Novel bleeding risk score for patients with atrial fibrillation on oral anticoagulants, including direct oral anticoagulants

Background Frequently used models, such as the HAS-BLED, ATRIA, ORBIT, and GARFIELD-AF evaluate the risk of bleeding when using an anticoagulant, for example warfarin, in patients with non-valvular atrial fibrillation. Limited studies are available reporting a model with a good discriminative ability to predict the bleeding risk score when using direct oral anticoagulants. Methods Patient data were collected from King Abdulaziz Medical City, King Fahad Cardiac Center, and Prince Sultan Cardiac Center in Riyadh, from outpatients, inpatients, or primary care clinics. In total, 1722 patients with a prescription for a new oral anticoagulant, Dabigatran, Rivaroxaban, or Apixaban, were enrolled. A resampling approach for variable selection was used and a five-fold cross-validation to assess the model fit and misclassification probabilities. The analysis used the receiver operating characteristics curve (ROC) and the concordance (c) statistic to assess the validation models’ discriminative power. The final penalized likelihood parameters were used for the development of the risk prediction tool. The accuracy of a classification and the prediction are reported with the sensitivity, specificity, and Brier score. Results Bleeding occurred in 11.15% of cases, of which 23.08% required a blood transfusion and 51.65% had a reduction in haemoglobin of more than 2 gm. The variable selection model identified 15 predictors associated with major bleeding. The discriminative ability of the model was good (c-statistic 0.75, p = 0.035). The Brier score of the model was 0.095. With a fixed cut-off probability value of 0.12 for the logistic regression equation, the sensitivity was 72.7%, and the specificity 66.3%. Conclusion This model demonstrated a good performance in predicting the bleeding risk in Arab patients treated with novel oral anticoagulants. This easy to use bleeding risk score will allow the clinician to quickly classify patients according to their risk category, supporting close monitoring and follow-up for high-risk patients, without laboratory and radiological monitoring.

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Abstract 15396: Atrial Fibrillation Bleeding Risk and Prediction While Treated With Direct Oral Anticoagulants in Warfarin Naïve and Experienced Patients

Circulation ◽

10.1161/circ.142.suppl_3.15396 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Alexander C Perino ◽

Krishna Pundi ◽

Jun Fan ◽

Susan K Schmitt ◽

Mitra Kothari ◽

...

Keyword(s):

Atrial Fibrillation ◽

Warfarin Therapy ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Risk Of Bleeding ◽

Warfarin Treatment ◽

Treatment Analysis ◽

Using Data ◽

Favorable Safety

Introduction: Direct oral anticoagulants (DOAC) are guideline-recommended over warfarin for stroke prevention in atrial fibrillation (AF). However, patients who are DOAC eligible are commonly maintained on warfarin. We sought to evaluate bleeding risk and prediction while on DOAC treatment (both for warfarin-naïve and -experienced patients) as compared to warfarin. Methods: We performed a retrospective cohort study using data from the Veteran Affairs health care system. We included patients with a prescription for warfarin and/or DOAC from 10/1/2010 to 9/30/2017 with an AF encounter in the 90 days prior to 30 days after prescription. We categorized DOAC treated patients as warfarin-naïve or -experienced and performed an on-treatment analysis to determine bleeding incidence and HAS-BLED score discrimination. In adjusted analyses, we compared risk of bleeding while treated with DOAC (both for warfarin-naïve and -experienced patients) to warfarin. Results: The analysis cohort included 99,143 patients treated with warfarin (71±10 years, HAS-BLED 2.6±1.2) and 73,732 and 26,760 patients treated with DOAC who were warfarin-naïve (74±10 years, HAS-BLED 2.4±1.0) and -experienced (71±9 years, HAS-BLED 2.8±1.1), respectively. DOAC patients with warfarin experience had more prior bleeds (DOAC, warfarin-experienced: 11.9%; DOAC, warfarin-naïve: 4.5%; warfarin: 6.2%; p<0.001 for both). Risk of intracranial bleeding was substantially lower while on DOAC treatment (both for warfarin-naïve and -experienced patients) as compared to warfarin ( Table ). HAS-BLED discrimination for bleeding outcomes, intracranial or any bleeding, was modest ( Table ). Conclusion: DOAC treatment had a favorable safety profile compared to warfarin treatment, even for DOAC treated patients with warfarin-experience who had more prior bleeds. These data argue against maintaining DOAC eligible patients on warfarin therapy regardless of HAS-BLED score.

