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Novel bleeding prediction model in atrial fibrillation patients on new oral anticoagulants
Heart ( IF 5.1 ) Pub Date : 2022-02-01 , DOI: 10.1136/heartjnl-2021-319702
Ofra Barnett-Griness 1 , Nili Stein 1 , Antonio Kotler 2 , Walid Saliba 1, 3 , Naomi Gronich 3, 4
Affiliation  

Objective Clinical models such as the HAS-BLED (standing for Hypertension, Abnormal liver/renal function, Stroke history, Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage) were developed to predict risk of major bleeding on vitamin K antagonists/antiplatelet therapy. We aimed to develop a model that will improve the ability to predict major bleeding events in patients with non-valvular atrial fibrillation (AF) treated with new oral anticoagulants (NOACs). Methods Clalit Health Services is the largest of four integrated healthcare organisations in Israel, which insures 4.7 million patients (53% of the population). We identified in Clalit Health Services all patients with AF, new users of an NOAC (2013–2017), and followed them until first occurrence of a major bleeding event, death, switch to another oral anticoagulant, 30 days after discontinuation of NOAC or end of follow-up (31 December 2019). Importance of the candidate model variables was estimated by inclusion frequencies across forward selection algorithm applied to 50 bootstrap samples. Then, backward selection algorithm using the modified Bayesian Information Criterion for competing risks was applied to select predictors for the final model. Results 47 623 patients with AF prescribed NOAC were studied. 28 055 patients with AF, initiators of apixaban (mean age 78.7, SD 9.0), were included in the first phase and had 662 major bleeding events. Nine variables were selected for inclusion in a final points-based risk-scoring system: male sex, anaemia, thrombocytopaenia (<99×103/µL), concurrent antiplatelet therapy, hypertension, prior major bleeding, risk factors for a fall, low cholesterol level and low estimated glomerular filtration rate, with apparent area-under-curve (AUC) of 0.6546. Applicability of the model was then shown for 14 118 and 5450 patients with AF, initiators of dabigatran and rivaroxaban, where the score achieved c indices of 0.62 and 0.61, respectively. Conclusions We present a novel and simple risk score for prediction of major bleeding in patients with non-valvular AF treated with NOACs. Validation in additional cohorts is warranted. Data are available upon reasonable request.

中文翻译:

新型口服抗凝剂房颤患者出血预测模型

目的 开发临床模型,如 HAS-BLED(代表高血压、肝/肾功能异常、中风史、出血史或易感性、不稳定的 INR、老年人、药物/酒精使用)来预测维生素 K 拮抗剂大出血的风险/抗血小板治疗。我们旨在开发一种模型,该模型将提高预测接受新型口服抗凝剂 (NOAC) 治疗的非瓣膜性心房颤动 (AF) 患者大出血事件的能力。方法 Clalit Health Services 是以色列四家综合医疗机构中最大的一家,为 470 万患者(占人口的 53%)提供保险。我们在 Clalit Health Services 中确定了所有 AF 患者、NOAC 的新使用者(2013-2017 年),并跟踪他们直到第一次发生大出血事件、死亡、改用另一种口服抗凝剂、停止 NOAC 或随访结束后 30 天(2019 年 12 月 31 日)。候选模型变量的重要性通过应用于 50 个引导样本的前向选择算法中的包含频率来估计。然后,使用针对竞争风险的修改后的贝叶斯信息准则的反向选择算法被应用于选择最终模型的预测变量。结果 研究了 47 623 名 AF 患者并使用 NOAC。28 055 名 AF 患者,阿哌沙班的发起者(平均年龄 78.7,SD 9.0)被纳入第一阶段,发生 662 次大出血事件。选择九个变量纳入基于最终分数的风险评分系统:男性、贫血、血小板减少症 (<99×103/µL)、同时进行抗血小板治疗、高血压、既往大出血、跌倒的危险因素、低胆固醇水平和低估计肾小球滤过率,表观曲线下面积 (AUC) 为 0.6546。然后,该模型适用于 14118 和 5450 名 AF 患者、达比加群和利伐沙班的起始者,其中得分分别达到 0.62 和 0.61 的 c 指数。结论 我们提出了一种新颖且简单的风险评分,用于预测用 NOAC 治疗的非瓣膜性 AF 患者的大出血。有必要在其他队列中进行验证。可根据合理要求提供数据。结论 我们提出了一种新颖且简单的风险评分,用于预测用 NOAC 治疗的非瓣膜性 AF 患者的大出血。有必要在其他队列中进行验证。可根据合理要求提供数据。结论 我们提出了一种新颖且简单的风险评分,用于预测用 NOAC 治疗的非瓣膜性 AF 患者的大出血。有必要在其他队列中进行验证。可根据合理要求提供数据。
更新日期:2022-01-28
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