative performance of the Hypertension, Abnormal kidney and liver function, Stroke, Bleeding, Labile INR, Elderly and Drugs or alcohol (HASBLED), the AnTicoagulation and Risk factors In Atrial fibrillation (ATRIA), the Hepatic or kidney disease, Ethanol abuse, Malignancy, Older age, Reduced platelet count or Reduced platelet function, Hypertension, Anaemia, Genetic factors, Excessive fall risk and Stroke (HEMORR2HAGES) and the Outcomes Registry for Better Informed Treatment (ORBIT) bleeding risk scores by calculating C-statistics with 95% confidence intervals (CI). In addition, calibration was evaluated by comparing predicted and observed risks. Of the 1745 dialysis patients, 183 patients had a bleeding event, corresponding to an incidence rate of 5.23/100 person-years. The HASBLED [C-statistic of 0.58 (95% CI 0.54-0.62)], ATRIA [C-statistic of 0.55 (95% CI 0.51-0.60)], HEMORR2HAGES [C-statistic of 0.56 (95% CI 0.52-0.61)] and ORBIT [C-statistic of 0.56 (95% CI 0.52-0.61)] risk scores had poor discriminative performances in dialysis patients. Furthermore, the calibration analyses showed that patients with a low risk of bleeding according to the HASBLED, ATRIA, HEMORR2HAGES and ORBIT bleeding risk scores had higher incidence rates for bleeding in our cohort than predicted. The HASBLED, ATRIA, HEMORR2HAGES and ORBIT bleeding risk scores had poor predictive abilities in dialysis patients. Therefore, these bleeding risk scores may not be useful in this population.

Mo1108 CAN THE ORBIT SCORE PREDICT DELAYED BLEEDING AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION IN PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY?

Oral anticoagulation therapy increases the risk of delayed bleeding after colorectal endoscopic dissection (ESD). The Outcomes Registry for Better Informed Treatment (ORBIT) score was recently proposed as a simple predictive model for major bleeding in patients with atrial fibrillation receiving warfarin or direct oral anticoagulants (DOACs). This study aimed to investigate the usefulness of the ORBIT score for predicting delayed bleeding after colorectal ESD in patients receiving oral anticoagulation therapy. This was a retrospective, single-center study. Colorectal ESD was performed on 581 consecutive patients with 635 lesions at our hospital between April 2005 and August 2017. Of these, we enrolled 23 patients receiving oral anticoagulation therapy. In patients with multiple lesions, the first treated or submucosal invasive lesion was considered the representative lesion. The ORBIT score was calculated from the total score of the following five factors: reduced hemoglobin/hematocrit and bleeding history (2 points each); and insufficient kidney function, antiplatelet treatment, and age >74 years (1 point each). In the original report, the high-risk group was defined as patients with a score of ≥4 points. Delayed bleeding was defined as bleeding requiring endoscopic intervention after ESD. Major delayed bleeding was defined as a hemoglobin loss of >2 g/dL or a transfusion requirement. The primary outcome was the incidence of delayed/major delayed bleeding associated with a high risk based on the ORBIT score. The secondary outcomes were predictive factors and diagnostic accuracy of the ORBIT score for delayed/major delayed bleeding. Of 23 patients, 9 were categorized as high-risk patients. The incidence of delayed bleeding and major delayed bleeding were 39.1% (warfarin, 3/8; DOAC, 6/15) and 17.4% (warfarin, 1/8; DOAC, 3/15), respectively. Delayed bleeding occurred more frequently in the high-risk group than in the non-high-risk group (66.7% vs. 21.4%, p=0.077). Major delayed bleeding was significantly more frequent in the high-risk group than in the non-high-risk group (44.4% vs. 0.0%, p=0.014). ORBIT score ≥4 was the only predictive factor for delayed bleeding in logistic regression analysis including age, sex, diabetes mellitus, hypertension, warfarin/DOAC, ORBIT score ≥4, location, macroscopic type, tumor diameter, procedure time, submucosal fibrosis, and histologic type (odds ratio, 7.33; 95% confidence interval, 1.11-48.26; p=0.038). The sensitivity and specificity of ORBIT score 4 for delayed/major delayed bleeding were 78.6%/73.7% and 66.7%/100.0%, respectively. All delayed bleeding cases were managed without surgery. ORBIT score might be useful for predicting delayed bleeding, especially major delayed bleeding, in colorectal ESD for patients receiving oral anticoagulation therapy.

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.