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BLEEDING RISK OF DIRECT ORAL ANTICOAGULANTS COMPARED WITH WARFARIN IN PATIENTS WITH ATRIAL FIBRILLATION AND HEART FAILURE

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(17)34289-4 ◽

2017 ◽

Vol 69 (11) ◽

pp. 900 ◽

Cited By ~ 1

Author(s):

Lingyun Lu ◽

Alberta Warner ◽

Zunera Ghaznavi ◽

Donald Chang ◽

Nikolas Tubert ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk

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Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation

Heart ◽

10.1136/heartjnl-2020-317923 ◽

2020 ◽

pp. heartjnl-2020-317923 ◽

Cited By ~ 1

Author(s):

Olivier Hanon ◽

Jean-Sébastien Vidal ◽

George Pisica-Donose ◽

Galdric Orvoën ◽

Jean-Philippe David ◽

...

Keyword(s):

Atrial Fibrillation ◽

Propensity Score ◽

Vitamin K ◽

Lower Risk ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Matched Sample ◽

Intracerebral Bleeding

ObjectiveDirect oral anticoagulants have been evaluated in the general population, but proper evidence for their safe use in the geriatric population is still missing. We compared the bleeding risk of a direct oral anticoagulant (rivaroxaban) and vitamin K antagonists (VKAs) among French geriatric patients with non-valvular atrial fibrillation (AF) aged ≥80 years.MethodsWe performed a sequential observational prospective cohort study, using data from 33 geriatric centres. The sample comprised 908 patients newly initiated on VKAs between September 2011 and September 2014 and 995 patients newly initiated on rivaroxaban between September 2014 and September 2017. Patients were followed up for up to 12 months. One-year risks of major, intracerebral, gastrointestinal bleedings, ischaemic stroke and all-cause mortality were compared between rivaroxaban-treated and VKA-treated patients with propensity score matching and Cox models.ResultsMajor bleeding risk was significantly lower in rivaroxaban-treated patients (7.4/100 patient-years) compared with VKA-treated patients (14.6/100 patient-years) after multivariate adjustment (HR 0.66; 95% CI 0.43 to 0.99) and in the propensity score–matched sample (HR 0.53; 95% CI 0.33 to 0.85). Intracerebral bleeding occurred less frequently in rivaroxaban-treated patients (1.3/100 patient-years) than in VKA-treated patients (4.0/100 patient-years), adjusted HR 0.59 (95% CI 0.24 to 1.44) and in the propensity score–matched sample HR 0.26 (95% CI 0.09 to 0.80). Major lower bleeding risk was largely driven by lower risk of intracerebral bleeding.ConclusionsOur study findings indicate that bleeding risk, largely driven by lower risk of intracerebral bleeding, is lower with rivaroxaban than with VKA in stroke prevention in patients ≥80 years old with non-valvular AF.

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115Anticoagulation in atrial fibrillation – a single-centre audit on patient education, stroke and bleeding risk assessments and use of direct oral anticoagulants (DOACs)

EP Europace ◽

10.1093/europace/eux283.109 ◽

2017 ◽

Vol 19 (suppl_1) ◽

pp. i48-i48

Author(s):

SM Ng ◽

B Jose ◽

A Sethi

Keyword(s):

Atrial Fibrillation ◽

Patient Education ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Risk Assessments ◽

Single Centre

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P675Current status of anticoagulation in patients with breast cancer and atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehz747.0281 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Pardo Sanz ◽

L M Rincon ◽

P Guedes Ramallo ◽

L Belarte ◽

G De Lara ◽

...

Keyword(s):

Breast Cancer ◽

Atrial Fibrillation ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Bleeding Events ◽

Patients With Cancer ◽

Oncologic Patients

Abstract Aims Balance between embolic and bleeding risk is challenging in patients with cancer. There is a lack of specific recommendations for the use of antithrombotic therapy in oncologic patients with atrial fibrillation (AF). We compared the embolic and bleeding risk, the preventive management and the incidence of events between patients with and without cancer. We further evaluated the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) within patients with cancer. Methods The AMBER-AF registry is an observational multicentre study that analysed patients with non-valvular AF treated in Oncology and Cardiology Departments in Spain. 1237 female patients with AF were enrolled: 637 with breast cancer and 599 without cancer. Mean follow-up was 3.1 years. Results Both groups were similar in age, CHA2DS2-VASc and HASB-LED scores. Lack of guidelines recommended therapies was more frequent among patients with cancer. Compared with patients without cancer, adjusted rates of stroke (hazard ratio [95% confidence interval]) in cancer patients were higher (1.56 [1.04–2.35]), whereas bleeding rates remained similar (1.25 [0.95–1.64]). Within the group of patients with cancer, the use of DOACs vs VKAs did not entail differences in the adjusted rates of stroke (0.91 [0.42–1.99]) or severe bleedings (1.53 [0.93–2.53]). Follow-up events Conclusions Antithrombotic management of AF frequently differs in patients with breast cancer. While breast cancer is associated with a higher risk of incident stroke, bleeding events remained similar. Patients with cancer treated with DOACs experienced similar rates of stroke and bleeding as those with VKAs.

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