Prediction of the risk of bleeding during anticoagulant treatment for venous thromboembolism

Prediction of the risk of bleeding during anticoagulant treatment for venous thromboembolism
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DOI:
10.1001/archinte.159.5.457
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发表时间:
1999-03-08
影响因子:
--
通讯作者:
Büller, HR
Büller, HR
中科院分区:
其他
文献类型:
--
作者:
Kuijer, PMM;Hutten, BA;Büller, HR

文献摘要

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目的:在大量接受抗凝治疗的静脉血栓栓塞症患者中,构建和验证出血风险预测评分,该评分基于文献中确定的变量,这些变量在实施抗凝治疗之前很容易获得,以便定量评估治疗的风险和收益,并相应地适应患者的管理。方法:我们根据文献中确定的变量及其优势比,构建了出血风险预测评分,在抗凝治疗前即可获得(评分=[1.6 x年龄]+[1.3 x性别]+[2.2 x恶性])。随后,我们评估了241名接受静脉血栓栓塞症抗凝治疗的患者的评分,以确定预测出血并发症的最佳截断点,使用接收器操作特征曲线分析。然后,我们在780名患者的独立队列中验证了这一评分。3分或以上、1~3分或0分分别代表高、中、低出血风险。结果:试验组中约五分之一的患者被归类为预测出血并发症的高风险。在本组中,所有出血并发症的风险为26%,主要出血并发症的风险为14%。所有出血并发症和主要出血并发症的曲线下面积分别为0.75(95%可信区间,0.64~0.84)和0.82(95%可信区间,0.66~0.98)。当被验证时,评分的预测力有中等程度的丧失,但根据评分对患者进行分类仍然具有临床实用价值;20%的患者被归类为高危患者,所有出血并发症的出血率为17%,严重出血并发症的出血率为7%,而低风险患者的出血率分别为4%和1%。结论:通过在预测模型中使用3个容易获得的临床变量,可以在抗凝治疗开始时识别出一组患者,他们发生出血并发症的风险很高。进一步的研究应该解决预防出血的额外措施是否在不影响疗效的情况下降低出血发生率。
Objectives: To construct and validate the bleeding risk prediction score, which is based on variables identified in the literature that can be easily obtained before the institution of anticoagulant therapy, ina large independent cohort of patients who were treated with anticoagulant therapy for established venous thromboembolism to allow for quantitative assessment of the risks and benefits of the therapy and to adapt the patient's management accordingly.Methods: We constructed a bleeding risk prediction score, based on variables and their odds ratios identified in the literature, which can be easily obtained before the institution of anticoagulant therapy (score = [1.6 x age] + [1.3 x sex] + [2.2 X malignancy]). Subsequently, we evaluated the score in a test group of 241 patients treated with anticoagulant therapy for venous thromboembolism to determine the optimal cutoff points for the prediction of hemorrhagic complications, using receiver operating characteristic curve analysis. We then validated this score in an independent cohort of 780 patients. A score of 3 or more points, 1 to 3 points, or 0 points represented a high, intermediate, or low bleeding risk, respectively.Results: The score in about one fifth of the patients in the test group was classified as predicting high risk for bleeding complications. The risk of all bleeding complications was 26% in this group and the risk of major bleeding complications was 14%. The area under the curve was 0.75 (95% confidence interval, 0.64-0.84) and 0.82 (95% confidence interval, 0.66-0.98) for all bleeding complications and major bleeding complications, respectively. When validated, there was a moderate loss of predictive power of the score, but the categorization of the patients by the score remained clinically useful; 20% of the patients were classified as high risk, and the bleeding rate was 17% for all bleeding complications and 7% for major bleeding complications compared with 4% and 1%, respectively, in those categorized as low risk.Conclusions: With the use of 3 easily obtainable, clinical variables in a prediction model, it is possible to identify a subgroup of patients at the start of anticoagulant therapy who have a high risk of developing hemorrhagic complications. Further studies should address whether additional measures to prevent bleeding decrease the bleeding incidence without compromising efficacy.